Gi Cancer Symposium 2012 Report Presentation

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Tonight’s speakers: Dr. Dan Sargent and Kim Ryan …

Tonight’s speakers: Dr. Dan Sargent and Kim Ryan

Disclaimer: “This Report is not an official event of the 2012 Gastrointestinal Cancers Symposium. Not sponsored or endorsed by any of the cosponsoring organizations of the 2012 Gastrointestinal Cancers Symposium.”

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  • 1. Welcome! Report from GI Cancer Symposium 2012 Part of Fight Colorectal Cancer’s Monthly Patient Webinar Series Our webinar will begin shortlywww.FightColorectalCancer.org www.CCAlliance.org877-427-2111 877-422-2030
  • 2. MANY THANKS TO OUR PARTNERS AT COLON CANCER ALLIANCE IN SUPPORT AND PROMOTION OF THIS WEBINARwww.FightColorectalCancer.org www.CCAlliance.org877-427-2111 877-422-2030
  • 3. Fight Colorectal Cancer1. Tonight’s speakers: Dr. Dan Sargent and Kim Ryan2. Archived webinars: Link.FightCRC.org/Webinars3. Follow up survey to come via email. Get a free Blue Star of Hopepin when you tell us how we did tonight.4. Ask a question in the panel on the right side of your screen5. Or call the Fight Colorectal Cancer Answer Line at 877-427-2111www.FightColorectalCancer.org www.CCAlliance.org877-427-2111 877-422-2030
  • 4. Fight Colorectal CancerDisclaimerThe information and services provided by Fight Colorectal Cancer arefor general informational purposes only.The information and services are not intended to be substitutes forprofessional medical advice, diagnosis, or treatment.If you are ill, or suspect that you are ill, see a doctor immediately. In anemergency, call 911 or go to the nearest emergency room.Fight Colorectal Cancer never recommends or endorses any specificphysicians, products or treatments for any condition. www.FightColorectalCancer.org www.CCAlliance.org 877-427-2111 877-422-2030
  • 5. Fight Colorectal CancerCheat sheet AE ~ Adverse Event BSC ~ Best Supportive Care CAPOX ~ (also called XELOX) Capecitabine and Oxaliplatin DCR ~ Disease Control Rate FOLFOX ~ 5FU/Leucovorin, Oxaliplatin KRAS WT ~ Kristen Rat Sarcoma/Wild Type mCRC ~ Metastatic Colorectal Cancer MSI ~ Microsatellite Instability OS ~ Overall Survival ORR ~ Overall Response Rate PET ~ Positron Emission Tomography Pt/Pts ~ Patient/Patients PFS ~ Progression Free Survival QOL ~ Quality of Life SD ~ Stable Disease
  • 6. Fight Colorectal Cancer Dr. Daniel Sargent, PhD Mayo Clinic Cancer CenterBiostatistician for the gastrointestinal research program atthe Mayo Clinic Cancer Center and is involved in multipleongoing clinical trials of both cancer treatment and cancer screening.
  • 7. Fight Colorectal Cancer Where have we been and where are we going? 2007 to 2012What’s happened in the last 5 years?
  • 8. Fight Colorectal CancerGI ASCO 2007 Family members of people with crc have a high risk of having polyps with the potential to become cancer • Increasing the dose of cetuximab (Erbitux®) until a rash • appeared increased tumor response ratesPET scanning before surgery helps make betterdecisions on which pts should have surgery& improves survival Patient communications & expectations data were shared showing more than 1/3 of pts would choose chemotherapy even if it only improved their chances against a recurrence by 1%
  • 9. Fight Colorectal CancerGI ASCO 2012• Biomarkers (Predictive and Prognostic)• Elderly patients responses to certain therapies• Erbitux and Brivanib in combination for refractory metastatic disease• Quality of life assessment data presented• New data for metastatic refractory colorectal cancer patients
  • 10. BiomarkersBackground ~ 20% of stage II CRC patients will experience a relapseof their disease, and may benefit from adjuvant chemotherapyQuestion ~ How do we determine who those patients are?The “ColoPrint index” was determined on 320 patients, using geneexpression, fresh tissue, MSI-status, and patient follow-upConclusions ~ ColoPrint:• Available as a diagnostic test with high precision and reproducibility• Improves the prognostic accuracy of pathological factors and MSI• Helps to identify low risk patients, who may be safely managed without chemotherapy Caveats ~ Requires fresh tissue, still a modest size trial
  • 11. BiomarkersBackground ~ Identifying a prognostic marker would aid in themanagement of patients with node negative colon cancerQuestion ~ What is the prognostic value of guanylyl cyclase for diseaserecurrence in untreated stage II colon cancer?GCC mRNA was quantified from 310 stage II patients, enrolled in 2studies between 1991-2006. Patients classified according to their GCClymph node ratio.Clinical outcomes included time to recurrence, overall survival, anddisease free survivalConclusion ~ Patients with GCC lymph node ratio high risk havesignificantly poorer outcomes compared to patients with low risk status. Caveats ~ Modest size study, limited institutions, validation study ongoing
