Multicentre phase II study of oxaliplatin as a single-agent in cisplatin/carboplatin ± taxane-pretreated ovarian cancer patients
Multicentre phase II study of oxaliplatin as a single-agent in cisplatin/carboplatin ± taxane-pretreated ovarian cancer patients
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DOI：
10.1093/annonc/mdf018
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发表时间：
2002-02-01
影响因子：
50.5
通讯作者：
Pouillart, P
中科院分区：
文献类型：
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作者：
Dieras, V;Bougnoux, P;Pouillart, P
背景：这项多中心II期开放标签研究评估了奥沙利铂在顺铂或卡铂(顺铂/卡铂)+/-紫杉烷预处理的晚期卵巢癌(AOC)患者中的安全性和抗肿瘤活性。患者和方法：48名患者每3周静脉注射奥沙利铂130 mg/m(2)，94%的患者表现状态(PS)0-1。所有患者均接受顺铂/卡铂联合化疗，21例(44%)接受紫杉醇联合化疗。受累器官数中位数为2个，其中18个(38%)为肝转移，23个(48%)为铂类耐药，14个(29%)为紫杉烷耐药。42例患者可评价疗效，18例(43%)对铂类药物耐药，11例(26%)紫杉烷耐药。结果：共治疗253个周期，中位数：5.5个/患者。奥沙利铂的中位累积剂量为666 mg/m(2)。国家癌症研究所-共同毒性标准毒性分析显示，7例(15%)患者出现3/4级血小板减少，2例(4%)患者出现3级中性粒细胞减少症，1例患者出现3级贫血。11例患者(23%)出现3级神经感觉毒性。29例治疗结束时有周围神经病变的患者中，55%在1个月后恢复或改善。42例可评价患者获得11个客观有效(2个完全)[ORR26%，95%可信区间(CI)14%~42%]，其中铂敏感患者10/24(42%，95%可信区间22%~63%)，铂耐药患者18例(5.6%，95%CI 0%~27%)，中位反应时间9.2个月(957o可信区间6.6%~11.8%)。所有患者的中位无进展和总生存期分别为4.3个月(95%CI 3.0%~5.7%)和15.0个月(95%CI 11.1%~18.8%)。结论：奥沙利铂对顺铂/卡铂+/-紫杉醇预处理的AOC患者具有良好的安全性。
Background: This multicentre phase II open-label study evaluated safety and antitumour activity of oxaliplatin in cisplatin or carboplatin (cis/carboplatin) +/- taxane-pretreated advanced ovarian cancer (AOC) patients.Patients and methods: Forty-eight patients received oxaliplatin 130 mg/m(2) intravenously every 3 weeks, 94% having a performance status (PS) 0-1. All were pretreated with cis/carboplatin and 21 (44%) with paclitaxel. The median number of involved organs was two, 18 (38%) had liver metastasis, 23 (48%) were platinum-resistant and 14 (29%) were taxane-resistant. Forty-two patients were evaluable for a response, 18 (43%) were platinum-resistant and 11 (26%) were taxane-resistant.Results: A total of 253 cycles was administered (median: 5.5/patient). Median cumulative oxaliplatin dose was 666 mg/m(2). National Cancer Institute-Common Toxicity Criteria toxicity analysis showed that seven patients (15%) had grade 3/4 thrombocytopenia, two patients (4%) had grade 3 neutropenia, and one patient had grade 3 anaemia. Eleven patients (23%) experienced grade 3 neurosensory toxicity. Of the 29 patients with peripheral neuropathy at the end of treatment, 55% had recovered or improved 1 month later. Eleven objective responses (two complete) were obtained in the 42 evaluable patients [ORR 26%, 95% confidence interval (CI) 14% to 42%], with 10/24 (42%, 95% CI 22% to 63%) in platinum-sensitive, and 1 of 18 (5.6%, 95% Cl 0% to 27%) in platinum-resistant patients, Median response duration was 9.2 months (957o CI 6.6% to 11.8%), and median progression-free and overall survival in all treated patients were 4.3 months (95% Cl 3.0% to 5.7%) and 15.0 months (95% CI 11.1% to 18.8%), respectively.Conclusion: Oxaliplatin has a good safety profile and is active in cis/carboplatin +/- paclitaxel-pretreated AOC patients.