(ChemotherapyAdvisor) – Patients administered bevacizumab with first-line FOLFOXIRI (irinotecan + oxaliplatin + leucovorin + 5-fluorouracil [5-FU]) chemotherapy regimen (FOLFOXIRI/bev) for metastatic colorectal cancer (mCRC) experience significantly longer progression-free survival (PFS) and better response rates than those administered the bevacizumab plus FOLFIRI (irinotecan + leucovorin + 5-FU) regimen (FOLFIRI/bev) chemotherapy, according to results from the Italian randomized phase 3 TRIBE clinical trial, which were presented during the 10th annual Gastrointestinal Cancers Symposium on January 25th in San Francisco, CA.
“The study met its primary endpoint: FOLFOXIRI/bev significantly increased PFS (median 9.5 vs. 11.9 months; HR, 0.72; 95% CI: 0.59-0.87;, P=0.001)” compared to FOLFIRI/bev, reported Fotios Loupakis, MD, PhD, of the Istituto Toscano Tumori in Livorno, Italy, and coauthors. “Response rate was also significantly increased (53% vs. 64%, P=0.015).”
Chemotherapy- and bevacizumab-related toxicities occurred at “the expected incidence,” they reported.
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A total of 508 patients at 35 Italian cancer centers diagnosed with measurable and unresectable mCRC and no previous chemotherapy treatment for advanced disease were randomly assigned between 2008 and 2011 to receive either FOLFIRI/bev (Arm A: bev 5 mg/kg, irinotecan 180 mg/m2, I-LV 200 mg/m2, 5-FU bolus 400 mg/m2, 5-FU infusion 2,400 mg/m2 over 48 hours every 2 weeks) or FOLFOXIRI/bev (Arm B: bev 5 mg/kg, irinotecan 165 mg/m2, oxaliplatin 85 mg/m2, I-LV 200 mg/m2, 5-FU infusion 3,200 mg/m2 over 48 hours every 2 weeks), Dr. Loupakis and colleagues reported.
“At a median follow-up of 20.9 months, 391 patients have progressed,” they reported.
Grade 3-4 toxicities included diarrhea (10% arm A; 18% arm B), thromboembolic events (7% in each study arm), vomiting (3% arm A; 4% arm B), stomatitis (4% arm A; 8% arm B), peripheral neurotoxicity (5% in arm B), neutropenia (20% arm A; 49% arm B), and febrile fneutropenia (6% arm A; 8% arm B), the authors reported.
“Deaths within 60 days were 3% [arm A] and 4% [arm B],” they noted.
The 2013 Gastrointestinal Cancers Symposium is co-sponsored by the American Gastroenterological Association (AGA) Institute, the American Society of Clinical Oncology (ASCO), the American Society for Radiation Oncology (ASTRO), and the Society of Surgical Oncology (SSO).
Clinicaltrials.gov ID: NCT00719797
