徐兵河教授:CDK4/6抑制剂在乳腺癌治疗中的价值

2018-10-16 肿瘤资讯 肿瘤资讯

内分泌治疗“加法”时代,CDK4/6抑制剂在乳腺癌中的治疗价值及前景 徐兵河教授:乳腺癌内分泌治疗在过去均为单药治疗。绝经前的患者通常选择雌激素受体拮抗剂,包括他莫昔芬、托瑞米芬等,或者在卵巢功能抑制的基础上加用他莫昔芬或芳香化酶抑制剂。对于绝经后的患者,通常选择芳香化酶抑制剂。近年来,乳腺癌单一内分泌治疗的疗效并未显著提高,进展相对缓慢。近几年,随着CDK4/6抑制剂的问世,乳腺癌

徐兵河教授:乳腺癌内分泌治疗在过去均为单药治疗。绝经前的患者通常选择雌激素受体拮抗剂,包括他莫昔芬、托瑞米芬等,或者在卵巢功能抑制的基础上加用他莫昔芬或芳香化酶抑制剂。对于绝经后的患者,通常选择芳香化酶抑制剂。近年来,乳腺癌单一内分泌治疗的疗效并未显著提高,进展相对缓慢。近几年,随着CDK4/6抑制剂的问世,乳腺癌内分泌治疗取得明显进展,特别是疗效方面明显提高。

CDK4/6抑制剂最主要有3种,疗效基本相似。CDK4/6抑制剂联合芳香化酶抑制剂治疗绝经后激素受体阳性的晚期乳腺癌,无进展生存期(PFS)延长一倍,从10个月左右延长至20个月左右。二线治疗联合氟维司群可使PFS延长6至8个月。总体上,无论一线治疗还是二线治疗,CDK4/6抑制剂均能使晚期乳腺癌患者PFS显著延长。

CDK4/6抑制剂在Luminal A和Luminal B两种亚型中的疗效差异

徐兵河教授:HR+HER2-乳腺癌包括Luminal A和Luminal B两种亚型。Luminal A型,即激素受体阳性、Her2阴性;Luminal B型包括两部分,一部分为激素受体阳性、Her2阴性,另一部分为激素受体阳性、Her2阳性,排除Her2阳性的Luminal B型后,主要是Ki67数值的区别。从目前的临床研究来看,CDK4/6抑制剂治疗这两种亚型在疗效方面并无显著差异。目前尚无预测CDK4/6抑制剂疗效的标记物,乳腺癌患者中ER/PR阳性是适合这种疗法的。

CDK4/6抑制剂疗效与起始DFI的相关性

徐兵河教授:PALOMA2(PAL2)和PALOMA3(PAL3)两项研究均显示,对于HR+HER2-晚期乳腺癌患者,CDK4/6抑制剂联合内分泌治疗相对于内分泌治疗单药,PFS更长。对于无病生存期(DFI)较长的患者,内分泌治疗效果更好。对于DFI在5年以上和5年以下的患者,既往多研究认为,DFS特别短尤其是2年以内复发的患者,内分泌治疗的疗效不及2年以上的患者。关于加入CDK4/6抑制剂治疗能否改善这类患者的疗效,目前尚无定论,需进一步开展研究加以探讨。我个人认为,内分泌治疗联合CDK4/6抑制剂治疗的疗效会更好,尤其是DFI较长的患者。

CDK4/6抑制剂未来前景

徐兵河教授:CDK4/6抑制剂未来前景非常可观。除了与芳香化酶抑制剂联合一线治疗、与氟维司群联合二线治疗之外,CDK4/6抑制剂与其他内分泌治疗如他莫昔芬联合治疗的疗效也值得探讨。Her2阳性、激素受体阳性的患者在内分泌治疗联合靶向治疗的基础上加用CDK4/6抑制剂,疗效能否改善,也值得进一步研究探讨。此外,CDK4/6抑制剂在辅助治疗中的疗效如何?长期CDK4/6抑制剂治疗的患者能否耐受因相关不良反应带来的生活质量影响如白细胞下降导致的反复升白治疗、长期的恶心呕吐?患者对CDK4/6抑制剂的依从性如何?CDK4/6抑制剂长期治疗的安全性(如对生殖功能、神经系统、脏器功能等方面的影响)如何?这些问题均需要进一步研究探讨。另外,未来也应开展CDK4/6抑制剂新辅助治疗的相关研究,探讨能否改善患者生存。

PALOMA2和PALOMA3的联合分析研究

背景

PALOMA2(PAL2)和PALOMA3(PAL3)两项研究均显示,对于HR+HER2-晚期乳腺癌患者,palbociclib(PAL)+内分泌治疗(ET)相对于ET单药,PFS更长。本次探索性分析旨在探讨新辅助或辅助治疗患者中,起始无病生存时间(DFI)(PAL3)或无治疗时间(PAL2)与PFS的相关性。同时还研究Luminal(lum)亚型与PAL疗效的相关性。

方法

既往内分泌治疗失败的绝经前/绝经后患者(PAL3;N=521)及确诊ABC后经治的绝经后患者(PAL2;N=666)按2:1随机接受ET(氟维司群(F)500mg或来曲唑(L)2.5mg/d)+PAL(125mg/d,每3周停1周)/安慰剂(PBO)。中位随访时间分别为14mos(PAL3;2015.10.23)和37mos(PAL2;2017.5.31)。PAL3的DFI定义为初诊乳腺癌至肿瘤复发的时间;PAL2中TFI定义为新辅或辅助治疗结束至肿瘤复发的时间。亚组疗效模式散点(STEPP)分析对比每个研究中干预组和对照组的DFI/TFI与PFS的相关性。从PAL3和PAL2研究中分别提取226名和364名已知Luminal亚型患者的复发或新发病灶石蜡包埋组织。通过HTG Molecular’s EdgeSeq OBP基因表达分析明确lumA/B亚型。

结果

355名患者(PAL3)及334名患者(PAL2)分别接受辅助治疗(PAL+F组n=232/347;F+PBO组n=123/174;PAL+L组n=219/444;L+PBO组n=115/222)。PAL3研究中,PAL+F组和F+PBO组的中位DFI分别为49.2mo和52.0mo;>80%患者DFI>2年。PAL2研究中,PAL+L组和L+PBO组的中位TFI分别为48.9mo和44.9mo;约70%患者DFI>2年。STEPP分析结果显示基线DFI或TFI与PFS无相关性。两项研究中,lumA和B亚型患者均从PAL+ET中获益较多。

结论

PAL联合ET能显著改善PFS且与起始TFI/DFI时长和lum亚型不相关。

点评

PALOMA2和3的研究结果支持晚期乳腺癌内分泌治疗的“加”法策略,进一步佐证CDK4/6抑制剂在“加”法时代下的重要地位。本次联合分析结果提示,联合治疗疗效与DFI和TFI无关,数据提示大部分患者的DFI或TFI均较长,提示联合治疗对于继发内分泌耐药患者的效果较好。但对于原发内分泌治疗耐药或不同转移部位的晚期乳腺癌患者,联合治疗的疗效又是如何呢?尚待进一步探讨。

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    2019-06-01 soongzhihua
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    2018-11-20 jklm09
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    2018-10-18 zhouqu_8
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    2018-10-18 zhangj7111

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