  • 12. Elderly Patient PopulationBackground ~ Cross trial comparison of age, comparing 3 trials inpatients with stage III diseaseQuestion ~ What affect does age have on the effectiveness ofOxaliplatin based adjuvant therapy? NSABP C-07 MOSAIC NO16968 FLOX FOLFOX XELOX Age, years <70 >70 <70 >70 <70 >70 DFS Hazard Ratio 0.76 1.03 ~0.75 0.91 0.8 0.86 OS Hazard Ratio 0.8 1.18 ~0.77 1.1 0.82 0.91 Conclusion ~ The benefits of adding Oxaliplatin to 5-FU are less in patients greater than 70 years of age
  • 13. Elderly Patient PopulationBackground ~ While colon cancer is predominantly a disease of the elderly,older patients are underrepresented in clinical trials.Question ~ Do treatment patterns and benefits realized by trial participantspertain to older patients?Retrospective analysis of 3390 stage II and stage III patients >66 years old whoreceived 5FU/LV, FOLFOX, CAP or CAPOX within 3 months after surgery. Risk of death HR 95% CI p-value 5FU/LV 1 FOLFOX 0.7 0.55 - 0.90 0.005 CAP 1.17 0.88 - 1.56 0.293 CAPOX 0.44 0.20 - 0.98 0.044 Conclusion ~ Treatment outcomes for elderly pts were comparable between CAP based and 5FU/LV-based regimens and consistent with results reported in randomized clinical trials.
  • 14. Cetuximab + BrivanibBackground ~ Cetuximab has improved overall survival in pts with metastatic, refractory,KRAS wild type CRCQuestion ~ Will the addition of Brivanib, a tyrosine kinase inhibitor targeting vascularendothelial and fibroblast growth receptors, improve overall survival in a phase III trial?Phase III trial, of pts with mCRC, previously treated w/combination therapy, randomized:• CET 400mg/m2 loading dose, followed by weekly 250mg/m2 + 800 mg oral BRIV dailyor placebo Brivanib Arm Placebo Arm Hazard Ratio Median OS 8.8 months 8.1 months 0.88 Median PFS 5.0 months 3.4 months 0.72 Partial Response 13.60% 7.20% Stable Disease 50% 44% Conclusion ~ Despite positive effects of PFS, the combination of CET and BRIV did not significantly improve overall survival
  • 15. Cetuximab + Brivanib QOL DataBackground ~ Although the primary endpoint (overall survival) was notimproved, PFS favored the CET + BRIV armQuestion ~ When looking at quality of life as a secondary endpoint, what effectdid the CET + BRIV arm have on QOL?750 randomized patients were assessable for QOLReceiving CET 400mg/m2 loading dose, followed by weekly 250mg/m2 + 800mg PO BRIV daily or placeboMedian time to QOL DET (deterioration)1.6 months vs 1.1 monthsMedian time to QOL PF (physical function) 5.6 months vs 1.7 monthsConclusion ~ Despite a PFS benefit, the combination of CET + BRIVworsened time to QOL DET and PF, in pts with refractory KRAS WT mCRC
  • 16. RegorafenibBackground ~ Regorafenib (small molecule), an oral multikinase inhibitor of abroad range of angiogenic, oncogenic, and stromal kinases, was study in aPhase 1 trial, and showed results in disease control of 74% in pts with mCRCwho had progressed after all approved therapiesQuestion ~ In a larger phase III CORRECT trial, what is the efficacy and safetyof regorafenib in this difficult to treat patient population?Phase III, 760 patients randomized 2:1 to receive regorafenib 160mg orally, 3wks on, 1 wk off, + BSC or placebo Regorafenib Placebo HR Median OS 6.4 months 5.0 months 0.77 Median PFS 1.9 months 1.7 months 0.49 ORR 1.60% 0.40% SD 43.80% 14.90% DCR 44.80% 15.30%
  • 17. Regorafenib (con’t)
  • 18. Regorafenib (con’t)
  • 19. Regorafenib (con’t)Affect did not differ by KRAS statusMost frequent grade 3 adverse events in the regorafenib arm:Hand foot reaction 16%Fatigue 9%Diarrhea 7%Hypertension 7%Conclusion ~ Statistically significant benefit in OS and PFS wasobserved for regorafenib over placebo in patients with mCRC whohave failed all approved standard therapies. No new or unexpectedsafety signals were found.
  • 20. Conclusions• Biomarkers will be key to treating stage II (and perhaps stage III) patients, as we know many patients do not need treatment• Less intensive therapy an appropriate option for elderly patients• Benefit in PFS may not be sufficient to truly benefit the patient• Regorafenib provides modest benefit in last line setting, but clearly worthy of further study in earlier lines of therapy
  • 21. Fight Colorectal Cancer
  • 22. Fight Colorectal Cancer Upcoming Webinar“The Importance of Diet, Exercise & Nutrition: Before and After a Cancer Diagnoses” March 21, 2012 8 - 9:30 PM Eastern time Register at www.FightColorectalCancer.org 1-877-427-2111
  • 23. Fight Colorectal Cancer CONTACT US Fight Colorectal Cancer 1414 Prince Street, Suite 204 Alexandria, VA 22314 (703) 548-1225 Toll-Free Answer Line: 1-877-427-2111 www.FightColorectalCancer.orgEmail us: Info@FightColorectalCancer.org