Palbociclib plus aromatase inhibitors in patients with metastatic breast cancer and cardiovascular diseases: real-world effectiveness

被引:0
作者
Brufsky, Adam [1 ]
Liu, Xianchen [2 ]
Li, Benjamin [2 ]
McRoy, Lynn [2 ]
Chen, Connie [2 ]
Makari, Doris [2 ]
Layman, Rachel M. [3 ]
Rugo, Hope S. [4 ]
机构
[1] Univ Pittsburgh, UPMC Hillman Canc Ctr, Med Ctr, Dept Med,Div Hematol Oncol, Pittsburgh, PA 15213 USA
[2] Pfizer Inc, 66 Hudson Blvd E, New York, NY 10001 USA
[3] Univ Texas MD Anderson Canc Ctr, Dept Breast Med Oncol, Houston, TX 77030 USA
[4] Univ Calif San Francisco, Helen Diller Family Comprehens Canc Ctr, Dept Med, Div Hematol Oncol, San Francisco, CA 94158 USA
关键词
breast neoplasms; comparative effectiveness research; electronic health records; palbociclib; retrospective studies; cardiovascular diseases; TREATMENT PATTERNS; OUTCOMES; SURVIVAL; THERAPY;
D O I
10.1093/oncolo/oyae273
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background Patients with cardiovascular disease (CVD) comorbidities are often excluded from participating in breast cancer clinical trials. Consequently, data to inform treatment decisions for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) and CVD are limited.Objective We compared the effectiveness of first-line palbociclib plus an aromatase inhibitor (AI) vs an AI alone and evaluated palbociclib treatment patterns in patients with HR+/HER2- mBC and CVD in routine clinical practice.Methods Data from the Flatiron Health Analytic Database were captured for patients with HR+/HER2- mBC and CVD who initiated first-line treatment with palbociclib plus an AI or an AI alone between February 2015 and March 2020 (data cutoff: September 30, 2020). Overall survival (OS), real-world progression-free survival (PFS), and treatment patterns were evaluated.Results Of the 469 patients with identifiable CVD, 160 received palbociclib plus an AI, and 309 received an AI alone. After stabilized inverse probability treatment weighting, both median OS (40.7 vs 26.5 months; hazard ratio [HR], 0.732 [95% CI, 0.537-0.997]; P = .048) and median real-world PFS (20.0 vs 12.5 months; HR, 0.679 [95% CI, 0.512-0.900]; P = .007) were significantly prolonged in patients treated with palbociclib plus an AI vs an AI alone. Among patients with a documented palbociclib starting dose, 78.5% started palbociclib at 125 mg/day, and 38.6% experienced dose adjustment.Conclusions In this real-world analysis, first-line palbociclib plus an AI was associated with improved effectiveness compared with an AI alone in patients with HR+/HER2- mBC and CVD.Trial Registration NCT05361655 (ClinicalTrials.gov) Patients with cardiovascular disease comorbidities are often excluded from participating in breast cancer clinical trials. This study evaluated palbociclib clinical outcomes in patients with HR+/HER2- metastatic breast cancer and cardiovascular disease in routine clinical practice. Graphical Abstract
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收藏
页码:1032 / 1043
页数:12
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