Lancet oncol:来曲唑维持治疗不能延长乳腺癌患者化疗后的无病存活期

2018-12-08 MedSci MedSci原创

绝经后乳腺癌患者芳香化酶抑制剂延长治疗的最佳持续时间尚不明确。在NSABP B-42研究中,我们意欲明确延长来曲唑治疗是否可提高绝经后乳腺癌患者基于芳香化酶抑制治疗5年后的无病存活率。本研究是一个在USA、加拿大和爱尔兰的158个中心开展的随机双盲安慰剂对照的3期试验,招募I-IIIA期的雌激素受体阳性的绝经后乳腺癌患者,且要求受试者是采用芳香化酶抑制剂或它莫西芬联合芳香化酶抑制剂治疗后5年内未复

绝经后乳腺癌患者芳香化酶抑制剂延长治疗的最佳持续时间尚不明确。在NSABP B-42研究中,我们意欲明确延长来曲唑治疗是否可提高绝经后乳腺癌患者基于芳香化酶抑制治疗5年后的无病存活率。

本研究是一个在USA、加拿大和爱尔兰的158个中心开展的随机双盲安慰剂对照的3期试验,招募I-IIIA期的雌激素受体阳性的绝经后乳腺癌患者,且要求受试者是采用芳香化酶抑制剂或它莫西芬联合芳香化酶抑制剂治疗后5年内未复发。符合要求的患者被随机(1:1)分至来曲唑(2.5mg/日,口服)或安慰剂组。主要结点是无病存活期(从分组到乳腺癌复发)、次发恶性肿瘤或死亡。

2006年9月28日-2010年1月6日,共3966位患者被随机分至来曲唑组或安慰剂组(各1983位)。3903位患者随访信息完善,可用于无病存活期分析。中位随访6.9年(IQR 6.1-7.5)。来曲唑治疗未明显提高患者无病存活期(安慰剂组339例无病存活事件,而来曲唑组仅292例;风险比0.85,95% CI 0.73-0.999;p=0.048)。安慰剂组和来曲唑组的7年无病存活率分别是82.3%(95% CI 79.3-83.1)和84.7(95% CI 82.9-86.4)。最常见的3级副反应是关节痛(安慰剂组 vs 来曲唑组:2% vs 3%)、背痛(2% vs 2%)。安慰剂组和来曲唑组最常见的4级副反应分别是血栓栓塞(<1%)和泌尿道感染、低钾血症和左心室收缩障碍(均<1%)。

以芳香化酶抑制为基础治疗5年后,来曲唑维持治疗5年并不能明显延迟乳腺癌患者的无病存活期。


原始出处:

Eleftherios P Mamounas,et al. Use of letrozole after aromatase inhibitor-based therapy (NRG Oncology/NSABP B-42): a randomised, double-blind, placebo-controlled phase 3 trial.The Lancet Oncology. November 30,2018. https://doi.org/10.1016/S1470-2045(18)30621-1

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    2019-10-09 howi
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    2019-11-06 minlingfeng
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