An observational study of bevacizumab combined with FOLFIRI as the first-line treatment in metastatic colorectal cancer

The aim of this retrospective study was to evaluate the first-line treatment of bevacizumab combined with the FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen, and to compare the toxicity and efficacy in Taiwanese patients with metastatic colorectal cancer (mCRC). Fifty-two patients with mCRC receiving bevacizumab combined with FOLFIRI chemotherapy in Kaohsiung Medical University Hospital between January 2008 and December 2009 were analyzed retrospectively. The patients were initially treated with bevacizumab [5 mg/kg; a 120-minute intravenous (IV) infusion] on Day 1, followed by irinotecan (180 mg/m2 as a 120-minute IV infusion), leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-fluorouracil (400 mg/m2 as an IV bolus infusion followed by 2400 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks. The characteristics of each patient, the adverse effects, and responses after chemotherapy were recorded. The objective responses for treatment of patients were evaluated, and the results showed that the overall response rate was 59.6% and the disease control rate was 82.7%. The major Grade 3/4 adverse events encountered in these patients were asthenia (5.8%), diarrhea (7.7%), nausea (7.7%), vomiting (3.8%), mucositis (1.9%), hematological toxicity (3.8%), and proteinuria (1.9%). The most common Grade 3/4 adverse events in our patients were diarrhea (0–15% in Caucasians, 4.2% in Asian, and 7.7% in the current study), nausea/vomiting (0–6%/0–7% in Caucasians and 7.7%/3.8% in the current study), neutropenia (9.5–30% in Caucasians and 3.8% in the current study), hypertension (0–26% in Caucasians and 0% in the current study), and gastrointestinal bleeding (0–4% in Caucasians and 0% in the current study). The considerable efficacy and safety profile in this retrospective study showed that bevacizumab combined with FOLFIRI regimen is consistent with the results in prospective randomized clinical trials. The combination of bevacizumab with FOLFIRI regimen for first-line treatment was effective for and well tolerated by Taiwan mCRC patients.