Addition of epirubicin as a third drug to carboplatin-paclitaxel in first-line treatment of advanced ovarian cancer: A prospectively randomized gynecologic cancer intergroup trial by the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group and the Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens
Addition of epirubicin as a third drug to carboplatin-paclitaxel in first-line treatment of advanced ovarian cancer: A prospectively randomized gynecologic cancer intergroup trial by the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group and the Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens
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DOI：
10.1200/jco.2005.03.2938
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发表时间：
2006-03-01
影响因子：
45.3
通讯作者：
Pujade-Lauraine, E
中科院分区：
文献类型：
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作者：
du Bois, A;Weber, B;Pujade-Lauraine, E
目的 尽管已经取得了进展，但晚期卵巢癌患者的长期生存率仍然令人失望。改善结果的一种尝试可能是在铂-紫杉醇联合治疗方案中添加非交叉耐药药物。蒽环类药物是作为第三种药物纳入一线治疗方案的候选药物之一。 患者和方法 我们进行了一项前瞻性随机 III 期研究，比较卡铂-紫杉醇（TC；曲线下面积分别为 5/175 mg/m(2)）与表柔比星 60 mg/m(2) 添加到相同组合 (TEC) 中，用于先前未经治疗的晚期上皮性卵巢癌患者。所有药物均在 3 周计划的第一天静脉注射，计划至少 6 个疗程。 结果 1997 年 11 月至 2000 年 2 月期间，1,282 名患者被随机分配分别接受 TC（635 名患者）或 TEC（647 名患者）。 3/4 级血液学和一些非血液学毒性（恶心/呕吐、粘膜炎和感染）在 TEC 组中发生的频率明显更高，因此，生活质量分析显示 TEC 相对于 TIC 较差。 TEC 组的中位无进展生存时间为 18.4 个月，TC 组为 17.9 个月（风险比 [HR]，0.95；95% CI，0.83 至 1.07；P = .3342）。 TEC 组的中位总生存时间为 45.8 个月，TC 组为 41.0 个月（HR，0.93；95% CI，0.81 至 1.08；P = .3652）。当单独分析各层时，观察到类似的非显着性差异。 结论 在 TC 中添加表柔比星并不能改善晚期上皮性卵巢癌患者的生存率或治疗失败时间；因此，不推荐在该人群中临床使用。
Purpose Despite the progress that has been achieved, long-term survival rates in patients with advanced ovarian cancer are still disappointing. One attempt to improve results could be the addition of non-cross-resistant drugs to platinum-paclitaxel combination regimens. Anthracyclines were among the candidates for incorporation as a third drug into first-line regimens.Patients and Methods We performed a prospectively randomized phase III study comparing carboplatin-paclitaxel (TC; area under the curve 5/175 mg/m(2), respectively) with epirubicin 60 mg/m(2) added to the same combination (TEC) in previously untreated patients with advanced epithelial ovarian cancer. All drugs were administered intravenously on day 1 of a 3-week schedule for a planned minimum of six courses.Results Between November 1997 and February 2000, 1,282 patients were randomly assigned to receive either TC (635 patients) or TEC (647 patients), respectively. Grade 3/4 hematologic and some nonhematologic toxicities (nausea/emesis, mucositis, and infections) occurred significantly more frequently in the TEC arm, Accordingly, quality-of-life analysis showed inferiority of TEC versus TIC. Median progression-free survival time was 18.4 months for the TEC arm and 17.9 months for the TC arm (hazard ratio [HR], 0.95; 95% CI, 0.83 to 1.07; P = .3342). Median overall survival time was 45.8 months for the TEC arm and 41.0 months for the TC arm (HR, 0.93; 95% CI, 0.81 to 1.08; P = .3652). Similar nonsignificant differences were observed when strata were analyzed separately.Conclusion Addition of epirubicin to TC did not improve survival or time to treatment failure in patients with advanced epithelial ovarian cancer; therefore, it cannot be recommended for clinical use in this population.