Fax: (011) 82-2-3010-6961
Multicenter phase 2 study of belotecan, a new camptothecin analog, and cisplatin for chemotherapy-naive patients with extensive-disease small cell lung cancer†
Article first published online: 10 NOV 2009
Copyright © 2010 American Cancer Society
Volume 116, Issue 1, pages 132–136, 1 January 2010
How to Cite
Lee, D. H., Kim, S.-W., Suh, C., Lee, J.-S., Ahn, J. S., Ahn, M.-J., Park, K., Na, I.-I., Lee, J. C., Ryoo, B.-Y. and Yang, S. H. (2010), Multicenter phase 2 study of belotecan, a new camptothecin analog, and cisplatin for chemotherapy-naive patients with extensive-disease small cell lung cancer. Cancer, 116: 132–136. doi: 10.1002/cncr.24719
Belotecan (Camtobell; CKD602) was kindly provided by Chong Kun Dang Corp, Seoul, Korea.
- Issue published online: 11 JAN 2010
- Article first published online: 10 NOV 2009
- Manuscript Accepted: 20 APR 2009
- Manuscript Revised: 17 APR 2009
- Manuscript Received: 17 JAN 2009
- Korea Health 21 R&D Project, Ministry of Health and Welfare, Republic of Korea. Grant Number: A060775
Vol. 116, Issue 2, 540, Article first published online: 15 DEC 2009
- extensive-stage disease;
- small cell lung cancer;
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).
Treatment consisted of belotecan 0.5 mg/m2 daily on Days 1 through 4 and cisplatin 60 mg/m2 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.
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.
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.