Clin Cancer Res:Palbociclib联合氟维司群治疗HR+/HER2-晚期乳腺癌的长期预后

2022-05-16 Nebula MedSci原创

Palbociclib联合氟维司群治疗可提高HR+/HER2-的晚期乳腺癌患者的长期总生存率

Palbociclib是一种口服的活性细胞周期依赖性激酶4/6 (CDK4/6) 抑制剂,已被批准用于治疗激素受体阳性/人表皮生长因子受体 2 阴性 (HR+/HER2-)的晚期乳腺癌 (ABC) 。

PALOMA-3研究的初期结果显示Palbociclib联合氟维司群相比安慰剂联合氟维司群可显著延长HR+/HER2-晚期乳腺癌女性患者的无进展生存期(11.2 vs 4.6个月)。但中位随访了44.8个月时,两组的总生存期无显著差异(34.9 vs 28.0个月)。

本文汇报了PALOMA-3研究中位随访时间时73.3 个月的总生存期分析结果,同时还评估循环肿瘤 DNA (ctDNA) 分子分析的预后价值。

在该研究中,HR+/HER2-的晚期乳腺癌患者被随机(2:1)分成两组,分别接受Palbociclib(125 mg/天,口服;连用3周停1周)和氟维司群(500 mg,肌肉注射)或安慰剂+氟维司群。本次分析是在75%的患者死亡后进行的。ctDNA分析是在提供了同意书的患者中进行的。


两组的总生存率

截止2020年8月17日,Palbociclib组和安慰剂组分别发生了258例和135例死亡。Palbociclib组和安慰剂组的中位总生存期分别是34.8个月和28.0个月(分层风险比 0.81,95% CI 0.65-0.99)。Palbociclib组和安慰剂组的六年总生存率分别是19.1%和12.9%。


PIK3CA突变状态对两组总生存率的影响

与大部分亚组分析中,Palbociclib联合氟维司群的总生存期均优于安慰剂联合氟维司群,特别是在内分泌敏感疾病、既往未进行过针对乳腺癌化疗的以及循环肿瘤DNA分数低的患者中,而且无论有无携带ESR1、PIK3CA及TP53突变。在本次分析中,未观察到新的安全性问题。

综上,在PALOMA-3研究长达6年的随访中,与安慰剂联合氟维司群相比,Palbociclib联合氟维司群治疗在HR+/HER2-的晚期乳腺癌患者的总生存期方面也表现出了具有临床意义的优势,支持将Palbociclib联合氟维司群作为这类患者的标准疗法。

 

原始出处:

Massimo Cristofanilli, et al. Overall Survival With Palbociclib And Fulvestrant in Women With HR+/HER2- ABC: Updated Exploratory Analyses of PALOMA-3, a Double-Blind, Phase 3 Randomized Study. Clin Cancer Res clincanres.0305.2022. https://doi.org/10.1158/1078-0432.CCR-22-0305.

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    2023-04-26 luwei00
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