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首页> 外文期刊>Breast cancer research and treatment. >Intermittent versus continuous first-line treatment for HER2-negative metastatic breast cancer: the Stop & Go study of the Dutch Breast Cancer Research Group (BOOG)
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Intermittent versus continuous first-line treatment for HER2-negative metastatic breast cancer: the Stop & Go study of the Dutch Breast Cancer Research Group (BOOG)

机译：间歇性与Her2阴性转移性乳腺癌的连续一线治疗：荷兰乳腺癌研究组的停止和去研究（Boog）

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PurposeWe determined if intermittent first-line treatment with paclitaxel plus bevacizumab was not inferior to continuous treatment in patients with HER2-negative, advanced breast cancer.MethodsPatients were randomized to 2x4 cycles or continuous 8 cycles of paclitaxel plus bevacizumab, followed by bevacizumab maintenance treatment until disease progression or unacceptable toxicity. The primary endpoint was overall progression-free survival (PFS). A proportional-hazards regression model was used to estimate the HR. The upper limit of the two-sided 95% CI for the HR was compared with the non-inferiority margin of 1.34.ResultsA total of 420 patients were included with well-balanced characteristics. In the intention-to-treat analysis, median overall PFS was 7.4months (95% CI 6.4-10.0) for intermittent and 9.7 months (95% CI 8.9-10.3) for continuous treatment, with a stratified HR of 1.17 (95% CI 0.88-1.57). Median OS was 17.5 months (95% CI 15.4-21.7) versus 20.9 months (95% CI 17.8-24.0) for intermittent versus continuous treatment, with a HR of 1.38 (95% CI 1.00-1.91). Safety results and actually delivered treatments revealed longer durations of treatment in the continuous arm, without significant unexpected findings.ConclusionIntermittent first-line treatment cannot be recommended in patients with HER2-negative advanced breast cancer. Clinical trial registration: EudraCT 2010-021519-18; BOOG 2010-02.
机译：目的我们确定与紫杉醇加贝伐单抗的间歇性第一线治疗不逊于HER2阴性，晚期乳腺癌患者的连续治疗。方法随机分为2x4循环或连续8个秋季的紫杉醇加贝伐单抗，其次是贝伐单抗维持治疗疾病进展或不可接受的毒性。主要终点是无进程无进程存活率（PFS）。比例危险的回归模型用于估计人力资源。将HR的双面95％CI的上限与1.34的非劣势余量进行比较。培养的特征均匀地包括420名患者的420名患者。在意向治疗分析中，间歇性的总体PFS为7.4个月（95％CI 6.4-10.0），适用于9.7个月（95％CI 8.9-10.3），用于连续治疗，分层为1.17（95％CI） 0.88-1.57）。中位数OS是17.5个月（95％CI 15.4-21.7）与20.9个月（95％CI 17.8-24.0）用于间歇性与连续治疗，HR为1.38（95％CI 1.00-1.91）。安全结果和实际递送的治疗揭示了连续手臂的较长的治疗持续时间，无需重大意外发现。在HER2阴性晚期乳腺癌患者中，不能建议闭塞的初始治疗。临床试验登记：Eudract 2010-021519-18; Boog 2010-02。

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