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CAIRO2 study of the Dutch Colorectal Cancer Group (DCCG)

Randomized phase III study of capecitabine, oxaliplatin and bevacizumab with or without cetuximab in advanced colorectal cancer. CAIRO2 study of the Dutch Colorectal Cancer Group (DCCG).

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CAIRO2 study of the Dutch Colorectal Cancer Group (DCCG)

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  1. Randomized phase III study of capecitabine, oxaliplatin and bevacizumab with or without cetuximab in advanced colorectal cancer CAIRO2 study of the Dutch Colorectal Cancer Group (DCCG) Authors: CJA Punt, J Tol, CJ Rodenburg, A Cats, GJ Creemers, JG Schrama, FLG Erdkamp, A Vos, L Mol, NF Antonini Presented at ASCO 2008

  2. Background:Bevacizumab andAnti EGFR Combinations

  3. Randomized Phase II Study in Irinotecan Resistant MCRC(Saltz et al ASCO, 2005) • Cetuximab • Bevacizumab • Irinotecan R A N D O M I Z A T I O N • Cetuximab • Bevacizumab EGFR expression not required for study entry

  4. Efficacy Comparison No unexpected toxicities / safety signals

  5. PACCE Study Schema Panitumumab 6 mg/kg Q2W + Ox-CT + Bevacizumab Ox-based CT (eg, FOLFOX) N = 800 Investigator choice S C R E E N I N G R A N D O M I Z E 1:1 Ox-CT + Bevacizumab Panitumumab 6 mg/kg Q2W + Iri-CT + Bevacizumab Iri-based CT (eg, FOLFIRI) N = 200 Investigator choice 1:1 Iri-CT + Bevacizumab

  6. PACCE Summary • See OncologyEducation.ca ASCO GI 2008 Updates for details • Chemo + Bev + Pmab : • Oxaliplatin arms: • More toxic, reduces PFS and OS • Irinotecan Arms • More Toxic – PFS : at best the same as Chemo + Bev

  7. CAIRO 2 SCHEMA N=755 Primary Outcome: PFS CAPECITABINE + OXALIPLATIN +BEVACIZUMAB R CAPECITABINE + OXALIPLATIN +BEVACIZUMAB+ CETUXIMAB UNTREATED METASTATIC COLORECTAL CANCER

  8. RESULTS - EFFICACY

  9. Results Toxicity (grade 3-4)

  10. KRAS

  11. KRAS - Survival

  12. Study Summary • The combination of cetuximab,bevacizumab and Cape Ox chemo appears to be less effective (PFS) and to cause more diarrhea than chemo and bevacizumab alone • These results are consistent with oxaliplatin arms of PACCE study • Analysis of KRAS data : • WT KRAS: adding cetuximab to chemo + bev does not confer benefit • MUTANT KRAS: adding cetuximab to chemo + bev reduces PFS and OS (not statistically significant for OS)

  13. Intergroup Phase III studyCALGB 80405 (NCIC CRC.5) FOLFOX or FOLFIRI, and bevacizumab Previously untreated patients with mCRC DESIGN CURRENTLY UNDER REVIEW FOLFOX or FOLFIRI, and cetuximab R FOLFOX or FOLFIRI, bevacizumab and cetuximab • Primary endpoint: overall survival • Secondary endpoints include response, PFS, toxicity and resection rate • Accrual = 1084/2289 • No safety concerns (regular IDMC review)

  14. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • Main implications are for current first line mCRC intergroup trial (CALGB 80405, NCIC CRC.5) • Trial had been activated and was preparing to open in Canada but accrual has now been suspended across North America as the trial is re-designed given CAIRO2 data and KRAS data presented at ASCO 200

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