February 2010, Vol 3, No 1

CONFERENCE NEWS

Healthcare Cost and Health Reform: Cost Containment Not LikelyBy Caroline Helwick

West Michigan Cancer Center(WMCC) has increased thequality of patient care while

updating its business model for today’seconomic times. In recognition of thisachievement, WMCC received a 2009Cancer Center Innovator Award. Theaward was presented by Foley & Lardnerat the third annual Cancer CenterBusiness Summit in Dallas, Texas.Journal of Multidisciplinary Cancer

Care recently spoke with Terry McKay,president and CEO, about how WMCCaccomplished these goals as well as itsplans for future improvements.

Cost-savingsWMCC was chosen, in part, because

of its aggressive stance on expense

©2010 Green Hill Healthcare Communications, LLC

BREAST CANCER

HypofractionatedWhole BreastIrradiation ShowsPromiseBy John Schieszer

Whereas some degree of health-care reform seems likely to beenacted, what is shaping up as

“reform” will likely be a failure in termsof “serious cost containment,” accordingto Paul B. Ginsburg, PhD, president ofthe Center for Studying Health SystemChange, Washington, DC, a think tankthat analyzes changes in financing andthe delivery of healthcare.Based on his broad experience in the

field of healthcare economics and poli-cy, Ginsburg delivered an invited lectureon cost and reform.Simply put, there is no single or simple

solution, Ginsburg said. “A single ap -proach to containing costs is unlikely to

be sufficiently successful,” he predicted.“We need to pursue many distinct butconsistent approaches to offset the riskthat some approaches will not succeed.”

Need to contain costsOn the national level, rising costs are

undermining the mechanisms that fi -nance healthcare and are a key factor inthe country’s “dire public fiscal outlook,”he noted. On the individual level, privateinsurance is increasingly unaffordable,and the affordability problem now affectsthe middle class, Ginsburg said.The cost of Medicare, Medicaid, and

tax expenditures for private health insur-ance are all growing faster than the gross

domestic product (GDP), and the resultis that other priorities are neglected, taxesare higher, and the deficit is growing.

Continued on page 6

Paul B. Ginsburg, PhD, lectures on health-care cost and reform at ASH.

Continued on page 12

CANCER CENTERPROFILE

West MichiganCancer Center: A Cancer Center Innovator

By Dawn Lagrosa

FEBRUARY 2010 www.JOMCC.com VOL 3, NO 1

InsideConference NewsManaged care pharmacistscan improve chemotherapyreimbursementBased on a presentation byShetal S. Desai, PharmD

page 8

Nursing challenges canaffect the efficiency ofthe chemotherapy infu-

sion suite. By following a staffingmodel that works best for yourinstitution, you can improve effi-ciency, save money, and increasesatisfaction among nurses andpatients, according to CathyMaxwell, RN, OCN, of Ad -vanced Medical Specialties,Miami, Florida.Maxwell is employed by a 15-

site private oncology practice,where she is director of clinicaloperations for three sites and is

responsible for staffing and run-ning their infusion suites.After trying a number of staffing

approaches over the past 28 years,she says she ultimately settled on a“triage nurse” model that worksbest for her large practice. She dis-cussed the pros and cons of variousstaffing models at the 2009Community Oncology Confer-ence in Scottsdale, Arizona.“Most infusion centers have

schedules that are set up to fail,”she observed. “Treatments areoverbooked, and scheduling of

PRACTICE MANAGEMENT

The Chemotherapy Infusion Suite:Staffing for EfficiencyBy Caroline Helwick

Continued on page 4

Complimentary CE CreditMultidisciplinary approach toa radiation-associatedangiosarcoma of the breast

page 10

The main campus in Kalamazoo offersmedical oncology, radiation oncology,a neurooncology clinic, a breast cancerclinic, and a thoracic clinic, along withlaboratory and support services.

Conference NewsFor MDS treatment, azaciti-dine confers economic valueover decitabineBased on a presentation byRisha Gidwani, DrPH

page 7

CHICAGO—A shortened, more intensive course ofradiation given to the whole breast, along with anextra dose of radiation given to the surgical bed ofthe tumor (concomitant boost), have been found toresult in excellent local control at a median follow-up of 2 years after completion of treatment with nosignificant side effects.Researchers said this shorter treatment, called

accelerated hypofractionated whole breast irradia-tion, is an especially attractive option, becausewomen can receive a full course of radiation therapyin half the time (3 weeks of daily treatments vs 5 to7 weeks). In addition, the cost of this treatment islower relative to the cost of standard whole breastradiation and also is less expensive than othernew approaches, such as partial breastirradiation (breast brachy -therapy).“The observations to

date suggest that a 3-week course of radiationtherapy with concomi-


Register Today for

Your Fre

e CE

www.coexm.com

Today, he got the cancer treatment he needed.Along with a healthy dose of peace of mind.

A cancer diagnosis gives a patient a lot to worry about. The truth is, it can also cause treatment concerns for physicians as well as reimbursement and coverage issues for practice administrators and insurers. Call us or visit our Web site to learn how we can partner with you to simplify it all. It’s the kind of support you need, while patients receive the treatment they need. For more information, visit www.LillyPatientOne.com or call 1-866-4PatOne (1-866-472-8663).

Lilly Oncology

Patient Assistance Insurance Expertise Claim Appeals

1-866-4PatOne

MQ43286 0807 PRINTED IN USA © 2009, Lilly USA, LLC. ALL RIGHTS RESERVED.

EDITOR-IN-CHIEFMark J. Krasna, MDSt. Joseph Cancer InstituteTowson, MDSurgical Oncology

PracticeManagementSteven L. D’Amato,RPh, BCOPMaine Center forCampus MedicineScarborough, MEOncology Pharmacy

John F. Aforismo,BSc Pharm, RPh, FASCPRJ Health SystemsInternationalWethersfield, CTOncology Pharmacy

Elizabeth Bilotti,RN, MSN, APNcJohn Theuer CancerCenterHackensack UniversityMedical CenterHackensack, NJOncology Nursing

Nicole A.Bradshaw, MS,CICMountain States TumorInstituteNampa, IDOncologyAdministration

Anna M.Butturini, MDChildren’s Hospital Los AngelesLos Angeles, CAMedical Oncology

Minsig Choi, MDG. V. Montgomery VA Medical CenterJackson, MSMedical Oncology

Scott E. Eggener,MDUniversity of ChicagoChicago, ILSurgical Oncology

Beth Faiman, RN,MSN, APRN,BC, AOCNCleveland Clinic TaussigCancer InstituteMayfield Heights, OHOncology Nursing

Mehra Golshan,MDDana-Farber CancerInstituteBoston, MASurgical Oncology

Patrick A.Grusenmeyer,ScD, FACHEChristiana Care HealthSystemNewark, DEOncologyAdministration

Marilyn L. Haas,PhD, CNS, ANP-BCMountain RadiationOncologyAsheville, NC Oncology Nursing

Dawn Holcombe,MBA, FACMPE,ACHEDGH ConsultingSouth Windsor, CTOncologyAdministration

Arun Kumar, MDVA Medical CenterHuntington, WVMedical Oncology

Shaji K. Kumar,MDMayo ClinicRochester, MNHematology-Oncology

Terry Macarol,RT(R)(M)(QM)Advocate Health CareOak Brook, ILRadiological Technology

Patrick Medina,PharmD, BCOPOklahoma UniversityCollege of PharmacyTulsa, OKOncology Pharmacy

Patricia Molinelli,RN, MSN,AOCNSSomerset Medical CenterSomerville, NJOncology Nursing

Judy A. Olson,RT(R), RDMSSt. Luke’s MountainStates Tumor InstituteBoise, IDOncologyAdministration

Nicholas Petrelli,MDHelen F. Graham Cancer CenterChristiana Care Health SystemNewark, DESurgical Oncology

Greg Pilat, MBAAdvocate Health CareOak Brook, ILOncologyAdministration

Ritu Salani, MDOhio State UniversityMedical CenterColumbus, OHMedical Oncology

Andrew Salner,MDHartford RadiationOncologists AssociationHartford, CTRadiation Oncology

Timothy G. Tyler,PharmD, FCSHPComprehensive CancerCenter Desert RegionalMedical CenterPalm Springs, CAOncology Pharmacy

Gary C. Yee,PharmD, FCCP,BCOPUniversity of NebraskaMedical CenterOmaha, NEOncology Pharmacy

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Editorial Board

www.jOmcc.com February 2010 I VOL 3, NO 1 1

Today, he got the cancer treatment he needed.Along with a healthy dose of peace of mind.

A cancer diagnosis gives a patient a lot to worry about. The truth is, it can also cause treatment concerns for physicians as well as reimbursement and coverage issues for practice administrators and insurers. Call us or visit our Web site to learn how we can partner with you to simplify it all. It’s the kind of support you need, while patients receive the treatment they need. For more information, visit www.LillyPatientOne.com or call 1-866-4PatOne (1-866-472-8663).

Lilly Oncology

Patient Assistance Insurance Expertise Claim Appeals

1-866-4PatOne

MQ43286 0807 PRINTED IN USA © 2009, Lilly USA, LLC. ALL RIGHTS RESERVED.

February 2010 VOL 3, NO 1

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CONTENTS

With this issue ofJournal of Multi -disciplinary Cancer

Care, we continue to improveour journal to better serve theneeds of the busy practitioner.You likely have noticed ournew, sleeker design, but if youlook closer, you will also seethat we have added a new fea-ture. We have established col-laboration with Veritas Institutefor Medical Education, Inc. toprovide a seamless way for youto receive continuing medicaleducation (CME) credit online.

Our multidisciplinary tumor board case study will now offercomplimentary CME credit. After reading the article, youcan apply for CME credits by completing a “posttest” andregistering to receive a statement of completion online.Veritas Institute for Medical Education provides a variety ofCE/CME activities designed to help physicians, nurses,pharmacists, and other healthcare professionals better treatand educate their patients. In 2007, Veritas Institutereceived 6-year Accreditation with Commendation fromthe Accreditation Council for Continuing MedicalEducation, one of an elite group of accredited providers to

receive this recognition. We look forward to working withVeritas Institute to provide high-quality educational pro-grams that will help enhance your professional development.Our first installment this year highlights how the

prospective discussion of one patient was used to weighthe benefits and risks and determine the team’s best rec-ommendation. As this case illustrates, “personalized med-icine” takes into account the complexity of each patient’smedical history. Disease-site specific prospective case con-ferences represent the best venue for determining the cor-rect multidisciplinary approach to a patient’s cancer care.Of course, clinical decision-making is not the only

aspect of healthcare that is complex. As Dr Paul Ginsburgtold his audience at the recent annual meeting of theAmerican Society of Hematology, healthcare cost con-tainment also is complex, with a single approach not like-ly to be the solution. In their ongoing work to remain in the business of pro-

viding high-quality cancer care, West Michigan CancerCenter, Advanced Medical Specialties, and USC NorrisCancer Hospital have each implemented business andstaffing solutions as part of their cost-saving efforts. Thisissue highlights these business models for those looking forpractice solutions. We hope you continue to benefit from reading the

Journal of Multidisciplinary Cancer Care. We look forwardto your feedback on our content and layout.

FEATURE ARTICLES7 Conference News: ASH

For MDS treatment, azacitidine confers greater economic value over decitabineMultiple myeloma treatment costs vary widely

8 Conference News: ASHPManaged care pharmacists can improve chemotherapy reimbursement

10 Continuing Education Multidisciplinary approach to a radiation-associated angiosarcoma of the breast

15 Practice ManagementStrategy and planning: the difference between being a player or a pawn

DEPARTMENTS

18 Oncology Drug CodesCervical cancer

21 Recent FDA Approval

Mark J. Krasna, MDST. JOSEPH CANCER

INSTITUTEEditor-in-Chief

Green Hill Healthcare Communications LLCGreen Hill Healthcare Communications, LLC HGYour Innovative Partners in Medical Media™

™

241 Forsgate Drive, Suite 205CMonroe Twp, NJ 08831

FROM THE EDITOR

2 February 2010 I VOL 3, NO 1 www.jOmcc.com

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Practice Management


infusion chairs is not in sync with whatactually happens. This leads to ineffi-ciency, uneven assignments, and dissatis-faction among nurses, physicians, andpatients.”The need to optimize staffing for the

infusion suite is based on the reality thatboth understaffing and overstaffing occurfrom time to time; that staff turnover isdisruptive and expensive; that not allnew nurses will have oncology experi-ence; and that chemotherapy is complex.An example of the increased com-

plexity of chemotherapy is the highernursing acuity for a patient receivingchemotherapy for colon cancer. “Ittakes a minimum of 11 nursing eventsand close monitoring to hang a FOLFOX [leucovorin/fluorouracil/oxali-platin] regimen, whereas a 5-FU/LCV[5-fluorouracil/leucovorin] intravenouspush given for this same patient a fewyears ago was just one event,” shepointed out.Factors related to patients, physicians,

and reimbursement can also be obstaclesto efficiency in the infusion center.Patients who arrive late can impact

the schedule, creating more waitingtime for other patients. “If you measurepatient satisfaction,” she said, “you findthat what patients dislike the most isthe waiting.”Because oncology scheduling is not

an exact science, delays should beanticipated; for instance, the scheduleshould take into account a patient withspecial needs or one who has difficultvenous access.Physicians impact efficiency when

they run late, or request same-day andoff-label chemotherapy. Delays in labo-ratory test results can throw the scheduleoff, as can a problem with insuranceauthorization and inconsistency in prac-tice patterns that require clarification.Physician “lag time” should be built

into the schedule. “If the patient’s visitis at 10 AM, and you know the physicianruns an average of 2 hours behind, youshould schedule the infusion chair timeto start at 12 PM,” she suggested.

Lower reimbursement for chemother-apy administration is also impacting thepotential for efficiency. Financial “cush-ions” have disappeared and practicescannot afford to waste supplies or payovertime. Safety products are costly,reimbursement amounts are in flux, anddocumentation must be precise. “Whenthere is a choice between similar proce-dures,” she said, “we may sometimes dowhat costs less and that may not be asefficient.”“We must run an efficient suite,”

Mawxell emphasized. Efficiency trans-lates into job satisfaction for the nurses,because they prefer a consistent flow ofpatient care. Patients are happier, aswell, because their waiting time is less.And physicians are happy, because theyare rarely required to stay “late.”Finally, reductions in overtime, staff

turnover, drug waste, and medicalerrors—all the result of efficiency—translates into cost-savings, which hasbecome more important today.

Triage nurse modelStaffing models vary, and some work

better at one infusion center thananother. “You should use the staffingmodel that is best suited for your situa-tion,” advised Maxwell, who believesthe triage nurse model may be the bestapproach for most centers.Under this model, the triage nurse

operates much like an air-traffic con-troller, knowing which patients will betreated and what their particular needswill be. The triage nurse also handles anumber of pretreatment tasks. Staffnurses are simply assigned the nextpatient by the triage nurse.“This model has been the best fit for

us,” she said. “We started this in 2002when we hired non-oncology nurses togive chemotherapy because of the nurs-ing shortage. The lack of oncologyknowledge worried me. I put an experi-enced oncology nurse in the triage posi-tion, and basically her knowledge fil-tered out to all our patients. It has beenvery successful.”

The triage nurse assesses charts theday before chemotherapy and deter-mines what tests are needed. Shechecks laboratory values and multiple-gated acquisition (MUGA) results andorders additional tests per standingorders. She verifies the physician’sorders and prior authorizations. She isan expert at the standing orders forantiemetics and growth factors andunderstands billing and coding.“The nurses consider the assignments

to be fair. They are not bombarded.They don’t get two or three patients atone time, which had been a problem,”she said. “Cancellations and add-onsdon’t affect the schedule—each nursegets the same number of assignments.”Even with this model, there can be

some difficulties, she acknowledged.The model requires cross-training, care-ful scheduling, and tracking of numbersof registered nurses needed. Bottlenecksstill occur in the triage area during peaktimes, requiring additional help to keepthe system moving.There are also prerequisites for the

triage nurse: she must be very detail-ori-ented, be able to concentrate on hertask, and have a quiet area to work.“This is a high-stress job,” she noted.

Other modelsFirst come/first serve. This model works

well for low-volume practices but cancreate problems in larger offices. It doesnot take into account nurse experienceand complexity of the chemo therapyregimen. It can result in uneven nursingassignments, overtime, and missedlunchtimes. Careful control of theschedule is required.“We used this model until our office

grew too large,” she said. “I found thatnurses were picking and choosingpatients out of the chart bin. The second

shift usually had to stay late to finish up.”Patient/nurse model. This is calculated

by the number of patients per day divid-ed by the number of nurses. It distrib-utes the workload among the staff in anattempt at fairness; however, it does notconsider nurse experience or complexi-ty of treatment, can result in overtimeand missed lunchtimes, and requirescareful control of the schedule.Acuity model. This model is probably

the best accepted and fair. It measuresnursing time rather than chair time andtakes into account different practicepatterns and special needs. Morepatients can be treated per nurse, facili-tating productivity. Satisfac t ion is highamong nurses and patients. However,the acuity model needs to be strictlymanaged, that is, someone must assignthe acuity points to the treatment.Schedulers do not always consider thenumber of nurses on hand, which canruin the schedule. Acuity is alteredwhen patients’ needs change. Overtimeis often needed and lunchtimes are fre-quently missed. In other words, the acu-ity model is not always modeled on a“real-time” visit.Schedule by nurse model. This model

takes acuity into consideration. Patientsare assigned to a specific nurse, whichfacilitates continuity of care, improvesthe productivity of the individual nurse,and reduces overtime. Nursing satisfac-tion is high; however, success depends oncareful control of the schedule andknowledge of the exact number of nursesto be needed. Further more, the scheduleeasily becomes inaccurate when there arecancellations and add-ons, and patientscome to depend on “their” nurse.

