Treating late stage colorectal cancer dr. saltz
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Transcript of Treating late stage colorectal cancer dr. saltz
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Welcome!
Treating Late Stage Colorectal Cancer Part of Fight Colorectal Cancer’s Monthly Patient Webinar Series
Our webinar will begin shortly
www.FightColorectalCancer.org877-427-2111
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Fight Colorectal Cancer
1. Tonight’s speaker: Dr. Leonard Saltz
2. Archived webinars: Link.FightCRC.org/Webinars
3. Follow up survey to come via email. Get a free Blue Star of Hope pin when you tell us how we did tonight.
4. Ask a question in the panel on the right side of your screen
5. Or call the Fight Colorectal Cancer Answer Line at 877-427-2111
www.FightColorectalCancer.org877-427-2111
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Fight Colorectal CancerUpcoming Webinars
Hospice vs Palliative CareDr. Jim Meadows, Tennessee Oncology
September 19, 20128 - 9:30 PM Eastern time
Sex After Rectal CancerDr. Joel Tepper, UNC
October 17, 20128 - 9:30 PM Eastern time
Register at www.FightColorectalCancer.org
1-877-427-2111
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Fight Colorectal CancerDisclaimer
The information and services provided by Fight Colorectal Cancer are for general informational purposes only.
The information and services are not intended to be substitutes for professional medical advice, diagnosis, or treatment.
If you are ill, or suspect that you are ill, see a doctor immediately. In an emergency, call 911 or go to the nearest emergency room.
Fight Colorectal Cancer never recommends or endorses any specific physicians, products or treatments for any condition.
www.FightColorectalCancer.org877-427-2111
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Fight Colorectal Cancer
www.FightColorectalCancer.org877-427-2111
Dr. Leonard SaltzMemorial Sloan Kettering Cancer Center
Chief, Gastrointestinal Oncology
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Understanding Colorectal Cancer Treatment Options
Leonard B. Saltz, MD
Chief, Gastrointestinal Oncology
Memorial Sloan Kettering Cancer Center, New York, NY
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Disclosures• I have consulted for and/or have research
supported by:
• Roche/Genentech• Bristol Myers Squibb• Imclone• Bayer• Merck• Biothera• Novartis• Sanofi• Immunomedex• Lorus• Morphotek
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Overview
• Understanding the language
• Standard chemotherapy options
• Toxicities and quality of life
• New agents
• Life after standard chemo
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Terms Requiring Definitions
• Cure• Overall Survival• Median Overall Survival• Progression-free Survival• Response• Stable Disease• Antitumor activity, Benefit• Progression of Disease
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Other terms
• “significantly better” – does not necessarily equal:
“substantially better”
• “statistically significantly better”– Does not necessarily equal:
“clinically significantly better”
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Anatomy of the Large Intestine
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Staging of Colorectal Cancer (CRC)
• Stage I: Not full thickness
• Stage II: Full thickness
• Stage III: Positive nodes
• Stage IV: Distant mets
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Colorectal Cancer Cure Rate
• Stage I 95%
• Stage II 80%
• Stage III 65% +
• Stage IV <10%
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Intent of Therapy
• Curative
• Adjuvant
• Neo-Adjuvant
• Palliative
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Chemotherapy for Metastatic
Disease
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1996: Drugs Available for CRC
• 5-FU (5-Fluorouracil)
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2012: Drugs Available for CRC
• 5FU (5-Fluorouracil)• Camptosar (Irinotecan)• Eloxatin (Oxaliplatin)• Xeloda (Capecitabine)• Erbitux (Cetuximab)• Avastin (Bevacizumab)• Vectibix (Panitumumab)
– Aflibercept (anticipated late 2012)– Regorafenib (anticipated late 2012)
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Combination Chemotherapy for CRC
Anatomy of the “FOLFs”• FOL = folinic acid (a.k.a. leucovorin)• F = 5FU (5-fluorouracil)• OX = oxaliplatin (Eloxatin)
= FOLFOX
• FOL = folinic acid (a.k.a. leucovorin)• F = 5FU (5-fluorouracil)• IRI = irinotecan (Camptosar)
= FOLFIRI
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FOLFIRI vs. FOLFOX
Efficacy of First Line Regimen
Tournigand et al, JCO 2004
p=0.9 21.5 m 20.4 mOS
p=0.65 8.1 m 8.5 mPFS
p=0.68 54% 56%RR
FOLFOXFOLFIRI
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Oral Chemotherapy
Cautionary Notes
• Just as likely to have side effects as i.v. chemo
• No convenience benefit unless all drugs taken are oral
• Requires a highly motivated patient capable of assuming substantial responsibility
• Difficult if nausea, vomiting, or diarrhea are present or expected
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Anti-AngiogenesisThe Angiogenic Switch
1-2 mm
Angiogenic
Switch
Small tumor• Nonvascular• “Dormant”
Larger tumor• Vascular• Metastatic potential
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........................
