First-line treatment of advanced ovarian cancer with paclitaxel/carboplatin with or without epirubicin (TEC versus TC)-a gynecologic cancer intergroup study of the NSGO, EORTC GCG and NCIC CTG
First-line treatment of advanced ovarian cancer with paclitaxel/carboplatin with or without epirubicin (TEC versus TC)-a gynecologic cancer intergroup study of the NSGO, EORTC GCG and NCIC CTG
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DOI：
10.1093/annonc/mds060
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发表时间：
2012-10-01
影响因子：
50.5
通讯作者：
Kristensen, G. B.
中科院分区：
文献类型：
--
作者：
Lindemann, K.;Christensen, R. D.;Kristensen, G. B.
背景：在铂类化疗基础上加用蒽环类抗生素可提高卵巢癌患者的生存率。我们评估了在标准卡铂和paclitaxi.Patients和方法中加入表阿霉素对生存率的影响：我们进行了一项前瞻性随机III期研究，比较卡铂加紫杉醇（TC;曲线下面积5和175 mg/m2）与相同的组合和表阿霉素（TEC; 75 mg/m2 i. v.）。在1999年3月至2001年8月期间，887名患有上皮性卵巢癌、输卵管癌或腹膜癌的患者被随机分配至国际妇产科联合会IIB-IV期，接受TC或（442例患者）或TEC结果：TEC组和TC组的中位进展时间分别为16.4个月和16.0个月（风险比0.99; 95%置信区间[CI]：0.9-1.2）。TEC组的中位总生存时间为42.4个月，TC组为40.2个月（风险比0.96; 95% CI：0.8-1.1）。3/4级血液学毒性反应和大多数3/4级非血液学毒性反应在TEC arm. Accordingly更频繁，生活质量分析显示TEC相对于TC.Conclusion的劣效性：除了表阿霉素标准卡铂和紫杉醇治疗晚期卵巢癌，输卵管癌或腹膜癌患者的生存没有改善。
Background: The addition of anthracyclines to platinum-based chemotherapy may provide benefit in survival in ovarian cancer patients. We evaluated the effect on survival of adding epirubicin to standard carboplatin and paclitaxel.Patients and methods: We carried out a prospectively randomized phase III study comparing carboplatin plus paclitaxel (TC; area under the curve 5 and 175 mg/m(2)) with the same combination and epirubicin (TEC; 75 mg/m(2) i.v.). Between March 1999 and August 2001, 887 patients with epithelial ovarian, tubal or peritoneal cancer International Federation of Gynecology and Obstetrics stages IIB-IV were randomized to receive either TC (442 patients) or TEC (445 patients).Results: Median time to progression was 16.4 months in the TEC arm and 16.0 months in the TC arm (hazard ratio 0.99; 95% confidence interval [CI]: 0.9-1.2). Median overall survival time was 42.4 months for the TEC arm and 40.2 for the TC arm (hazard ratio 0.96; 95% CI: 0.8-1.1). Grade 3/4 hematologic toxic effects and most grade 3/4 non-hematologic toxic effects were more frequent in the TEC arm. Accordingly, a quality-of-life analysis showed inferiority of TEC versus TC.Conclusion: The addition of epirubicin to standard carboplatin and paclitaxel treatment did not improve survival in patients with advanced ovarian, tubal or peritoneal cancer.