2011 Cancer Program Annual Report

Adele R. Decof Cancer Centerat Roger Williams Medical Center

TABLE OF CONTENTS

p. 3 Cancer Committee Membershipp. 4 Message from the Cancer Committee Chairp. 5 Message from the Hospital President and Cancer Center Director

Cancer Registryp. 6-11 Cancer Registry & Statisticsp. 6-7 2010 cases for Roger Williamsp. 8-9 Analytic Primary Site Tablep. 10-11 State and national comparison data for breast cancer

Special studiesp. 12-14 Accuracy and Yield of Diagnostic Laparoscopy for Pancreatic Cancer

at Roger Williams from 2004-2011

Departmental Reportsp. 15-16 Hematology Oncologyp. 17-18 Surgical Oncologyp. 18-19 Radiation Oncologyp. 19-20 Diagnostic Imagingp. 20 Blood and Marrow Transplantationp. 20-21 Protocol Officep. 21 Oncology Nursingp. 21 Case Managementp. 21 Nutritionp. 22 Cancer Center Pharmacyp. 22 Rehabilitationp. 22 Outreach

2011 CANCER COMMITTEE MEMBERSHIP

Physician Members

Dr. Mohit Kasibhatla, Radiation Oncology, ChairmanDr. Brian Stainken, Interventional RadiologyDr. Peter Libbey, PathologyDr. Francis Cummings, Medical OncologyDr. Bharti Rathore, Medical OncologyDr. Ritesh Rathore, Medical OncologyDr. James Koness, Surgical Oncology, Cancer Liaison PhysicianDr. N. Joseph Espat, Surgical OncologyDr. Timothy Connelly, Anesthesiology, Pain Control/Palliative CareDr. Marshall Kadin, Dermatology

Non Physician Members

Cancer Center Director: Kathy Perry, RN, MBA, Cancer Program AdministratorCancer Center Manager: Kathleen Starick, RNOncology Nurses: Jennifer Parker, RN; Patricia Cafaro, RNCase Management: Mary Beaudette, RNCertified Tumor Registrar: Cheryl Raffel, RHIA, CTRPerformance Improvement: Nancy Fogarty, Quality Improvement CoordinatorDietary/Nutrition: Donna Castricone, RDCancer Center Pharmacist: Thomas Habershaw, RPhPastoral Care: James WillseyAmerican Cancer Society: Lisa StorsTumor Board Coordinator: Billie BakerProtocol Office Manager: Robin Davies, RNRehabilitation: Lorraine SloanePsychiatry: Elinor Collins, RN, MS, CS, PPNSPublic Relations: Brett Davey, Public Relations, Community Outreach CoordinatorBMT Unit Manager: Karen Bissonnette, RN

3.

From the Committee Chairman

I am pleased to share the 2011 Cancer Committee report from RogerWilliams Medical Center. The past year has been an eventful one as ourteam of dedicated physicians, scientists and nurses continue to makeimportant advances in cancer research, diagnosis and treatment. Thanksto these efforts, Roger Williams’ cancer program is growing in reputationas a place where the latest in treatment options intersect with the best inpersonalized, compassionate care.

This report will provide you with an overview of the people and programsthat maintain excellence in cancer care at RWMC. A particular highlightof our cancer care program is the emphasis we place on providing all ourpatients with multi-disciplinary care. In our cancer program, there arenumerous opportunities — from tumor board and grand rounds tophysician lectures and cancer committees — where our clinicians shareinformation and collaborate to improve care. Our multi-disciplinary approach ensures that each andevery patient receives cutting-edge, expert care.

Of course, data and selected highlights from our program do not adequately capture the personallevel of care that we strive to provide for all our patients and their families. We dedicate this annualreport to the people who entrust their care in our hands and the many members of the healthcareteam who fulfill that sacred promise.

Dr. Mohit KasibhatlaCancer Committee Chairman

4.

Clinical leadership carries with it many responsibilities, rangingfrom setting standards of excellence, to educating others, improvingtreatment modalities or evaluating emerging technologies.

Against these benchmarks, we are proud to assert our belief thatRoger Williams Cancer Center is today our state’s unquestionedleader in cancer care and research. 2011 was another growthyear for the Cancer Center at Roger Williams. In medical oncology,our outpatient visits increased by 11 percent, due in part to ourdelivery of care in the community at satellite locations. And ourinfusion center provided a record number of treatments.

In terms of setting the bar for quality in cancer care in RhodeIsland, we are proud to note that the Hematology/OncologyDivision is one one of only 41 practices in the nation to receive the inaugural certification from the QualityPractice Initiative from the American Society of Clinical Oncology. In addition, last year the Hematology/Oncology fellowship program at Roger Williams received full ACGME accreditation for another three yearsand we were pleased to be able to recruit our our first Surgical Oncology Research fellow.

Leaders educate...and in the past year, we reached new levels in teaching other clinicians. Over the courseof two days in March 2011, leading cancer experts from around the country came to Providence to participatein the first-ever New England Sarcoma Symposium. We were proud to host and organize this academicsymposium, which attracted more than 140 clinicians.

Other programs — like the “Advanced Laparoscopic Liver Resection & Digital Pancreatectomy MasterClass” that we hosted in November — gave us further opportunity to share our knowledge and learn morefrom our colleagues in cancer care from around the country. And, as an affiliate of the Boston UniversitySchool of Medicine, we are proud to host one of only 18 surgical oncology fellowships in America.

This is a microcosm of our approach to cancer care: bring together the best possible multi-disciplinary teamand build off the best practices of our own team and of others. This is happening in our research laboratories,nursing units, infusion center, operating rooms, and numerous other areas where care is provided.

We have a proud history of firsts in Rhode Island in places like our Blood and Marrow Transplant unit,which is the only program of its kind in the state. Roger Williams continues to innovate in our approaches tocancer. In 2011, we became the first hospital in New England to utilize the NanoKnife system to destroytumors on sensitive organs like the pancreas and liver.

Perhaps the most important aspect of our cancer leadership is our abilitiy to integrate the various modalities-- medical, radiation, surgical -- with our commitment to research and technology. Through this integration,we have forged a powerful tool in the treatment of cancer...one that drives quality and efficiency. And weplace this tool in the hands of an extremely gifted team of physicians, nurses, technologists andresearchers....compassionate people who have brought to our patients a rare blend of clinical excellenceand extremely personal care.

We will not rest on our laurels. In the coming year, we will continue our pursuit of excellence and thechallenge of clinical leadership in cancer.

Kenneth H. Belcher Dr. N. Joseph EspatPresident and CEO Director, Adele R. Decof Cancer CenterRoger Williams Medical Center Chief, Surgical Oncology

From the Hospital President and Cancer Center Director

5.

THE CANCER REGISTRY AT ROGER WILLIAMS

The Cancer Registry at Roger Williams Medical Center is responsible for capturing a complete summary of acancer patient’s disease; from diagnosis through the lifetime of the patient. This summary or abstract provides anon-going account of the cancer patient’s history, diagnosis, stage of disease at diagnosis, treatment, and currentstatus. In addition to data analysis, the Cancer Registry also monitors quality of care and clinical practice guidelines,provides benchmarking services, and provides information relating to patterns of care and referrals.

2010 CASES for Roger Williams Medical CenterThe 2011 Cancer Registry report utilizes complete data from the calendar year 2010. A total of 504 new caseswere added to the Cancer Registry database in 2010, including 418 analytic1 (newly diagnosed) cases and 86non-analytic2 cases (those diagnosed and treated elsewhere in the past, and new to RWMC in 2010). The CancerRegistry maintains a 90% or greater follow-up rate on patients diagnosed and treated at Roger Williams MedicalCenter and is currently following over 4,000 patients.

