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Lancet:芳香化酶抑制剂 vs 他莫昔芬治疗早期乳腺癌

2015-07-24 MedSci MedSci原创

使用芳香化酶抑制剂或他莫昔芬作为早期乳腺癌的内分泌治疗的最佳方式仍存在不确定性。    研究人员对31920例绝经后患有雌激素受体阳性的早期乳腺癌的女性患者进行了个人数据的荟萃分析,该随机试验包括:第1组为芳香酶抑制剂 vs 他莫昔芬分别进行5年治疗;第2组为5年的芳香化酶抑制剂 vs 2〜3年的他莫昔芬然后应用芳香化酶抑制剂治疗到第5年;第3组为2—3年的他莫昔芬然

使用芳香化酶抑制剂或他莫昔芬作为早期乳腺癌的内分泌治疗的最佳方式仍存在不确定性。
    
研究人员对31920例绝经后患有雌激素受体阳性的早期乳腺癌的女性患者进行了个人数据的荟萃分析,该随机试验包括:第1组为芳香酶抑制剂 vs 他莫昔芬分别进行5年治疗;第2组为5年的芳香化酶抑制剂 vs 2〜3年的他莫昔芬然后应用芳香化酶抑制剂治疗到第5年;第3组为2—3年的他莫昔芬然后再用芳香化酶抑制剂治疗到第5年 vs 5年的他莫昔芬治疗。主要成果是任何乳腺癌的复发,因乳腺癌死亡率,无复发乳腺癌事件的死亡,和全因死亡率事件。采用意向性治疗数秩分析,按年龄,淋巴结状态和试验进行分层,并得到芳香酶抑制剂 vs 他莫昔芬治疗后第一次事件发生率比(RRs)。
    
在第1组的比较中,复发RRs在芳香酶抑制剂组0-1年(RR 0.64,95%Cl为0.52-0.78)和2-4年(RR 0.80,0.68-0.93)时较显著,但在芳香酶抑制剂治疗的第5年及以后复发RRs不显著。芳香酶抑制剂治疗后的患者10年乳腺癌死亡率低于他莫昔芬治疗的患者(12.1% vs 14.2%;RR 0.85, 0.75–0.96;2p=0.009)。在第2组中,复发RRs在芳香化酶抑制剂治疗的0-1年显著(RR 0.74,0.62-0.89),但接受芳香酶抑制剂的两个群体在2-4年或在其后不显著;纵观这3组试验,接受5年芳香化酶抑制剂比接受他莫昔芬然后芳香酶抑制剂的患者有较少的复发(RR 0.90,0.81-0.99;2p=0.045),虽然乳腺癌死亡率降低并不显著(RR 0.89,0.78-1.03;2p=0.11)。在第3组比较中,使用芳香化酶抑制剂的人群复发RRs在2-4年显著(RR 0.56,0.46-0.67),但随后不显著,转向芳香酶抑制剂治疗的患者的10年乳腺癌死亡率低于仍使用他莫昔芬治疗的患者死亡率(8.7% vs 10.1%;2p=0.015)。在所有三种类型的比较中,当治疗发生变化时,复发RRs在芳香化酶抑制剂治疗时期显著(RR 0.70,0.64-0.77),但此后不显著(RR 0.93,0.86-1.01;2p=0.08)。乳腺癌死亡率的降低是随着两者同时治疗变化的(RR 0.79,0.67-0.92),随后(RR 0.89,0.81-0.99),以及各个时期的联合治疗(RR 0.86,0.80-0.94;2p=0.0005)。各种原因的死亡率也降低(RR 0.88,0.82-0.94;2p=0.0003)。RRs随着年龄,身体质量指数,分期,分级,孕激素受体状态,或HER2状态不同而变化。使用芳香酶抑制剂治疗的患者发生子宫内膜癌的几率低于他莫昔芬治疗的患者(10年发病率 0.4% vs 1.2%;RR 0.33,0.21-0.51),但发生更多的骨折事件(5年风险 8.2 % vs 5.5%;RR 1.42,1.28-1.57);非乳腺癌死亡率是相似的。
    
与他莫昔芬相比,芳香酶抑制剂治疗降低了约30%的复发率(按比例),但此后发生变化。与5年他莫昔芬治疗相比,5年芳香酶抑制剂治疗减少10年乳腺癌死亡率约15%,与没有内分泌治疗的患者相比,死亡率降低了约40%

原始出处:

Early Breast Cancer Trialists' Collaborative Group (EBCTCG),Aromatase inhibitors versus tamoxifen in early breast cancer,Lancet,2015.7.23

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    2021-11-20 湘雅科教

    已阅,受益匪浅。

    0

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    2015-09-09 howi
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    2016-01-24 jklm09
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    2015-07-26 DocterSunshine

    非常有意义的临床研究

    0

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    2015-07-26 shenyifeiyang

    好研究!

    0

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