Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Women's Cancer Clinic, Yonsei University College of Medicine, Seongsan-no 250, Seodaemun-gu, Seoul, Korea.
Am J Clin Oncol. 2010 Jun;33(3):233-7. doi: 10.1097/COC.0b013e3181a650bc.
This study was performed to determine the safety and efficacy of belotecan, a new camptothecin analogue and potent topoisomerase I inhibitor, with and without platinum in patients with recurrent ovarian cancer.
Fifty-three patients with recurrent or persistent ovarian cancer were enrolled between March 2005 and March 2008. Eligible patients received 0.5 mg/m of intravenous (IV) belotecan on days 1 to 5, every 3 weeks belotecan monotherapy (B) or 50 mg/m of IV cisplatin on day 1 plus 0.3 mg/m of IV belotecan on days 1 to 5, every 3 weeks (belotecan plus cisplatin combination therapy [BP]).
Of the 53 treated patients, 34 received BP and 19 received B. Thirty-four patients had platinum-sensitive (PS) disease and 19 had platinum-resistant disease. The overall response of the 53 patients was 37.7% (20/53). According to regimen, the response rate in the BP group was 47.1% (16/34) and that of the B group was 21.1% (4/19). BP had better response (66.7%, 14/21) than B (15.4%, 2/13) for PS disease (P = 0.004), but it was not superior in terms of progression-free survival (BP, 6 month; B, 7 months). Grade 3 or 4 toxicity was less common in B than in BP.
Both BP and B seems to be effective and safe regimens for patients with PS or platinum-resistant recurrent ovarian cancer. These results warrant further prospective randomized trials. Both BP and B seems to be effective and safe regimens for patients with PS or platinum-resistant recurrent ovarian cancer.
本研究旨在确定贝洛替康（一种新型喜树碱类似物和强效拓扑异构酶 I 抑制剂）联合或不联合铂类药物治疗复发性卵巢癌患者的安全性和有效性。
2005 年 3 月至 2008 年 3 月期间，共纳入 53 例复发性或持续性卵巢癌患者。符合条件的患者接受 0.5mg/m 的静脉注射（IV）贝洛替康，第 1 至 5 天，每 3 周接受贝洛替康单药治疗（B）或第 1 天给予 50mg/m 的 IV 顺铂，第 1 至 5 天给予 0.3mg/m 的 IV 贝洛替康，每 3 周一次（贝洛替康联合顺铂联合治疗[BP]）。
53 例接受治疗的患者中，34 例接受 BP 治疗，19 例接受 B 治疗。34 例患者患有铂敏感（PS）疾病，19 例患有铂耐药疾病。53 例患者的总体缓解率为 37.7%（20/53）。根据方案，BP 组的缓解率为 47.1%（16/34），B 组的缓解率为 21.1%（4/19）。BP 对 PS 疾病的反应优于 B（66.7%，14/21 比 15.4%，2/13；P=0.004），但在无进展生存期方面没有优势（BP，6 个月；B，7 个月）。B 组的 3 级或 4 级毒性比 BP 组少见。
BP 和 B 似乎都是 PS 或铂耐药复发性卵巢癌患者有效且安全的治疗方案。这些结果需要进一步前瞻性随机试验来验证。BP 和 B 似乎都是 PS 或铂耐药复发性卵巢癌患者有效且安全的治疗方案。
