Department of Gynaecologic Oncology, Catholic University of the Sacred Heart, Largo Agostino Gemelli 8, Rome, Italy.
Oncology. 2011;80(5-6):390-4. doi: 10.1159/000330537. Epub 2011 Aug 5.
It was the aim of our study to evaluate the efficacy and safety of weekly topotecan in patients with advanced or recurrent cervical disease.
Topotecan was administered intravenously as a weekly infusion at a dose of 3.5 mg/m(2) on days 1, 8 and 15 of a 28-day cycle. After the second cycle, the dose was increased to 4 mg/m(2) if no grade >2 toxicity occurred. Treatment was continued until disease progression or unacceptable toxicity.
Twenty-one patients were enrolled, but only 18 were evaluable for response and toxicity. Ten patients (56%) had received primary surgery + chemoradiation, 6 patients (33%) had previously received surgery + chemotherapy and 2 patients (11%) exclusive chemoradiation. Patients received a mean of 3.5 courses (range 1-6). No complete or partial responses were reported. Two patients (11%) presented disease stabilization as maximum response. Median progression-free survival was 11 weeks (95% CI 15-25), and median overall survival was 28 weeks (95% CI 24-72). The treatment was generally well tolerated.
This trial did not report any activity of weekly bolus topotecan in the treatment of advanced or recurrent cervical cancer. Actually, there is no evidence to recommend this therapy in this patient population.
本研究旨在评估每周拓扑替康治疗晚期或复发性宫颈癌患者的疗效和安全性。
拓扑替康静脉滴注，剂量为 3.5mg/m²，第 1、8 和 15 天为一个 28 天周期。如果没有发生>2 级毒性，则在第二个周期后将剂量增加至 4mg/m²。治疗持续至疾病进展或不可接受的毒性。
共纳入 21 例患者，但仅 18 例可进行疗效和毒性评价。10 例患者（56%）接受了原发性手术+放化疗，6 例患者（33%）接受了手术+化疗，2 例患者（11%）接受了单纯放化疗。患者接受了平均 3.5 个疗程（范围 1-6）。无完全或部分缓解。2 例患者（11%）最大缓解为疾病稳定。无进展生存期中位数为 11 周（95%CI 15-25），总生存期中位数为 28 周（95%CI 24-72）。治疗总体耐受良好。
本试验未报告每周推注拓扑替康治疗晚期或复发性宫颈癌的任何疗效。实际上，没有证据推荐在该患者人群中使用这种治疗方法。
