帕博西尼+内分泌治疗在hr阳性/ her2阴性MBC中的实际研究和随机研究的比较疗效:系统评价和荟萃分析。

IF 4.1 Q2 ONCOLOGY
Francesco Schettini, Sabrina Nucera, Giuseppe Di Grazia, Fabiola Giudici, Carla Strina, Manuela Milani, Richard Tancredi, Benedetta Conte, Carmen Criscitiello, Mario Giuliano, Matteo Lambertini, Rodrigo Sánchez-Bayona, Tomás Pascual, Grazia Arpino, Lucia Del Mastro, Paolo Vigneri, Massimo Cristofanilli, Hope S Rugo, Alessandra Gennari, Giuseppe Curigliano, Daniele Generali
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引用次数: 0

摘要

背景:细胞周期蛋白依赖性激酶4/6抑制剂(CDK4/6i)联合内分泌治疗是激素受体阳性(HR+)/HER2阴性(HER2-)转移性乳腺癌(MBC)的标准治疗方法。Palbociclib是首个获批的CDK4/6i药物,在随机对照试验(RCTs)中显著改善了无进展生存期(PFS)。然而,现实世界(RW)的结果可能会因更广泛的患者群体而有所不同。本荟萃分析评估了关键RCT结果对RW设置的适用性。方法:我们对使用帕博西尼+芳香酶抑制剂(AI)或氟维司汀治疗HR+/HER2- MBC的RW研究进行了系统回顾和荟萃分析,报告了中位PFS (mPFS)和/或总生存期(mOS)。使用中位数中位数(MM)和加权MM (WM)估计合并mPFS/OS。如果MMPFS/OS或WMPFS/OS在rct的95%置信区间(CI)内,则认为RW估计值与rct相当。类似的标准适用于帕博西尼+AI与AI在内脏/非内脏亚组的PFS/OS的合并风险比(HR)。结果:共分析了12项RW研究。一线palbociclib+AI MMPFS(22.5个月,95%CI: 19.5-31.8)与PALOMA-1/2合并mPFS (23.9, 95%CI: 20.2-27.6)一致。一线palbociclib+fulvestrant MMPFS (13.5, 95%CI: 11.6-28.5)超过PALOMA-3 (11.2, 95%CI: 9.5-12.9)。二线palbociclib+fulvestrant MMPFS(11.5个月,95%CI: 6.3-15.3)与PALOMA-3一致。RW一线mOS(51.2个月,95%CI: 49.1-53.3)超过PALOMA-1/2合并mOS(45.7个月,95%CI: 37.5-53.8)。WMOS(49.1个月,95%CI: 49.1-53.3)略低于rct(53.7个月,95%CI: 37.5-53.8)。Palbociclib+AI在RW内脏疾病中的表现优于AI,与rct一致,在非内脏疾病中表现出异质性但有利的益处。结论:RW数据证实了帕博西尼+内分泌治疗的有效性,增强了其在更广泛患者群体中的适用性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Comparative efficacy between real-world and randomized studies of palbociclib+endocrine therapy in HR-positive/HER2-negative metastatic breast cancer: systematic review and meta-analysis.

Comparative efficacy between real-world and randomized studies of palbociclib+endocrine therapy in HR-positive/HER2-negative metastatic breast cancer: systematic review and meta-analysis.

Comparative efficacy between real-world and randomized studies of palbociclib+endocrine therapy in HR-positive/HER2-negative metastatic breast cancer: systematic review and meta-analysis.

Comparative efficacy between real-world and randomized studies of palbociclib+endocrine therapy in HR-positive/HER2-negative metastatic breast cancer: systematic review and meta-analysis.

Background: Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) combined with endocrine therapy are the standard-of-care for hormone receptor-positive (HR+)/HER2-negative (HER2-) metastatic breast cancer (MBC). Palbociclib, the first approved CDK4/6i, significantly improved progression-free survival (PFS) in randomized controlled trials (RCTs). However, real-world (RW) outcomes may differ due to broader patient populations. This meta-analysis evaluates the applicability of pivotal RCT findings to RW settings.

Methods: We conducted a systematic review and meta-analysis of RW studies on HR+/HER2- MBC treated with palbociclib+aromatase inhibitors (AI) or fulvestrant, reporting median PFS (mPFS) and/or overall survival (mOS). Pooled mPFS/OS was estimated using the median of medians (MM) and weighted MM (WM). RW estimates were deemed comparable to RCTs if MMPFS/OS or WMPFS/OS fell within RCTs' 95% confidence intervals (CIs). Similar criteria applied to pooled hazard ratios (HRs) of PFS/OS for palbociclib+AI vs AI in visceral/nonvisceral subgroups.

Results: Twelve RW studies were analyzed. First-line palbociclib+AI MMPFS (22.5 months, 95% CI = 19.5 to 31.8) aligned with PALOMA-1/2 pooled mPFS (23.9, 95% CI = 20.2 to 27.6). First-line palbociclib+fulvestrant MMPFS (13.5, 95% CI = 11.6 to 28.5) exceeded PALOMA-3 (11.2, 95% CI = 9.5 to 12.9). Second-line palbociclib+fulvestrant MMPFS (11.5 months, 95% CI = 6.3 to 15.3) was consistent with PALOMA-3. RW first-line mOS (51.2 months, 95% CI = 49.1 to 53.3) surpassed PALOMA-1/2 pooled mOS (45.7, 95% CI = 37.5 to 53.8). WMOS (49.1 months, 95% CI = 49.1 to 53.3) was slightly lower than RCTs (53.7, 95% CI = 37.5 to 53.8). Palbociclib+AI outperformed AI in RW visceral disease, aligning with RCTs, and showed heterogeneous but favorable benefit in nonvisceral disease.

Conclusions: RW data confirm palbociclib+endocrine therapy effectiveness, reinforcing its applicability to broader patient populations.

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来源期刊
JNCI Cancer Spectrum
JNCI Cancer Spectrum Medicine-Oncology
CiteScore
7.70
自引率
0.00%
发文量
80
审稿时长
18 weeks
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