Meta-analysis of two randomized phase III trials (TCOG GI-0801 and ECRIN TRICS) of biweekly irinotecan plus cisplatin versus irinotecan alone as second-line treatment for advanced gastric cancer

Background Biweekly irinotecan (CPT-11) plus cisplatin (CDDP) combination (BIRIP) and CPT-11 alone are both expectable options for treating advanced gastric cancer (AGC) in a second-line setting. We conducted a meta-analysis to compare the efficacy and safety of these two regimens in patients enrolled two randomized phase III trials. Patients and methods Individual patient-level data from two randomized phase III trials were collected for this study. In both trials, patients with AGC refractory to S-1-based chemotherapy were randomly allocated to BIRIP (CPT-11, 60 mg/m 2 ; CDDP, 30 mg/m 2 , q2w) or to CPT-11 (150 mg/m 2 , q2w). Results Cumulative data from 290 eligible patients were evaluated. The OS was 12.3 months [95% confidence interval (CI) 10.5–14.1] in the BIRIP group and 11.3 months (95% CI 10.0–13.2) in the CPT-11 group (hazard ratio 0.87; 95% CI 0.68–1.12, P = 0.272), while PFS was significantly longer in the BIRIP group (4.3 months [95% CI 3.5–5.1]) than in the CPT-11 group (3.3 months [2.9–4.1]; HR 0.77; 95% CI 0.61–0.98, P = 0.035). The response rate was 20.5% in the BIRIP group and 16.0% in the CPT-11 group ( P = 0.361). However, the disease control rate was significantly better in the BIRIP group (72.1%) than in the CPT-11 group (59.2%) ( P = 0.032). The two groups did not differ significantly in the incidences of grade 3 or worse adverse events. Conclusions Both BIRIP and CPT-11 may be good therapeutic options for patients with AGC as second-line treatment. Clinical trial registration UMIN 000025367.