Other ways to improve efficiencyMaxwell suggested that each patient’s

The Chemotherapy Infusion Suite... Continued from cover

Tips for SchedulingChemotherapy Infusions• Develop and follow guidelines for scheduling• Consider time needed for intravenous access and premedication• Allow extra time for new patients• Schedule in 15-minute slots (ie, 2-hour treatment = 8 slots)• Stagger the infusion schedules (ie, recliner 1 at 8:15; recliner 2 at 8:30; …)

• Assign four to five recliners per nurse, and arrange them close together in pods

• Make necessary adjustments to schedule the day before treatment• Have enough chairs and enough time to handle patients

Cathy Maxwell (first row, far right) with some of her staff at Advanced Medical Specialties.

Continued on page 8

FACULTY

Neal P. Christiansen, MDAssistant Professor of MedicineMedical University of South CarolinaDivision of Hematology/OncologyCharleston, South Carolina

TARGET AUDIENCEThis activity is intended for hematologists, oncologists, oncology nurses, oncology/specialtypharmacists, and others who are involved with the care of patients with metastatic colorectalcancer (mCRC).

STATEMENT OF NEEDColorectal cancer (CRC) is the third most commonly diagnosed malignancy and the secondleading cause of cancer death in the United States. Approximately 149,000 new cases are diag-nosed each year. At the time of presentation, about 20% of patients with CRC will havemetastatic disease. Cure at this stage is rarely possible, although some patients whose metastasesare limited (especially if to the liver or lung) may be “cured” by surgical means. For most suf-ferers of mCRC, however, treatment is palliative, offering prolonged survival, improvement insymptoms, and enhanced quality of life.

EDUCATIONAL OBJECTIVESOn completion of this activity, participants should be able to:

• Evaluate and assess current findings in the management of mCRC• Identify current first-line therapies, both chemotherapeutic and biologic agents, and practices in mCRC

• Tailor a therapeutic regimen to meet the needs of the individual patient with mCRC• Employ select strategies to minimize exposure to ineffective therapies and their toxicities

INSTRUCTIONSTo receive a statement of credit, you must:

• Review the content of the activity• Successfully complete the post-test (70% or higher)• Complete the evaluation at the end of the activity

Your statement of credit will be issued immediately upon successful completion of the post-testand submission of the evaluation

ACCREDITATION STATEMENTThis activity has been planned and implemented in accordance with the Essential Areas andpolicies of the Accreditation Council for Continuing Medical Education (ACCME) throughthe joint sponsorship of the University of California, Irvine School of Medicine (UCI) andCenter of Excellence Media, LLC. The University of California, Irvine School of Medicine isaccredited by the ACCME to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENTThe University of California, Irvine School of Medicine designates this educational activity fora maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should only claim credit com-mensurate with the extent of their participation in the activity. This activity is complimentary.

Metastatic Colorectal Cancer:Sound Strategies for Selecting First-Line Therapies

FACULTY INFORMATION AND DISCLOSURESDr Christiansen has received consultancy fees

from sanofi-aventis and Genentech.Off-label use of cetuximab (in patients in whom

irinotecan has not failed) and bevacizumab (con-tinuing after first-line therapy) will be discussed inthis presentation.Conflict resolution: This presentation has been

peer reviewed for evidence base and fair balance.

GENERAL DISCLOSURE STATEMENTIt is the policy of the University of California, Irvine

School of Medicine and the University of CaliforniaCME Consortium to ensure balance, independence,objectivity, and scientific rigor in all CME activities. Fulldisclosure of conflict resolution will be made in writingvia handout materials or syllabus.

Bonnie Carroll, Director, CME, UC Irvine School ofMedicine, has no financial or other relationship to prod-ucts or devices with commercial interests related to thecontent of this CME/CE activity.

Center of Excellence Media, LLC: The planners andmanagers have nothing to disclose related to the contentof this activity.

Erica Johansson, RN, Astute CE, LLC, has nothing todisclose related to the content of this activity.

Dr. Randall F. Holcombe, University of California,Irvine School of Medicine, peer-reviewed the content forevidence base and fair balance. Dr Holcombe has no realor apparent conflicts of interest related to this activity.

Conflict resolution: This presentation has been peerreviewed for evidence base and fair balance.

This activity is in compliance with CaliforniaAssembly Bill 1195, which requires continuing medicaleducation components to include curriculum in the sub-jects of cultural and linguistic competency. For specificinformation regarding Bill 1195 and definitions of cultur-al and linguistic competency, please visit the CME website at http://www.cme.uci.edu.

This activity is supported by an educational grant fromGenentech BioOncology.

www.coexm.com/ace01.aspLOG ON TODAY TO PARTICIPATE

Release Date: November 25, 2009 Expiration Date: November 24, 2010

In collaboration with

ASTUTEad_Layout 1 2/2/10 11:00 AM Page 1

Conference News

ASH 2009

The following articles are based on presentations at the 51st Annual Meeting and Exposition of theAmerican Society of Hematology (ASH) held in New Orleans, Louisiana, December 5-9,2009.

An international comparison pro-vides evidence of undue healthcarecosts in the United States. Althoughhealthcare accounts for 16% of theGDP in this country, for a number ofother countries it is around 11%.“Adjusting for income, the United

States spends an extra $477 billion peryear on healthcare,” he noted.Evidence of rising costs comes from a

comparison of cost trends with incometrends. “There has been a 37% increasein earnings to support a 120% increasein premiums,” he said. “This gapexplains three fourths of the long-termdecline in the percent of the insuredpopulation.”

What’s driving up costs?The key drivers of rising costs are

higher incomes (more money is avail-able to spend on healthcare), develop-ments in medical technology, lesshealthy lifestyles, small gains in produc-tivity related to the delivery of healthservices, new patterns of competition inhealthcare, and, to a lesser degree thanmost assume, the aging of the popula-tion. Aging contributes just one half ofone percent or less to the spendingtrend each year, according to Ginsburg.Additional drivers include the poorly

functioning medical liability system andstate insurance mandates.At least one third of the trend in

spending stems from technological“advances.” New treatments are moreeffective—yielding better outcomeswith lower risks—but the tendency is tooveruse them to the point of limited ornegative gains, he pointed out.Marginally effective, ineffective, orharmful treatments also add to risingcosts, and little funding is available foreffectiveness research to weed these out.Unhealthy lifestyles create more

health problems. Obesity alone is esti-mated to account for 12% of the spend-ing growth in recent years. Declines insmoking have held down cost trends butstill contribute, he said.Although the prosperity of the econ-

omy largely derives from gains in pro-ductivity, this is true only for certainindustries, such as banking and airlines.“There is much less productivity inhealthcare,” he noted.One reason is the lack of the proper

incentives for healthcare providers. Fewincentives exist to produce episodes oftreatment or to help improve a patient’shealth more efficiently, he noted. Andefficiency of the care delivered varieswidely.

The term new patterns of competi-tion refers to the “more entrepreneurialdelivery system” of today, that is, theexpansion of profitable services thatmay not add true value. Medicare andprivate insurers have failed to set pay-ment rates to appropriately reflect relative cost of services; this has led hospitals to expand services that areprofitable, such as cardiac procedures,and to open special facilities, such as“heart hospitals.” It is possible, he con-tinued, that expansions of capacity areactually creating a demand for services.Tied to this is an increase in physician

self-referrals, such as more referrals formagnetic resonance imaging when aphysician owns an imaging center. “Withownership of facilities, the scope ofphysician self-referral is wider, and this isworrisome to me,” he told the audience.

Why are costs so hard to contain?Cost containment is complex and, for

various reasons, is viewed by many sec-tors as threatening. “All spending per-tains to someone’s income, and there isan increasingly effective lobby to pro-tect incomes,” Ginsburg observed.The country’s political leaders are

also “falling down on the job” by foster-ing the notion that costs can be con-tained without sacrifice, he added. “Theconcept of ‘cutting waste, fraud, and

abuse’ goes way back,” he said.“Politicians claim there will be largesavings through reducing waste. It’s aterrific idea, but it won’t solve the costproblem.”It is highly uncertain that such “pain-

less solutions” will contain costs, hemain tained. The other current proposalsinclude the promotion of quality report-ing and payment for quality, the ad-vancement and adoption of health infor-mation technology, and application ofcomparative effectiveness research.

The “red herrings” of healthcarereform and cost containmentThe motivator of health reform is the

expansion of insurance coverage; how-ever, coverage expansion will exacer-bate, not alleviate, the cost problem,according to Ginsburg.“Uninsured people spend less,” he

pointed out. “More comprehensiveinsurance leads to higher spending—bringing the uninsured up to insured sta-tus will increase healthcare spending.”The public plan option is also faulty,

he said. “Only the ‘robust’ version canimpact costs through lower providerpayment rates,” he noted. “The versionin the bill has little potential to reducecosts.” He said increased competition ininsurance markets has limited potential.Cost-savings through increased well-

ness and prevention is another fallacy, headded. “The evidence on the lack ofpotential for savings is very strong. Manyin Congress are unwilling to accept theevidence, but the Congress ional BudgetOffice analysis found that preventionwill not reduce federal outlays.”

Which approaches may work?A single approach will not be the sole

solution to cost containment, and mostof the strategies being discussed haveadvantages and disadvantages.Increased patient cost-sharing (bene-

fits “buy-downs,” consumer-directedhealth plans, and health savingsaccounts) is part of a demand-sideapproach to cost containment, and it isnot favored by political liberals. In fact,patient cost-sharing does a fairly poorjob of addressing spending trends,Ginsburg added, because most spending

is concentrated within a relatively smallpopulation of patients. “The burden ofhealthcare falls more on the sick andthe poor,” he observed.However, patient financial incentives

“clearly work,” he continued, but willnot accomplish much because health-care use is not particularly sensitive topatient incentives. Certainly, to beeffective, the “tools” for patient incen-tives need refinement, he said.One proposal is a “value-based bene-

fits design,” which will vary cost-sharingby service type and patient condition—with low barriers to the management ofchronic disease and higher barriers forelective services. This approach wouldpromote the choice of more efficientproviders, because consumers wouldreap savings when they choose less cost-ly providers and less efficient providerswould have incentives to improve.

Another “tool” is the excise tax on theso-called “Cadillac plans.”Also part of the demand-side ap -

proach is greater research on price andquality, which in theory is favored by allexcept providers, but in practice may beless useful because its impact will not befelt for years. The government’s rolewould be in data gathering rather thanprice setting, which would fall to insur-ers to customize and simplify.In addition, some believe that pro-

grams aimed at wellness and health pro-motion will help contain costs, but theeffect of prevention is unproven, hereiterated.

More accurate payment structureproposedAs a supply-side approach, the craft-

ing of a more accurate payment struc-ture is widely proposed, based on theunintended wide variation in profitabil-ity by service. Medicare is well posi-tioned to make structures more accurate(and private insurers and Medicaid pro-grams will follow), but Medicare needsto apply more political and financialresources to this, which is problematicbecause many hold a negative view ofMedicare governance, he added.The supply-side approach also in -

cludes broader payment units (BPUs) asa means of reducing the role of fee-for-service, which is faulted by havingincentives for service volume and lack-ing motivations or rewards for coordi-nated services. BPUs introduce ele-ments of capitation in the form ofaccountable care organizations. Thestrategy can incorporate episode-basedpayments, in which actual per-episodepayments can be made to a joint entityor by fee-for-service with incentives forall involved.But Ginsburg questioned whether

BPUs will be developed and implement-ed and whether the idea will succeed.“BPUs have opportunities for physi-cians—rewards for reducing spending onhospital care, pharmaceuticals, anddevices. They can save money by reduc-ing hospitalizations, choice of drugs, andso forth and not just by reducing thephysician’s own services. They can cap-ture rewards from this,” he said.Finally, he concluded, the search for a

solution is geared toward “pragmatismthat recognizes the need to build onpresent institutions.” Although debateonce focused on “competition versusregulation,” he pointed out that thecountry proved unwilling to embraceeither of these approaches. l

Healthcare Cost and Reform... Continued from cover


The motivator of health reform is the expansion ofinsurance coverage; however, coverage expansionwill exacerbate, not alleviate, the cost problem.

Conference News

In a cost-effectiveness analysis for thetreatment of myelodysplastic syn-drome (MDS), azacitidine was

shown to be cost-saving or cost-effec-tive, compared with decitabine. Theanalysis, funded by Celgene, was per-formed by Abt Bio-Pharma Solutions,Inc (Lexington, MA) and presented byRisha Gidwani, DrPH, lead healtheconomist for the research company.The National Comprehensive Can -

cer Network 2010 clinical practiceguidelines recommend azacitidine anddecitabine for the treatment of MDS,with azacitidine being the preferred cat-egory 1 treatment for inter-mediate-2 orhigh-risk patients ineligible for trans-plant.“While the clinical benefits of azaci -

t idine have been shown, this is the firststudy to evaluate its cost-effectivenessrelative to decitabine,” Gidwani said.Investigators developed a decision-

analytic Markov model with 1-monthcycles, which was run alternatively for12-month and 36-month periods.Patients in the model replicated thedemographics of subjects enrolled inphase 3 trials for the drugs, and based onthese data, the patients modeled in thedecitabine arm had lower MDS severitythan those in the azacitidine arm.During each cycle of the Markov

model, patients could either remain inor transition among four health states,including MDS and transfusion inde-pendence, MDS and transfusion depen -dence, progression to acute myeloid

leukemia (AML), or death.Therefore, in any given modelcycle a patient could be stableor become healthier, sicker, ordie. The analysis used modelparameters derived from pub-lished literature, product labels,clinical trial data, and drugpricing and medical servicescost databases.“Despite a higher-risk profile

in the underlying data for aza -citidine, treatment of MDSwith azacitidine was either cost-saving—meaning that it costless and conferred greater clinical bene-fit—or was cost-effective, compared withdecitabine,” Gidwani reported.“Azacitidine changed from dominat-

ing decitabine in the 12-month scenarioto being cost-effective in the 36-monthscenario due to the survival advantagefor azacitidine-treated patients. Patientstreated with azacitidine live longer, andtherefore have more opportunity to incurtreatment costs,” she explained.In both the 12-month and 36-month

scenarios, azacitidine-treated patientsexperienced a greater number of life-years and quality-adjusted life-years

(QALYs), attained a greater number oftransfusion-independent months, andwere more likely to avoid progression toAML (Table).In the 12-month scenario, the use of

azacitidine resulted in $9242 saved perpatient. In the 36-month scenario, aza ci -tidine treatment cost $11,534 more thantreatment with decitabine, but conferred aclinical benefit of 0.2707 additionalQALYs gained. The incremental cost-effectiveness ratio of $42,615 per QALY isconsidered cost-effective, she noted.l

—CH

For MDS Treatment, Azacitidine Confers GreaterEconomic Value Over Decitabine

Table. Comparisons for Azacitidine and Decitabine

Parameter Azacitidine DecitabineTotal cost per patient at 12 months $53,518 $62,760Total cost per patient at 36 months $154,112 $142,578QALYs gained at 12 months 0.579 0.526QALYs gained at 36 months 1.446 1.175QALYs indicates quality-adjusted life-years.

Acost analysis that comparedtreatments for multiple myelo-ma found that bortezomib,

which is an injectable drug, was associ-ated with less out-of-pocket expensethan the oral medications lenalidomideand thalidomide, according to a studypresented.Bortezomib is a proteasome inhibitor,

and lenalidomide and thalidomide areimmunomodulatory drugs. These agentsare sometimes combined in regimens.“Multiple myeloma is a complex dis-

ease. Improved outcomes have beenachieved with these novel agents; how-ever, few studies have reported the eco-nomic burden on patients,” said BrettW. Pinsky, MPH, a senior researcher ati3 Innovus, Eden Prairie, Minnesota.The study was sponsored by Millen -nium: The Takeda Oncology Company.The investigators drew from a claims

database of a large national commercialhealth plan with 14 million members.Treatment episodes (defined as eachcourse of therapy) were identified fromclaims records for each patient. Patientout-of-pocket costs and patient visit

data were examined for 1 year from thebeginning of each treatment episode.Descriptive analyses were supple-

mented with multivariate regressionanalyses to control for patient charac-teristics, comorbidities, and line oftreatment. A total of 2642 treatment

episodes were identified for the 1900patients. The majority of episodes wereclassified as “other chemotherapy orradiation therapy” (66.6%), followed by thalidomide (20.8%), bortezomib(9.2%), and lenalidomide (3.4%).Ambulatory visits accounted for

much of the patient visit burden. Asexpected, patients treated with bor -tezomib for injection had more visitsthan those treated with oral lenalido-mide, but the difference was not signifi-cant after adjustment for patient char-acteristics, line of treatment, and

comorbidities by multivariate analysis.Patients were also burdened with a sig-nificant number of outpatient hospitalvisits, which occurred most frequentlywith thalidomide.Pinsky said that patients must visit

doctors more often to receive bor tez -

omib injections; therefore, it is assumedthis is a more expensive treatment. Thedata did not support that assumption,he pointed out.

