Reduced-intensity FOLFOXIRI in Treating Refractory Metastatic Colorectal Cancer: A Pilot Study

Objectives: To report on the efficacy and safety of reduced-intensity FOLFOXIRI (RI-FOLFOXIRI) as salvage chemotherapy for patients with refractory metastatic colorectal cancer (mCRC). Methods: From October 2009 to March 2014, a total of 45 patients with refractory mCRC received RI-FOLFOXIRI as salvage chemotherapy. The initial dose of RI-FOLFOXIRI was 85% of the dose last used for each drug. All patients received a 2-hour infusion of folinate, followed by a bolus of 5-fluorouracil, and then 2400 to 3000 mg/m2 for 46 hours; in addition, patients were either administered irinotecan on day 1 followed by oxaliplatin on day 3 (group A), oxaliplatin on day 1 followed by irinotecan on day 3 (group B), or irinotecan and oxaliplatin on day 1 (group C). Results: Seven patients (15.6%) showed a partial response, and 15 patients (33.3%) had stable disease. The median progression-free and overall survival durations were 3.9 and 7.6 months, respectively. Patients who had wild-type K-RAS showed a longer overall survival duration (8.5 vs. 7.0 mo; P=0.04) but no difference in progression-free survival durations (4.4 vs. 3.4 mo; P=0.20) compared with patients with mutant K-RAS. The most common adverse events were neutropenia (28.9%) and diarrhea (26.7%). Conclusions: RI-FOLFOXIRI as salvage chemotherapy is effective and enables management of patients with refractory mCRC.

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