.... ..... .... .....
........................
.... .....
........................
........................
........................
Maturation factors present
Normal and Tumor Blood Vessels
Normal Blood Vessels Tumor Blood Vessels
Reduced integrin expression
Less dependent on cell survival factors
.... ..... Less permeable
Leaky
Preferential expression of v3 v5 & 51
integrins
Fewer pericytes
Growth and survival factors (eg, VEGF)
present
.... .....
Supporting pericytes present
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Phase III IFL +/- Avastin in Metastatic
Colorectal Cancer
IFL + Placebo (n = 412)
IFL + Avastin(n=403) P Value
Median overall survival 15.6 m 20.3 m 0.00003
Median Progression-Free Survival
6.2 m 10.6 m <0.00001
Response Rate 35% 45% 0.003
Hurwitz et al.. NEJM 2004
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Bevacizumab: Safety concerns
• Gastrointestinal perforation
• Arterial thrombotic events
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EGF Receptor Signaling Transduction
MAPK
MEK
Gene TranscriptionCell Cycle Progression
M
G1S
G2
PI3-K
RAS RAF
SOS
GRB2
PTEN AKTSTAT
R
KpY
R
pY
pY
K
Proliferation / Maturation
Survival / Apoptosis
Angiogenesis Metastasis
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Cetuximab + Irinotecan)Independent Radiology Review
Irinotecan-Refractory Patients, n=120 (Saltz et al: ASCO 2001)
PR 27 (22.5%) (95% C.I. 15%-31%)SD 9 ( 7%) (minimum 12 weeks)
• Median Dur. of response (n=27): 186 days• Investigator-reported PR= 23 (19%)
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Single Agent Cetuximab: Investigator-Reported Response Rate (n=57)
(Saltz et al, JCO 2004)
• PR = 6 (10.5%, 95% CI 4%-22%)• SD = 21 (37%)
– Minimum 12 weeks required for stable disease.
• Independent review confirmed 5 PR’s, for response rate of 8.8%.
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“BOND” Trial
• Randomized Phase II trial in Irinotecan-refractory CRC
• Cetux + Irinotecan versus Cetux• 2:1 randomization, 300 pts• 1o endpoint: response rate
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Bond Trial: Results(Cunningham et al, NEJM 2004)
Cetux + Irino Cetux
RR 22.9% 10.8%
PFS 4 m 1.6 m
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Cetux Trials in Refractory CRC
Response Rate
Cetux + CPT-11 (Saltz, ASCO 2001)
22.5%
Cetux + CPT-11 (Cunningham, NEJM 2004)
22.9%
Cetux (Saltz, JCO 2004)
10.5%
Cetux (Cunningham, NEJM 2004)
10.8 %
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CRYSTAL Trialvan Cutsem et al: NEJM 2009
• Randomized phase III trial of first line FOLFIRI +/- weekly cetuximab.
• Measurable metastatic colorectal cancer
• 1217 patients randomized
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CRYSTAL TRIAL: EfficacyVan Cutsem: ASCO 2007
FOLFIRI-Cetux
(n=599)
FOLFIRI(n=599)
P value
PFS 8.9 m 8.0 m 0.048
1 yr PFS 34% 23%
RR 47% 39% 0.0038
SD 37% 47%
DCR 84% 86%
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Understanding KRAS
• Protein in the cell involved in transmitting signal from receptor on cell surface to the nucleus
• If the gene for KRAS is mutated, then the KRAS protein sends a signal regardless of whether there is a signal from the surface receptor or not
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EGF Receptor Signaling Transduction
MAPK
MEK
Gene TranscriptionCell Cycle Progression
M
G1S
G2
PI3-K
RAS RAF
SOS
GRB2
PTEN AKTSTAT
R
KpY
R
pY
pY
K
Proliferation / Maturation
Survival / Apoptosis
Angiogenesis Metastasis
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Understanding KRAS
• If KRAS is mutated, Erbitux and Vectibix won’t work, and therefore are not used
• If KRAS is wild-type (non-mutated) then Erbitux or Vectibix might work
• Median overall survival benefit in trials with KRAS wild-type tumors is in range of 3-4 months
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CRYSTAL Trial:PFS time by
skin reactions: cetuximab + FOLFIRI
Grade of Skin Rash
0-1 (none or mild)
2 (moderate)
3 (severe)
Progression-free survival 5.4 m 9.4 m 11.3 m
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Some Other Toxicities
• Nausea / Vomiting
• Diarrhea
• Fatigue
• Neurotoxicity
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MOSAIC: FOLFOX for Stage II – III Colon Cancer: Peripheral Sensory Neuropathy
Andre et al: JCO 2009%
of
trea
ted
pat
ien
ts
48.1
30.9
22.2
1412
8.8
31.4
7.24.2 2.9 1.7 2.1
12.5
1.4 1.2 0.5 0.5 0.50
10
20
30
40
50
60
During Tx 6 months 1 year 2 years 3 years 4 years
Grade 1
Grade 2
Grade 3
27.6 17.4 14.2 11.4
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Neurotoxicity from Oxaliplatin• Cold sensitivity
• Numbness and tingling
• Loss of position sense
• Loss of fine motor skill
• Pain
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What’s new?