Patient out-of-pocket costs“Direct out-of-pocket costs were sig-

nificantly higher for patients treatedwith the oral drugs thalidomide andlenalidomide compared with bortez -omib for injection,” Pinsky reported.The total adjusted patient out-of-

pocket costs for the year after treatmentinitiation were $3504 for bortezomib,

$4443 for thalidomide, and $4766 forlenalidomide. The differences weregreatest for Medicare patients, with theadjusted costs being $4395, $8824, and$12,568, respectively. This means treat-ment with bortezomib amounted to lessthan half the cost of oral drug therapy,he said.“The out-of-pocket cost discrepancy

was magnified in the Medicare popula-tion likely due to the coverage gap,commonly known as the ‘doughnuthole,’ in Medicare Part D,” addedHenry Henk, PhD, also of i3 Innovus.“For the Medicare Advantage group,

there is the doughnut-hole effect that iscausing a huge spike in the cost of theoral drugs,” he pointed out.The investigators concluded that

because patients with myeloma requirea great deal of care and resources, mostpatients will not see a major differencein the number of healthcare visitsregardless of type of treatment, but theymay feel the pinch of higher out-of-pocket costs with the oral drugs. l

—CH

Multiple Myeloma Treatment Costs Vary Widely

Risha Gidwani, DrPH

“For the Medicare Advantage group, there is thedoughnut-hole effect that is causing a huge spike in the cost of the oral drugs.”


ASHP Midyear Clinical Meeting

The following article is based on a presentation at the 44th American Society of Health-SystemPharmacists (ASHP) Midyear Clinical Meeting held in Las Vegas, Nevada, December 6-10, 2009.

Conference News


Managed care phar-macists, throughimplementation of

a clinical authorizationprocess, can play a pivotalrole in securing payer reim-bursement of chemotherapyagents at a cancer hospital,according to re cent data.What’s more, by develop-

ing a clinically staffed chemo - therapy authorization department, managed care pharmacists can alsohelp increase the procurement of re -placement chemo therapy drugs.Those conclusions were reported by

Shetal S. Desai, PharmD, who washired 2 years ago as the director of theClinical Authorization Center at theUniversity of Southern California (USC)Norris Cancer Hospital in Los Angeles.“My study is actually my job,” said

Desai, who has worked extensively inmanaged care. Her job required that sheexamine the issues surrounding finan-cial reimbursement of chemotherapydrugs. Afterward, she was responsiblefor implementing procedures that wereintended to decrease disputed claimsand improve drug replacement throughenrollment in pharmaceutical manufac-turer–driven programs.The USC Norris Cancer Hospital is a

private, 60-bed research and teachinghospital with an onsite outpatientchemotherapy infusion center that serv-ices between 20 and 45 patients daily.The payer mix includes commercialinsurers and Medicare.

When Desai was broughtonboard, the facility was hav-ing problems with payerreimbursement of chemo -therapy agents. “In fact,monthly total disputedclaims dollars averaged be -tween $600,000 and $1 mil-lion,” she said.The hospital administra-

tion was unclear about thereasons for unpaid or disput-

ed claims, she added.Desai, who is also an assistant professor

at the USC School of Pharmacy, found:• The main reasons for disputed orunpaid claims were a lack of author-ization before treatment was admin-istered and the use of an agent forunapproved indications

• Bevacizumab was the most common-ly used chemotherapy agent and theone most frequently disputed; themain reason why the claims weredisputed was that payment wasbeing requested for off-label use ofbevacizumab (eg, treating metastat-ic breast cancer before it had beenapproved for that indication)

• Roughly 40% of all visits for chemo -therapy administration were notscheduled in advance

• Physician chemotherapy orders werenot routinely sent to the authoriza-tion department prior to a scheduledappointment

• Third-party payers requested from 3to 5 days to respond to an authoriza-tion request

• Authorizations were requested bynonclinical hospital personnel, whodid not have the clinical knowledgeto be able to respond to clinical ques-tions prospective payers needed an -swered before authorizing payment

• It was difficult to request payment frompayers when authorizations for chemo -therapy were not accurately obtainedor appropriately documented

• Clinical criteria for authorizationvaried by payer and coverage plan.After reporting her results to the hos-

pital administration, Desai recommend-ed that a new clinically staffed chemo -therapy authorization department bedeveloped. “A staff that is clinical iscrucial, because they can actually speakthe language of the insurance compa-nies and they can obtain the properauthorization before treatment,” shesaid. “In addition, they can supply theinsurance companies with any peer-reviewed journal articles that mightprovide enough evidence for treatmentin unapproved indications.”Ideally, a managed care pharmacist

should serve as the director of theauthorization department, and nurseswith a case-management backgroundshould be hired as clinical authorizationspecialists, Desai observed.Medical staff, she said, should submit

orders 3 to 5 days before treatment to allowsufficient time to obtain authorization.The authorization department should

also determine whether patients beingconsidered for off-label treatments areeligible for pharmaceutical manufactur-

er–sponsored patient-assistance pro-grams. If an insurance company deniesreimbursement because a drug is to beused off-label, the authorization depart-ment will contact the company thatmanufactures the drug to determinewhether the patient is eligible for drugreplacement through the pharmaceuti-cal manufacturer–sponsored patient-assistance programs, she added.One year after the implementation of

a clinical-based authorization center,more than $1.1 million in total drugreplacement has been recovered, Desaireported.Also, claims were processed more

rapidly and in some cases on the sameday the request was made. There wasalso a reduction in the number of claimsdenied due to lack of authorization.An additional benefit of the new

clinically staffed authorization depart-ment is improved communicationbetween the authorization departmentand medical and nursing staff.Desai was unable to determine the

extent of improvement in reimburse-ment to the hospital for chemotherapywith the new authorization process,because her hospital changed ownershipearlier this year and retrospective datathus became unavailable.“If hospitals want to improve their

reimbursement, they need to have amanaged care pharmacist in charge ofthis area,” Desai said. “Otherwise you’llhave someone who will not know howto get around some of the obstacles theinsurance companies put up.” l

Managed Care Pharmacists Can ImproveChemotherapy ReimbursementBy Jill Stein

Shetal S. Desai, PharmD

The Chemotherapy Infusion Suite... Continued from page 4

office visit and pretreatment assessmentoccur the day before the treatment visit.Under this approach, the patient willhave been assessed for toxicities and theneed for dose reductions prior to enter-ing the infusion suite. Patients like thisapproach, as it shortens their waitingtime. It also avoids the nurse’s wait forthe patient to complete the office visit.Scheduling of chair time and staffing ismore accurate when these visits are sep-arate, and more patients can be treatedin a given day. There is tighter invento-ry control and less drug waste.

Efficiency is also increased when non-infusion needs are managed in a separatearea staffed by one or two nurses and oneor two medical assistants, depending onthe number of patients. Procedures han-dled in this area will include injections,pump disconnects, complete bloodcounts, monitoring, nursing assessment,and port flushes. “This allows infusionnurses to concentrate on giving chemo -therapy, making assessments, educatingpatients, and performing nursing inter-ventions,” she noted.Maxwell also recommends having a

per diem pool of registered nurses whocan be brought onboard as needed, with-out restrictions, such as mandatory num-ber of working hours. Float nurses can beused to enhance patient flow by coveringfor nurses who are at lunch or out sick.Start times should be staggered and

extra staff hired for peak times. If oncol-ogy nurses are not available, non-oncol-ogy nurses can be used in the infusionarea for non-chemotherapy infusions.Nurses should rotate to satellite sites asneeded, which allows flexibility withstaffing based on the patient census.

They should also be rewarded for men-toring new nurses and sharing knowl-edge with each other.Finally, because nursing salaries are a

large part of the budget, making efficientuse of nurses translates into cost-savings.When possible, ancillary staff should per-form tasks for which a registered nurse isnot necessary. These might include tasksrelated to authorizations, telephoning,drug assistance, coding, scheduling,injections, vital signs, escorting patients,laboratory work, and stocking and order-ing of supplies. l

PRACTICE MANAGEMENT

Current activities at www.COEXM.com include:

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Multidisciplinary Approach to a Radiation-associated Angiosarcoma of the BreastBy Emily J. Penman, MD; Jon F. Strasser, MD; David D. Biggs, MDHelen F. Graham Cancer Center, Christiana Care Health System, Newark, Delaware

PROGRAM MCC1 • RELEASE DATE: FEBRUARY 15, 2010 • EXPIRATION DATE: FEBRUARY 15, 2011

ESTIMATED TIME TO COMPLETE: 1.0 HOUR

CONTINUING MEDICAL EDUCATION ACCREDITATION AND DESIGNATION OF CREDIT STATEMENTVeritas Institute for Medical Education, Inc. is accredited by the AccreditationCouncil for Continuing Medical Education to provide continuing medical educationfor physicians.Veritas Institute for Medical Education, Inc. designates this educational activity fora maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should only claimcredit commensurate with the extent of their participation in the activity.

METHOD OF PARTICIPATION1. Read the article in its entirety2. Log on to www.jomcc.com3. Click on “CME Credits”4. Click on “Click here to complete the posttest and obtain a CME certificate online”5. Register to participate6. Enter program number MCC17. Complete and submit the CME posttest and CME Activity Evaluation and Request for

Credit Form online8. Print your Certificate of Credit

This activity is provided free of charge to participants.

FINANCIAL DISCLOSURESVeritas Institute for Medical Education, Inc. is required to dis-close to the activity audience the relevant financial relation-ships of the planners and faculty involved in the develop-ment of CME/CE content. An individual has a relevant

financial relationship if he or she has a financial relationship in any amount occurringin the last 12 months with a commercial interest whose products or services are dis-cussed in the CME/CE activity content over which the individual has control. In addition,all faculty are expected to openly disclose any unlabeled/unapproved/investigationaluses of drugs or devices discussed in this activity. Disclosures are as follows:

• Emily J. Penman, MD, has nothing to disclose.• Jon F. Strasser, MD, has nothing to disclose.• David D. Biggs, MD, has nothing to disclose.

The staffs of Veritas Institute for Medical Education, Inc. and Green Hill HealthcareCommunications, LLC have nothing to disclose.

DISCLAIMERThe opinions expressed in this activity are those of the presenters and do not necessar-ily reflect the opinions or recommendation of Veritas Institute for Medical Education, Inc.Copyright © 2010 Veritas Institute for Medical Education, Inc. All rights reserved.

EDITORIAL BOARDEmily J. Penman, MDMedical DirectorBreast Center at the Helen F.Graham Cancer Center

Associate Vice ChairDepartment of SurgeryChristiana Care HealthSystem4701 Ogletown-StantonRoadNewark, DE 19713

Jon F. Strasser, MD Assistant Professor ofRadiation OncologyThomas Jefferson University111 South 11th StreetPhiladelphia, PA 19107

Attending Physician inRadiation OncologyHelen F. Graham Cancer CenterChristiana Care Health System4701 Ogletown-Stanton RoadNewark, DE 19713

David D. Biggs, MDAssistant Professor ofMedicineThomas Jefferson University1025 Walnut StreetPhiladelphia, PA 19107

Chief of Oncology SectionHelen F. Graham Cancer CenterChristiana Care Health System4701 Ogletown-Stanton RoadNewark, DE 19713

PLANNING COMMITTEEGloria MuiMedical DirectorVeritas Institute for MedicalEducation, Inc.611 Route 46 West Hasbrouck Heights, NJ07604

Julie Ann TagliareniCME DirectorVeritas Institute for MedicalEducation, Inc.611 Route 46 West Hasbrouck Heights, NJ07604

Anne L. FingerPresidentVeritas Institute for MedicalEducation, Inc.611 Route 46 West Hasbrouck Heights, NJ07604

Dawn LagrosaManaging EditorGreen Hill HealthcareCommunications, LLC241 Forsgate DrvieMonroe Twp, NJ 08831

Karen RosenbergEditorial DirectorGreen Hill HealthcareCommunications, LLC241 Forsgate DrvieMonroe Twp, NJ 08831

Chief complaint: Pain in the right breastnipple and a skin lesion.

History of present illness: A 58-year-oldwhite woman presented with acute changesin her right breast, including pain, eversionof a previously inverted nipple, and a “bloodblister” on the nipple that she thought wastraumatic. Eight years ago, she was treated fora right-breast, stage IIB, grade 3 invasive duc-tal carcinoma that was 3.8 cm with 1/18nodes positive for metastatic disease; sheunderwent a lumpectomy, axillary node dis-section, doxorubicin/cyclophosphamide/pac li-taxel chemotherapy, and standard breastradiation.

Other medical history: None.

Other surgical history: Cholecystectomy.

Family history: Leukemia, lung, and brain

cancers. No family history of breast cancer.

Social history: Unemployed, smoked in thepast, no alcohol use, divorced with threechildren.

Medications: None.

Allergies: None.

Physical examination:General: Obese, in no acute distress.Head, eyes, ears, nose, and throat: Nopallor, no icterus.Neck:No lymphadenopathy, no thyroid mass.Respiratory: Clear to auscultation.Cardiovascular: Regular rate and rhythm,no murmurs.Breasts: Right nipple enlarged with a deepbluish purple hue and nonspecific subareo-lar fullness, periareolar skin thickened andedematous. Left breast had no masses or

skin changes. No axillary adenopathynoted.Abdomen: Soft, nontender, no hepato -splenomegaly, normal bowel sounds.Extremities: Full range of motion.

Imaging studies:Mammography/breast ultrasound: Skinthickening and ill-defined hypoechoicretroareolar 3.7-cm mass.Computed tomography: Chest, abdomen,and pelvis negative for metastatic disease.Pathology: Ultrasound-guided core biopsyrevealed an angiosarcoma.Laboratory values: White blood cell count:6.9 x 103/µL; hemoglobin/hematocrit: 13.1g/dL/40%; platelets: 314 x 103/µL; segment-ed neutrophils: 51%; lymphocytes: 30%;eosinophils%: 1; monocytes: 7%; alkalinephosphatase: 82 U/L; aspartate aminotrans-ferase: 54(H) U/L; alanine aminotransferaseU/L: 26; bilirubin: 0.4 mg/dL.

STATEMENT OF NEEDThis program will enhance comprehension of the thought processes involved in applyingpersonalized medicine by elucidating one team’s prospective discussion in their treat-ment decisions for a woman with an angiosarcoma of the breast.

TARGET AUDIENCEMedical, surgical, and radiation oncologists, and other interested healthcare profession-als, especially those caring for cancer patients.

LEARNING OBJECTIVESAfter completing this activity, the reader should be better able to:• Identify risk factors and characteristics for radiation-associated angiosarcoma ofthe breast

• Discuss appropriate diagnostic testing and preoperative evaluation techniques

• Review the benefits and limitations of postsurgical radiation and/or chemotherapy

The Breast Cancer Multidisciplinary Clinic at the Helen F. Graham Cancer Center offers its patients the latest and most comprehensive breast care, diag-nosis, and treatment. The following case illuminates the thought processes behind the treatment decisions for a woman with an angiosarcoma of the breast.Commentaries by the surgical, radiation, and medical oncologists discuss the evidence and show how the multidisciplinary approach benefited the patient.

Case Presentation

CONTINUING EDUCATION


Surgical oncologist’s commentary A 58-year-old white woman presented

to the Helen F. GrahamBreast Cancer Multi dis -ciplinary Clinic. Her chiefcomplaints were pain, ever-sion of a previously invertednipple, and a “blood blister”on the nipple of her rightbreast. Although she be -lieved the papule was fromtrauma, her history suggestedit should be investigated.Eight years previously, thepatient had a right-breast, stage IIB, grade3 invasive ductal carcinoma that was 3.8cm with 1/18 nodes positive for metastatic disease. At that time, she had alumpectomy, axillary node dissection,doxorubicin/cyclophosphamide/paclitax-el chemotherapy, and standard breastradiation.

