Randomised phase III trial of second-line irinotecan plus cisplatin versus irinotecan alone in patients with advanced gastric cancer refractory to S-1 monotherapy: TRICS trial

摘要: Abstract Aim The optimal second-line regimen for treating advanced gastric cancer (AGC) remains unclear. While irinotecan (CPT-11) plus cisplatin (CDDP) combination therapy and CPT-11 monotherapy have been explored in the setting, superiority of platinum-based therapies AGC patients initially treated with S-1 has not yet evaluated; therefore, we aimed to examine survival benefit CPT-11/CDDP over monotherapy. Methods showing progression after or recurrence within 6 months completion adjuvant were randomly allocated (CPT-11, 60 mg/m2; CDDP, 30 mg/m2, q2w) (150 mg/m2, q2w). Results Sixty-eight 95 recurrent cases evaluated. median overall survivals 13.9 (95% confidence interval [CI]: 10.8–17.6) 12.7 CI: 10.3–17.2) months CPT-11, respectively (hazard ratio: 0.834; 95% 0.596–1.167, P = 0.288). No significant differences observed secondary end-points, including progression-free (4.6 [95% 3.4–5.9] versus 4.1 3.3–4.9] months) response rate (16.9% 8.8–28.3] 15.4% 7.6–26.5]). incidences grade 3–4 anaemia (16% 4%) elevated serum lactate dehydrogenase levels (5% 0%) higher than CPT-11. Exploratory subgroup analysis revealed that was significantly more effective intestinal-type AGC, compared (overall survival: 15.8 14.0 months; P = 0.019). Conclusion upon adding CDDP failure.