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- Title
Comparative effectiveness of first-line palbociclib plus letrozole versus letrozole alone for HR+/HER2- metastatic breast cancer in US real-world clinical practice.
- Authors
DeMichele, Angela; Cristofanilli, Massimo; Brufsky, Adam; Liu, Xianchen; Mardekian, Jack; McRoy, Lynn; Layman, Rachel M.; Emir, Birol; Torres, Mylin A.; Rugo, Hope S.; Finn, Richard S.
- Abstract
<bold>Background: </bold>Findings from randomized clinical trials may have limited generalizability to patients treated in routine clinical practice. This study examined the effectiveness of first-line palbociclib plus letrozole versus letrozole alone on survival outcomes in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor-negative (HER2-) metastatic breast cancer (MBC) treated in routine clinical practice in the USA.<bold>Patients and Methods: </bold>This was a retrospective observational analysis of electronic health records within the Flatiron Health Analytic Database. A total of 1430 patients with ≥ 3 months of follow-up received palbociclib plus letrozole or letrozole alone in the first-line setting between February 3, 2015, and February 28, 2019. Stabilized inverse probability treatment weighting (sIPTW) was used to balance baseline demographic and clinical characteristics. Real-world progression-free survival (rwPFS) and overall survival (OS) were analyzed.<bold>Results: </bold>After sIPTW adjustment, median follow-up was 24.2 months (interquartile range [IQR], 14.2-34.9) in the palbociclib group and 23.3 months (IQR, 12.7-34.3) in those taking letrozole alone. Palbociclib combination treatment was associated with significantly longer median rwPFS compared to letrozole alone (20.0 vs 11.9 months; hazard ratio [HR], 0.58; 95% CI, 0.49-0.69; P < 0.0001). Median OS was not reached in the palbociclib group and was 43.1 months with letrozole alone (HR, 0.66; 95% CI, 0.53-0.82; P = 0.0002). The 2-year OS rate was 78.3% in the palbociclib group and 68.0% with letrozole alone. A propensity score matching analysis showed similar results.<bold>Conclusions: </bold>In this "real-world" population of patients with HR+/HER2- MBC, palbociclib in combination with endocrine therapy was associated with improved survival outcomes compared with patients treated with letrozole alone in the first-line setting.<bold>Trial Registration: </bold>Clinicaltrials.gov; NCT04176354.
- Subjects
METASTATIC breast cancer; LETROZOLE; EPIDERMAL growth factor; PROPENSITY score matching; ELECTRONIC health records
- Publication
Breast Cancer Research, 2021, Vol 23, Issue 1, p1
- ISSN
1465-5411
- Publication type
journal article
- DOI
10.1186/s13058-021-01409-8