Kent12%

Washington3%

Bristol4%

Massachusetts4%

All Others2%Providence

75%

ROGER WILLIAMS MEDICAL CENTERDistribution by County ‐ 2010 Analytic Cases ‐ Total 418

CANCER REGISTRY STATISTICS

ALL OTHERS50%

BREAST12%

COLON11%

LUNG11%

SKIN11%

PANCREAS5%

ROGER WILLIAMS MEDICAL CENTERFive Most Frequent Sites ‐ 2010 Analytic Cases ‐ Total 418

MOST FREQUENT SITESThe five most common sites of cancerseen in 2010 at Roger Williams wereBreast (12% - 49 cases) Colon (11%- 48 cases) Lung (11% - 45 cases)Skin (11% - 44 cases - excludingbasal & squamous cell ca) andPancreas (5% - 22 cases). Thesefive sites comprise nearly half of allnewly diagnosed cancers seen at thehospital during 2010.

RESIDENCE AT DIAGNOSISRoger Williams Medical Center islocated in Providence County. Themajority of the new cancer casesseen at the hospital during 2010resided in Providence County,comprising three-quarter of allcases. With close proximity toMassachusetts, four percent of thenew cases resided in thatneighboring state. Included in theother category are several casesfrom Connecticut.

6.

26

2

9

2421

3834

60

4944 44

27

42

4

12

0

10

20

30

40

50

60

Number of

 Cases

0‐29 30‐39 40‐49 50‐59 60‐69 70‐79 80‐89 90+

ROGER WILLIAMS MEDICAL CENTERAge at Diagnosis by Gender ‐ 2010 Analytic Cases ‐ 418 total

MALE ‐ 201 Cases FEMALE ‐ 217 Cases

26

84

5761

100

23

67

0102030405060708090

100

Number of

 Cases

Stage 0 Stage I Stage II Stage III Stage IV Unknown N/A

ROGER WILLIAMS MEDICAL CENTERAJCC Stage at Diagnosis ‐ 2010 Analytic Cases ‐ 418 total

N/A = Sites with no AJCC Stage

AGE AT DIAGNOSIS BYGENDERIn 2010 the gender distribution ofnew cases was 52% female and 48%male, similar to previous years. Themost common age group for casesoverall was the 60-69 year oldgroup, which accounted for over onequarter of all cases (26%). This agegroup also saw a higher number ofmales than females, whereas femalesaccounted for more cases in theyounger and older age groups, thoseunder age 40 and over age 80.

AJCC STAGE OF DISEASE ATDIAGNOSISCases in the Cancer Registrydatabase are categorized accordingto the TNM Staging systemdeveloped by the American JointCommittee on Cancer (AJCC) todescribe the extent or spread ofdisease at diagnosis. Most cases inthe database are able to be stagedusing this staging system, althoughsome sites do not have an AJCCstaging schema, including braintumors, leukemias and multiplemyeloma. (These are included in theN/A grouping – not applicable).Other cases are unable to be stageddue to an incomplete workup or thepatient going elsewhere for furtherstaging or treatment. Cases with anunknown stage were kept to a lownumber during 2010, with only 5.5%of the newly diagnosed cases beingunknown stage.

7.

ROGER WILLIAMS MEDICAL CENTER

2010 Cases - Cancer Registry Analytic Primary Site Table

Primary Site

Total

Stage 0

Stage I

Stage II

Stage III

Stage IV

N/A

Unknown

ORAL CAVITY & PHARYNX 14 0 1 1 4 7 0 1

Tongue 3 0 1 0 0 2 0 0

Salivary Glands 1 0 0 0 1 0 0 0

Floor of Mouth 3 0 0 0 0 2 0 1

Gum & Other Mouth 2 0 0 1 1 0 0 0

Nasopharynx 1 0 0 0 1 0 0 0

Tonsil 2 0 0 0 0 2 0 0

Oropharynx 2 0 0 0 1 1 0 0

DIGESTIVE SYSTEM 131 5 19 24 32 42 1 8

Esophagus 10 0 1 0 4 5 0 0

Stomach 12 0 5 0 2 4 0 1

Small Intestine 4 0 0 1 2 1 0 0

Colon Excluding Rectum 48 4 5 7 13 15 0 4

Cecum 10 0 0 3 3 4 0 0

Appendix 1 0 1 0 0 0 0 0

Ascending Colon 11 0 1 2 3 3 0 2

Hepatic Flexure 3 0 1 0 1 1 0 0

Transverse Colon 2 0 1 0 0 1 0 0

Splenic Flexure 2 1 0 0 0 0 0 1

Descending Colon 2 0 0 1 1 0 0 0

Sigmoid Colon 12 3 1 0 5 2 0 1

Large Intestine, NOS 5 0 0 1 0 4 0 0

Rectum & Rectosigmoid 21 1 5 7 6 1 0 1

Rectosigmoid Junction 11 1 2 4 3 1 0 0

Rectum 10 0 3 3 3 0 0 1

Anus, Anal Canal & Anorectum 1 0 0 0 1 0 0 0

Liver & Intrahepatic Bile Duct 5 0 1 0 1 2 0 1

Gallbladder 4 0 0 0 1 3 0 0

Other Biliary 3 0 0 1 0 1 1 0

Pancreas 22 0 2 8 2 9 0 1

Retroperitoneum 1 0 0 0 0 1 0 0

8.

Myeloid & Monocytic Leukemia 9 0 0 0 0 0 9 0

Acute Myeloid Leukemia 6 0 0 0 0 0 6 0

Acute Monocytic Leukemia

1 0 0 0 0 0 1 0

Chronic Myeloid Leukemia

2 0 0 0 0 0 2 0

Other Leukemia 1 0 0 0 0 0 1 0

KAPOSI SARCOMA 1 0 0 0 0 0 1 0

Kaposi Sarcoma 1 0 0 0 0 0 1 0

OTHER DEFINED SITES 22 0 0 0 0 0 22 0

Total 418 26 84 57 61 100 67 23

RESPIRATORY SYSTEM 50 1 5 3 6 31 1 3

Larynx 5 0 0 0 1 3 1 0

Lung & Bronchus 45 1 5 3 5 28 0 3

SOFT TISSUE 5 0 0 2 1 1 0 1

Soft Tissue (including Heart) 5 0 0 2 1 1 0 1

SKIN (Excluding Basal/Squamous) 44 7 24 2 4 2 2 3

Melanoma -- Skin 40 7 24 2 3 1 0 3

Other Non-Epithelial Skin 4 0 0 0 1 1 2 0

BREAST 49 8 15 17 2 3 0 4

Breast 49 8 15 17 2 3 0 4

FEMALE GENITAL SYSTEM 2 0 1 0 1 0 0 0

Corpus & Uterus, NOS 1 0 1 0 0 0 0 0

Ovary 1 0 0 0 1 0 0 0

MALE GENITAL SYSTEM 7 0 2 1 1 2 0 1

Prostate 7 0 2 1 1 2 0 1

URINARY SYSTEM 20 5 5 2 4 2 0 2

Urinary Bladder 12 5 3 2 0 1 0 1

Kidney & Renal Pelvis 8 0 2 0 4 1 0 1

BRAIN & OTHER NERVOUS 15 0 0 0 0 0 15 0

Brain 6 0 0 0 0 0 6 0

Cranial Nerves / Other Nervous 9 0 0 0 0 0 9 0

ENDOCRINE SYSTEM 13 0 10 1 1 0 1 0

Thyroid 12 0 10 1 1 0 0 0

Other Endocrine including Thymus 1 0 0 0 0 0 1 0

LYMPHOMA 21 0 2 4 5 10 0 0

Hodgkin Lymphoma 4 0 0 1 2 1 0 0

Non-Hodgkin Lymphoma 17 0 2 3 3 9 0 0

NHL - Nodal 13 0 2 2 2 7 0 0

NHL - Extranodal 4 0 0 1 1 2 0 0

MYELOMA 10 0 0 0 0 0 10 0

Myeloma 10 0 0 0 0 0 10 0

LEUKEMIA 14 0 0 0 0 0 14 0

Lymphocytic Leukemia 4 0 0 0 0 0 4 0

Acute Lymphocytic Leukemia

1 0 0 0 0 0 1 0

Chronic Lymphocytic Leukemia

2 0 0 0 0 0 2 0

Other Lymphocytic Leukemia

1 0 0 0 0 0 1 0

ROGER WILLIAMS MEDICAL CENTER

2010 Cases - Cancer Registry Analytic Primary Site Table

Primary Site

Total

Stage 0

Stage I

Stage II

Stage III

Stage IV

N/A

Unknown

9.