We investigated the current symptomswith a mammogram and breast ultra-sound, which revealed skin thickeningand an ill-defined hypoechoic retroareo-lar 3.7-cm mass. Ultrasound-guided corebiopsy revealed an angiosarcoma. Shethen underwent computed tomography(CT) of the chest, abdomen, and pelvis,which indicated that she was negativefor metastatic disease.Angiosarcoma of the breast is a very

rare clinical entity. The estimated inci-dence of postradiation soft-tissue sarco-mas of the breast ranges from 0.01% to0.02% per year.1 Very few series havebeen published because of its rarity. In aretrospective analysis of patients treat-ed at The University of Texas M. D.Anderson Cancer Center between 1990to 2003, Vorburger and colleagues iden-tified only 55 patients treated forangiosarcoma of the breast, of whomonly 23 had radiation-associated dis-ease.1 Working with the Rare CancerNetwork, Bosquet and associates per-formed a retrospective multicenteranalysis of 103 patients treated from1976 to 2002.2 They reported only 42radiation-associated angiosarcomas ofthe breast. Posttreatment lymphedemahas been thought to be associated withthe development of postradiation sarco-ma, possibly by affecting local growthfactors.3 There are reports of an in -creased incidence of postradiationangiosarcoma in BRCA1- and BRCA2-positive patients.4Radiation-associated angiosarcoma pa -

tients are older (>60 years), and theytend to have a higher grade sarcoma than

radiation-naïve angiosarcoma pa tients.1The median interval is 7 to 8 years from

completion of their radiationtherapy to diagnosis of theirangiosarcoma.1A patient with angiosar-

coma can present with red-dish purple papules on theskin. The patient may alsohave a breast lesion, whichmay or may not be palpable.Diagnostic imaging is non-specific, with skin thicken-ing and occasionally spicu-

lated masses seen on mammographyand nonspecific hypo- or hyperechoicmasses detected on ultrasound. Breastmagnetic resonance imaging can indi-cate malignancy, with rapid enhance-ment of the angiosarcoma.5Diagnosis should be established by an

image-guided core biopsy, not an exci-

sional biopsy. Fine-needle aspirationshould be avoided, because it is oftennot diagnostic.5 Immunohistochemistrymay be necessary to establish the diag-nosis in higher grade tumors. Stains forvimentin, CD31, CD34, and factor VIIIsupport the diagnosis of angiosarcoma.Poor prognostic indicators are size

greater than 5 cm, positive surgical mar-gins, a high pathologic grade, premeno -pausal age at diagnosis, and metastaticdisease at diagnosis.2 Angiosarcomashave particularly infiltrative margins.Preoperative evaluation should in -

clude CT scans to detect metastatic dis-ease, which usually occurs in the lung andbone. A higher percentage of patientswith radiation-associated angio sarcomapresent with distant metastatic diseasethan of those who are radiation-naïve(38% vs 13%, respectively).1Treatment of breast angiosarcoma is

surgical. Because these tumors presentin an irradiated breast, a mastectomy is

the procedure of choice.2 Axillary nodesneed not be sampled, because angiosar-comas do not spread to lymph nodes.2Immediate reconstruction is somewhatcontroversial at this time because of thereported high local recurrence rate.In the retrospective analysis by

Vorburger and associates,1 the 2- and 5-year overall survival rates were 64% and 38%, respectively. Survival ratesimproved if patients presented withlocalized disease. Within 3.6 years ofdiagnosis, 28% experienced recur-rences. This was seen in the higher riskgroups—especially if the angiosarcomawas >5 cm at diagnosis. Positive surgicalmargins also were associated with veryhigh risk for local recurrence. Luini andcolleagues,3 in a retrospective review of16 patients treated from January 1996to January 2006, found that the mediantime to first recurrence was 5 months,and locoregional recurrence developedin 25% of their patients.We recommended this patient under-

go a mastectomy. The patient acceptedthe treatment. After removal of themass, pathologic examination revealeda 4.5-cm high-grade angiosarcoma. Allmargins were pathologically negative.

Radiation oncologist’s commentary This patient had a stage IIB breast

cancer diag-nosed in 2001that was treat-ed with breast-c o n s e r v i n gtherapy, adju-vant systemicchemotherapy,and adjuvantbreast radia-tion therapy.She re ceived a

total dose of 60 Gy to the right breastdelivered in two courses. The firstcourse of radiotherapy was targeted tothe whole breast and delivered a totaldose of 45 Gy in 25 fractions of 1.8Gy/day using standard tangential-basedtreatment techniques. Given her breastsize and chest wall separation, this treat-ment was delivered with a combinationof 6 MV and 23 MV photons toimprove dose homogeneity. She thenreceived a boost to the lumpectomy siteof an additional 15 Gy in 8 fractions of1.88 Gy/day using a 12-MeV en faceelectron beam prescribed to the 90%isodose line.Although angiosarcomas have been

seen after breast radiotherapy, they arerare events, often developing in pa -tients who have Stewart-Treves syn-drome after comprehensive chest wallradiation.6 However, radiation therapyis a risk factor in the development ofsoft-tissue sarcomas, which are seen as a

late event in many other disease siteswhere radiation therapy is used with acurative intent (ie, radiation therapy forHodgkin’s disease). Mery and associatesevaluated the Surveillance, Epi de -miology and End Results (SEER) data-base for second sarcomas after breastcancer radiotherapy and noted thatpatients who had radiation had a high-er incidence of soft-tissue sarcoma ver-sus those who had no breast radiothera-py (31 vs 22 per 100,000 person-years;hazard ratio [HR], 1.5), with angiosar-comas having an HR of 7.7.7 Also basedon analysis of the SEER database,Huang and Mackillop found that thisrisk peaked at 10 years, but extended 23years after radiation.8 In general, overallsurvival was poor for soft-tissue sarco-mas after radiation (32% at 5 years).DeSmet and colleagues reported similarpoor overall survival (27% at 5 years) insarcomas that developed within a previ-ously radiated bed.9 Cahan and col-leagues found that a few angiosarcomasoccur with doses less than 30 Gy, andthat virtually all who get this diseasehave had doses over 40 Gy.10In this patient, given her prior history

of whole breast radiotherapy, there is,unfortunately, a limited role for addi-tional radiotherapy after mastectomy.Although some have advocated usinghyperfractionated radiotherapy after sur-gery to combat the high growth rate ofthis tumor type, the data are retrospec-tive and the risks of long-term complica-tions or recurrence are high.11 Somehave advocated hyperthermia in combi-nation with radiotherapy, but again thedata are limited. In this case, given thepatient’s relatively recent radiotherapyin 2001 along with a complete surgicalresection, we believed the risks of re-irradiation outweighed the limited ben-efit that radiation would provide.

Medical oncologist’s commentary Improvements in early detection and

adjuvant therapy have re sulted in in -creasing numbers of long-term survivorsfrom breast cancer. As breast conserva-tion is the ac knowledged standard of

care for mostbreast cancerpa tients andthe indicationsfor postmastec-tomy radiationtherapy havebecome broad-er, more long-term survivorshave receivedradiation ther-

apy. Ionizing radiation is a well-recog-nized risk factor for sarcomas in generaland angiosarcomas in particular. Theabsolute incidence of angiosarcomapostradiation is difficult to assess,

Emily J. Penman, MD

Jon F. Strasser, MD

David D. Biggs, MD

www.JOMCC.com


Diagnostic imaging is nonspecific, with skin thickening and occasionally spiculated masses seen on mammography and nonspecific hypo- or hyperechoic masses detected on ultrasound.

Given the patient’s relatively recent radiotherapy in2001 along with a complete surgical resection, webelieved the risks of re-irradiation outweighed thelimited benefit that radiation would provide.


because it is an uncommon event. In areview of the SEER database, the cumu-lative 15-year risk of angiosarcoma inbreast cancer patients was 0.9 per 1000for patients who received radiation and0.1 per 1000 for those who did not.12Angiosarcomas have a latency of 5 to

7 years after treatment.13 They tend toinvolve a larger field than initiallyapparent clinically. Urgent mastectomyis the treatment of choice if the breast isintact. Large chest wall resection maybe required if the patient already had amastectomy. Local recurrences are com-mon (up to 73%11) and repeated chestwall resections may be indicated.The benefit of adjuvant therapy is

undefined. For the treatment of unre-sectable or metastatic disease, pegylat-ed-liposomal doxorubicin has activity.14In contrast to other sarcomas, the tax-anes have also been shown to have sig-

nificant activity in angiosarcomas.15Overall prognosis of radiation-associat-ed angiosarcoma is poor. Median sur-vival is 2.3 years; 5-year survival is inthe 30% range.12 Because angiosarco-mas are composed of vascular tissue, theuse of agents with antiangiogenic prop-

erties is under study.16 It is hoped thatclinical trials using bevacizumab,sorafenib, and thalidomide, as well asother agents, will result in improvedtreatment options.No data are available on adjuvant or

neoadjuvant chemotherapy for a radia-tion-associated angiosarcoma of thebreast. As there is no role for breastconservation, standard indications forneoadjuvant chemotherapy would notapply. If there was disease extendingoutside the breast onto the chest wall,one could consider using chemotherapyto try to reduce the tumor size to allow

for mastectomy and chest wall resec-tion. In this setting, I would consider ataxane, as they have been shown tohave the most activity in this disease.Again, there is no data to support thisapproach.

ConclusionEarly diagnosis improves overall sur-

vival as the tumor size is important as aprognostic indicator. For this patient,our discussion guided us to a recom-mendation of mastectomy because webelieved the risks of re-irradiation out-weighed the limited benefit that radia-tion would provide and the benefit ofadjuvant chemotherapy is not yet deter-mined. With many agents under study,multimodal treatment recommenda-tions may change the future for thesepatients. This patient continues to dowell after 1 year. l

References1. Vorburger SA, Xing Y, Hunt KK, et al. Angio -

sarcoma of the breast. Cancer. 2005;104:2682-2688.

2. Bosquet G, Confavreux C, Magné N, et al.Outcome and prognostic factors in breast sarcoma:a multicenter study from the rare cancer network.Radiother Oncol. 2007;85:355-361.

3. Luini A, Gatti G, Diaz J, et al. Angiosarcoma of thebreast: the experience of the European Institute ofOncology and a review of the literature. Breast

Cancer Res Treat. 2007;105:81-85.4. West JG, Weitzel JN, Tao ML, et al. BRCA muta-tions and the risk of angiosarcoma after breast can-cer treatment. Clin Breast Cancer. 2008;8:533-537.

5. Pencavel TD, Hayes A. Breast sarcoma—a reviewof diagnosis and management. Int J Surg. 2009;7:20-23.

6. Abbott R, Palmieri C. Angiosarcoma of the breastfollowing surgery and radiotherapy for breast can-cer. Nat Clin Pract Oncol. 2008;12:727-736.

7. Mery C, George S, Bertagnolli MM, Raut CP.Secondary sarcomas after radiotherapy for breastcancer: sustained risk and poor survival. Cancer.2009;115:4055-4063.

8. Huang J, Mackillop W. Increased risk of soft tissuesarcoma after radiotherapy in women with breastcarcinoma. Cancer. 2001;92:172-180.

9. DeSmet S, Vandermeeren L, Christiaens MR, et al.Radiation induced sarcoma: analysis of 46 cases.Acta Chir Belg. 2008;108:574-579.

10. Cahan WG, Woodard HQ, Higinbothavn, NL, etal. Sarcoma arising in irradiated bone: report of 11cases. Cancer. 1948; 1:3-29.

11. Monroe A, Feigenberg SJ, Mendenhall NP. Angio -sarcoma after breast-conserving therapy. Cancer.2003;97:1832-1840.

12. Yap J, Chuba PJ, Thomas R, et al. Sarcoma as a sec-ond malignancy after treatment for breast cancer.Int J Radiat Ondol Biol Phys. 2002;52:1231-1237.

13. Sher T, Hennessy BT, Valero V, et al. Primary angio -sarcomas of the breast.Cancer. 2007;110:173-178.

14. Skubitz KM, Haddad PA. Paclitaxel and pegylated-liposomal doxorubicin are both active in angiosar-coma. Cancer. 2005;104:361-366.

15. Fury MG, Antonescu CR, Van Zee KJ, et al. A 14-year retrospective review of angiosarcoma: clinicalcharacteristics, prognostic factors, and treatmentoutcomes with surgery and chemotherapy.Cancer J.2005;11:241-247.

16. Vogt T, Hafner C, Bross K, et al. Antiangiogenetictherapy with pioglitazone, rofecoxib and metronom-ic trofosfamide in patients with advanced malignantvascular tumors. Cancer. 2003;98:2251-2256.

CONTINUING EDUCATION


West Michigan Cancer Center... Continued from cover

reduction and revenue enhancement,which is evident by its consolidationand affiliation efforts, according toFoley & Lardner. McKay explained howtechnology cut overall spending: “Thesingle most important endeavor we pur-sued for efficiency and cost-effective-ness was to implement an electronicmedical record [EMR]. We have had anEMR since 2004, and it has taken half amillion dollars out of operating expens-es each year. We saved in medicalrecords, the charts themselves, thepaper, the copying of the paper, and thefiling of the paper. We saved in goodsand services and personnel.”Benchmarks were also used to ensure

that staff need and staff numbers aligned.Since 2000, WMCC has placed all of itsemployees, both clinical and nonclini-cal, on productivity benchmarks. “Weuse those benchmarks to monitor theemployees’ productivity, but also todetermine if an additional employee isneeded,” McKay explained. “Managersno longer request additional staff unlessthey can substantiate the need throughadditional benchmarks, which is a prettyconcrete number.”WMCC also tracks the American

Society of Clinical Oncology’s QualityOncology Practice Initiative (QOPI)indicators for clinical quality. Each year,

one or two indicators are tracked. Todate, WMCC has tracked the QOPIguidelines in chemotherapy, clinicalstaging, and appropriate conversationand referral to hospice, according toMcKay. In 2010, WMCC is trackingchemotherapy treatments in the last 14

days of life. “I think when you start toexamine your processes and you canmeasure them and you compare them,you can always see room to improve,”said McKay. “What we did was generalawareness with physicians. Just by themknowing that we are tracking a guide-line, it becomes more top of mind.”WMCC also tracks patient satisfac-

tion through satisfaction surveys. Twicea year, staff meet to determine whatthey can change to make the patientexperience better. As an example, in

2009, the center’s goal was to seepatients within 15 minutes, 65% of thetime. This year, that goal has beenincreased to 70% of the time, accordingto McKay. “We track [satisfaction] verycarefully. If any other issues are broughtup in our satisfaction survey, we address

those very quickly and head-on to makesure that we continuously strive for highpatient satisfaction,” McKay explained.

Patient-focusedWMCC, a joint venture of Borgess

Medical Center and Bronson Metho distHospital, is its region’s only truly com-prehensive cancer treatment facility. Inits main campus in Kalamazoo, WMCCoffers medical oncology, radiation oncol-ogy, a neurooncology clinic, a breast can-cer clinic, a thoracic clinic, laboratories,

x-ray technology, positron-emissiontomography/computed tomography, phar -maceutical services, social and psycho-logical counseling, nutrition counseling,and key allied support services forpatients and their families. WMCC alsohas six satellite locations where its med-ical oncologists treat patients.The center employs a multidiscipli-

nary approach with thoracic, breast, andneurooncology. Although not as large asthe breast clinic, the thoracic and neu-rooncology teams are “aggressive andprogressive.” WMCC has recentlyexpanded the multidisciplinary ap -proach to gynecologic cancers, with anew team onboard. The center’s currentgoals include adding additional clinicsfor palliative care and survivorship. Thisyear, “we are going to start laying thegroundwork for them,” said McKay.WMCC has always had the philoso-

phy of treating the entire person, notjust the disease. To this end, the centeroffers many services: social workers, psy-chologists, onsite pharmacy, dieti-tians/nutritionists, and personal coach-es. It also offers Tai Chi, meditation,Pilates, yoga, and massage therapy. Inaddition, the center provides financialcounseling, transportation assistance,and lodging.

CANCER CENTER PROFILE

Urgent mastectomy is the treatment of choice if the breast is intact. Large chest wall resection may be required if the patient already had amastectomy.

“The single most important endeavorwe pursued for efficiency and cost-effectiveness was to implement anelectronic medical record.”

—Terry McKayPresident and CEO


Continued from page 11

You prepare anthracyclines, but are you prepared for an anthracycline extravasation?

1 Mouridsen HT et al. Treatment of anthracycline extravasation with savene (dexrazoxane). Results from two prospective clinical multicentre studies. Ann Oncol 2007; 18:546-550. All images and captions are copyright © Photo Researchers, Inc. They may not be copied, reproduced or used in any way without permission from Photo Researchers, Inc. Use without permission is a breach of copyright under national and international laws.

© TopoTarget USA. All rights reserved. TOT0075/3-09 Totect and its logo mark are registered trademarks of TopoTarget USA, Inc., Rockaway, NJ, USA.

