Phase II study of oxaliplatin in platinum-resistant and refractory ovarian cancer: A gynecologic group study

Phase II study of oxaliplatin in platinum-resistant and refractory ovarian cancer: A gynecologic group study
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DOI:
10.1200/jco.2003.03.077
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发表时间:
2003-08-01
影响因子:
45.3
通讯作者:
Hoffman, JS
Hoffman, JS
中科院分区:
医学1区
文献类型:
--
作者:
Fracasso, PM;Blessing, JA;Hoffman, JS

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目的:进行了一项II期研究,以确定奥沙利铂治疗铂耐药或难治性上皮性卵巢癌患者的疗效。材料和方法:符合条件的患者接受奥沙利铂130 mg/m(2)静脉注射2小时以上,每21天一次,直到疾病进展或不良反应禁止进一步治疗。结果:进入研究的25例患者中,23例符合条件并可评估。没有患者完全缓解。1例患者(4.3%)达到部分缓解,缓解持续时间为6.4个月。9例患者(39.1%)病情稳定,中位病程5.6个月以上(范围1.8 - 13.1个月)。最常报道的药物相关毒性是血液学、胃肠道和神经学。结论:在试验剂量和方案下,奥沙利铂作为单一药物对铂耐药或难治性卵巢癌患者的活性极小。然而,奥沙利铂联合其他活性药物治疗铂源性或铂敏感上皮性卵巢癌的未来研究可能需要进行。
Purpose: A phase II study was conducted to determine the efficacy of oxaliplatin therapy in patients with platinum-resistant or refractory epithelial ovarian carcinoma.Materials and Methods: Eligible patients were to receive oxaliplatin 130 mg/m(2) intravenously over 2 hours, every 21 days, until progression of disease or adverse effects prohibited further therapy.Results: Of 25 patients entered onto the study, 23 were eligible and assessable. There were no patients with complete response. One patient (4.3%) achieved a partial response, with a response duration of 6.4 months. Nine patients (39.1%) experienced stable disease, with a median duration of 5.6+ months (range, 1.8 to 13.1 months). The most frequently reported drug-related toxicities were hematologic, gastrointestinal, and neurologic.Conclusion: Oxaliplatin as a single agent has minimal activity in patients with platinum-resistant or refractory ovarian cancer at the dosage and schedule tested. However, future studies of oxaliplatin combined with other active agents in women with platinum-naive or platinum-sensitive epithelial ovarian carcinoma may be indicated.