Salvage chemotherapy of biweekly irinotecan plus S-1 (biweekly IRIS) in previously treated patients with advanced gastric cancer

Purpose This phase II trial first describes the combination chemotherapy of biweekly irinotecan plus S-1 (biweekly IRIS) for pretreated advanced gastric cancer (AGC) patients. Methods Patients who had previously been treated with greater than or equal to one regimen were enrolled. They received S-1 35 mg/m 2 twice daily on days 1–14 and irinotecan 150 mg/m 2 on days 1 and 15, every 4 weeks. The primary endpoint was overall survival (OS). Results Among the 38 patients enrolled, 18 patients were treated as second line, and the remaining 20 patients were enrolled as third- or fourth line. A total of 208 cycles were administered with the median being four cycles (range 1–16). The median OS was 8.7 months [95% confidence interval (CI) 7.5–10.3], and the median progression-free survival was 6.3 months (95% CI 5.3–7.3). Low serum albumin (