A randomized clinical trial of cisplatin/paclitaxel versus carboplatin/paclitaxel as first-line treatment of ovarian cancer
A randomized clinical trial of cisplatin/paclitaxel versus carboplatin/paclitaxel as first-line treatment of ovarian cancer
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DOI：
10.1093/jnci/djg036
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发表时间：
2003-09-03
影响因子：
10.3
通讯作者：
Pfisterer, J
中科院分区：
文献类型：
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作者：
du Bois, A;Lück, HJ;Pfisterer, J
背景：尽管晚期卵巢癌的治疗有了长足的进步，但疗效和耐受性的优化仍然是一个重要的问题。因此，我们在晚期卵巢癌患者中进行了一项随机的III期非劣效性试验，比较了紫杉醇联合顺铂(PT)和紫杉醇联合卡铂(TC)。方法：将798例国际妇产科联合会IIB-IV期患者随机分成6个疗程，每隔3周接受PT或TC治疗。主要终点是2年后没有进展的患者的比例。次要终点包括毒性、治疗反应、生活质量、总体和无进展生存时间。生活质量的评估使用欧洲癌症研究和治疗组织生活质量问卷(QLQ)-C30，2.0版。生存曲线用Kaplan-Meier法计算，危险比用Cox比例风险模型估计。结果：两组患者2年内无进展的比例差异无统计学意义(PT组40.0%，TC组37.5%，差异=2.5%，单侧95%可信区间[CI]=-8.2%)。中位无进展生存期TC组(17.2个月，95%CI=15.2~19.3个月)和PT组(19.1个月，95%CI=16.7~21.5个月)差异无统计学意义，中位总生存期(TC组43.3个月，95%CI=37.2~47.8个月，PT组44.1个月，95%CI=40.2~49.4个月)。与PT方案相比，TC方案的血液毒性发生率较高，而胃肠道和神经毒性的发生率较低。治疗结束时，TC组的总体生活质量评分显著好于PT组(分别为65.25分和51.97分；差异=-13.28，95%CI=-18.88~-7.68)。结论：TC方案与PT方案疗效相当，但耐受性更好，生活质量更高，可作为晚期卵巢癌标准一线化疗的重要替代方案。
Background: Despite considerable improvement in the treatment of advanced ovarian cancer, the optimization of efficacy and tolerability remains an important issue. Therefore, we performed a randomized, phase III non-inferiority trial comparing paclitaxel plus cisplatin (PT) with paclitaxel plus carboplatin (TC) in patients with advanced ovarian cancer. Methods: A total of 798 patients with International Federation of Gynecology and Obstetrics stage IIB-IV were randomly assigned to receive six courses of either PT or TC at 3-week intervals. The primary endpoint was the proportion of patients without progression at 2 years. Secondary endpoints included toxicity, response to treatment, quality of life, and overall and progression-free survival time. Quality of life was evaluated using the European Organization for Research and Treatment of Cancer quality-of-life questionnaire (QLQ)-C30, version 2.0. Survival curves were calculated using the Kaplan-Meier method, and hazard ratios were estimated using the Cox proportional hazards model. Results: The proportion of patients without progression at 2 years was not statistically significantly different between the two treatment arms (40.0% for PT versus 37.5% for TC, difference = 2.5%, one-sided 95% confidence interval [CI] = -infinity to 8.2%). Median progression-free survival time in the TC arm (17.2 months, 95% CI = 15.2 to 19.3 months) and the PT arm (19.1 months, 95% CI = 16.7 to 21.5 months) were also not statistically significantly different; the same was true of median overall survival time (43.3 months, 95% CI = 37.2 to 47.8 months versus 44.1 months, 95% CI = 40.2 to 49.4 months, for the TC and PT arms, respectively). The TC regimen was associated with a higher frequency of hematologic toxicity, but a lower frequency of gastrointestinal and neurologic toxicity, than the PT regimen. Mean global quality-of-life scores at the end of treatment were statistically significantly better in the TC arm than in the PT arm (65.25 versus 51.97, respectively; difference = -13.28, 95% Cl = -18.88 to -7.68). Conclusion: The TC regimen achieved comparable efficacy to the PT regimen but was associated with better tolerability and quality of life, and should, therefore, be considered as an important alternative for standard first-line chemotherapy in patients with advanced ovarian cancer.