State and national comparison data for breast cancerAge at diagnosis and AJCC stage at diagnosis for the RWMC breast cancer cases, themost common cancer in 2010, are compared to data available from the National CancerData Base (NCDB). This data is grouped into national data (U.S.) and state data (RhodeIsland) to see how cases from RWMC compare to cases reported by other facilities.(Cases from 2009 are the most recent year available for the NCDB). Survival data isalso available from the NCDB, but is grouped by U.S. cases and by the northeast regionof the U.S. By reviewing this information, our hospital can determine if any changes needto be made to improve care available to cancer patients.

Age Group of Breast Cancer Diagnosed in 2009 Roger Williams Medical Center, Providence RI

vs. U.S. Hospitals & State of Rhode Island Hospitals (Data from 1397 U.S. Hospitals, 11 Rhode Island Hospitals)

Age Group RWMC (N) U.S. (N) RI (N) RWMC (%) U.S. (%) RI (%)

Under 20 0 18 0 0% 0.01% 0%

20 - 29 0 1002 3 0% 0.47% 0.27%

30 - 39 1 8674 29 1.67% 4.10% 2.59%

40 - 49 10 37501 214 16.67% 17.72% 19.09%

50 - 59 17 52943 286 28.33% 25.02% 25.51%

60 - 69 14 53727 276 23.33% 25.39% 24.62%

70 - 79 7 36142 177 11.67% 17.08% 15.79%

80 - 89 8 19250 124 13.33% 9.10% 11.06%

90 + 3 2371 12 5.00% 1.12% 1.07%

Unknown 0 1 0 0 0% 0%

TOTAL 60 211629 1121 100% 100% 100%

Age of RWMC breast cancer patients was fairly similar to RI & US ages, with a slightly higher percentage of

RWMC patients age 80 and older, and slightly lower percentage of patients age 70-79.

AJCC Stage of Breast Cancer Diagnosed in 2009 Roger Williams Medical Center, Providence RI

vs. U.S. Hospitals & State of Rhode Island Hospitals (Data from 1397 U.S. Hospitals, 11 Rhode Island Hospitals)

STAGE RWMC (N) U.S. (N) RI (N) RWMC (%) U.S. (%) RI (%)

0 8 36788 228 13.33% 17.38% 20.34%

I 20 67173 433 33.33% 31.74% 38.63%

II 15 43318 248 25.00% 20.47% 22.12%

III 6 14920 63 10.00% 7.05% 5.62%

IV 2 6680 38 3.33% 3.16% 3.39%

NA 0 189 0% 0% 0.09% 0%

UNK 9 42561 111 15.00% 20.11% 9.90%

TOTAL 60 211629 1121 100% 100% 100%

Stage at diagnosis for RWMC overall followed the same general pattern as RI & US cases with more early

stage cases and only 3% that were stage IV. RWMC had less Stage 0 cases than RI & US and a slightly higher

percentage of Stage III cases. RWMC also had 5% lower unknown stage cases than the US, but 5% higher than

the RI cases.

10.

Breast Cancer Survival RWMC VS NCDB & Northeast Northeast Region = MA, ME, CT, RI, NH, VT NCDB All U.S. Cases 2003-2004

Data from 1361 Programs in U.S. & from 108 Programs in Northeast Region

AJCC

Stage At

Diagnosis

# of

Cases

U.S.

2003-04

#of Cases

NE

Region

2003-04

# of

Cases

RWMC

2003-04

# of

Cases

RWMC

2005-06

5 Yr

Survival

U.S

2003-04

5 Year

Survival

NE Region

2003-04

5 yr

Survival

RWMC

2003-04

5 Yr

Survival

RWMC

2005-06

Stage 0 41,257 3,610 24 22 95.2 95.8 90.5 89.8

Stage I 82,523 6,421 43 26 91.5 91.8 88.1 95.5

Stage II 59,761 3,864 22 25 84.0 84.1 86.4 75.4

Stage III 22,990 1,334 23 7 64.0 70.1 77.7 51.0

Stage IV 8,181 554 6 3 20.7 21.1 16.7 33.3

OVERALL 214,712 15,783 118 83 84.4 86.5 82.8 80.7

C: 2012 By James M. Banasiak

CONCLUSIONThe primary purpose of any Cancer Registry is to collect complete, timely, high quality data toreflect all aspects of a patient’s disease. As the data is combined with that from other medicalcenters and other communities, researchers can learn and understand more about cancer andthe overall disease process. The Cancer Registry works with physicians, researchers andhospital administration to assist with cancer program development. The Cancer Registry is alsocommitted to assisting the Cancer Program’s multidisciplinary health care team to ensurecompliance with the required standards and maintain accreditation by the American College ofSurgeons Commission on Cancer. – Cheryl Raffel, RHIA, CTR

END NOTES / DEFINITIONS1Analytic – a case newly diagnosed at the facility and/or administered any of the first course oftreatment.2Non-analytic – a case that was diagnosed elsewhere and all of the first course of treatment wasadministered elsewhere, or the case was diagnosed and/or treated prior to the facility’sreference date, or the case was diagnosed at autopsy. These cases are added to the registrywhen they present at the facility with active disease for treatment of persistent or recurrentdisease. These cases are not included in treatment or survival statistics.

11.

Table 1. Patient Demographics and Clinical Characteristics

All Patients (n=92) Surgical Patients (n=51)

Age (mean) 71.0 68.8

Gender

Male 45 25

Female 47 26

CA 19-9 (mean U/ml) 18,413 3,014

Diagnostic laparoscopy

Yes 35

No 13

Unknown 3

Laparoscopy Findings

Negative 30

Positive 5

Deferred Laparotomy

Yes 4

No 46

Aborted Laparotomy

Yes 17

No 32

Sanjay Munireddy, MD, John Dentel, MD, Andreas Schneider, MD, Sarah Counts, MD, Ponnandai Somasundar,MD, N. Joseph Espat, MD, and Steven Katz, MD

Division of Surgical Oncology, Roger Williams Medical Center

Purpose: To determine the utilization of diagnostic laparoscopy (DL) and nontherapeutic laparotomy rate at theRoger Williams Cancer Center.

Methods: We performed a retrospective chart review to identify patients with potentially resectable pancreaticadenocarcinoma or neuroendocrine tumors treated at RWMC from 2004-2011. Patients were deemed potentiallyresectable if there was no evidence of distant metastases and if pre-operative pancreas protocol CT scan or endoscopicultrasound (EUS) showed no celiac axis involvement, encasement of the SMA, or obstruction of the PV. Patientinformation including age, sex, and CA 19-9 levels was also obtained.

