Erschienen in:
01.01.2012 | Original Article
Phase II study of combined belotecan and cisplatin as first-line chemotherapy in patients with extensive disease of small cell lung cancer
verfasst von:
Junshik Hong, Minkyu Jung, Yu Jin Kim, Sun Jin Sym, Sun Young Kyung, Jinny Park, Sang Pyo Lee, Jeong Woong Park, Eun Kyung Cho, Sung Hwan Jeong, Dong Bok Shin, Jae Hoon Lee
Erschienen in:
Cancer Chemotherapy and Pharmacology
|
Ausgabe 1/2012
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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-naïve ED SCLC were eligible if the following criteria were met: age ≥18 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/m2/day) on days 1–4 and cisplatin (60 mg/m2) 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.