NEW LOWER PRICE OPTION Now Available Totect® (dexrazoxane for injection)

is indicated for the treatment of

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Demonstrates 98% overall e�cacy based on two biopsy-con�rmed clinical trials1,2 in preventing the need for:

o Surgical debridement, plastic surgery and related healthcare costso Postponement of a patient’s chemotherapy treatmentso Rehabilitation, follow-up and avoidance of long-term consequences

Totect® – Brief prescribing information Please refer to the package insert for full prescribing information. Each Totect carton contains 10 vials of Totect® (dexrazox-ane for injection) 500 mg and 10 vials of 50 mL diluent. Indication: Treatment of extravasation resulting from IV anthracycline chemotherapy. Dosage and admin-istration: Administration of Totect should begin as soon as possible and within 6 hours following the anthracycline extravasation. Totect should be given as an intravenous (IV) infusion once daily for 3 consecutive days. The dose of Totect is based on the patient’s body surface area: day one, 1000 mg/m2; day two, 1000 mg/m2; day three, 500 mg/m2. For patients with a body surface area of > 2 m2, a dose of 2000 mg should be given on days 1 and 2, and a dose of 1000 mg should be given on day 3. The Totect dose should be reduced 50% for patients with creatinine clearance values of <40 mL/minute. Cooling procedures such as ice packs should be removed from the a�ected area at least 15 minutes prior to Totect administration. Totect (dexrazoxane for injection) must be reconstituted with diluent, supplied in the carton. The patient’s Totect dose is diluted in 0.9% 1000 mL NaCl prior to administra-tion. Contraindications: None known. Warnings: Pregnancy Category D. Dexrazoxane was toxic to pregnant rats at doses of 2 mg/kg (1/80 the human dose on a mg/m2 basis) and embryotoxic and teratogenic at 8 mg/kg when given daily during the period of organogenesis. Teratogenic e�ects in the rat included imperforate anus, microphthalmia, and anophthalmia. In o�spring allowed to develop to maturity, fertility was impaired in the male and female rats treated in utero during organogenesis at 8 mg/kg. In rabbits, doses of 5 mg/kg daily during the pe-riod of organogenesis caused maternal toxicity and doses of 20 mg/kg were embryotoxic and teratogenic. Terato-

genic e�ects in the rabbit included several skeletal mal-formations such as short tail, rib and thoracic malforma-tions, and soft tissue variations including subcutaneous, eye and cardiac hemorrhagic areas, as well as agenesis of the gallbladder and of the intermediate lobe of the lung. There is no adequate information about the use of Totect in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Precautions: Totect is a cytotoxic drug. When administered to patients receiving anthracycline-con-taining cytotoxic therapy, additive cytotoxicity may occur. Treatment with Totect is associated with leukopenia, neu-tropenia, and thrombocytopenia. Reversible elevations of liver enzymes may occur. Blood counts and liver enzymes should be monitored. Greater exposure to dexrazoxane may occur in patients with compromised renal function. The Totect dose should be reduced by 50% in patients with creatinine clearance values <40 mL/min. Dimethyl sulfoxide (DMSO) should not be used in patients who are receiving dexrazoxane to treat anthracycline-induced extravasation. Women who have the potential to become pregnant should be advised that Totect might cause fetal harm. There are no known drug interactions. No carcino-genicity studies have been done with Totect in animals. The carcinogenic potential of dexrazoxane has not been investigated. Long term dosing with razoxane (the race-mic mixture of dexrazoxane, ICRF-187, and its enantiomer ICRF-186) is associated with the development of malig-nancies in rats and possibly in mice. Dexrazoxane was not mutagenic to bacteria in vitro (Ames assay), but caused signi�cant chromosomal aberrations in mammalian cells in vitro. It also increased the formation of micronucleated polychromatic erythrocytes in mice. Dexrazoxane is mu-

tagenic and clastogenic. The possible adverse e�ects of Totect on the fertility of humans and experimental ani-mals, male or female, have not been adequately studied. Testicular atrophy was seen with dexrazoxane administra-tion at doses as low as 30 mg/kg weekly for 6 weeks in rats (about 1/5 the human dose on a mg/m2 basis) and as low as 20 mg/kg weekly for 13 weeks in dogs. The e�ect of dexrazoxane on labor and delivery in humans has not been studied. It is not known whether dexrazoxane or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from dexrazoxane, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The safety and e�ectiveness of Totect in pediatric patients have not been established. No di�erences in safety or e�-cacy were observed between older and younger patients, and other reported clinical experience has not identi�ed di�erences in responses between the elderly and younger patients, but greater sensitivity of some older patients has been observed. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal func-tion. Adverse reactions: Adverse reactions of nausea/vomiting, diarrhea, stomatitis, bone marrow suppression (neutropenia, thrombocytopenia), altered liver function (increased AST/ALT), and infusion site burning have been observed. These adverse reactions have been reversible.

Rx onlyTotect® is a registered trademark ofTopoTarget A/SUS Patent No. 6,727,253B2 NDC 38423-110-01

Manufactured by:Ben Venue Laboratories, Inc.Bedford, OH 44146

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Manufactured for:TopoTarget A/SSymbionScience ParkFruebjergvej 3DK-2 100 CopenhagenDenmark

Marketed by:TopoTarget USA Inc.100 Enterprise DriveRockaway, New Jersey07866(866) 478-8274

www.totect.com

TOT0075/03-09©2009 TopoTarget USA

February 2010 I VOL 3, NO 1 15www.jOmcc.com

The world is changing all aroundoncology practices today. Moneyis tight, staff and

physicians are stressed, pa -tients have more choicesthan they can understand,and those who pay for careare worried about waste,quality, and value. Takingtime away from your prac-tice and family to suspendthe daily routine and focuson strategic planning andthe future for yourselvesand your partners may seemimpossible, but it may be the mostimportant step you take this year toregain control of where you are headed.Strategic plan ning is a staple of busi-

ness management. It affords those respon-sible for the business an opportunity forre flec tion, introspection, and vision.When done with the guidance and sup-port of a strong facilitator who not onlyunderstands strategy but also the uniquechaos that is unfolding in the public andprivate sectors for oncology, it canincrease the understanding and aware-ness of practice physicians and leaders ofnew opportunities and threats.

Who’s managing oncology?How to manage the costs and quality

choices involved in oncology practice isone of the most common topics of con-versations in the public and privatepayer markets. Numerous external org a -nizations are knocking on the doors ofmedical and pharmacy directors pre-senting programs intended to reduceoncology spending. Hospitals and otherorganizations are exploring the creationof cancer and infusion centers, mostlythrough affiliations with or employmentof physicians and physician extenders.

Where will you go from here?What are the immediate and pending

issues for your practice in your market?Who are the players, and what role areyou going to play in that market? Whatmarket do you expect to serve? What ishappening or might happen to yourreferral base? What external trends ornational discussions might affect yourpractice while you are looking in anoth-er direction? These are the questionsthat a practice/cancer center will addressin the course of strategic planning.

Know yourself What are the basics of strategic plan-

ning, and how does it differ from your

regular monthly operational reviews andmeetings? On a monthly basis, a well-

run oncology practice isreviewing both financialand operational dashboards,watching the flow of rev-enues and expenses, staffinglevels, chair utilization, andpatient satisfaction. Thepractice is also trending pat-terns in referrals, newpatients, disease-specific volumes, and patient care andretention.

Know your market/environmentStrategic planning means stepping

away from the daily routine to look atthe practice from an internal and exter-nal perspective and allows the time toconsider options and goals and to setaction plans and timelines. Practiceswill collect certain statistics relating topatient volume, staffing, financials, andphysician expectations, as well as

benchmarking where possible. Thosedata become a platform for more strate-gic questions and issues, found in whatis commonly called a SWOT analysis(Strengths, Weaknesses, Opportunities,and Threats) (Table 1).

Oncology issues are in the eye ofthe beholderOne of the best values to be derived

through a strategic planning process,especially when using the correct con-sulting facilitator, is to be able to look atboth oncology and your practice/cancercenter from the perspectives of poten-tial competition or key payers. It is easyto fall into the trap of myopic vision,especially when the daily routine is con-sumed with caring for patients, seekingreimbursement, and addressing billingand authorization issues.To patients, in addition to the diagno-

sis of cancer and all that entails in termsof the battle ahead, changes by employ-ers and insurers are forcing new attention

to choices of providers, choices of drugsor treatment options, sources for drugsand treatments, and even preferentialbenefit design that may drive patientchoices via copayment or coinsurancediscounts. This means that patients mayconsider the source and cost of care morecarefully both before and after selecting aprovider, perhaps in addition to consid-eration of “one-stop shopping,” as well asthe provider’s position on their insur-

ance’s preferred network. Understandingthose issues, in addition to the serviceand care that would normally be expect-ed, is critical to developing your strategyfor future direction.Payers see oncology care as a very

expensive cost. Sometimes, payers needto focus on the short term when consid-ering financial costs. This may makechoices such as more costly drugs thatwill lower long-term costs and thechance of recurrence less appealing tothem and their stakeholders than treat-ment choices that are less costly com-pared with alternatives during a 1-yearwindow. The message they want to hearis how oncology costs are going to bereduced in the next year. As oncologypractices/cancer centers prepare tomore deeply engage their key payers indiscussions on oncology management,the payers will not be receptive to thosewho are unprepared to address the mes-sage of costs.“Quality of care,” “best care,” and

“most appropriate care” actually canhave different meanings whether youare a patient, physician, center adminis-trator, hospital administrator, payer, oremployer. Good strategic planning andan experienced facilitator should recog-nize these differences so that the prac-tice/cancer center can clarify its intend-ed messages and approaches for each ofthese constituent markets.

Becoming a player or a pawnNo matter where you deliver cancer

care, someone is talking about the costsof care in that area. Someone else istalking about creating databases on

Strategy and Planning: The Difference betweenBeing a Player or a PawnBy Dawn Holcombe, FACMPE, MBA, ACHEDGH Consulting, South Windsor, Connecticut

Table 1. Key Elements of a SWOT Analysis

Strengths—identification of the practice’s• Unique characteristics• Value/assets, both quantifiable and perceived• Positive or supportive key relationships/collaborations• Positive differentiating factors in local, regional, or other markets• Solid knowledge/understanding of financial and market position• Leadership and business skill sets that reveal strengths

Weaknesses—identification of the practice’s• Internal or external distractions from daily business, discord, problems, or behaviors

• Lack of knowledge/understanding of financial and market position• Weak or troublesome key relationships/collaborations• Lack of or negative distinguishing factors in local, regional, or other markets• No recognition/identification of value/assets (either quantifiable or perceived)• Leadership or skill set issues that expose weaknesses

Opportunities—identification of the practice’s• Expected and unexpected market changes that could open up new possibilities

• New potential or possible improvements/enhancements of existing key relationships/collaborations

• Potential reconfigurations/expansion/enhancement of services and assets• Physician plans and expectations for personal and professional goals and opportunities

Threats—identification of the practice’s• Market changes that might close doors or create barriers• Relationships/expectations changing due to influence or activity of external players in the oncology space

• Internal expectations or decisions that might derail opportunities or progressContinued on page 16

Dawn Holcombe,FACMPE, MBA, ACHE

“Planning is bringing thefuture into the present so that you can dosomething about it now.”

—Alan Lakein

Practice Management

oncology treatments, drugs, or care.Someone else is offering to help payersevaluate their cancer spending andreduce their costs through a variety ofmethods. Yet someone else is offering todeliver drugs to offices at a lower cost ora better revenue or control process todrive reductions in care variation andcompliance. Careful strategic planningand action is the most effective weaponyou hold to recognize these issues anddevelop your approach.Planning in and of itself will not solve

the issue of getting you a seat at the table(player) or getting blindsided by changesout of your control (pawn). It is essentialto set aside time to decide where youwant to go, and what will need to hap-pen to get you there. Table 2 details somestrategies and action plans created out ofthe planning process.

Where to go from here?There is an old axiom about when is

the best time to plan and strategize:When business is good, or when businessis bad? The answer: All the time. Whenbusiness is good, strategic planning isessential to maintain and improve mar-

ket position and business successes in thefuture. When business is bad, strategicplanning can help to understand what isgoing wrong and determine what, if any,corrections are possible to achieve suc-cesses in the future.The selection of a facilitator for the

strategic planning process is also essen-tial. You want a guide with specificstrengths, especially in oncology trends

and payer relationships. Many facilitatorsare well equipped for general businessstrategy, but oncology practices and can-cer centers in the current market needfacilitators who are also experienced inpublic and private oncology policy issuesand who understand not only oncologybut also the payer and other third-party

players who are seeking to enter andmanage the oncology market.A window of opportunity still exists

for oncology practices and cancer cen-ters to make the strategic adjustmentsnecessary to survive in their markets. Itis critical to understand the keen inter-est in managing oncology by otherthird-party organizations and the needs/expectations of payers and employersregarding the costs and variation of theoncology spend. When oncology prac-tices/cancer centers are proactive andbring that message to their regionalmarkets and payers, they preserve theability to sit at the table and be a playerin the management of oncology fortheir patients. On the other hand, whenthey are not pro active and don’t makean effort to understand and get involvedin their markets, they open the door forsomeone to fill that void and offer tomanage the oncology market for theirpayers (also taking dollars out of thehealthcare system in fees), making thephysician a pawn to be moved aroundor managed according to someone else’sgoals. Stepping out of the daily routineand engaging in strategic planning canbe the first step in moving from “pawn”to “player” status. l

Table 2. Strategies and Action Plans Created Out of the Planning Process

Defining/Implementing Market Position• What steps need to be taken in the next months and years to solidify, estab-lish, or reinforce the role and market position you will achieve to meet your goals?

Operational/Facility Position• What changes/modifications need to be taken to position you to meet the market demands and your expectations for services?

Affiliations/Collaborations• What are the critical factors and drivers of the referral market in your area?• Where can you enhance/improve relations with other key institutions and payers, and when do you bring them closer and when do you watch or compete?

• Where do you prioritize affiliations or collaborations?• Are mergers or consolidations an option?

Infrastructure/Leadership• What infrastructure will achieve the goals of the group?• What skill sets are strong or weak, and how will necessary adjustments be made?

• Are changes in leadership needed, and how will that be accomplished?• What will public ramifications of leadership changes be?• What are the personal and professional goals of the physicians in the group?• Does the practice have the financial and operational or leadership and business skills to navigate through the next few years and change needed?

Marketing/Referral Relations• What are referral trends?• What are implications of key hospital market strategies on your group?• What does your internal and external marketing plan cover, what is missing, and what needs to change?

Payer Relations/Negotiations• How will you interact with payers?• What messages/programs will you offer that recognize competing organiza-tions’ messages?

• Who else is talking to payers about oncology in this market (or at a national level), and what programs will be needed to maintain a key position in the management of oncology in the market?

Strategy and Planning... Continued from page 15

“It pays to plan ahead. It wasn’t raining whenNoah built the ark.”

—Unknown

Practice Management


Beforethe research is published…

Beforethe guideline is issued…

Beforethe drug is approved…

www.JOMCC.com

You read it first in

“To be prepared is halfthe victory.”

—Miguel de Cervantes Saavedra

West Michigan Cancer Center... Continued from page 12

WMCC’s focus on its patients andtheir families has afforded it high stand-ing in its community. “Our programs—the psychological counseling, the nutri-tion, the Tai Chi, the meditation, thePilates, the yoga, everything we have—extend to the caregiver as well. We arevery encompassing of what the familymember is going through caring for thepatient,” said McKay.The old medical records room did not

go to waste. WMCC has converted itinto a fitness center. “The fitness centeris open all day for patients and their

caregivers, as well as our staff during specific hours. Patients are actively

involved in living a healthier lifestyleeven if it is for the first time in their lifethat they decided to exercise, because of

the cancer diagnosis,” explained McKay.Many decide to continue after cancer.“We have a lot of patients who still useour facilities after cancer; we don’t put atime limit on it,” McKay said.

Nationally affiliatedWMCC receives timely results of

National Cancer Institute (NCI) clini-cal trials of advanced cancer treatmentdrugs and techniques. For the rightpatient, participation in a trial of a newmedication or procedure is available atthe center or in his or her home. “We

have a very robust clinical trial programfunded by the NCI, and we put onabout 112 to 115 patients a year,” saidMcKay. “That is a double-digit percent-age of new patients who go on clinicaltrials, which is rather impressive.”WMCC also works closely with

regional physicians and healthcare pro-fessionals, and with cancer specialiststhroughout the United States. In addi-tion, WMCC is professionally affiliatedwith the NCI, Susan G. Komen Racefor the Cure, and the American CancerSociety. l

CANCER CENTER PROFILE

“We have a very robustclinical trial programfunded by the NCI, andwe put on about 112 to115 patients a year.”

Beforethe research is published…

Beforethe guideline is issued…

Beforethe drug is approved…

www.JOMCC.com

CONFERENCE NEWSHealthcare Cost and Health Reform:

Cost Containment Not Likely

By Caroline Helwick

West Michigan Cancer Center(WMCC) has increased thequality of patient care while

updating its business model for today’s

economic times. In recognition of this

achievement, WMCC received a 2009

Cancer Center Innovator Award. The

award was presented by Foley & Lardner

at the third annual Cancer Center

Business Summit in Dallas, Texas.Journal of Multidisciplinary Cancer

Care recently spoke with Terry McKay,

president and CEO, about how WMCC

accomplished these goals as well as its

plans for future improvements. Cost-savingsWMCC was chosen, in part, because

of its aggressive stance on expense

©2010 Green Hill Healthcare Communications, LLC

BREAST CANCERHypofractionatedWhole BreastIrradiation ShowsPromiseBy John Schieszer

Whereas some degree of health-care reform seems likely to beenacted, what is shaping up as

“reform” will likely be a failure in terms

of “serious cost containment,” according

to Paul B. Ginsburg, PhD, president of

the Center for Studying Health System

Change, Washington, DC, a think tank

that analyzes changes in financing and

the delivery of healthcare.Based on his broad experience in the

field of healthcare economics and poli-

cy, Ginsburg delivered an invited lecture

on cost and reform.Simply put, there is no single or simple

solution, Ginsburg said. “A single ap -

proach to containing costs is unlikely to

be sufficiently successful,” he predicted.

“We need to pursue many distinct but

consistent approaches to offset the risk

that some approaches will not succeed.”Need to contain costsOn the national level, rising costs are

undermining the mechanisms that fi -

nance healthcare and are a key factor in

the country’s “dire public fiscal outlook,”

he noted. On the individual level, private

insurance is increasingly unaffordable,

and the affordability problem now affects

the middle class, Ginsburg said.The cost of Medicare, Medicaid, and

tax expenditures for private health insur-

ance are all growing faster than the gross

domestic product (GDP), and the result

is that other priorities are neglected, taxes

are higher, and the deficit is growing.Continued on page 6

Paul B. Ginsburg, PhD, lectures on health-

care cost and reform at ASH.


