Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: Three-year results
Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: Three-year results
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DOI：
10.1093/jnci/92.9.699
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发表时间：
2000-05-03
影响因子：
10.3
通讯作者：
Pecorelli, S
中科院分区：
文献类型：
--
作者：
Piccart, MJ;Bertelsen, K;Pecorelli, S
背景资料：美国妇科肿瘤组（GOG，研究#111）进行的一项随机试验显示，晚期卵巢癌患者接受紫杉醇-顺铂方案治疗的结局优于接受标准环磷酰胺-顺铂方案治疗的患者。在考虑将紫杉醇-顺铂方案作为新的“标准”之前，一组欧洲和加拿大的研究人员计划进行一项确证性III期试验。研究方法：这项组间试验招募了680名患者，其选择标准比GOG #111研究更广泛，并以3小时而不是24小时输注的方式给予紫杉醇;无进展生存期是主要终点。使用Kaplan-Meier技术分析患者生存率。通过考克斯比例风险回归模型估计治疗对患者生存期的影响。所有统计检验均为双侧检验。结果如下：紫杉醇组和环磷酰胺组的总体临床应答率分别为59%和45%;完全临床缓解率分别为41%和27%;两组差异均有统计学意义（P = 0.01）。在中位随访38.5个月时，尽管首次检测到疾病进展时从环磷酰胺组到紫杉醇组的交叉率很高（48%），但较长的无进展生存期（对数秩P = 0.0005;中位数为15.5个月vs 11.5个月）和更长的总生存期（对数秩P = 0.0016;中位数为35.6个月vs 25.8个月）。结论：两项大型随机III期试验提供了强有力的确证性证据，支持紫杉醇-顺铂作为晚期卵巢癌患者治疗的新标准方案。
Background: A randomized trial conducted by the Gynecologic Oncology Group (GOG, study #111) in the United States showed a better outcome for patients with advanced ovarian cancer on the paclitaxel-cisplatin regimen than for those on a standard cyclophosphamide-cisplatin regimen. Before considering the paclitaxel-cisplatin regimen as the new "standard," a group of European and Canadian investigators planned a confirmatory phase III trial. Methods: This intergroup trial recruited 680 patients with broader selection criteria than the GOG #111 study and administered paclitaxel as a 3-hour instead of a 24-hour infusion; progression-free survival was the primary end point. Patient survival was analyzed by use of the Kaplan-Meier technique. Treatment effects on patient survival were estimated by Cox proportional hazards regression models. All statistical tests were two-sided. Results: The overall clinical response rate was 59% in the paclitaxel group and 45% in the cyclophosphamide group; the complete clinical remission rates were 41% and 27%, respectively; both differences were statistically significant (P = .01 for both). At a median follow-up of 38.5 months and despite a high rate of crossover (48%) from the cyclophosphamide arm to the paclitaxel arm at first detection of progression of disease, a longer progression-free survival (log-rank P = .0005; median of 15.5 months versus 11.5 months) and a longer overall survival (log-rank P = .0016; median of 35.6 months versus 25.8 months) were seen in the paclitaxel regimen compared with the cyclophosphamide regimen. Conclusions: There is strong and confirmatory evidence from two large randomized phase III trials to support paclitaxel-cisplatin as the new standard regimen for treatment of patients with advanced ovarian cancer.