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Real-world effectiveness of palbociclib plus endocrine therapy in HR+/HER2− advanced breast cancer: final results from the POLARIS trial
by
Wang, Yao
, Kurian, Sobha
, Rocque, Gabrielle B
, Tripathy, Debu
, Gauthier, Eric
, Karuturi, Meghan S
, Zhang, Zhe
, Moezi, Mehdi
, Montelongo, Monica Z
, McCune, Steven
, Anderson, Daniel
, Blum, Joanne L
in
Adult
/ Aged
/ Aged, 80 and over
/ Antineoplastic Combined Chemotherapy Protocols - pharmacology
/ Antineoplastic Combined Chemotherapy Protocols - therapeutic use
/ Breast Cancer
/ Breast Neoplasms - drug therapy
/ Breast Neoplasms - pathology
/ Cancer
/ Care and treatment
/ Female
/ Fulvestrant
/ Hormone therapy
/ Humans
/ Middle Aged
/ Oncology, Experimental
/ Patient outcomes
/ Physiological aspects
/ Piperazines - administration & dosage
/ Piperazines - pharmacology
/ Piperazines - therapeutic use
/ Product development
/ Prospective Studies
/ Pyridines - administration & dosage
/ Pyridines - pharmacology
/ Pyridines - therapeutic use
/ Receptor, ErbB-2 - metabolism
/ Receptors, Estrogen - metabolism
/ Receptors, Progesterone - metabolism
2025
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Real-world effectiveness of palbociclib plus endocrine therapy in HR+/HER2− advanced breast cancer: final results from the POLARIS trial
by
Wang, Yao
, Kurian, Sobha
, Rocque, Gabrielle B
, Tripathy, Debu
, Gauthier, Eric
, Karuturi, Meghan S
, Zhang, Zhe
, Moezi, Mehdi
, Montelongo, Monica Z
, McCune, Steven
, Anderson, Daniel
, Blum, Joanne L
in
Adult
/ Aged
/ Aged, 80 and over
/ Antineoplastic Combined Chemotherapy Protocols - pharmacology
/ Antineoplastic Combined Chemotherapy Protocols - therapeutic use
/ Breast Cancer
/ Breast Neoplasms - drug therapy
/ Breast Neoplasms - pathology
/ Cancer
/ Care and treatment
/ Female
/ Fulvestrant
/ Hormone therapy
/ Humans
/ Middle Aged
/ Oncology, Experimental
/ Patient outcomes
/ Physiological aspects
/ Piperazines - administration & dosage
/ Piperazines - pharmacology
/ Piperazines - therapeutic use
/ Product development
/ Prospective Studies
/ Pyridines - administration & dosage
/ Pyridines - pharmacology
/ Pyridines - therapeutic use
/ Receptor, ErbB-2 - metabolism
/ Receptors, Estrogen - metabolism
/ Receptors, Progesterone - metabolism
2025
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Real-world effectiveness of palbociclib plus endocrine therapy in HR+/HER2− advanced breast cancer: final results from the POLARIS trial
by
Wang, Yao
, Kurian, Sobha
, Rocque, Gabrielle B
, Tripathy, Debu
, Gauthier, Eric
, Karuturi, Meghan S
, Zhang, Zhe
, Moezi, Mehdi
, Montelongo, Monica Z
, McCune, Steven
, Anderson, Daniel
, Blum, Joanne L
in
Adult
/ Aged
/ Aged, 80 and over
/ Antineoplastic Combined Chemotherapy Protocols - pharmacology
/ Antineoplastic Combined Chemotherapy Protocols - therapeutic use
/ Breast Cancer
/ Breast Neoplasms - drug therapy
/ Breast Neoplasms - pathology
/ Cancer
/ Care and treatment
/ Female
/ Fulvestrant
/ Hormone therapy
/ Humans
/ Middle Aged
/ Oncology, Experimental
/ Patient outcomes
/ Physiological aspects
/ Piperazines - administration & dosage
/ Piperazines - pharmacology
/ Piperazines - therapeutic use
/ Product development
/ Prospective Studies
/ Pyridines - administration & dosage
/ Pyridines - pharmacology
/ Pyridines - therapeutic use
/ Receptor, ErbB-2 - metabolism
/ Receptors, Estrogen - metabolism
/ Receptors, Progesterone - metabolism
2025
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Real-world effectiveness of palbociclib plus endocrine therapy in HR+/HER2− advanced breast cancer: final results from the POLARIS trial
Journal Article
Real-world effectiveness of palbociclib plus endocrine therapy in HR+/HER2− advanced breast cancer: final results from the POLARIS trial
2025
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Overview
Abstract
Background
Strict eligibility criteria for participation in randomized clinical trials (RCTs) often limit the generalizability of data when applied to a more heterogeneous real-world population. Thus, evidence generated directly from real-world populations, including subgroups underrepresented in RCTs, can help inform routine clinical practice. POLARIS (NCT03280303), a prospective, observational, multicenter, cohort study, evaluated patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (ABC) receiving palbociclib + endocrine therapy (ET) in routine care.
Methods
Demographics, baseline characteristics, and treatment patterns were summarized descriptively. Real-world response and clinical benefit rates, real-world progression-free survival (rwPFS), and overall survival (OS) were summarized descriptively by line of therapy and endocrine partner in the overall cohort and various subgroups.
Results
Between January 2017 and October 2019, 1250 patients (median age of 64.0 years) initiated treatment with palbociclib-based therapy, including 901 in the first-line (1L) setting and 349 in the second-line or later (≥2L) settings. Real-world response and clinical benefit rates with palbociclib + ET were 34.0% and 69.4%, respectively, in 1L, and 21.8% and 57.9% in ≥2L. Median rwPFS was 20.9 (95% CI, 18.7-24.7) and 13.5 (10.6-17.1) months, and median OS was 48.5 (42.0-not estimable) and 37.2 (31.2-40.8) months, with 1L and ≥2L palbociclib + ET, respectively.
Conclusions
Outcomes in this large, heterogeneous, real-world population are generally consistent with previously reported results from clinical trials and other real-world studies, further supporting the use of palbociclib + ET in patients with HR+/HER2− ABC.
Trial registration
NCT03280303 (ClinicalTrials.gov).
Publisher
Oxford University Press
Subject
/ Aged
/ Antineoplastic Combined Chemotherapy Protocols - pharmacology
/ Antineoplastic Combined Chemotherapy Protocols - therapeutic use
/ Breast Neoplasms - drug therapy
/ Breast Neoplasms - pathology
/ Cancer
/ Female
/ Humans
/ Piperazines - administration & dosage
/ Piperazines - therapeutic use
/ Pyridines - administration & dosage
/ Receptor, ErbB-2 - metabolism
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