Phase II study of FOLFIRI regimen in patients with advanced colorectal cancer refractory to fluoropyrimidine and oxaliplatin
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To evaluate the efficacy and safety of FOLFIRI regimen in patients with advanced colorectal cancer refractory to fluoropyrimidine and oxaliplatin.
The FOLFIRI regimen consisted of intravenous infusion of irinotecan 180 mg/m2 on day 1 plus leucovorin (LV) 400 mg/m2 on day 1 plus 5-fluorouracil (5-FU) 400 mg/m2 bolus on day 1 plus 46-hour intravenous infusion of 5-FU 2,400 mg/m2, every 2 weeks as one cycle. The main selection criterion for this study was the advanced colorectal cancer refractory to fluoropyrimidine and oxaliplatin.
Of the 57 evaluable patients for efficacy, 4 (7.5%) had a partial response, 36 (67.9%) had stable disease, and 13 (24.5%) had progressive disease. Median progression-free survival was 4.8 months (95% CI 3.9–5.7 months), and median overall survival was 7.8 months (95% CI 13.1–16.5 months). Safety analysis was based on the data of 57 evaluable patients. The most frequently observed grade 3 or 4 toxicities were neutropenia 16 (27.8%), nausea/vomiting 7 (12.3%), and diarrhea 1 (1.8%).
FOLFIRI regimen is effective and well tolerated in patients with advanced colorectal cancer refractory to fluoropyrimidine and oxaliplatin in Chinese population.
KeywordsFOLFIRI Metastatic colorectal cancer Irinotecan Second-line chemotherapy
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