Multicenter phase 2 dose-ranging study of liposomal irinotecan as second-line treatment for small cell lung cancer
A phase 2 study at ten centers in China evaluated three doses of liposomal irinotecan (LY01610) as second-line therapy for patients with small cell lung cancer (SCLC) after failure of platinum-based treatment. Patients received liposomal irinotecan at doses 60, 80, or 100 mg/m2 every two weeks. Among all patients, the objective response rate was 32% (95% CI 21-44), with a median duration of response 5.2 months (3.0-8.3). Median progression-free survival and overall survival were 4.0 months (95% CI 2.9-5.5) and 9.7 months (7.2-12.3). The ORR in the 60 mg/m2, 80 mg/m2, and 100 mg/m2 dose groups was 33%, 33%, and 30%, respectively, with median duration of response 4.2, 6.9, and 4.0 months, respectively. The incidence of grade ≥ 3 treatment-related adverse events in the three groups was 33%, 47%, and 50%, respectively. The authors conclude that liposomal irinotecan had promising clinical activity and manageable safety among patients with relapsed SCLC, with the best benefit-risk ratio in the 80 mg/m2 group.