Topotecan for the treatment of advanced epithelial ovarian cancer:: An open-label phase II study in patients treated after prior chemotherapy that contained cisplatin or carboplatin and paclitaxel
Topotecan for the treatment of advanced epithelial ovarian cancer:: An open-label phase II study in patients treated after prior chemotherapy that contained cisplatin or carboplatin and paclitaxel
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DOI：
10.1200/jco.1998.16.10.3345
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发表时间：
1998-10-01
影响因子：
45.3
通讯作者：
Fields, SZ
中科院分区：
文献类型：
--
作者：
Bookman, MA;Malmström, H;Fields, SZ
目的：Topatecan是一种拓扑异构酶I抑制剂，在一项多中心II期研究中进行了评估，该研究对象是在一到两次包括铂和紫杉醇的治疗方案后复发的上皮性卵巢癌妇女。患者和方法：Topotecan 1.5 mg/m(2)，每日输注30分钟，连续5天，21天为一个周期。入选标准包括：二维可测量疾病，东部肿瘤合作组表现状态为2或以下，骨髓、肝脏和肾脏功能正常。疗效由独立放射学评价评估。结果：治疗患者139例；81%是耐铂的。62名患者接受了一种先前的方案，77名患者接受了两种先前的方案。9例患者无法评估反应；然而，所有患者都被纳入了疗效分析。总有效率为13.7%；铂耐药患者12.4%，铂敏感患者19.2%。27.3%的患者病情稳定持续至少8周。中位缓解持续时间和进展时间分别为18.1周和12.1周。中位生存期为47.0周。4级中性粒细胞减少发生在82%的患者（34%的疗程），血小板减少发生在30%的患者（9%的疗程）。6%的疗程出现感染并发症。非血液学毒性较轻。没有与药物有关的中毒死亡。结论：作为单一药物，拓扑替康在1或2次铂和紫杉醇治疗后进展或无反应的晚期上皮性卵巢癌患者中具有适度的活性。根据作用机制和耐受性，建议在卵巢癌的主要治疗方案中进一步研究联合方案。(C)美国临床肿瘤学会1998。
Purpose: Topatecan, a topoisomerase I inhibitor, was evaluated in a multicenter, phase II study of women with epithelial ovarian carcinoma who relapsed after one or two prior regimens that included platinum and paclitaxel.Patients and Methods: Topotecan 1.5 mg/m(2) daily was administered as a 30-minute infusion for 5 consecutive days on a 21-day cycle. Eligibility criteria included bidimensionally measurable disease, Eastern Cooperative Oncology Group performance status of 2 or less, and adequate bone marrow, liver, and renal function. Efficacy was assessed by independent radiologic review.Results: One hundred thirty-nine patients were treated; 81% were platinum resistant. Sixty-two patients had received one prior regimen and 77 patients had received two prior regimens. Nine patients were not assessable for response; however, all patients were included in the response analysis. The overall response rate was 13.7%; 12.4% in platinum-resistant and 19.2% in platinum-sensitive patients. Stable disease lasted at least 8 weeks in 27.3% of the patients. The median duration of response and time to progression were 18.1 and 12.1 weeks, respectively. The median survival was 47.0 weeks. Grade 4 neutropenia occurred in 82% of the patients (34% of the courses) and thrombocytopenia in 30% of the patients (9% of the courses). Infectious complications occurred in 6% of the courses. Nonhematologic toxicities were mild. There were no drug-related toxic deaths.Conclusion: As a single agent, topotecan has modest activity in women with advanced epithelial ovarian carcinoma who have progressed or not responded after one or two prior regimens with platinum and paclitaxel. Further investigation of combination regimens is indicated in the primary therapy for ovarian cancer based on the mechanism of action and tolerability. (C) 1998 by American Society of Clinical Oncology.