Lee, Dae Ho; Kim, Sang-We; Suh, Cheolwon; Lee, Jung-Shin; Ahn, Jin Seok; Ahn, Myung-Ju; Park, Keunchil; Na, Im-Il; Lee, Jae Cheol; Ryoo, Baek-Yeol; Yang, Sung Hyun
Cancer
2010Jan ; 116 ( 1 ) :132-6.
PMID : 19904804
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Lee, Dae Ho -
Kim, Sang-We -
Suh, Cheolwon -
Lee, Jung-Shin -
Ahn, Jin Seok -
Ahn, Myung-Ju -
Park, Keunchil -
Na, Im-Il -
Lee, Jae Cheol -
Ryoo, Baek-Yeol -
Yang, Sung Hyun -
ABSTRACT
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. CI - Copyright 2010 American Cancer Society.
belotecan, cisplatin, extensive-stage disease, small cell lung cancer, chemotherapy-naive
MESH
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use, Camptothecin/administration & dosage/adverse effects/*analogs & derivatives, Cisplatin/*administration & dosage/adverse effects, Female, Humans, Lung Neoplasms/*drug therapy/mortality/pathology, Male, Middle Aged, Neutropenia/chemically induced, Small Cell Lung Carcinoma/*drug therapy/mortality
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