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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 .

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