CANCER CENTERPROFILEWest MichiganCancer Center: A Cancer Center Innovator

By Dawn Lagrosa

FEBRUARY 2010

www.JOMCC.com

VOL 3, NO 1

InsideConference NewsManaged care pharmacistscan improve chemotherapyreimbursement�� page 8

Nursing challenges canaffect the efficiency ofthe chemotherapy infu-

sion suite. By following a staffingmodel that works best for yourinstitution, you can improve effi-ciency, save money, and increasesatisfaction among nurses andpatients, according to CathyMaxwell, RN, OCN, of Ad -vanced Medical Specialties,Miami, Florida.Maxwell is employed by a 15-site private oncology practice,where she is director of clinicaloperations for three sites and is

responsible for staffing and run-ning their infusion suites.After trying a number of staffingapproaches over the past 28 years,she says she ultimately settled on a“triage nurse” model that worksbest for her large practice. She dis-cussed the pros and cons of variousstaffing models at the 2009Community Oncology Confer-ence in Scottsdale, Arizona.“Most infusion centers have

schedules that are set up to fail,”she observed. “Treatments areoverbooked, and scheduling of

PRACTICE MANAGEMENTThe Chemotherapy Infusion Suite:

Staffing for EfficiencyBy Caroline Helwick

Continued on page 4

Complimentary CE CreditMultidisciplinary approach toa radiation-associatedangiosarcoma of the breastpage 10

The main campus in Kalamazoo offers

medical oncology, radiation oncology,

a neurooncology clinic, a breast cancer

clinic, and a thoracic clinic, along with

laboratory and support services.

Conference NewsFor MDS treatment, azaciti-dine confers economic valueover decitabine�� page 7

CHICAGO—A shortened, more intensive course of

radiation given to the whole breast, along with an

extra dose of radiation given to the surgical bed of

the tumor (concomitant boost), have been found to

result in excellent local control at a median follow-

up of 2 years after completion of treatment with no

significant side effects.Researchers said this shorter treatment, called

accelerated hypofractionated whole breast irradia-

tion, is an especially attractive option, because

women can receive a full course of radiation therapy

in half the time (3 weeks of daily treatments vs 5 to

7 weeks). In addition, the cost of this treatment is

lower relative to the cost of standard whole breast

radiation and also is less expensive than other

new approaches, such as partial breast

irradiation (breast brachy -therapy).“The observations to

date suggest that a 3-week course of radiationtherapy with concomi-Continued on page 21

Register Today for

Your Free CE

��

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You read it first in

Medications Used for the Treatment of Cervical CancerCervical cancer forms in tissues of the cervix(the organ connecting the uterus and vagina).It is usually a slow-growing cancer that may nothave symptoms but can be found with regularPap tests. Cervical cancer is almost alwayscaused by human papillomavirus (HPV) infec-tion. The following sections will assist health-care professionals and payers by providingappropriate coding, billing, and reimbursementinformation associated with the management ofcervical cancer.

The following sections include:• Associated ICD-9-CM codes used for the classification of cervical cancer

• Drugs that have been FDA-approved in the treatment of cervical cancer. Please note: if a check mark appears in the FDA column it will NOT appear in the Compendia section even if a drug is included in the NCCN (National Comprehensive Cancer Network) Drugs & Biologics Compendium

• Drugs included in the NCCN Drugs & Biologics Compendium for off-label use in cervical cancer. NCCN is recognized by CMS (Centers for Medicare & Medicaid Services) as a referencing source

• Corresponding HCPCS/CPT Codes and Code Descriptions

• Current Code Price (AWP-based pricing)• Most recent ASP plus 6% (Medicare allowable)

• Possible CPT Administration Codes for each medication

Associated ICD-9-CM Codes Used for Cervical Cancer

180 Malignant neoplasm of cervix uteriIncludes: invasive malignancy [carcinoma]Excludes: carcinoma in situ (233.1)

180.0 EndocervixCervical canal, not otherwise specifiedEndocervical canalEndocervical gland

180.1 Exocervix180.8 Other specified sites of cervix

Cervical stumpSquamocolumnar junction of cervixMalignant neoplasm of contiguous or overlapping sites of cervix uteri whose point of origin cannot be determined

180.9 Cervix uteri, unspecified

233 Carcinoma in situ of breast and genitourinary system233.1 Cervix uteri

Adenocarcinoma in situ of cervixCervical intraepithelial glandular neoplasia, > grade III <Cervical intraepithelial neoplasia III [CIN III]Severe dysplasia of cervixExcludes: cervical intraepithelial neoplasia II [CIN II] (622.12)

cytologic evidence of malignancy without histologic confirmation(795.06)high-grade squamous intraepithelial lesion (HGSIL) (795.04)moderate dysplasia of cervix (622.12)

NCCN Drugs Current MedicareFDA- & Biologics code price allowableapproved Compendium (AWP-based (ASP + 6%), CPT

generic (Brand) HCPCS code: for cervical off-label use for pricing), effective effective administrationname code description cancer cervical cancer 1/10/10 1/10/10-3/31/10 codes

bevacizumab J9035: injection, ✓ $66.99 $57.46 96413, 96415(Avastin) bevacizumab, 10 mgbleomycin J9040: injection, ✓ $45.30 $28.47 96401, 96409(Blenoxane) bleomycin sulfate, 15 unitscarboplatin J9045: injection, ✓ $85.10 $4.84 96409, 96413, 96415(Paraplatin) carboplatin, 50 mgcisplatin J9060: cisplatin, ✓ $4.33 $2.08 96409, 96413, 96415(Platinol AQ) powder or solution, per 10 mgcisplatin J9062: cisplatin, ✓ $21.66 $10.41 96409, 96413, 96415(Platinol AQ) 50 mgdocetaxel J9171: injection, ✓ $23.23 $17.62 96413(Taxotere) docetaxel, 1 mgdoxorubicin HCl J9001: injection, ✓ $559.32 $471.38 96413liposome doxorubicin hydrochloride, (Doxil) all lipid formulations, 10 mgepirubicin J9178: injection, ✓ $8.16 $2.65 96409, 96413(Ellence) epirubicin HCl, 2 mg



O N C O L O G Y D R U G C O D E SSupplied by: RJ Health Systems

A Newsletter Series for Cancer Care Professionals

Center of Excellence Media, along with Editor-in-ChiefSagar Lonial, MD, of Emory University, are pleased tooffer your multidisciplinary cancer team this series ofnewsletters focusing on the challenges of treatingpatients with multiple myeloma.

SAGAR LONIAL, MDAssociate Professor of

Hematology and Oncology Emory University School of Medicine

� Earn Continuing Education Credits �

Each newsletter will feature:

These activities are supported by an educational grant from Millennium Pharmaceuticals, Inc.

• Front-line therapy• Maintenance Settings• Transplant Settings• Retreatment Settings

• Non-Transplant Patients• Cytogenetics• Side Effect Management• Bone Health

• Contributions from thought-leadingphysicians, nurses, and pharmacists

• Continuing Education credits availableto physicians, nurses, and pharmacists

Presents the Third Annual Curriculum for CONSIDERATIONS IN MULTIPLE MYELOMA

PARTICIPATE TODAY at www.COEXM.com

8-part newsletter series

CASE STUDY DISCUSSIONS:

For complete learning objectives and accreditation information, please refer to each activity.

Target AudienceThese activities were developed for physicians, nurses, and pharmacists.

These activities are jointly sponsored by

NCCN Drugs Current MedicareFDA- & Biologics code price allowableapproved Compendium (AWP-based (ASP + 6%), CPT

generic (Brand) HCPCS code: for cervical off-label use for pricing), effective effective administrationname code description cancer cervical cancer 1/10/10 1/10/10-3/31/10 codes

fluorouracil J9190: injection, ✓ $3.30 $1.60 96409(Adrucil) fluorouracil, 500 mggemcitabine J9201: injection, gemcitabine ✓ $169.46 $144.93 96413(Gemzar) hydrochloride, 200 mgifosfamide J9208: injection, ✓ $56.40 $30.08 96413, 96415(Ifex) ifosfamide, 1 gramirinotecan J9206: injection, ✓ $84.71 $6.94 96413, 96415(Camptosar) irinotecan, 20 mgmesna J9209: injection, ✓ $10.44 $4.64 96409(Mesnex) mesna, 200 mgmitomycin J9280: mitomycin, ✓ $67.20 $17.15 96409(Mutamycin) 5 mgmitomycin J9290: mitomycin, ✓ $218.40 $68.60 96409(Mutamycin) 20 mgmitomycin J9291: mitomycin, ✓ $300.00 $137.19 96409(Mutamycin) 40 mgpaclitaxel J9265: injection, ✓ $17.70 $9.44 96413, 96415(Taxol, Onxol) paclitaxel, 30 mgpemetrexed J9305: injection, ✓ $59.25 $50.59 96409(Alimta) pemetrexed, 10 mgtopotecan J9350: injection, ✓ $1264.99 $1031.91 96413(Hycamtin) topotecan, 4 mgvinorelbine J9390: injection, ✓ $42.60 $11.59 96409(Navelbine) vinorelbine tartrate,

per 10 mg

References

• HCPCS Level II Expert 2010 • CPT 2010 • ICD-9-CM for Professionals Volumes 1 & 2; 2010 • The Drug Reimbursement Coding and Pricing Guide, Vol 7, No 1; RJ Health Systems International LLC;1st Quarter 2010 • FDA-approved indication (from products’ prescribing information) • The NCCN Drugs & Biologics Compendium™ © 2010 National Comprehensive Cancer Network, Inc. Availableat: http://www.ncc.org. Accessed [January 1, 2010]. To view the most recent and complete version of The NCCN Compendium, go online to www.nccn.org • National Cancer Institute •www.ReimbursementCodes.com powered by RJ Health Systems International, LLC, Wethersfield, Connecticut • CMS-Medicare allowable 1st Quarter 2010 (effective dates 1/1/10-3/31/10).

Prices listed herein are effective as of January 1, 2010.

ASP indicates average sales price; AWP, average wholesale price; CMS, Centers for Medicare & Medicaid Services; CPT, Current Procedural Terminology; FDA, US Food and Drug Administration; HCPCS,Healthcare Common Procedure Coding System; NCCN, National Comprehensive Cancer Network.

This information was supplied by:

PO BOX 290616, Wethersfield, CT 06109 T: (860) 563-1223F: (860) 563-1650

www.RJHealthSystems.com

2010 UPDATES OF THE HEALTHCARE COMMON PROCEDURE

CODING SYSTEM (HCPCS)Effective: January 1, 2010

NewC9257: injection, bevacizumab, 0.25 mg (Avastin)J9155: injection, degarelix, 1 mg (Firmagon)J9171: injection, docetaxel, 1 mg (Taxotere)J9328: injection, temozolomide, 1 mg (Temodar)

DeletedQ2024: injection, bevacizumab, 0.25 mg

(code deleted effective 1/1/10; see C9257 and J9035)J9170: injection, docetaxel, 20 mg

(code deleted effective 1/1/10; see J9171)C9253: injection, temozolomide, 1 mg

(code deleted effective 1/1/10; see J9328)


Continued from page 18

O N C O L O G Y D R U G C O D E SSupplied by: RJ Health Systems

February 2010 I VOL 3, NO 1 21www.jOmcc.com

Breast Cancer

GEMZAR� (GEMCITABINE HCl) FOR INJECTIONBRIEF SUMMARY (OVARIAN). For complete safety please consult the package insert for completeprescribing information.

INDICATION AND USAGE: THERAPEUTIC INDICATION—Ovarian Cancer—Gemzar in combination withcarboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed atleast 6 months after completion of platinum-based therapy.

CLINICAL STUDIES: Ovarian Cancer—Gemzar was studied in a randomized Phase 3 study of 356 patientswith advanced ovarian cancer that had relapsed at least 6 months after first-line platinum-based therapy.Patients were randomized to receive either Gemzar 1000 mg/m2 on Days 1 and 8 of a 21-day cycle andcarboplatin AUC 4 administered after Gemzar on Day 1 of each cycle or single-agent carboplatin AUC 5administered on Day 1 of each 21-day cycle as the control arm. The primary endpoint of this study wasprogression free survival (PFS).

The addition of Gemzar to carboplatin resulted in statistically significant improvement in PFS and overallresponse rate. Approximately 75% of patients in each arm received poststudy chemotherapy. Only 13 of120 patients with documented poststudy chemotherapy regimen in the carboplatin arm received Gemzarafter progression. There was not a significant difference in overall survival between arms.

CONTRAINDICATION: Gemzar is contraindicated in those patients with a known hypersensitivity to the drug(see Allergic under ADVERSE REACTIONS).

WARNINGS: Caution—Prolongation of the infusion time beyond 60 minutes and more frequent thanweekly dosing have been shown to increase toxicity (see CLINICAL STUDIES in the full Prescribing Information).

Hematology—Gemzar can suppress bone marrow function as manifested by leukopenia, thrombocytopenia,and anemia (see ADVERSE REACTIONS), and myelosuppression is usually the dose-limiting toxicity.Patients should be monitored for myelosuppression during therapy. See DOSAGE AND ADMINISTRATIONin the full Prescribing Information for recommended dose adjustments.

Pulmonary—Pulmonary toxicity has been reported with the use of Gemzar. In cases of severe lung toxicity,Gemzar therapy should be discontinued immediately and appropriate supportive care measures instituted(see Pulmonary under Single-Agent Use and under Post-marketing experience in ADVERSE REACTIONSin the full Prescribing Information).

Renal—Hemolytic Uremic Syndrome (HUS) and/or renal failure have been reported following one or moredoses of Gemzar. Renal failure leading to death or requiring dialysis, despite discontinuation of therapy,has been rarely reported. The majority of the cases of renal failure leading to death were due to HUS (seeRenal under Single-Agent Use and under Post-marketing experience in ADVERSE REACTIONS in the fullPrescribing Information).

Hepatic—Serious hepatotoxicity, including liver failure and death, has been reported very rarely inpatients receiving Gemzar alone or in combination with other potentially hepatotoxic drugs (see Hepaticunder Single-Agent Use and under Post-marketing experience in ADVERSE REACTIONS in the fullPrescribing Information).

Pregnancy—Pregnancy Category D. Gemzar can cause fetal harm when administered to a pregnant woman.Gemcitabine is embryotoxic causing fetal malformations (cleft palate, incomplete ossification) at doses of 1.5 mg/kg/day in mice (about 1/200 the recommended human dose on a mg/m2 basis). Gemcitabine is fetotoxic causing fetal malformations (fused pulmonary artery, absence of gall bladder) at doses of0.1 mg/kg/day in rabbits (about 1/600 the recommended human dose on a mg/m2 basis). Embryotoxicitywas characterized by decreased fetal viability, reduced live litter sizes, and developmental delays. There areno studies of Gemzar in pregnant women. If Gemzar is used during pregnancy, or if the patient becomespregnant while taking Gemzar, the patient should be apprised of the potential hazard to the fetus.

PRECAUTIONS: General—Patients receiving therapy with Gemzar should be monitored closely by aphysician experienced in the use of cancer chemotherapeutic agents. Most adverse events are reversibleand do not need to result in discontinuation, although doses may need to be withheld or reduced. Therewas a greater tendency in women, especially older women, not to proceed to the next cycle.

Laboratory Tests—Patients receiving Gemzar should be monitored prior to each dose with a completeblood count (CBC), including differential and platelet count. Suspension or modification of therapy shouldbe considered when marrow suppression is detected (see DOSAGE AND ADMINISTRATION in the fullPrescribing Information).

Laboratory evaluation of renal and hepatic function should be performed prior to initiation of therapyand periodically thereafter (see WARNINGS).

Carcinogenesis, Mutagenesis, Impairment of Fertility—Long-term animal studies to evaluate thecarcinogenic potential of Gemzar have not been conducted. Gemcitabine induced forward mutations invitro in a mouse lymphoma (L5178Y) assay and was clastogenic in an in vivo mouse micronucleus assay.Gemcitabine was negative when tested using the Ames, in vivo sister chromatid exchange, and in vitrochromosomal aberration assays, and did not cause unscheduled DNA synthesis in vitro. Gemcitabine IP dosesof 0.5 mg/kg/day (about 1/700 the human dose on a mg/m2 basis) in male mice had an effect on fertilitywith moderate to severe hypospermatogenesis, decreased fertility, and decreased implantations. In femalemice, fertility was not affected but maternal toxicities were observed at 1.5 mg/kg/day IV (about 1/200 thehuman dose on a mg/m2 basis) and fetotoxicity or embryolethality was observed at 0.25 mg/kg/day IV(about 1/1300 the human dose on a mg/m2 basis).

Pregnancy—Category D. See WARNINGS.Nursing Mothers—It is not known whether Gemzar or its metabolites are excreted in human milk.

Because many drugs are excreted in human milk and because of the potential for serious adversereactions from Gemzar in nursing infants, the mother should be warned and a decision should be madewhether to discontinue nursing or to discontinue the drug, taking into account the importance of the drugto the mother and the potential risk to the infant.

Elderly Patients—Gemzar clearance is affected by age (see CLINICAL PHARMACOLOGY in the fullPrescribing Information). There is no evidence, however, that unusual dose adjustments (i.e., other thanthose already recommended in DOSAGE AND ADMINISTRATION section in the full Prescribing Information)are necessary in patients over 65, and in general, adverse reaction rates in the single-agent safety databaseof 979 patients were similar in patients above and below 65. Grade 3/4 thrombocytopenia was morecommon in the elderly.

