Multicenter phase 2 study of belotecan, a new camptothecin analog, and cisplatin for chemotherapy‐naive patients with extensive‐disease small cell lung cancer

BACKGROUND: The objective of this study was to investigate the efficacy of belotecan, a new camptothecin analog, combined with cisplatin for the treatment of chemotherapy‐naive patients with extensive‐disease small cell lung cancer (ED SCLC). METHODS: Treatment consisted of belotecan 0.5 mg/m 2 daily on Days 1 through 4 and cisplatin 60 mg/m 2 on Day 1 of a 3‐week cycle for up to 6 cycles unless there was disease progression, unacceptable toxicity, or patient refusal. Response assessment was done every 2 cycles using the Response Evaluation Criteria in Solid Tumors, and toxicity assessment was done every cycle using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0. RESULTS: Between September 2006 and March 2008, 30 patients participated in the study. Among them, 21 patients achieved a partial response, and the response rate was 70% (95% confidence interval [CI], 50.6%‐85.3%); and, after a median follow‐up of 20.2 months, the median progression‐free survival was 6.9 months (95% CI, 6.3‐7.5 months), and the overall survival was 19.2 months (95% CI, 13.3‐25.2 months). Grade 3 and 4 adverse events included neutropenia in 23 patients, thrombocytopenia in 8 patients, febrile neutropenia in 9 patients, nausea in 3 patients, and pneumonia in 3 patients. There was 1 treatment‐related death from pneumonia. However, nonhematologic toxicity generally was mild and manageable. CONCLUSIONS: The belotecan and cisplatin combination that was studied demonstrated promising response rates and survival outcomes with a manageable toxicity profile for chemotherapy‐naive patients who had ED SCLC. The authors concluded that the combination warrants further randomized trials. Cancer 2010. © 2010 American Cancer Society.