Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.
Lung Cancer. 2010 Oct;70(1):77-81. doi: 10.1016/j.lungcan.2010.01.006. Epub 2010 Mar 16.
Belotecan is a topoisomerase I inhibitor. This phase II trial was conducted to evaluate the efficacy and toxicity of belotecan in relapsing small-cell lung cancer (SCLC) patients after irinotecan failure.
SCLC patients, who had relapsed at least 3 months after achieving objective response to irinotecan plus platinum chemotherapy, were eligible. Belotecan was administered at a dose of 0.5 mg/m(2)/day for 5 consecutive days every 3 weeks.
Twenty-seven patients were enrolled in this study. Twenty-five patients were evaluated for response, and 27 patients were evaluated for toxicity and survival. The overall response rate was 22%. The median time to progression was 4.7 months (95% CI, 3.6-5.8 months), and the median overall survival was 13.1 months (95% CI, 10.4-15.8 months). The most frequent grade 3/4 toxicities were neutropenia (93%) and thrombocytopenia (48%). There was one treatment-related death due to pneumonia.
Belotecan showed modest activity and manageable toxicities in relapsing SCLC patients in this study which was conducted in Asia. But further study in Caucasian patients is needed.
贝洛替康是一种拓扑异构酶 I 抑制剂。本 II 期临床试验旨在评估贝洛替康在伊立替康治疗失败后的复发小细胞肺癌（SCLC）患者中的疗效和毒性。
至少在伊立替康联合铂类化疗达到客观缓解后 3 个月复发的 SCLC 患者符合入组条件。贝洛替康的剂量为 0.5mg/m²/天，连续 5 天，每 3 周给药 1 次。
本研究共纳入 27 例患者。25 例患者进行了疗效评估，27 例患者进行了毒性和生存评估。总体缓解率为 22%。中位无进展生存期为 4.7 个月（95%CI，3.6-5.8 个月），中位总生存期为 13.1 个月（95%CI，10.4-15.8 个月）。最常见的 3/4 级毒性为中性粒细胞减少（93%）和血小板减少（48%）。有 1 例因肺炎导致的治疗相关性死亡。
在亚洲进行的这项研究中，贝洛替康在复发 SCLC 患者中显示出适度的疗效和可管理的毒性。但仍需要在高加索患者中进一步研究。
