Intermittent versus continuous first-line treatment for HER2-negative metastatic breast cancer: the Stop & Go study of the Dutch Breast Cancer Research Group (BOOG)
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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DOI：
10.1007/s10549-018-4906-8
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发表时间：
2018-11-01
影响因子：
3.8
通讯作者：
Erdkamp, Frans L. G.
中科院分区：
文献类型：
--
作者：
Claessens, Anouk K. M.;Bos, Monique E. M. M.;Erdkamp, Frans L. G.
PurposeWe determined if intermittent first-line treatment with paclitaxel plus bevacizumab is not inferior to continuous treatment in patients with HER 2-negative，advanced breast cancer.MethodsPatients被随机分配到2x 4周期或连续8周期的紫杉醇加贝伐单抗，随后贝伐单抗维持治疗，直到疾病进展或不可接受的毒性。主要终点是总体无进展生存期（PFS）。采用比例风险回归模型估计HR，将HR的双侧95%CI上限与非劣效界值1.34进行比较。在意向治疗分析中，间歇性治疗的中位总体PFS为7. 4个月（95% CI 6. 4 - 10. 0），连续性治疗的中位总体PFS为9. 7个月（95% CI 8. 9 - 10. 3），分层HR为1. 17（95% CI 0. 88 - 1. 57）。间歇治疗与连续治疗的中位OS分别为17.5个月（95% CI 15.4-21.7）和20.9个月（95% CI 17.8-24.0），HR为1.38（95% CI 1.00-1.91）。安全性结果和实际交付的治疗显示，在连续臂治疗的持续时间较长，没有显着的意想不到的findings.ConclusionIntermittent一线治疗不能推荐在HER 2阴性晚期乳腺癌患者。临床试验注册：EudraCT 2010-021519-18; BOOG 2010-02。
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.