TY - JOUR
T1 - Real-world study of overall survival with palbociclib plus aromatase inhibitor in HR+/HER2− metastatic breast cancer
AU - Rugo, Hope S.
AU - Brufsky, Adam
AU - Liu, Xianchen
AU - Li, Benjamin
AU - McRoy, Lynn
AU - Chen, Connie
AU - Layman, Rachel M.
AU - Cristofanilli, Massimo
AU - Torres, Mylin A.
AU - Curigliano, Giuseppe
AU - Finn, Richard S.
AU - DeMichele, Angela
N1 - Funding Information:
This study was sponsored and funded by Pfizer Inc. Editorial/medical writing support was provided by Jill Shults, PhD, of ICON (Blue Bell, PA, USA) and was funded by Pfizer Inc.
Funding Information:
The authors declare no competing non-financial interests but the following competing financial interests: H.S.R. reports sponsored research to her institution from Pfizer Inc, Merck, Novartis, Eli Lilly, Roche, Daiichi-Sankyo, Seattle Genetics, Macrogenics, Sermonix, Boehringer Ingelheim, Polyphor, AstraZeneca, Ayala, and Gilead and honoraria from PUMA, Samsung, and Mylan. A.B. reports advisory/consultancy fees from Pfizer Inc. R.M.L. reports advisory/consultancy fees from Novartis, Eli Lilly, and Celcuity and research/grant funding from Pfizer Inc, Novartis, Eli Lilly, GlaxoSmithKline, Zentalis, Puma, and Celcuity. M.C. reports advisory/consultancy fees (Data Safety Monitoring Board or Advisory Board) from Merck and AstraZeneca; research grant/funding from Pfizer Inc, Menarini, Eli Lilly, and G1 Therapeutics; consulting fees from Novartis, Menarini, Eli Lilly, Sermonix, G1 Therapeutics, AstraZeneca, Pfizer Inc, and Foundation Medicine; and travel support from Foundation Medicine. M.A.T. reports research grant/funding from Pfizer Inc and Genentech, advisory/consulting fees from Centers for Disease Control and Oncohealth, and honoraria from MJH Life Sciences. G.C. reports consulting fees from Seagen, Roche, Novartis, Lilly, Daiichi Sankyo, Astra Zeneca, Pfizer, Sanofi, Pierre Fabre, and Gilead and fees for non-CME services (eg, speakers’ bureaus) from Lilly, Pfizer, and Daiichi Sankyo. R.S.F. reports consulting fees/honoraria from Pfizer Inc and research grant/funding from Pfizer Inc, Eli Lilly, and Novartis. A.D. reports research grant/funding from Pfizer Inc, Novartis, Calithera, and Genentech. X.L., B.L., L.M., and C.C. are employees of and stockholders in Pfizer Inc.
Publisher Copyright:
© 2022, Pfizer Inc.,.
PY - 2022/12
Y1 - 2022/12
N2 - Data on real-world effectiveness of cyclin-dependent kinase 4/6 inhibitor combination therapy versus endocrine therapy alone are limited. The Flatiron Health Analytic Database was used to assess overall survival (OS) in patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2−) metastatic breast cancer (MBC) treated with first-line palbociclib plus an aromatase inhibitor (AI) versus an AI alone in routine US clinical practice. In total, 2888 patients initiated treatment during February 3, 2015–March 31, 2020, with a potential ≥6-month follow-up (cutoff date, September 30, 2020). After stabilized inverse probability treatment weighting, median OS (95% CI) is significantly longer among palbociclib versus AI recipients (49.1 [45.2–57.7] versus 43.2 [37.6–48.0] months; hazard ratio, 0.76 [95% CI, 0.65–0.87]; P < 0.0001). Progression-free survival (95% CI) is 19.3 (17.5–20.7) versus 13.9 (12.5–15.2) months, respectively (hazard ratio, 0.70 [95% CI, 0.62–0.78]; P < 0.0001). These data support first-line palbociclib plus an AI treatment for HR+/HER2− MBC. (Trial number NCT05361655).
AB - Data on real-world effectiveness of cyclin-dependent kinase 4/6 inhibitor combination therapy versus endocrine therapy alone are limited. The Flatiron Health Analytic Database was used to assess overall survival (OS) in patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2−) metastatic breast cancer (MBC) treated with first-line palbociclib plus an aromatase inhibitor (AI) versus an AI alone in routine US clinical practice. In total, 2888 patients initiated treatment during February 3, 2015–March 31, 2020, with a potential ≥6-month follow-up (cutoff date, September 30, 2020). After stabilized inverse probability treatment weighting, median OS (95% CI) is significantly longer among palbociclib versus AI recipients (49.1 [45.2–57.7] versus 43.2 [37.6–48.0] months; hazard ratio, 0.76 [95% CI, 0.65–0.87]; P < 0.0001). Progression-free survival (95% CI) is 19.3 (17.5–20.7) versus 13.9 (12.5–15.2) months, respectively (hazard ratio, 0.70 [95% CI, 0.62–0.78]; P < 0.0001). These data support first-line palbociclib plus an AI treatment for HR+/HER2− MBC. (Trial number NCT05361655).
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U2 - 10.1038/s41523-022-00479-x
DO - 10.1038/s41523-022-00479-x
M3 - Article
C2 - 36220852
AN - SCOPUS:85139634967
SN - 2374-4677
VL - 8
JO - npj Breast Cancer
JF - npj Breast Cancer
IS - 1
M1 - 114
ER -