乳腺癌治疗领域首个免疫检查点抑制剂惨败:T药联合新辅助双妥+化疗未能改善早期乳腺癌pCR!

2022-07-01 MedSci原创 MedSci原创

J Clin Oncol:阿替珠单抗联合新辅助抗HER2治疗和化疗治疗人HER2阳性早期乳腺癌:随机III期IMpassion050试验的主要结果

人表皮生长因子受体2HER2)在大约15%-20%乳腺癌中过度表达,赋予更具侵略性的表型和较差的患者预后。然而,HER2 靶向治疗帕妥珠单抗和曲妥珠单抗 PH 显著改善了患者早期和转移性疾病的预后。在高危(肿瘤> 2 cm/淋巴结阳性)、HER2 阳性早期乳腺癌 EBC)、新辅助/辅助 PH(共 1 年)和化疗是标准治疗 SOC)。病理完全缓解 pCR HER2 阳性乳腺癌 BC 的长期结局显著改善相关。乳房和/或腋窝残留疾病或处于初始晚期临床阶段的患者复发或死亡的风险增加。对于新辅助治疗后残留疾病的患者,根据 KATHERINE批准T-DM1

然而,尽管在残余疾病患者中使用了T-DM1,但> 10% 的患者在大约 3.5 年后复发,这强调了需要提高高危 HER2 阳性 EBC pCR 率和结局。

在新辅助标准治疗(帕妥珠单抗和曲妥珠单抗 [PH] 和化疗)中加入阿替利珠单抗能否改善高危人表皮生长因子受体 2 阳性早期乳腺癌的结局? IMpassion050是第一个评估这个问题的研究。

原发性肿瘤> 2 cm 且组织学证实淋巴结状态阳性(T2-4N1-3M0)的患者随机分配 11 至阿替珠单抗/安慰剂,联合剂量密集的阿霉素/环磷酰胺,随后给予紫杉醇和 PH。手术后,患者继续服用阿替珠单抗/安慰剂和PH(总计:1年的HER2靶向治疗);那些有残留疾病的患者可以T-DM1与阿替珠单抗/安慰剂。共同主要疗效终点是意向治疗(ITT)和程序性细胞死亡配体1PD-L1)阳性人群的pCR率。

结果显示,在临床截止日期(202125日)时,ITT人群中安慰剂组和阿佐珠单抗组的pCR率分别为62.7%n = 143/228)和62.4%n = 141/226)(差异-0.33%;95%CI-9.28.6;P = .9551)。PD-L1阳性肿瘤患者安慰剂组和阿替珠单抗组的pCR率分别为72.5%n = 79/109)和64.2%n = 70/109)(差异–8.26%;95%CI–20.64.0;P = .1846)。

与安慰剂组相比,3-4级和严重不良事件在阿替利珠单抗组中更常见。发生了五次5级不良事件,均出现在阿替利珠单抗组。总体而言,安全性与其他联合研究中的阿替利珠单抗一致。

总的来说,ITTPD-L1阳性人群中,与安慰剂相比,阿替利珠单抗联合新辅助剂量密集的阿霉素/环磷酰胺-紫杉醇和PH治疗高危HER2阳性早期乳腺癌的pCR率没有增加。PH和化疗仍然是标准治疗方案,更长的随访可能有助于了解阿替利珠单抗的长期影响。

 

原文来源:

Huober J, Barrios CH, Niikura N, Jarząb M, Chang YC, Huggins-Puhalla SL, Pedrini J, Zhukova L, Graupner V, Eiger D, Henschel V, Gochitashvili N, Lambertini C, Restuccia E, Zhang H. Atezolizumab With Neoadjuvant Anti-Human Epidermal Growth Factor Receptor 2 Therapy and Chemotherapy in Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: Primary Results of the Randomized Phase III IMpassion050 Trial. J Clin Oncol. 2022 Jun 28:JCO2102772. doi: 10.1200/JCO.21.02772. Epub ahead of print. PMID: 35763704.

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    2022-08-17 jackeyxu1975

    以往新辅助的强度已经挺大了,再加一个PD-1可能也显现不出什么效果

    0

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    2023-05-10 jklm09
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    2022-07-03 Tommy1950

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