Results: A total of 92 patients with pancreatic cancer were identified. Of the 51 patients who were deemed potentiallyresectable, 35 (69%) underwent DL prior to planned surgical resection and 13 (25%) patients were subjected tolaparotomy without DL. Overall, 11 patients (31%) who had DL were ultimately found to have unresectable disease.Five patients were determined to be unresectable following DL and 6 by laparotomy following a negative DL. Assuch, DL prevented nontherapeutic laparotomy in 14% (5 of 35) patients and had a sensitivity of 45% amongpatients ultimately proven to have unresectable disease. There were no false positive DL procedures. Of those whohad initial laparotomy, 7 of 13 (54%) were deemed unresectable because of regional vessel involvement, peritonealdisease, or liver metastases. Among patients deemed resectable by DL, 24/30 (80%) underwent successful definitivesurgery.

Conclusions: DL, which was performed in 69% of surgical patients, enabled our surgeons to avoid nontherapeuticlaparotomy in 14% of cases in this series. Nontherapeutic laparotomy was more likely if DL was not performed.We continue to perform DL in carefully selected patients to avoid nontherapeutic laparotomy and to select patientsfor neoadjuvant therapy.

Accuracy and Yield of Diagnostic Laparoscopy for Pancreatic Cancerat Roger Williams Medical Center from 2004-2011

12.

Figure 1. Patient classification

All Patients (92)

Resectable (51)

Laparotomy (13) Laparoscopy (35)

Negative Laparoscopy (30)

Nontherapeutic Laparotomy (6)

Therapeutic Laparotomy(24)

Positive Laparoscopy (5)

Unresectable (41)

13.

Age Group of Pancreas Cancer Diagnosed in 2009 Roger Williams Medical Center, Providence RI

vs. U.S. Hospitals & State of Rhode Island Hospitals (Data from 1377 U.S. Hospitals, 10 Rhode Island Hospitals)

Age Group RWMC (N) U.S. (N) RI (N) RWMC (%) U.S. (%) RI (%)

Under 20 0 15 0 0% 0.05% 0%

20 - 29 0 72 0 0% 0.25% 0%

30 - 39 0 300 1 0% 1.03% 0.78%

40 - 49 0 1527 5 0% 5.26% 3.88%

50 - 59 5 4871 20 19.23% 16.79% 15.50%

60 - 69 8 8140 22 30.77% 28.06% 17.05%

70 - 79 9 8113 42 34.62% 27.97% 32.56%

80 - 89 3 5238 30 11.54% 18.06% 23.26%

90 + 1 734 9 3.85% 2.53% 6.98%

TOTAL 26 29010 129 100% 100% 100%

More of a difference was seen between RWMC & RI age at diagnosis for pancreas cancer, with RWMC

percentages being more in line with those seen in the US. RWMC saw more patients between 60-79 and the US

and RI had higher percentages in 80-89 year old patients.

AJCC Stage of Pancreas Cancer Diagnosed in 2009 Roger Williams Medical Center, Providence RI

vs. U.S. Hospitals & State of Rhode Island Hospitals (Data from 1377 U.S. Hospitals, 10 Rhode Island Hospitals)

STAGE RWMC (N) U.S. (N) RI (N) RWMC (%) U.S. (%) RI (%)

0 1 159 1 3.85% 0.55% 0.78%

I 1 2247 9 3.85% 7.75% 6.98%

II 7 5873 21 26.92% 20.24% 16.28%

III 4 2511 6 15.38% 8.66% 4.65%

IV 9 10743 57 34.62% 37.03% 44.19%

NA 0 31 0 0% 0.11% 0%

UNK 4 7446 35 15.38% 25.67% 27.13%

TOTAL 26 29010 129 100% 100% 100%

For RWMC pancreas cases, the biggest difference is the much lower percentage of unknown stage cases, 10%

lower than the US and nearly 12% lower than in RI. Stage IV cases at RWMC were 3% lower than the US and

10% lower than in RI. RWMC did have a higher percentage of Stage II and III cases than the US & RI cases, of

between 6-10%.

14.

Pancreatic Cancer Survival RWMC VS NCDB & Northeast Northeast Region = MA, ME, CT, RI, NH, VT NCDB All U.S. Cases 2003-2004

Data from 1300 Programs in U.S. & from 100 Programs in Northeast Region

AJCC

Stage At

Diagnosis

# of

Cases

U.S.

2003-04

#of Cases

NE

Region

2003-04

# of

Cases

RWMC

2003-04

# of

Cases

RWMC

2005-06

5 Yr

Survival

U.S

2003-04

5 Year

Survival

NE Region

2003-04

5 yr

Survival

RWMC

2003-04

5 Yr

Survival

RWMC

2005-06

Stage 0 183 9 0 0 55.1 ** N/A N/A

Stage I 2,175 127 2 2 17.9 21.3 0.0 50.0

Stage II 5,363 310 5 4 10.3 10.6 20.0 0.0

Stage III 3,750 226 7 4 2.7 1.8 14.3 0.0

Stage IV 13,209 852 10 10 2.4 1.1 0.0 10.0

OVERALL 24,680 1524 24 20 5.9 5.3 8.3 14.3

** Insufficient cases to display survival information

Comparison of survival data by each individual AJCC stage for pancreas cancer is somewhat difficultdue to the small number of cases. However, the overall 5-year pancreas cancer survival for RogerWilliams Medical Center is at 8.3% for 2003-2004 cases and 14.3% for 2005-2006 cases, both of whichare above the 5-year survival for U.S. cases (5.9%) and the New England region (5.3%).

OverviewThe Hematology/Oncology Division atRoger Williams is comprised of teachingfaculty affiliated with Boston UniversitySchool of Medicine. The divisionconducts cancer-related clinical,research, and academic activitiesincluding the Hematology/OncologyFellowship program. Additionally, thedivision conducts the operations of theCancer Protocol Office.

Clinical Activities: There wereapproximately 3550 outpatient visitsaccounting for an increase of over 11%when compared to 2010. The satelliteoffice in Cranston, RI continues to servepatients and practices in that area andis staffed by Dr. Ritesh Rathore. Asecond satellite office in Lincoln, RI isexpected to start functioning inNovember 2011 with Dr. BhartiRathore serving patients in that area.

Hematology/Oncology physicians havespecialized in core areas and haverecognized disease specific expertise inhead/neck cancer, thoracic cancers,breast cancer, gastrointestinal cancers,and hematologic malignancies.

National Certification by QOPI:The Hematology/Oncology Division isone of only 41 practices in the countrythat received inaugural certification fromthe Quality Oncology Practice Initiative(QOPI) from the American Society ofClinical Oncology (ASCO).

A total of 80 quality metrics in bothgeneral and disease-specific moduleswere evaluated and the group scoredhighly above national scores withconsistently excellent quality outcomeresults in Colorectal, Breast, Lung andLymphoma modules.

Research: In 2010-11, Hematology/Oncology Division Faculty publishedmultiple articles in major journals andalso presented several abstracts atnational hematology and oncologymeetings:

Published articles Rathore B., Kadin ME. Hodgkin’s

lymphoma therapy: past, present, andfuture. Expert Opin Pharmacother.2010;11(17):2891-906.

Rathore R, Birnbaum A, RathoreB., DiPetrillo T., Kennedy T., ReadyN. Carboplatin with weekly docetaxeland ifosfamide in advanced head andneck cancers: A Phase I BrownUniversity Oncology Group doseescalation study (HN-93). CancerChemother Pharmacol 2010Nov;66(6):1013-7. Epub 2010 Feb4.

Wanebo H., Rathore R., ChouguleP., Disiena M.R., Koness R.J., McRaeR.G.,Nigri PT, Radie-Keane K, ReadyN. Selectiveo r g a npreservation inoperable locallyadvanced headand necksquamous cellc a r c i n o m a sguided by primarysite restagingbiopsy: long-term results of twosequential Brown University oncologygroup chemo-radiotherapy studies.Ann Surg Oncol. 2011Nov;18(12):3479-85. Epub 2011May 7.