Gender—Gemzar clearance is affected by gender (see CLINICAL PHARMACOLOGY in the full PrescribingInformation). In the single-agent safety database (N=979 patients), however, there is no evidence thatunusual dose adjustments (i.e., other than those already recommended in DOSAGE AND ADMINISTRATIONsection in the full Prescribing Information) are necessary in women. In general, in single-agent studies of Gemzar, adverse reaction rates were similar in men and women, but women, especially older women,were more likely not to proceed to a subsequent cycle and to experience Grade 3/4 neutropenia andthrombocytopenia.

Pediatric Patients—The effectiveness of Gemzar in pediatric patients has not been demonstrated. Gemzarwas evaluated in a Phase 1 trial in pediatric patients with refractory leukemia and determined that themaximum tolerated dose was 10 mg/m2/min for 360 minutes three times weekly followed by a one-weekrest period. Gemzar was also evaluated in a Phase 2 trial in patients with relapsed acute lymphoblasticleukemia (22 patients) and acute myelogenous leukemia (10 patients) using 10 mg/m2/min for 360 minutesthree times weekly followed by a one week rest period. Toxicities observed included bone marrow suppression,febrile neutropenia, elevation of serum transaminases, nausea, and rash/desquamation, which were similarto those reported in adults. No meaningful clinical activity was observed in this Phase 2 trial.

Patients with Renal or Hepatic Impairment—Gemzar should be used with caution in patients withpreexisting renal impairment or hepatic insufficiency as there is insufficient information from clinicalstudies to allow clear dose recommendation for these patient populations. Administration of Gemzar inpatients with concurrent liver metastases or a preexisting medical history of hepatitis, alcoholism, or livercirrhosis may lead to exacerbation of the underlying hepatic insufficiency.

Drug Interactions—No specific drug interaction studies have been conducted. For information on the pharmacokinetics of Gemzar and cisplatin in combination, see Drug Interactions under CLINICALPHARMACOLOGY.

Radiation Therapy—A pattern of tissue injury typically associated with radiation toxicity has beenreported in association with concurrent and non-concurrent use of Gemzar.

Non-concurrent (given >7 days apart)—Analysis of the data does not indicate enhanced toxicity whenGemzar is administered more than 7 days before or after radiation, other than radiation recall. Datasuggest that Gemzar can be started after the acute effects of radiation have resolved or at least one weekafter radiation.

Concurrent (given together or ≤7 days apart)—Preclinical and clinical studies have shown that Gemzarhas radiosensitizing activity. Toxicity associated with this multimodality therapy is dependent on manydifferent factors, including dose of Gemzar, frequency of Gemzar administration, dose of radiation,radiotherapy planning technique, the target tissue, and target volume. In a single trial, where Gemzar at adose of 1000 mg/m2 was administered concurrently for up to 6 consecutive weeks with therapeutic thoracicradiation to patients with non-small cell lung cancer, significant toxicity in the form of severe, andpotentially life-threatening mucositis, especially esophagitis and pneumonitis was observed, particularly inpatients receiving large volumes of radiotherapy [median treatment volumes 4795 cm3]. Subsequent studieshave been reported and suggest that Gemzar administered at lower doses with concurrent radiotherapyhas predictable and less severe toxicity. However, the optimum regimen for safe administration of Gemzarwith therapeutic doses of radiation has not yet been determined in all tumor types.

ADVERSE REACTIONS: Combination Use in Ovarian Cancer—In the Gemzar plus carboplatin versuscarboplatin study, dose reductions occurred with 10.4% of Gemzar injections and 1.8% of carboplatininjections on the combination arm, versus 3.8% on the carboplatin alone arm. On the combination arm,13.7% of Gemzar doses were omitted and 0.2% of carboplatin doses were omitted, compared to 0% ofcarboplatin doses on the carboplatin alone arm. There were no differences in discontinuations due toadverse events between arms (10.9% versus 9.8%, respectively).

Table 1 presents the adverse events (all grades) occurring in ≥10% of patients in the ovarian cancer study.

In addition to blood product transfusions as listed in Table 1, myelosuppression was also managed withhematopoetic agents. These agents were administered more frequently with combination therapy than with monotherapy (granulocyte growth factors: 23.6% and 10.1%, respectively; erythropoetic agents:7.3% and 3.9%, respectively).

The following are the clinically relevant adverse events, regardless of causality, that occurred in >1% and<10% (all grades) of patients on either arm. In parentheses are the incidences of Grade 3 and 4 adverseevents (Gemzar plus carboplatin versus carboplatin): AST or ALT elevation (0 versus 1.2%), dyspnea(3.4% versus 2.9%), febrile neutropenia (1.1% versus 0), hemorrhagic event (2.3% versus 1.1%),hypersensitivity reaction (2.3% versus 2.9%), motor neuropathy (1.1% versus 0.6%), and rash/desquamation(0.6% versus 0).

No differences in the incidence of laboratory and non-laboratory events were observed in patients65 years or older, as compared to patients younger than 65.

Post-marketing experience—The following adverse events have been identified during post-approvaluse of Gemzar. These events have occurred after Gemzar single-agent use and Gemzar in combination withother cytotoxic agents. Decisions to include these events are based on the seriousness of the event,frequency of reporting, or potential causal connection to Gemzar.

Cardiovascular—Congestive heart failure and myocardial infarction have been reported very rarely withthe use of Gemzar. Arrhythmias, predominantly supraventricular in nature, have been reported very rarely.

Vascular Disorders—Clinical signs of peripheral vasculitis and gangrene have been reported very rarely.Skin—Cellulitis and non-serious injection site reactions in the absence of extravasation have been rarely

reported. Severe skin reactions, including desquamation and bullous skin eruptions, have been reportedvery rarely.

Hepatic—Increased liver function tests including elevations in aspartate aminotransferase (AST),alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase, and bilirubinlevels have been reported rarely. Serious hepatotoxicity including liver failure and death has been reportedvery rarely in patients receiving Gemzar alone or in combination with other potentially hepatotoxic drugs.

Pulmonary—Parenchymal toxicity, including interstitial pneumonitis, pulmonary fibrosis, pulmonaryedema, and adult respiratory distress syndrome (ARDS), has been reported rarely following one or moredoses of Gemzar administered to patients with various malignancies. Some patients experienced the onsetof pulmonary symptoms up to 2 weeks after the last Gemzar dose. Respiratory failure and death occurredvery rarely in some patients despite discontinuation of therapy.

Renal—Hemolytic-Uremic Syndrome (HUS) and/or renal failure have been reported following one ormore doses of Gemzar. Renal failure leading to death or requiring dialysis, despite discontinuation oftherapy, has been rarely reported. The majority of the cases of renal failure leading to death were due to HUS.

Injury, Poisoning, and Procedural Complications — Radiation recall reactions have been reported (seeRadiation Therapy under PRECAUTIONS).

Dosage and administration: Gemzar is for intravenous use only. Please consult full prescribing informationfor complete dosage and administration guidelines.

Literature revised May 7, 2007

PV 4067 AMP PRINTED IN USA

Eli Lilly and CompanyIndianapolis, IN 46285, USA

Copyright 1996, 2007, Eli Lilly and Company. All rights reserved.

GEMZAR� (GEMCITABINE HCl) FOR INJECTION PV 4067 AMP GEMZAR� (GEMCITABINE HCl) FOR INJECTION PV 4067 AMP

CTC Grades (% incidence)Gemzar plus Carboplatin (N=175) Carboplatin (N=174)All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4

Laboratoryb

HematologicNeutropenia 90 42 29 58 11 1Anemia 86 22 6 75 9 2Leukopenia 86 48 5 70 6 <1Thrombocytopenia 78 30 5 57 10 1RBC Transfusionsc 38 15Platelet Transfusionsc 9 3

Non-laboratoryb

Nausea 69 6 0 61 3 0Alopecia 49 0 0 17 0 0Vomiting 46 6 0 36 2 <1Constipation 42 6 1 37 3 0Fatigue 40 3 <1 32 5 0Neuropathy-sensory 29 1 0 27 2 0Diarrhea 25 3 0 14 <1 0Stomatitis/pharyngitis 22 <1 0 13 0 0Anorexia 16 1 0 13 0 0

a Grade based on Common Toxicity Criteria (CTC) Version 2.0 (all grades ≥10%).b Regardless of causality.c Percent of patients receiving transfusions. Transfusions are not CTC-graded events. Blood transfusionsincluded both packed red blood cells and whole blood.

Table 1: Adverse Events From Comparative Trial of Gemzar Plus Carboplatin Versus Single-Agent Carboplatin in Ovarian Cancera

HypofractionatedIrradiation...Continued from cover

tant boost results in outcomes compara-ble with that of a 5- to 7-week coursefor early-stage breast cancers. Addi -tional studies with a larger body of dataand a longer follow-up period will helpestablish whether this type of radiationtreatment should be routinely used,”said lead author of the study ManjeetChadha, MD, who is the associatechairman of radiation oncology atAlbert Einstein College of Medicineand a radiation oncologist at Beth IsraelMedical Center, New York, New York.“Studies from Europe and Canada haveused accelerated schedules for breastradiation therapy with favorable resultsreported on longer follow-up. In theUnited States, however, there are limit-ed data on this topic.”Chadha, who presented the study

findings at the American Society ofRadiation Oncology’s 51st annualmeeting, said the radiation therapytechnique used in this study is differentfrom previously published experiences.For each patient, the clinicians devel-oped a conformal, personalized planusing three-dimensional dosimetry dataderived from the patient’s unique com-puted tomography scan images.The researchers analyzed data on 112

women who were treated from June2004 to the present for early-stagebreast cancer. All patients had breast-conserving surgery and received accel-erated hypofractionated whole breastirradiation plus concomitant boost. Theresults were reported on 105 patientswho had completed therapy and had aminimum of 6 months of follow-up.The median age of the women was 66years. The concomitant boost wasdelivered using photons in 88 patients,and electron boost was used in 18patients.The researchers found this approach

was highly effective as well as safe. Thecancer did not return to the original siteor to the surrounding region in any ofthe patients. The mean follow-up was24 months (range, 6-57 months). Sur -vival was greater than 95% for patientswith 5 years of follow-up. The re -searchers also found no significantphysical or cosmetic side effects fromthe radiation treatment.The investigators concluded that the

3-week accelerated hypofractionatedwhole breast radiation therapy withconcomitant boost appears to be a well-tolerated schedule and worthy of fur-ther evaluation. Their findings suggestexcellent local control and results thatare comparable with what other investi-gators have found. However, they cau-tion that more research is needed. l

Abraxane for Pancreatic Cancer and Stage IIB to IV MelanomaThe US Food and Drug Administration (FDA) has

granted orphan drug status to nanoparticle albumin-boundpaclitaxel for injectable suspension (Abraxane, AbraxisBioScience) for the treatment of pancreatic cancer as well

as stage IIB to IV melanoma. The drug is currently enteringtwo phase 3 trials. One will compare paclitaxel plus gem -citabine against gemcitabine alone as a first-line therapy foradvanced metastatic pancreatic cancer. The other willcompare paclitaxel against dacarbazine in chemo-naïvemelanoma patients. l

Recent FDA Approval

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GEMZAR plus Carboplatin 95% Cl (8.0-9.7) (N=178)

0 2 4 6 8 10

Carboplatin 95% Cl (5.2-7.1) (N=178)

8.6

5.8(p=0.0038)

Median progression-free survival (months)

0% 10% 20% 30% 40% 50%

GEMZAR plus Carboplatin (N=178)

Carboplatin (N=178)

47.2%

30.9%(p=0.0016)

Overall response rate (%)†

ThThThThThThThThe e eeee ovovovoovo ererrerralalalalll ll l l susususurvrvrvrvr ivivivivalalalalalalaaa d d ddddififififififfefefefefeff rererereereer ncncncncnnnnnnn e e e eee bebebebebebebb twtwtwtwtwtwweeeeeeeeeeeeen n nnnnnnn GEGEGEGEGEGEGEGGEGGEMZMZMZMZMZZMZMZZM ARARARARARARARA /c/c/c/c/c/c/c/carararara boboboboboboboboooplplplplp atatatatttttininininininin ( ( ( (18181818818188.0.0.0.0.0.0.0 m m mmmononononnnththththhhths)s)s)s)s) v vvvvvvvss s s s caccacacaarbrbrbrbbbbbbbopopoopopopoplalalalalalalaatitittitt nn n nn (1(1(1(1( 7.7.7.777 3 3 3 333 momomomomontntntntntnntnthshshshshshshshs) ) ))))))))) wawwawawawaas s ssss nononooonooot t tttt sisisis gngngngngngngngng ififififi iciciciccccanananananannt t t t ttt ((((pppp=0=0=0=00=00.8.8.88.8897979797977)7)777 ..

**** PlPlPlPlPlatatatataa ininininnnumummmmm-s-s-s-senenennsisisisisiisitititittitiveveveee p p pppppatataaaaa ieieieiiientntnntntntnn s s ararararare ee eee dededddedeefiffififfineneneneneneddd d dd dd asasasasasasas p p p p ppatatatatatatata ieieieieieieieii ntnttttts s s s whwhwhwhwww o o oooo dededededdedeveveveveelololollolololop p p p dididididisesessesesss asassase e ee e prprprprprogogogogoggoggrererereressssssssssss ioioioioon n nnn ≥≥≥≥≥6 6 66 66 momomomooom ntntntntnn hshshshshshhhh a aaaftftftftftf erererereer r rrrecececeieieieiviviviviviingngngnggg f f ffiririririrrrstststst-l-l-l-linininine e e plplplpplppp atatatataaa ininiiinumumumummumu -b-b-b-basasasassssededeedeedeeeee c ccchehehhhhhh momomommm ththththtthererererapapapppapppapy.y.†††† InInInInveveveveeststststssstigiggiggatatatorororoororoo -r-rrr-rrevevvvevevieieieieiewewewew d.d.dd.ddddd

