The aim of this study was to investigate the efficacy and safety of belotecan in combination with cisplatin in patients with previously non-treated extensive stage small cell lung cancer. A total of 42 patients were enrolled and treated with combination of belotecan 0.5mg/m2 on daily basis throughout day 1-4 and cisplatin 60mg/m2 on day 1 of a 3-week cycle, up to 6 cycles. Treatment was continued until the completion of 6 cycles of the chemotherapy, disease progression, detection of unacceptable toxicity, withdrawal of the consent, or death of the patient. Response was assessed every 2 cycles of chemotherapy by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Toxicity was assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.0. The overall response rate was 73.8% in an intention to treat population and 83.9% in the evaluable patients. With the median follow up of 9.9 months, the median progression free survival was 6.9 months (95% CI, 6.6-7.2 months), and median overall survival was 11.2 months (95% CI, 9.9-12.5 months). The frequently reported grade≥3 toxicities were neutropenia (90.2%), thrombocytopenia (63.4%), and anemia (34.1%). Febrile neutropenia was reported in 16 patients (39.0%). Although most of non-hematologic toxicities were grade 1 or 2, there were 4 patient deaths caused by pneumonia complicated by septic shock. Belotecan and cisplatin combination chemotherapy demonstrated a promising efficacy in ED SCLC patients. But, the hematologic toxicity of this regimen requires considerable amount of attention.
All Science Journal Classification (ASJC) codes
- Pulmonary and Respiratory Medicine
- Cancer Research