Ready N.E., Rathore R., JohnsonT.T., Nadeem A., Chougule P., RuhlC., Radie-Keane K., Theall K.,Wanebo H., Marcello J., Kennedy T.Weekly Paclitaxel and CarboplatinInduction Chemotherapy Followed byConcurrent Chemoradiotherapy inLocally Advanced Squamous CellCarcinoma of the Head and Neck. AmJ Clin Oncol. 2011 Feb 2. [Epubahead of print]

Birnbaum A., Dipetrillo T., RathoreR., Anderson E., Wanebo H., PuthwalaY., Joyce D., Safran H., Henderson D.,Kennedy T., Ready N., Sio T.T..Cetuximab, paclitaxel, carboplatin, and

radiation for head and neck cancer: atoxicity analysis. Am J Clin Oncol.2010 Apr;33(2):144-7.

Rathore R., Safran H., Soares G.,Dubel G., McNulty B., Ahn S., IannittiD., Kennedy T. Phase I study ofhepatic arterial infusion of oxaliplatinin advanced hepatocellular cancer: aBrown University oncology groupstudy. Am J Clin Oncol. 2010Feb;33(1):43-6.

Kurniali P.C.,Luo L., WeitbergAB. Role ofcalcium/ magnesiuminfusion inoxaliplatin-basedchemotherapy forcolorectal cancerpatients. Oncology (Williston Park).2010 Mar;24(3):289-92.

Meeting presentations Lum L., Rathore R., Al-Kadhimi

Z., Davol P., Thakur A., Pray C., LiuQ., Tomaszewski E., Cummings F.,Steele P., Wedge J., Kouttab N.,Maizel A., Colaiace W., Joyrich R.,Ratanatharathorn V., Uberti J.P. T-cells targeted with anti-CD3 x anti-HER2 bispecific antibody fortreatment of women with stage IVbreast cancer (phase I): Clinical andimmune function results. Posterpresentation at ASCO 2011 ( abstr2548)

Junghans R.P., Rathore R., MaQ., Davies R., Bais A., Gomes E.,Beaudoin E., Boss H., Davol P.,Cohen S.. Phase I trial of anti-PSMAdesigner T-cells in advanced prostatecancer. J Clin Oncol 28, 2010(suppl; abstr e13614)

Wanebo HJ, Sanikommu SR,Taneja C, Begossi G, Cummings FJ,Belliveau J. Hepatic artery infusion forrecurrent or chemotherapy-resistanthepatic malignancy. J Clin Oncol 29:2011 (suppl; abstr e14151)

HEMATOLOGY/ONCOLOGY

Departmental Reports

15.

Fellows were authors or co-authorsof the following publications in 2010-11:

Castillo J.J., Winer E.S.,Stachurski D, Perez K., Jabbour M.,Milani C., Colvin G., Butera J.N.Clinical and pathological differencesbetween human immunodeficiencyvirus-positive and humanimmunodeficiency virus-negativepatients with plasmablastic lymphoma.Leuk Lymphoma. 2010 Nov;51(11):2047-53. Epub 2010 Oct 4.

Castillo J.J., Winer E.S., StachurskiD, Perez K., Jabbour M., Milani C.,Colvin G.A., Butera J.N. HIV-negative plasmablastic lymphoma: notin the mouth. Clin LymphomaMyeloma Leuk. 2011Apr;11(2):185-9. Epub 2011 Apr 8.

Castillo J.J., Winer E.S.,Stachurski D., Perez K., Jabbour M.,Milani C., Colvin G., Butera J.N.Prognostic factors in chemotherapy-treated patients with HIV-associatedPlasmablastic lymphoma. Oncologist.2010; 15 (3) :293-9. Epub 2010Feb 18.

Dalia S., Milani C., Castillo J.,Mega A., Schiffman F.J. Fooled bythe fragments: masqueradingmicroangiopathy. Med Health R I.2010 Jan;93(1):25-6.

Jabbour M., Tuncer H., CastilloJ., Butera J., Roy T., Pojani J., Al-Malki M., Al-Homsi A.S.Hematopoietic SCT for adult T-cellleukemia/lymphoma: a review. BoneMarrow Transplant. 2011Aug;46(8):1039-44. Epub 2011 Feb28

Fellows had the following NationalMeeting presentations in 2010-11:

Elamil Z.G., Tuncer H.H., Roy T.,Al Homsi S.A. Consistent hypofibrinogenemia associated withinduction anti-tumor chemotherapyfor Acute Myeloid Leukemia.

Presented at ASH 2010 (Abstract1400).

Colvin G.A., Milani C., Berz D.,Quesenberry P.J. Consolidationtherapy following autologous stem celltransplantation for Non-Hodgkins andHodgkins lymphomas. Presented atASBMT 2010 (Abstract S209)

Milani C., Abourahma R., WelchP., Roy T., Pojani J., Al Homsi A.S..Isolated Epstein-Barr Virs-inducedcentral nervous system post-transplantation lymphoproliferativedisorder despite negative serum PCR.Presented at ASBMT 2010(Abstract S297).

Division staff

Attending physicians:Ritesh Rathore, MD (Director)Francis J. Cummings, MDBharti Rathore, MDAlan B.Weitberg, MD

Fellows:Kevin Jain, MD (PGY-6)Melham Jabour, MD (PGY-6)Naveed Rana, MD (PGY-5)Zena ElAmil, MD (PGY-5)David Aljadir, MD (PGY-4)Philip Marjon, MD (PGY-4)

Administrative staff:Mary Cordo(Administrative Associate)Cynthia Boutin(Fellowship Coordinator)

Butera J., Winer E., Wang E.,Castillo J.J., Thomas A.G., Safran H.,Mega A.E., Colvin G.A., Rathore B.,Quesenberry P.J. A phase II studywith decitabine, low-dose cytarabineand G-CSF priming in high-riskmyelodysplastic syndromes,refractory/relapsed acutemyelogenous leukemia or acutemyeloid leukemia in patients withsignificant comorbidities. Posterpresentation at ASCO 2011 (suppl;abstr 6537)

Lum L.G., Thakur A., Al-KadhimiZ.S., Abhedi M., Ayash L.,Cummings F., Rathore R., UbertiJ.P., Ratanatharathorn V.. PrimedAnd Boosted Anti-Breast CancerTumor Immunity After AutologousPeripheral Blood Stem CellTransplant (PBSCT): In VivoPriming With T-Cells Armed WithAnti-CD3 X anti-Her2/neu BispecificAntibody (Her2Bi) Pre PBSCT AndBoostingCells Armed With Anti-CD3X anti-Her2/neu Bispecific Antibody(Her2Bi) Pre PBSCT And BoostingAfter PBSCT With Activated T-Cells(ATC). Poster presentation atASBMT 2010 (abstr S166).

In February 2011, the Hematology/Oncology Fellowship Programsuccessfully underwent a successfulACGME site review and receivedfull accreditation from 2001-14. Theprogram has a full complement of 6fellows over a 3-year span. Dr.David Aljadir and Dr. Phillip Marjonjoined in 2011 as 1st year Fellows.Dr. Kevin Jain & Dr. MelhemJabbour graduated in 2011 andjoined private practices in NewHaven, CT and Grand Island, NE,respectively.

Also in 2011, Dr. Bharti Rathore wasappointed as Associate ProgramDirector with responsibilities oforganizing all educational activitiesand site rotations.

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H e m a t o l o g y /Oncology Fellowship

SURGICAL ONCOLOGYOverviewThe Division of Surgical Oncology atthe Roger Williams Medical Centerhas developed into an internationallyrecognized academic program.Presentations at national andinternational meetings, numerouspeer-reviewed publications, and alarge volume of complex surgicalprocedures have established ourscientific and clinical programs asamong the very best in the region. Theopening of the Phase I HepaticImmunotherapy for Metastases(HITM) trial is drawing patient interestfrom across the nation and globe.

