Phase II study of combined belotecan and cisplatin as first-line chemotherapy in patients with extensive disease of small cell lung cancer
- Authors
- Hong, Junshik; Jung, Minkyu; Kim, Yu Jin; Sym, Sun Jin; Kyung, Sun Young; Park, Jinny; Lee, Sang Pyo; Park, Jeong Woong; Cho, Eun Kyung; Jeong, Sung Hwan; Shin, Dong Bok; Lee, Jae Hoon
- Issue Date
- Jan-2012
- Publisher
- Springer Verlag
- Keywords
- Belotecan; Cisplatin; Small cell lung carcinoma; Chemotherapy
- Citation
- Cancer Chemotherapy and Pharmacology, v.69, no.1, pp 215 - 220
- Pages
- 6
- Indexed
- SCI
SCIE
SCOPUS
- Journal Title
- Cancer Chemotherapy and Pharmacology
- Volume
- 69
- Number
- 1
- Start Page
- 215
- End Page
- 220
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/65733
- DOI
- 10.1007/s00280-011-1689-6
- ISSN
- 0344-5704
1432-0843
- Abstract
- Purpose To determine the efficacy and safety of belotecan in combination with cisplatin as first-line chemotherapy for extensive disease of small cell lung cancer (ED SCLC). Methods Patients with chemotherapy-na < ve ED SCLC were eligible if the following criteria were met: age a parts per thousand yen18 years; a measurable lesion; Eastern Cooperative Oncology Group Performance Status (PS) 0-2; and adequate organ function. Each cycle consisted of belotecan (0.5 mg/m(2)/day) on days 1-4 and cisplatin (60 mg/m(2)) intravenously on day 1. The cycle was repeated every 3 weeks until the completion of the 6th cycle, disease progression, or intolerable toxicity. Results Thirty-five patients (median age, 68 years) were enrolled: 32 males (91.4%); and PS = 0 (n = 3), PS = 1 (n = 18), and PS = 2 (n = 14). The median number of cycles delivered was 5 (range, 1-6). The relative dose intensity was 70.1% for belotecan and 83.0% for cisplatin. Of 30 evaluable patients, objective response rate was 71.4% (95% confidence interval [CI], 55.7-87.2) by the intent-to-treat principle. The median duration of follow-up was 14.3 months. The median progression-free survival was 5.7 months (95% CI, 3.9-7.5) and the median overall survival was 10.2 months (95% CI, 9.3-11.1). The frequently reported grade 3 or 4 toxicities included neutropenia in 24 patients (68.6%), thrombocytopenia in 10 (28.6%), and anemia in 7 (20.0%). There was no grade 3 or 4 non-hematologic toxicity except three patients (8.6%) with fatigue. Conclusions Belotecan and cisplatin combination therapy showed significant efficacy in ED SCLC with improved non-hematologic toxicities.
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