Dieras V, Bougnoux P, Petit T, Chollet P, Beuzeboc P, Borel C, Husseini F, Goupil A, Kerbrat P, Misset J L, Bensmaïne M A, Tabah-Fisch I, Pouillart P
Institut Curie, Paris, France.
Ann Oncol. 2002 Feb;13(2):258-66. doi: 10.1093/annonc/mdf018.
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.
Forty-eight patients received oxaliplatin 130 mg/M2 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.
A total of 253 cycles was administered (median: 5.5/patient). Median cumulative oxaliplatin dose was 666 mg/m2. 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% CI 0% to 27%) in platinum-resistant patients. Median response duration was 9.2 months (95% CI 6.6% to 11.8%), and median progression-free and overall survival in all treated patients were 4.3 months (95% CI 3.0% to 5.7%) and 15.0 months (95% CI 11.1% to 18.8%), respectively.
Oxaliplatin has a good safety profile and is active in cis/carboplatin +/- paclitaxel-pretreated AOC patients.
这项多中心II期开放标签研究评估了奥沙利铂在接受顺铂或卡铂（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。
48例患者每3周静脉注射130mg/m²奥沙利铂，94%的患者体能状态（PS）为0 - 1。所有患者均接受过顺铂/卡铂预处理，21例（44%）接受过紫杉醇预处理。受累器官的中位数为2个，18例（38%）有肝转移，23例（48%）对铂类耐药，14例（29%）对紫杉烷耐药。42例患者可评估疗效，其中18例（43%）对铂类耐药，11例（26%）对紫杉烷耐药。
共给药253个周期（中位数：5.5个/患者）。奥沙利铂的累积剂量中位数为666mg/m²。根据美国国立癌症研究所通用毒性标准进行的毒性分析显示，7例患者（15%）出现3/4级血小板减少，2例患者（4%）出现3级中性粒细胞减少，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。在治疗结束时出现周围神经病变的29例患者中，55%在1个月后恢复或改善。42例可评估患者中获得了11例客观缓解（2例完全缓解）[客观缓解率（ORR）26%，95%置信区间（CI）14%至42%]，铂类敏感患者中24例中有10例（42%，95%CI%22%至63%），铂类耐药患者中18例中有1例（5.6%，95%CI0%至27%）。缓解持续时间中位数为9.2个月（95%CI6.6%至11.8%），所有接受治疗患者的无进展生存期和总生存期中位数分别为4.3个月（95%CI3.0%至5.7%）和15.0个月（95%CI11.1%至18.8%）。
奥沙利铂具有良好的安全性，在接受顺铂/卡铂+/-紫杉醇预处理的AOC患者中具有活性。
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