Clinical ProgramsThe Roger WilliamsSurgical Oncologyteam is wellrecognized forexcellence in thetreatment ofh e p a t o b i l i a r ycancers. Weperform a highvolume of complexsurgical procedures, including majorliver and pancreas resections. Ourteam is able to perform a significantproportion of liver and pancreasresections using minimally invasiveapproaches. This program offersspecialized care to patients withdiseases of the liver, biliary tract, andthe pancreas. Liver and pancreaticdiseases are complex and requirecritical decisions founded uponintensive training.

As a result of our surgical team’sexperience and expertise, our patientsbenefit from the latest techniques andtechnologies in treating patients withliver and pancreas disease, withmanagement plans formulated in amulti-disciplinary fashion. RogerWilliams is one of only a few centersacross the nation offering microwaveablation therapies for the treatment ofliver tumors. We are the first center inNew England to offer NanoKnifetreatment for pancreas and livertumors not amenable to surgicalresection. The physicians managing

these diseases are all Society ofSurgical Oncology fellowship-trainedand well recognized for theirexperience in the use of minimallyinvasive approaches.

Our team has also become a regionalreferral center for soft tissue sarcomas.Sarcomas are tumors arising frommuscle, nerve, or fat cells, and oftenaffect young adults in the primes oftheir lives. Management of these rareneoplasms requires particularexpertise and our surgical oncologistshave a wealth of experience in caringfor sarcoma patients. It is thereforenot surprising that we receive referralsfrom outside of our state and region.

We are one of the few centers offeringhyperthermic intra-operativeperitoneal chemotherapy (HIPEC), asophisticated treatment for cancer thathas spread throughout the abdomen.This therapy is offered for advancedappendiceal cancers, metastaticcolorectal cancer, metastatic ovariancancer and other cancers which arelocalized to the peritoneal cavity.

As patients who receive HIPEC areat elevated risk for woundcomplications, we also specialize incomplex abdominal wallreconstructions. HIPEC representsanother complex therapeuticintervention offered by the Division ofSurgical Oncology, positioning us tohelp lead ongoing growth of the RogerWilliams Cancer Center.

Recently, the Division launched ourGeriatric Oncology Program (GOP)to develop clinical and researchprograms focused on the uniquebiology, needs, and outcomesencountered in our elderly patients. Acornerstone of the GOP will be theopening of a new tissue bank whichwill allow for correlative tissue studiesto further our understanding of thenatural history of malignancies andresponse to treatment in thispopulation. Multidisciplinary breastand head and neck programs areunder development as well.

Research ProgramsThe laboratory currently has severalprojects designed to develop newimmunotherapies for difficult to treatcancers and develop a betterunderstanding of how immune cellsin the liver function. The immunesystem is a powerful weapon that webelieve can be harnessed to destroytumors.Presently, we have experimentalmodels for the treatment ofmetastatic colon cancer andgastrointestinal stromal tumor, a typeof sarcoma. Each of our researchprojects is designed to provideimportant information that we canapply to our patients within theclinical trials offered through ourcancer center.

Since its inception two years ago, theSurgical Immunotherapy Laboratoryhas been awarded in excess of$650,000 in research funding,including an award through theRWMC NIH COBRE grant. Otherfunding has been awarded by theSociety of Surgical Oncology,Kristen Ann Carr Fund, Associationfor Academic Surgery, and RhodeIsland Foundation. A publicationrecently appeared in the Journal ofImmunology and oral presentationswere delivered at the ExperimentalBiology, American College ofSurgeons, and AmericasHepatopancreatobiliary Associationmeetings. In total, the Divisionproduced 16 publications, 2 bookchapters, and 10 abstracts over thepast three years.

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RADIATION ONCOLOGYThe Radiation Oncology Department atRoger Williams is dedicated to providingpatients with expert cancer care in an en-vironment that is compassionate andhopeful.

Radiation therapy is an essential compo-nent in the curative and palliative treat-ment of cancer. Recent advances in treat-ment technology, known as IMRT andIGRT, have dramatically improved ourability to accurately target and treat a tu-mor while sparing nearby normal organs.IMRT or intensity modulated radio-therapy, relies on careful CAT scan basedplanning and advances in radiation deliv-ery technology to direct dose to the tu-mor with little spillage of radiation intonormal structures.

IGRT or image guided radiotherapy, in-volves the use of imaging, such as a CATscan, to verify patient positioning imme-diately before radiation delivery. Our de-partment has a state of the art linear ac-celerator which is capable of both IMRTand IGRT. Ultimately, IMRT and IGRTallow the safe escalation of radiation doseto the tumor while lowering the dose tonearby normal organs - improving thechances of cancer cure with fewer andless intense side effects.

We are very happy to announce the ar-rival of Dr. Darlene Gabeau, M.D., PhD,who joined our practice group in Sep-tember. Dr. Gabeau comes to RI fromNY where she was an Assistant Profes-sor in Radiation Oncology at AlbertEinstein Medical. She graduated with anMD, PhD from the Yale UniversitySchool of Medicine and completed herresidency in Radiation Oncology at theJoint Center for Radiation Oncology atHarvard Medical School. She brings aunique expertise in stereotactic body ra-diosurgery, breast and head and neckcancer.

In June 2009, we opened the Radiosur-gery Center of Rhode Island housing thefirst and only Cyberknife Radiosurgerymachine in Rhode Island. Radiosurgeryinvolves the delivery of high doses of ra-diation therapy in one to five treatments.Historically, it was used in the treatmentof static tumors, such as those in thebrain.

Educational ProgramsThe Society of Surgical Oncology(SSO) Fellowship represents one ofonly eighteen of its kind in NorthAmerica. For the past four years, wehave been able to match our first choiceapplicant and we recently passed a sitereview by the SSO with no majordeficiencies noted. Based upon ourclinical volume, our Fellowship offers arich experience with complexmalignancies. Fellows also have ampleopportunity to present research atnational meetings and conductindependent studies in the laboratory.

In July 2011, our first Surgical OncologyResearch Fellow joined the team. TheSurgical Oncology Research Fellowshiprepresents an important addition, as itwill offer general surgery residents theopportunity to develop scientificbackgrounds necessary for obtainingcompetitive clinical fellowship spots andfor pursuing careers as academicsurgical oncologists. We have alsof o r g e dagreementswith St.R a p h a e lHospital inN e wHaven, CTand theBerkshiresM e d i c a lCenter toallow their general surgery residents torotate on our service.

To accommodate the expandededucation needs within our Division, wehave instituted a 3 hour CME accreditedconference each week. During ourweekly conference, we reviewindications, complications, researchprojects, and pertinent journal articles.We are certainly pleased to have a largenumber of fellows, residents, andmedical students spending time with ourteam and benefiting from our robustclinical and didactic experience.

In March 2011, we held the inauguralNew England Sarcoma Symposium.Over 300 people attended thisspectacular two day event, whichbrought leading sarcoma clinicians fromacross the United States and Canadato Providence for a world classacademic seminar. In keeping with oureducational mission, we have made theseminar lectures available on our website, www.rhodeislandcancer.org. Guestspeakers at the event included MarkHerzlich of the New York Giants, UnitedStates Senator Sheldon Whitehouse,and Rhode Island Lieutenant GovernorElizabeth Roberts. Symposia will beheld on a bi-annual basis.

In November of 2011, the Divisionhosted a national Liver and PancreasSurgery Seminar that included didacticand technical training sessions. Theseminar was attended by more than 25general and fellowship-trained surgeonsfrom aroundthe country.

In parallel with our laboratory research,we presently have a clinical trials openfor patients with metastatic cancer thatinvolves treatment with reprogrammedT cells. In brief, patient T cells areharvested through an IV, programmedto attacked cancer cells, and then givenback to patients. Our Phase I HepaticImmunotherapy for Metastases (HITM,NCT01373047) trial recently openedand accrual has begun. We lookforward to bringing promising newimmunotherapies from bench tobedside for our patients.

