Irinotecan plus fluorouracil‐based regimen as second or third‐line chemotherapy for recurrent or metastatic esophageal squamous cell carcinoma

BACKGROUND: No standard second‐line regimen exists for the treatment of advanced esophageal squamous cell carcinoma (ESCC). The aim of this study was to evaluate the efficacy and safety of irinotecan and fluorouracil‐based chemotherapy as a second or third‐line regimen for advanced ESCC patients. METHODS: We retrospectively reviewed a cohort of 27 consecutive patients with advanced ESCC in one institute, treated with a combination of irinotecan plus fluorouracil‐based regimens after the failure of first‐line platinum‐based therapy. Nine patients were treated with 150–160 mg/m(2) irinotecan and 400 mg/m(2) fluorouracil (5‐FU) on day 1, followed by 2000 mg/m(2) 5‐FU during a 48‐hour infusion every two weeks. Eighteen patients received 150–160 mg/m(2) irinotecan on day 1 and 80–120 mg/day S‐1 on days 1–10 every two weeks. The S‐1 dose was based on the patients' body surface area. RESULTS: Twenty‐four of the 27 patients were assessable for response. One (3.7%) patient achieved complete response, seven (25.9%) achieved partial response, eight (29.6%) had stable disease, and eight (29.6%) had progressive disease. The median progression‐free and overall survival were 4.8 (95% confidence interval [CI]: 1.2–8.4) and 10.5 months (95% CI: 8.4–12.7), respectively. Grade 3 neutropenia and diarrhea were detected in four (15%) and one (4%) patient, respectively. No grade 4 toxicity was noted. CONCLUSIONS: Our study indicates that an irinotecan plus 5‐FU‐based regimen is effective and well‐tolerated as a second or third‐line chemotherapy for patients with advanced ESCC.