SeSeSeSeeSSeSS leeleeeeectctctctctccctccctcct I I I Impmpmpmpmmpm orororororooorrtatattatt ntntntntnttn S SSSSSSSafafafafffffetetetetety y y yy y InInnnInnfofofofofofoormrmrmmmmatatatattatioioioioiooon n nnnnGEGEGEGEGEMZMZMZMZMMMMMM ARARARARARRARRR s s shohohohoululu d d ddd nonononnoot t ttttt bebebebebebb a aadmdmdmdmdmdmininininisisisisisisisstetetetetetererererereered d dd dd totottott p ppp ppatatatata ieieeieei ntntntnttnn s s ss ss wiwiwiwiwiththththhhhhhh k k kknononononononownwnwnwnwnwnn h h hh hypypypypypppypyperererere sesesesess nsnsnsnsn itititttitivivivivitititititty y y y yy ttototototottot t t tt tthihihihihh s s sdrdrdrdrdrdrruguguguguguguggggug. .. . InInnInfufuufuuuuusisiiionononononn t ttttimimmimeseseseseseess o oof f f f GEGEGEGEGEGGEMZMZMZMZMZZMZZARARARARA l llonononongegegegegegeegeer r r r rr ththththanananannnan 6 6 666660 0 0 0 0 00 mimimimimimmmm nunununununnnutetetetetett s s s ss ananananananndd d d momomomomomoomom rerererereee f f fffffrererererererreququququqquqq eneneneneeneeeent t tt t ththhhhhananananan weweweweekekekekee lylylylyyy d dd d ososososininining g g g gg hahahahaaahaaveveveveee b bb bbeeeeeeeen n n nnn shshshshsss owowowwowwn n nn nnn tototoooo i iiincncncnccnn rererereasasasasassasse e e e eee tototototooooooooooxixixiciciccccc tytytytytytytyy. . PPuPuPPuP lmlmlmlmlmlmlmlmlmononononnarararary y y totototooooxixixxixx ciciciciciciitytytytyyyyy h h hhasasasasa b bbbbbeeeeeeeeeeeeeeen n nnnnnnrereereeepopopopportrtrtrtedededede . . InInInIn c cc ccccasasasssssesesesese ooooof f ffff seseseseseeveveveveveveerererereee l llununununu g g g g gggggg tototototot xixixixicicicicccc tytytytytytytty, , ,, GEGEGEGEGEGEGEEMZMZMZMZM ARARARAARAAARAR t tt ttheheheheh raraararaaaapypyypypyyy s s shohohohohohoululuuld d ddd bebebebebebbb d dd dddisisisisi ccocococontntntntn ininininnnueueueueeeu d d dddddddddimimmmmmememmememmmmm dididd atatatatttteleleleeee y y yy anaanna d d dd apapapapppppprprprprp opopopopopopririririiiatattatatttte e eeee susssus pppppppppppppororoortititt vevevevevevevee c cc cararrararree e eeeee memememmeem asasaaaasururururuuu esesesesesss i insnsnsnsssnssn tititititit tututuuuuuteteteteteed.d.dddd H H HHemememememeeee ololololo ytytyytyyty iciccic UrUrUrUrUrUrUUUU emememememmicicccic S S S SSynynynynnyndrdrdrdrrromomomome e e e e (H(H(H(HHHHUSUSUSUSUSUSUUUS)) ) ananananaa d/d/d/d/d//d orororoo r rrrrreneneneneeneene alalalal f f f faiaiaiiaiiilulululul rererererrer h hhhhhavavavavvvve e bebebeeeeeeeenenenenenenn r r r repepepeepepeporororororro teteteteteteteted d d d d fofofofofoofoof lllllllowowowowowoooo inininininnnnnnng g g g gg ggggg onononononooone e e orororor momomomoooooooorereeeee d d d dosososoooo esesesesees o ooooooff f GEGEGEGEGEGGEGEMZMZMZMZMZMZARARARARARRA . ReReReReRRRRR nanannnnn l l l fafafafaf ililurururuuure e e e eeeeee leleeeadadadaddddinini g g gg gg totototoo d dd deaeaeaeaeeaththhthhh o o o oooor rr rr rereeeeeququququuququiririri ininnng g g g g g gg dididididid alalalalalalaa ysysysysy isisisis, , , , dededededddeded spspspspitititititii eeedididddddd scscccscccononononntitit nunununuatatatata ioioioioiooi n n ofofofo t thehehehehhehhh raraaaaapypypypyyyyy, , ,, hahahahahhh ss s s sss bebebebebebeenenenenee r rrrrrarararrrreleleleleleee y y y y rererereepopopopoppp rtrtrtrtededededee . . ThThThThThThThhhe e e eee mamamamamamamam jojojojojoriririririr tytytytytyty o o oo oooof f f fff ththththththe e e eeee cacacaaaaasesesesesees s ss ofofofofoo rererererrrrr nanaanal l fafafafafaff ilililillururururururu e e e ee leleleleadadadadadaddddddininning g ggg tototototoooo d ddddeaeaeaeaeaaeae thththththt w wwwwwwerererere e ee dudududududuee e eee totototott H HHHHHHUSUSUSUSUS. . SeSeSeSeSeSeeriririr ouououooooo s s s s s ssss heheheheheheheh papapapaapaapaatotototoot totototoooooxixixixixxx cciciccitytytytytyyy, , ,,, inininininiinnclclclclcllududududdududinininining gg gggglililivevevevevevev r rr rrrr fafafafaililii ururururrre e e ee anananaannaa d d ddd dedededeeatatata h,h,h,h,hh,h h hhhhhhhhasasasas b b bbbbbeeeeeeeeee n n nnnn rerererererr popopopoppp rtrtrttrtrtrtr ededdeddd v v v verererery y yy y rarararaaraaarererereelylyylylylylylyy i i iiin n papapapaapp titittt enenenne tststststtsss r rececececee eieieieieiivivivivingngngngggng G G G GG GGEMEMEMEMMMMMMZAZAZAZAAR R RRRRalalalalllononononoooonono e e e ororororooo i i iin nn nn cococococc mbmbmbmbmbmbmbininnatatatatattaa ioioioioioioon n n nn n wiwiwiwiwiththththttht o oooootththththththerererererere p pppototototttttenenenenenntitittttt alalalalaa lylyylyly h h h hepepepepepee aatataaaa otototottototooo oxoxoxoxoxoxoxxiciciccccc d d d dddrururururrrur gsgsggsgg . . GEGEGEGEGEEMZMZMZMZMZMMMM ARARARARR i iiiiiis s s sPrPrPrPrPrPPrrrP egegegege nananananaann ncncncy y y y y yy CaCaCCaC tetetetettt gogogogogg ryryryryy D D DD.. GEGEGEGEG MZMZMZMZZARARARARAA cccananannnn c ccccauauauauusesessesss f f f fffetetetete alalalala h h h h hharaararrraarm m mm m whwhwhwwhwhwhwwww enenenennnn a a a aadmdmdmdmddmdmininininnisissssssteteteteteteeeererered d d ddd totototto a a aa aa prprprprprpp egegegeggggggggnananannnantntnt w wwwwwomomomomomoomanananaaaa . UsUsUsUsssUse e eeee cacacacacccc ututututu ioioioion n n n inininin p pp patatatatieieeeientntntntttttts s s ssssss wwiwiwiww ththththhhh p ppppprererere-e-e-e-e-- xixixixiixistststststststsstttsssts ininining g g ggg rererererererereenananannnan l l l l imimimmimmimpapapapaaaaaaaaaaiririririrmemememmmmmm ntntntnttn ororor h hhhhhhhhhepepepepepeeeee atatatatticicicccc i i insnsnsnsn ufufufufufufffififiif cicicicicicic enenennnncycycyyy. . AdAdAdAdAAA mimimimimimininnininnnn ststtttraraaaaatittit onononn o o oof f f GEGEGEGEGEGEEMZMZMZMZMZMZARARARARAARA m mmmmmmmayayayayaaa e eeeeexaxaxaxaaaaacececeeceecerbrbrbbbbbbatatatate e eee ee ununununuu dedededded rlrlrrr yiyiyingngngngngnggg heheheheeepapapappapappp tititititic c cc cc ininininnsususuufffffffff icicicicieieiieieieencncncn y.y.y.y.yy TT T Theheheheh o oo oo ooptptptptptp imimimimimi umumumumumuu r r r rr egegegeggegee imimimimimmmenenenn f fffffforororor ss ssafafafafafaafe e eeeee adadadadaddmimimimimmmm nininininiststststss rarararaaaatititttttt ononononnoo ooo of f f f ff GEGEGEGEGEGEGEGEGEEMZMZMZMZMZMZMZMZARARARARAAAAwiwwiw thththth t tt theheheeheeeerararar pepepepepepep utututuuticicicci dd d ddddosososoososesesesesess o ooof f f fffffff rararrraraadidididiatatatatttioioiooooon n nnnn hahahahahaas s ssss nononononnot t tttttt yeyeyeyeeet t ttt bebebebebebebeenenenene d d d ddeteteteteteeee ererererre mimimimiiminenenennenn d d ddddd ininnn a aallllll tt t tttttumumumumu orororororor t t t typypypyppeseseseseee . . GEGEGEGEGGGG MZMZMZMZMZZZZZARARARARRR h hhhhhasasasassss r r radadadadadaadioioioioioooseseseeeeensnsnsnsnsnsitititiitizizizzzzininininng g g acacaaca tititit viviviviviv tytytytyttyty a aa andndndndndnddd r rrrrradadadaddaa iaiaiaiatitititionononn r rrrecececececcee aalalalalalaaa l l ll rererereacacacactititititt ononononnnnns s s s hahahahahaavevevevevevev b b b b bbeeeeeeeeeeeeeeen nnnnnnnnnnnrererererepopopopopooppp rtrtrtrtededededddddd.. ItItItItItItItIt i is s s s sss nononooooonot tt knknknkkkkknowowowowowoowoo n n nnnn whwhwhwhwhwwhetetetetee heheheheh r r r r GEGEGEGGEEGEG MZMZMZMZMMZMZMM ARARARARARARRA o oo ooooor r rrr itittittts s ss mememeeemetatataaaaaaaabobobobobobb liliiiteteteteteess s arararaare e eeee exexexxxxcrcrcrcrretetetetetee ededededede i i i n n n

huhuhuhuhhuumamamamamamamamaamannn n mimimimimimimm lkllk. . ThThThThThThThThTTTTT e e eeee efefefeffefefefectcttcttivivivivvi eneneeeee esesesesss s ssssss ofofofofff G G G G GEMEMEMEMEMEMEMZAZAZAZAZAZAZAAR R RR RR ininininiinnn p p pppppedededdeddiaiaiaiaatrtrtrtrrriciciicic p ppp pppatatatata ieieeentntntnts s ss hahahhahh s s nonononoonn t t tttt bebebebebeenenenene dedededededededdeddd momomomoomoooooonsnsnsnssnn trtrrtratatatataaaaa ededededeeed. . ThThThThT e e e tototototoxixixixiciciccitititititititittt eseseseseee o o oooooof f f f fff GEGEGGGGGGG MZMZMZMZMZMMZZARARARARAA o ooobsbsbsbssserererereervevevevvv d d dddd ininininnnn p ppppedededededede iaiaiatrtrtrtrrt icicicicicic p p p pp pppatatatattieieeeeentntntntntntttss s s wewewewewewerereeeeee s ssimimimimmilililillllararararaa totototo t t ttttthohohohoooseseseseees r r r rrepepepepepororororortetetetetettt d d dd inininini a aaadudududududd ltltltttts.s.s.s.s. G GGGGGEMEMEMEMEMMMEMMZAZAZAZAZAZZAAAAAAAR R RR R RRR clclccccc eaeaeaaearararararancncncncceee eeee isisisisi a aaffffffffececececeee teteeeed d dddd bybybybyb a a a aaaaaaagegegg a aaaas s s ss weweweeeeelllllll a aas s s gegegegegeegendndndndererererr. . .PaPaPaPaatititititt enennnenennntstststs r rrrecececececceieieieiee viviviviingngngngnggng t t t theheheerarar pypypyppypyp w w www wwititititiitth hh hhh GEGGEGEGEGEG MZMZMMMMMZMM ARARARARAAAAAR s s sshohohoohohoulululululd d ddddd bebebebebbebe m m mmmmmmononononoonooo itititititi ororororooo edededed cc ccccccccloololosesesses lylyyyyy b bb by y yyyy a a aaa phphphphhhysysysysysyysysysyssiciciaiaaaan n nnnnnexexexeexexexxpepepepeppepp ririririririirr enenenenencecececeed d ddd ininininin t ttt tttheheheheheehee u usesesesesees o ooof f f f f cacacccccc ncncncncncerererereee c c c cheheheheeeemomommomom thththththhhererereerapapappapappeueueueue titittittiiccc c cc agagagagagenenennnenentstststs. .

AbAbAbAbAbbbrbbrbbbb eveveveveve iaiaiaiaaaateteteteeeteed d d d AdAdAdAdAAdAdAdveveveveveversrsssse e e e EvEvvvenenenene tstststst ( (( ((((((% % %%%% %% ininininnciciccicccccccc dededeeeencnccncncnn e)e)e)e))e))eeThThThTTThThhe e e e momomomoomoststststststt s s ss ssseveveveveeeee erererereeeee e e ee ee adadadadadadadvevevevvevv rsrsrsrse e ee evevvvenennne tstststst ( ((( ((((GrGrGrGrGrG adadadadddeseseses 3 3 3 3333/4/4/4///4// ) ) ) ) )) wiwiwiwiwiwiw ththhththhh G GGGGGEMEMEMEMEMMZAZAZAZAAAAAR RR RR RR plplplplp usususususu c cccarararararara boboboboboooopplplplpplp atatataatininnininn v v vvererererersusususus s s cacaccacccc rbrbrbrbrbbrbopopopopooopoplalalalalaatititititittitin n n alalalalla onononoone,e,e,eee r r resesessspepepepepeectctctcttiviviviviveleleeee y,y,y,y,y, f forororor tt tthehehehheheheheee t tt ttrereereeeeatatattttmememememeem ntntntntn o ooooof f fffff papapapapatititititiienenenene tstststststs w w w wwwititititith h hhh adadadaddaaaaaa vavavavaavv ncncncncnn edededdedd o ooovavavaavaririrrr ananaaaaaa cacacacacac ncncncncncererrerrrere w wwwwwererererrrrre e eee neneneeutututututtttrorororoooooopepepepeeep nininiiaa aa aa (7(7(7(7(771 1 1 1 1 1 vsvsvvv 1 11112)2)2)2)2)2))2)222); ; ; ; ;;;; hththththhrorororrrrombmbmbmbbm ocococococococo ytytytytopopopooppeneneeee iaiaiiiaiaiiia ( (((((3535353 v v s s sss 1111111111););); l llleueueueuukokokokooopepepepep ninin a a a a (5(5(5(5(553 3 333 vsvsvsvsss 7 777););); anananana ememememeee iaiaaiaaaaa ( ( (282828288282 v vvvvs ss sss 11111111111);););););; n nnnnnnauauauauauauuseseseea a a aaa (6(6(6(6(6(6(6 v v v vvvvs ss s 3)3)3)3))3 ; ; ; ;; ; vovovovomimimimimmm tititt ngngngngnggng ( ( ( (6 6 66 vsvsvsvsvsv 33 3 3););;);; a aaaandnndndnnn c c ccconononooooononststststipipipippipatataa ioioioioii n n n n n n n (7(7(77(7 v vvvs s s s s 3)3)3)3)3)33).... ThThThThThThe e e momomomomoststststtsttt cococococcommmmmmmmmm ononononnon a a a advdvdvdvdvdvdd erererererseseseseeeseee ee eeevevevevevevevv ntntntntnnnts s s s s (a(a(a((aalllllllll G GG GGGGrarararaaaadededeedees)s)s)s)s) w wwwwereereere e e eeeee neneneneneneututututututu roroooooppepepepepep nininn a a aa (9(9(9(9990 0 000 vsvsvsvsvsvsv 5 5 5 5 58)8)8)8)8); ; ; ;;; lelelelleleukukukukukukuu opopoppopopeneneneniaiaiaiaia ( ( (8686868686868 v vvvvvvvs s s 707070707070077 );););))))) anananannnnnnnememememmemmmiaiaiaiaaiaaa ( ( ((8686868686868666 v vvvs s ss 7575757577 );););); t tttttthrhrhrhrhhhhhhh omomomomommmmmmmboboboboboooocycycycyycycytotototopepeppepepenininiia a a aaaa (7(7(7(7(7(778 8 8 8 vsvsvsvvv 55 557)7)7)7)7)7)))); ; ;; RBRBRBRRRBR C C CCCCCC trtrtrtrrananananannnsfsfsssfusususuu ioioioioon n nnn (3(3(3338 8 888 vsvsvsvsvvs 1 111115)5)5)5)5 ; ; ; ; ; alalaaa opopopopo ecececececciaiaaaaaa (4(4(44449 9 999 vsvsvsvsvvss 1 17)7)7)7)); ; ; ; neneneneurururropopopopopatatatattaaa hyhyhyhyhhyh /s/s/s/s//seneneneeee sosossosoryryryryryryyyryry ( (((29292992992 v vvvvs s ss 2727272777););));) n nnnnnauauauaauseseseseeeeea a aa (6(6(6(6(6(69 9 9 99999 vsvsvsvsvs 6 6 661)1)1); ; ;;; fafafafatitititittt guguguugue e e e ee (4(4(4440 00 000 vsvsvsvsvsv 3 3 333332)2)2)2)); ; ; ; vovovovoomimimimimm titititiitingngngngngngng (4(4(4(44446 6 666666 vsvsvsvsvv 3 3333336)6)6)6)); ; ;;; ;; didididdd arararara rhrhrhrhhrheaeaeaeaaa ( ( ( (252525252555 v v v s ss s ss 1414141444444)););); a a aaandndndndn c c c cconononstststststssss ipipi atatatatta ioioioiooooon n nn (4(4(4(444442 22 222 vsvsvsvsvsvss 3 3 3 3337)7)7)7)7)7)..FoFoFoFFoF r r rrrr adadadadaaaa didididititititionononononnalalalalaa s ss afafafafaaa etetetetty y yy ininininfofofofoof rmrmrrmrmatattatatata ioioioion,n,n,n, p pp ppleleleleeeleasassa e e ee sesesesee e e ee BrBrBrBrBrBBBB ieieieiiei ffff f f SuSuSuSuSuS mmmmmmmmararaa y y yyyy ofofofofoof P PPPPPrerererereeeeescscscscs ririririrrr bibibibibibibiingngnggggg InInInInnInnI fofofofofofofformrmrmrmmatatatatataata ioioiooion n nnnn ononononono a aaaaaadjdjdjdjddd acacacacaaa eneneeeneeeee tttttttt papapapapappap gegegegege..

FoFoFoFooFoor r r rrr r momomomoorerererrr i infnfnnfn orororormamamamam titititititit onononnoon a aaabobobobobobobobobb ututututttt c c c c c anananancececececccer r rr trtrtrttreaeaeaeeaeeeee tmtmtmtmtmmeneneneene t t t wiwiwiwiiwiwiw ththththhtt G G GGGGGEMEMEMEMEMEE ZAZAZAZAAAAR,R,R,R, v vvvvvvvisisisisitittit GEGEGEGEGGG MZMZMZMZMZZARARARAR.c.cccomomomomoomooo ..

GEMZAR/carboplatin is one option for 2nd-line treatment of your patients with platinum-sensitive* advanced ovarian cancer.

Myelosuppression is usually the dose-limiting toxicity with GEMZAR therapy.

GEMZGEMZGEMZGEMZEG ARARAAAR®®®®® is is isis s a rea rea rer gistgiststsgisterederederedderee tra tratttt demademademamamm rk ork ork okkkkk f Elf Elf Ef E i Lii Lii Lii L lly lly lyyyyy and and annn CompCompCompCompCCompCCCComC any.any.yanyanyny GC5GC58GC58GC583213213213213 050 050050 0509 9 9 9 9 9 PRINPRINPRINNTED TED TEDTED IN UIN UIN UUUSA SASASA S © ©©© 200 200 200 20020009, L9, L9, L9, LLillyillyillyilly USA USAUSA USASU AA, LL, LL, LL, LLLL C. AC. AC. AC. ACCCCCC LL RLL RLL RLL RRRRIGHTIGHTIGHTIGHTHTTTS RES RERERERRR SERVSERVERVERSERVERVSE ED.ED.ED.ED

February 2010, Vol 3, No 1

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Transcript of February 2010, Vol 3, No 1