18.

The Cyberknife Radiosurgery Systemis a unique tool because it can accu-rately deliver radiation to both staticand dynamic tumors, such as those inthe lung or abdomen, which move withrespiration. Recently, national guide-lines support the use of radiosurgeryas a primary alternative to surgery forpatients who decline surgery or thosewho are not medically fit to undergosurgical therapy.

Over the past 2 years, we have forgeda strong clinical partnership with Dr.Laurie Reeder, a Thoracic Surgeon,to provide Cyberknife Radiosurgeryto approximately twenty five, carefullyselected patients with stage I lung can-cer. These patients have achieved ex-cellent disease control with minimalacute and late side effects.

Our body radiosurgery program con-tinues to grow and over the last yearwe have treated patients with primaryand metastatic lesions in the brain,bone and abdomen.

With the arrival of Dr. Charles Kanaly,in the Department of Neurosurgery atRWMC, we will be able to greatlyexpand our ability to provide pallia-tive and curative radiosurgery for brainand spine lesions.

Soon, our department will be able tooffer high dose rate brachytherapy orHDR as a treatment option for patientswith breast, prostate, sarcoma andgynecologic cancers. For selectwomen with breast cancer, HDRbrachytherapy is an attractive alterna-tive to conventional radiation therapy.HDR offers similar rates of cancer con-trol and toxicity compared with con-ventional therapy over a time frame of1-2 weeks instead of a conventionalseven week treatment course.

DIAGNOSTIC IMAGINGThe Diagnostic Imaging Departmentprovides Cancer Center patientsaccess to the most advanced diagnosticand treatment options available today.We offer the full range of imagingservices including CT, MRI,Ultrasound, Digital Radiography,Mammography, Nuclear medicine,PET, non invasive vascular testing, andInterventional Radiology. All of theseservices are centralized on the firstfloor of the diagnostic wing of the mainhospital building.

We deliver careusing a multimilliondollar state of theart PictureArchiving andCommunicationSystem (PACS)interfaced with ourenterprise wideElectronic Medical

Record (EMR) and voice recognitiontranscription.

This year, with support from aChamplain foundation grant we wereable to complete our transformation toan entirely digital (no paper and no x-ray film) environment. This translatesinto consistent access to the bestquality images and most expertinterpretation often minutes after theimaging procedure is completed.

It also means that we maintain a fullyintegrated record of every study youor your patient has here. A completeimaging archive is critical to accuratestaging and effective individualizedcancer care. All of this is available 24/7/365, accessible from any site in theworld by any member of the RogerWilliams cancer team. When you needit, this matters.

Our subspecialty board certifiedradiologists are fellowship trained inNeuro Radiology , MusculoskeletalRadiology, Abdominal Imaging, andInterventional Radiology. Our MRIand Mammography divisions areaccredited by the American College ofRadiology.

We are one of two sites in RI withcomputer assisted diagnostic softwarefor MR guided diagnosis and MRguided breast biopsy. We supportMR guided neurosurgical navigation.And we offer dedicated parking! InCT, we support a regionallyuniquecollection of specializedexaminations important forcomprehensive cancer care includingmultiphase liver and pancreaticimaging, CT angiography,enterography, and colonography. Wehave in house technologist staff toscan around the clock. When youneed us, we are there.

In Mammography, we offer digitalimaging both at the breast healthcenter and at the main hospital site.We offer same day diagnosticultrasound and biopsy. We also offerthe most experienced staff ofcompassionate mammographycertified Radiologic Technologists andour equipment is state of the art. Our1.5T MRI is equipped with aexhaustive array of specialized coils(receivers) that can be critical toaccurate imaging. This is of particularimportance in addressing potentialcancers involving the liver andpancreas.

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BLOOD AND MARROWTRANSPLANTATION

PROTOCOL OFFICEThe Roger Williams Protocol Office hashad another productive year.

Staffing includes a registered nursemanager and a clinical researchcoordinator at full time. This year anadministrative assistant completed theclinical research certification and willassume added clinical trialsresponsibility, at half time. Part time staffhas been added to assist withadministrative duties. This increase instaffing has resulted in expandedscreening and enrollment efforts. Duringthe period 2010-2011, the officescreened over 800 patients for potentialentry into open clinical trials.

Potential subjects are generated frompatient lists provided by the Departmentof Surgery, and medical oncologypatients seen in the outpatient clinic.Office personnel now enter screeningdata into a shared drive in Excel format.

The Protocol Office has approximately20-25 trials open for accrual andapproximately 10-15 closed trialsrequiring long term subject survivalfollow up, at any given time. Trials areopened for enrollment here that areaccessed through Brown University,Eastern Cooperative Oncology Group,National Surgical Adjuvant Breast andBowel Program, American College ofSurgeons Oncology Group, ClinicalTrials Support Unit, many industrybased sponsors, as well as on siteinvestigator initiated protocols.

Since 1994, hundreds of cancerpatients from throughout the regionhave come to Roger Williams, hometo Rhode Island’s only Blood andMarrow Transplantation Program. Inthis comprehensive transplant center,autologous, allogeneic (related andunrelated) and cord bloodtransplantation services are offered.In 2011, the Blood and Marrow Unitperformed a total of 25 transplants (11autologous, 14 allogeneic). Efforts are underway to streamline the

protocol review process to assure thattrials offered meet the needs of the sitepopulation, and offer access to the latestand most promising treatments.

New guidelines for timely closure of nonaccruing trials are being developed in2011. The procedure for protocolreview is being assessed and updatedin 2011, in order to maintain standardsof excellence in trial selection.

The Protocol Office has supportedresearch projects of students andFellows, and worked to promote trialenrollment for investigators who havebeen awarded grants at this site.

Protocol Office staff have worked tostreamline the enrollment and datacollection processes by working closelywith clinical staff in the Cancer Center,other areas throughout the hospital andwith the Principal Investigators, to assuretimely evaluations and overall protocolcompliance.

Bone Marrow Unit and Tumor Boardconferences are attended weekly byPO staff to maintain close workingrelationships with clinical staff andscreen for eligible subjects. PO staff hasworked with Department of SurgeryPrincipal Investigators this year toaccomplish the opening of a novelimmunotherapy protocol using patientT cells to target metastatic cancersaffecting the liver. Potential participantsinclude those from RI, other states , aswell as from other countries.

The Division ofI n t e r v e n t i o n a lRadiology is a leaderin the developing subdiscipline ofi n t e r v e n t i o n a loncology. We offerlocal and regionaltumor therapy,provide percutaneous image guidedablation of lung, renal, and liver tumorsas well as the most advanced array oftransarterial therapies includingconventional chemoembolization, drugeluting beads, and transarterialbrachytherapy.

Minimally invasive techniques areassuming an increasingly important rolein management of cancers in the liver,lung, and kidney. Roger Williams is theonly hospital in RI that offers all of theseservices in an integrated setting, allowingus to choose the best solution andcustomize care to each patient’s uniquepresentation.

In addition to these services,Interventional Radiology offers the fullarray of venous access services (ports,central lines, piccs), peripheral vascularservices, varicose vein ablation, imageguided biopsy, pain and palliativeprocedures including cementoplasty forthe treatment of painful pathologicfractures, CT guided nerve blockade,and placement of intrathecal narcoticinfusion systems. We see and follow ourpatients in the IR clinic on the RWMCcampus every day.

Excellence in advanced imaging andinterventional radiology/interventionaloncology are increasingly central to thedelivery of best quality cancer careserviced. We are proud to deliver ourbest to the cancer program and itspatients.

