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Open Access 30-10-2023 | Breast Cancer | Clinical trial

Outcomes of male patients with HR+/HER2– advanced breast cancer receiving palbociclib in the real-world POLARIS study

Authors: Joanne L. Blum, Caroline DiCristo, David Gordon, Meghan S. Karuturi, David Oubre, Erin Jepsen, Juan Cuevas, Shailendra Lakhanpal, Monica Z. Montelongo, Zhe Zhang, Joseph C. Cappelleri, Yao Wang, Debu Tripathy

Published in: Breast Cancer Research and Treatment | Issue 3/2024

Abstract

Purpose

Data on treatments for male breast cancer patients are limited owing to rarity and underrepresentation in clinical trials. The real-world POLARIS study gathers data on palbociclib use for the treatment of hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2–) advanced breast cancer (ABC) in female and male patients. This sub-analysis describes real-world palbociclib treatment patterns, clinical outcomes, and quality of life (QoL) in male patients.

Methods

POLARIS is a prospective, noninterventional, multicenter, real-world study of patients with HR+/HER2– ABC receiving palbociclib. Assessments included medical record reviews, patient QoL questionnaires (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire–Core 30), site characteristics questionnaires, and physician treatment selection surveys. Variables included demographics, disease history, global health status/QoL, clinical assessments and adverse events. Analyses were descriptive in nature. For clinical outcomes, real-world tumor responses and progression were determined by physician assessment in routine clinical practice. Real-world progression-free survival (rwPFS) was described using the Kaplan–Meier method.

Results

At data cutoff, 15 male patients were enrolled (median age, 66 years). Nine patients received palbociclib as a first-line treatment and 6 as a second-line or later treatment. Patients received a median of 20 cycles of palbociclib. Neutropenia was experienced by 2 patients and grade ≥ 3 adverse events were reported in 11 patients. Global health status/QoL scores remained generally consistent during the study. One patient (6.7%) achieved a complete tumor response, 4 (26.7%) a partial response, and 8 (53.3%) stable disease. Median rwPFS was 19.8 months (95% CI, 7.4–38.0). Median follow-up duration was 24.7 months (95% CI, 20.0–35.7).

Conclusion

This real-world analysis showed that palbociclib was well tolerated and provides preliminary data on treatment patterns and outcomes with palbociclib in male patients with HR+/HER2– ABC, helping inform the use of palbociclib in this patient subgroup.

Trial identifier

NCT03280303.

Available only for authorised users

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Title: Outcomes of male patients with HR+/HER2– advanced breast cancer receiving palbociclib in the real-world POLARIS study
Authors: Joanne L. Blum
Caroline DiCristo
David Gordon
Meghan S. Karuturi
David Oubre
Erin Jepsen
Juan Cuevas
Shailendra Lakhanpal
Monica Z. Montelongo
Zhe Zhang
Joseph C. Cappelleri
Yao Wang
Debu Tripathy
Publication date: 30-10-2023
Publisher: Springer US
Keywords: Breast Cancer
Breast Cancer
Fulvestrant
Published in: Breast Cancer Research and Treatment / Issue 3/2024
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI: https://doi.org/10.1007/s10549-023-07145-1

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