Info

CALGB-SWOG 80405

CALGB/SWOG 80405: Phase III trial of irinotecan/5-FU/leucovorin (FOLFIRI) or oxaliplatin/5-FU/leucovorin (mFOLFOX6) with bevacizumab (BV) or cetuximab (CET) for patients (pts) with KRAS wild-type (wt) untreated metastatic adenocarcinoma of the colon or rectum (MCRC). | Journal of Clinical Oncology

  • Design: Phase III, randomized, multicenter trial
  • Number of patients: 1137 (out of 2334 KRAS wild-type patients randomized; original study included unselected patients)
  • Patients characteristics: KRAS wild-type metastatic adenocarcinoma of the colon or rectum, performance status 0-1
  • Agent: FOLFIRI or mFOLFOX6, combined with cetuximab (CET) or bevacizumab (BV)
  • Treatment line: first-line
  • Trial Name/NCT Number: NCT00265850
GroupPFSOSResponse rate (RR)
Chemo/BV10.84 months29.04 monthsnot reported
Chemo/CET10.45 months29.93 monthsnot reported
  • Other findings:

    • OS was equivalent between chemo/CET and chemo/BV
    • PFS was similar between chemo/CET and chemo/BV
    • On-study toxicity and deaths were as expected
    • Analyses underway for expanded RAS, FOLFOX vs. FOLFIRI, subsequent therapies, long-term survivors, and other correlates
  • Summary: The study showed that chemo/CET and chemo/BV were equivalent in OS for patients with KRAS wild-type metastatic adenocarcinoma of the colon or rectum and performance status 0-1. PFS was also similar between the two groups. The preference for FOLFOX limits the comparison of chemotherapy regimens. Analyses are underway to identify subsets of patients who may receive more or less benefit from specific regimens.