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ONCOLOGY NURSINGThe staff of Center 4 cares for themajority of inpatients receivingchemotherapy. There are 12 OncologyNursing Society Biotherapy/Chemotherapy providers on theCenter 4 nursing staff. In 2011, thestaff delivered more than 30 inpatientchemotherapies.

The Comprehensive Cancer Programprovides a professional environment fornurses to focus on both the healing artand science of the nursing profession.Nurses are intimately involved in thecomprehensive cancer care we provideto our patients across the continuumof healthcare. Our exceptional andskillful staff touches patients throughdiagnosis and treatment plans,research, palliative care andsurvivorship programs.

The Hematology/Oncology, BoneMarrow Day Program and SurgicalOncology staff provides high qualitycare in the Infusion Center and theclinic. They receive recognition andpraise for their exceptional patientsatisfaction feedback.

The specialized team in RadiationOncology creatively meets the needsof patients receiving innovative newtechnologies including stereotactic

cranial andextracranial,radiotherapya n dbrachytherapy.T h e yident i f iedtheir uniquerole inmeeting thechallenges ofcutting-edgetechnology while supporting thespecial and emotional needs of theirpatients. Nursing leadership continuesto promote certification in CancerNursing. Our nurses’ dedication andunwavering commitment to patientsand families continues to be thecommon bond amongst thesespecialized teams.

Roger Williams’s employs two full-time masters prepared LICSW(Licensed Independent Clinical SocialWorkers). Four hours of Social Worktime is spent daily at the OutpatientCancer Center. Patients are visited,needs assessed and resourcesmatched with patient/family need.Patients and families receivepsychosocial support, counseling andare referred to Roger Williams BloodCancer Support Group affiliated withthe Leukemia/Lymphoma Society andother community support groups.Social Workers are employed in theCase Management Department. Arepresentative from the CaseManagement Department attends theCancer Center Committee Meetings.

Representatives from casemanagement assess the needs of thepatient/family unit, plan and implementinterventions and evaluateeffectiveness, efficiency, timeliness,and appropriateness of theinterventions. The goal is to ensure thatpatients/families receive appropriateand timely psychosocial support.

Hospice: General Inpatient HospiceProgram is available at Roger Williamsand with contract Hospice Agencies

CASE MANAGEMENT

throughout the state. Support takes theform of a multi-disciplinary teamapproach to ensure coordinatedcontinuity of care, and respect for theautonomous prerogative of the patientand family to make decisions andchoices regarding care, to help ensurequality of life, and to respect thepatient/ family worth, dignity andcomfort.

The focus is on the palliation ofdistressing physical, psychological,emotional and spiritual symptomsencountered by the patient and familyduring a terminal illness. The teamincludes: Physicians, Staff Nurses,Hospice nurses, Social Workers,Nursing Aides, Hospice NursingAides, Chaplin, Dietitian, Pharmacists,RN Case Managers and Therapists.

NUTRITIONThe cancer center is dedicated toeducating patients on how optimalnutrition can help lessen side effects,support the immune system, and helpmaintain weight. The multi-disciplinaryapproach of the cancer center alsoallows patients to meet with a dietitianat the same time as otherappointments.

In 2010-2011, the NutritionDepartment at Roger Williams had oneregistered dietitian, Donna Castricone,RD, CSO, LDN, located onsite atthe Cancer Center and available forconsults. In 2011 we began trackingproductivity and to date have recordedseeing just over 400 patients either inthe chemo infusion suite or in clinic.

This past year, Donna also achievedBoard Certification as a Specialist inOncology Nutrition. In order tobecome board certified by theCommission on Dietetic Registration(CDR), the credentialing agency forthe Academy of Nutrition andDietetics, a registered dietitian mustsuccessfully meet rigorous specialtypractice requirements and pass anationally administered examination.

The efforts on behalf of the ProtocolOffice to distribute researchinformation within and outside of thefacility were commended by ACOSin the past. The office continues tooutreach to Principal Investigators atthis site and throughout Rhode Island.The Protocol Office creates anddistributes the “Clinical Trial Watch”(CTW) to over 200 care providersevery month. The CTW highlightsvarious trials on a monthly basis. TheCTW and a current list of open trialsis provided to outside care providers,is posted and updated on the RWMCInternet, and is distributed to theCancer Center for staff and patients,as well as at Tumor BoardConferences in flyer format, on amonthly basis.

21.

Roger Williams partnered with otherhospitals in Rhode Island and theAmerican Cancer Society to hostRhode Island’s second annualstatewide Cancer Survivors Day. Theevent was attended by 400 survivorsand friends.

In September, Roger Williams hostedits annual prostate cancer screeningfor more than 75 men.

Free community education wasprovided by a number of physiciansaffiliated with Roger Williams.

OUTREACH

REHABILITATIONThe Rehab Department has fourPhysical Therapists, an OccupationalTherapist and two Speech LanguagePathologists who provide Rehabservices to Cancer Center patients inthe inpatient setting. Physical Therapyand Occupational Therapy focus onbed mobility, ambulation and ADLs.

Created with the opening of theCancer Center in February 2009, theCancer Center Pharmacy is staffedMonday through Friday from 7:00a.m.-- 5 p.m.

With the relocation of the Day Chemounit to the Cancer Center Infusionroom, the pharmacy departmentcreated a pharmacy satellite, with“clean room” preparation areas incompliance with USP 797 guidelines,dedicated solely to servicing the needsof the Cancer Center.

In addition to the compounding of allout-patient chemotherapy and ancillarymedications, pharmacist work with thephysicians and nurses reviewing andprocessing chemotherapy orders.

The Cancer Center Pharmacy hascommitted to the education of cancercenter patients. Each patient, who iseither new to chemotherapy or isreceiving a new treatment regimen, isprovided with information on theirmedication(s) from a pharmacist. Eachpatient receives a contact card with thetelephone numbers of the CancerCenter Pharmacy and the HospitalPharmacy, which is in operation 24hours a day, 7-days a week, for anyfollow-up questions they may have.

In its first year of operation, theCancer Center Pharmacy received anHonorable Mention Award forHealthcare Innovation from QualityPartners of Rhode Island.

During the second year of operation,Pharmacy provided education to 155patients who were either beginninginitial chemotherapy or beginning a newtreatment and provided follow-upinformation to 107 patients in responseto telephone calls or in the CancerCenter.

CANCER CENTERPHARMACY

During the second year of operationthe Cancer Center Pharmacyincreased education coordination withDietary and Social Work throughinteraction with those areas for specificpatient concerns.

In addition, increased focus was givento specific adverse reactions, commonto many oncology patients, such asfatigue.

STAFF: Tom Habershaw, RPh,Helene Delisle, RPh, Robin Ferra,CRPhTII, Amanda Burch, CRPhTII

Speech Language Pathologistsprovide services to inpatientswith dysphagia to assess theirability to swallow and teaching, provide modified bariumswallow evaluations,recommend specific diettextures and provide exerciseto improve ability to swallow.All three disciplines areavailable to work with patientson the BMT, ICU, SurgicalOncology and other units thatthe patient may be on.

Mary-Anne Forgione, M.Ed.,CCC-Sp, is available to provideoutpatient Swallow Evaluation orModified Barium Swallow Evaluationwith follow up Swallowing Therapyat the Cancer Center. Mary-Annespecializes in working with head andneck cancer patients who arereceiving radiation therapy. This yearshe completed advanced trainingthrough Harvard Medical School toprovide services for patients withneed for Tracheo-Esophageal VoiceRestoration and swallowing needs.

Outpatient Physical Therapy,Occupational Therapy,Lymphedema and Speech LanguageServices are available at theOutpatient Satellites of Fatima/StJoseph’s Hospital.

22.

Adele R. Decof Cancer Centerat Roger Williams Medical Center

50 Maude Street Providence, Rhode Island www.rwmc.org 1-401-456-2077