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Continuing Avastin
• TML trial shows that continuation of Avastin with 2nd line therapy improves median overall survival by 1.4 months
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Aflibercept
• Adding aflibercept to second line FOLFIRI improves median overal survival by 1.5 months.
• Not clear that this offers any advantage over second line Avastin
• No evidence that Aflibercept by itself, or with chemo that has failed, has any benefit
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Regorafenib vs Placebo
RegorafenibN=505
PlaceboN=255
Median Overall Survival 6.4 months 5.0 months
Partial Response 1% 0.4%
Stable Disease 43% 15%
DCR* 41.0 15%
*DCR = PR+SD (≥6 weeks after randomization)
Van Cutsem et al: Proc ASCO 2012
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What can we do when we’ve used up the standard drugs?
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Treatment options after standard care
• Clinical trials
• Supportive care / hospice care
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Clinical Trials
• Phase I What is the highest tolerable dose and what are the side effects?
• Phase II Is it safe and active in a defined population?
• Phase III Is it better that standard care?
• Phase IV Post-marketing studies; variations on a theme.
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Clinical Trials: Important Concepts:
• Informed consent
• Right to refuse/withdraw
• No hidden agendas
• No hidden placebos
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Supportive care
• Important in ALL aspects of cancer care– Pain control– Emotional Support– Nutrition– Exercise– Discussions of end of life care preferences
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Seductive Traps• The internet
• Alternative care
• Unproven drugs and procedures– (Beware the rhetorical “what harm could it do?”
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A. Venook (Discussant) ASCO 2012
COST of
CARE
The Elephant in the Room
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Average Selling Price (ASP) + 6% (about 5 yr old data)
(Patient assumption: 75 kg, 1.8 m2 patient, two weeks Rx)
• 5FU 500 mg/m2 $ 7• Leucovorin 500 mg/m2 $ 47• Xeloda 2000 mg/m2/d $ 1065• Camptosar 180 mg/m2 $ 2135• Eloxatin 85 mg/m2 $ 3296
• Avastin 5 mg/kg $ 2283• Erbitux 250 mg/m2 $ 4964
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Impact on Cost of Care: back of the envelope
• Bevacizumab – $2864 per 400 mg vial*– Average weekly dose = 175 mg
• Regorafenib – Sorafenib $8377 / month
• Aflibercept– $$$ unknown
– A Venook, Discussant ASCO 2012
$$ per UCSF pharmacy
$$$ unknown
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Cost of Bev beyond progression(Cost of only the bev; no MD, nursing, or pharmacy fees, no other meds)
• $2864 per 400 mg vial -> $7.16 per mg– 175 mg/week x 4.33 weeks/month = 758 mg/month – If vials are shared:
758 mg/month x $7.16/mg = $5427.28 per month,
x 5.7 months = $30,935.50 per patient treated
for 1.4 months OS benefit ->
$30,935.50 x 8.57 = $265,117 per year of life saved
– If vials not shared, then $2864 every 2 weeks for 24.7 weeks (5.7 months) -> $35,370.40 per patient treated
$35,935.40 x 8.57 = $303,124 per year of life saved
– (note: these are not Quality-adjusted)
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Colorectal cancer in 2012: my reality check
• These are modest advances• A minority of patients appear to benefit• And the costs are unsustainable
THE CHALLENGE • Actually deliver on promise of personalized
medicine• To do so, we need better tools to predict
outcomes• And it must be affordable
A. Venook, ASCO Discussant 2012
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Challenges
• Maintain optimism tempered by, and grounded in, reality
• Select therapies rationally
• Assure availability of appropriate therapies to all patients
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Conclusions
• Treatment options for colon cancer patients are better than they were, but not as good as they need to be.
• Please consider participation in clinical trials when they are appropriate. Without your help, we can’t make the progress that we all so desperately need.
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Fight Colorectal Cancer
www.FightColorectalCancer.org877-427-2111
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Fight Colorectal Cancer
Funding Research DirectlyLisa Dubow Fund
http://fightcolorectalcancer.org/research/lisa-fund
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Fight Colorectal CancerCONTACT US
Fight Colorectal Cancer1414 Prince Street, Suite 204
Alexandria, VA 22314(703) 548-1225
Toll-Free Answer Line: 1-877-427-2111www.FightColorectalCancer.org
Email us: [email protected]