Markman M, Blessing J A, Alvarez R D, Hanjani P, Waggoner S, Hall K
The Cleveland Clinic Cancer Center, The Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.
Gynecol Oncol. 2000 Apr;77(1):112-5. doi: 10.1006/gyno.2000.5755.
The aim of this study was to develop an alternative effective and more convenient administration schedule for intravenous topotecan when used as palliative treatment in ovarian cancer.
The Gynecologic Oncology Group conducted a Phase II trial of 24-h infusional topotecan (8.5 mg/m(2)) with treatment repeated every 3 weeks in 29 patients with platinum-sensitive recurrent ovarian cancer (prior response to platinum-based chemotherapy with a minimum treatment-free interval >/=6 months).
The major toxicities of therapy were grade 4 neutropenia and thrombocytopenia which developed in 86 and 14% of patients, respectively. Other severe side effects were uncommon. Only 2 partial responses (7%) were observed in the 28 patients evaluable for response.
Despite the relatively favorable ovarian cancer patient population treated in this trial (platinum-sensitive recurrent disease), the response rate was disappointingly low. Considering the three- to fivefold higher objective response rates observed in other trials employing topotecan in individuals with platinum-sensitive ovarian cancer utilizing a 5-day treatment program (delivered every 3 weeks), the results of the current study provide strong support for the conclusion that clinically relevant antineoplastic activity of this agent is highly schedule dependent.
本研究的目的是为静脉注射拓扑替康在卵巢癌姑息治疗中开发一种替代的有效且更方便的给药方案。
妇科肿瘤学组对29例铂敏感复发性卵巢癌患者（先前对铂类化疗有反应且至少有6个月的无治疗间隔≥6个月）进行了一项II期试验，采用24小时输注拓扑替康（8.5mg/m²），每3周重复治疗一次。
治疗的主要毒性为4级中性粒细胞减少和血小板减少，分别发生在86%和14%的患者中。其他严重副作用不常见。在可评估反应的28例患者中仅观察到2例部分缓解（7%）。
尽管本试验中治疗的卵巢癌患者群体相对有利（铂敏感复发性疾病），但反应率低得令人失望。考虑到在其他试验中，采用5天治疗方案（每3周给药一次）对铂敏感卵巢癌患者使用拓扑替康观察到的客观反应率高出三到五倍，本研究结果有力支持了该药物的临床相关抗肿瘤活性高度依赖给药方案这一结论。
