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

• Published in: Breast cancer research and treatment Vol. 203; no. 3; pp. 463 - 475
• Main Authors: Blum, Joanne L., DiCristo, Caroline, Gordon, David, Karuturi, Meghan S., Oubre, David, Jepsen, Erin, Cuevas, Juan, Lakhanpal, Shailendra, Montelongo, Monica Z., Zhang, Zhe, Cappelleri, Joseph C., Wang, Yao, Tripathy, Debu
• Format: Journal Article
• Language: English
• Published: New York Springer US 01-02-2024; Springer Nature B.V
• Subjects: Adverse events; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Breast cancer; Breast Neoplasms - pathology; Clinical outcomes; Clinical Trial; Clinical trials; ErbB-2 protein; Female; Humans; Male; Medicine; Medicine & Public Health; Neutropenia; Oncology; Patients; Piperazines; Prospective Studies; Public health; Pyridines; Quality of Life; Questionnaires; Receptor, ErbB-2 - metabolism; Tumors; Male; Advanced breast cancer; Hormone receptor–positive/human epidermal growth factor receptor 2–negative; Palbociclib; Real-world; CDK4/6 inhibitor
• ISSN: 0167-6806; 1573-7217; 1573-7217
• DOI: 10.1007/s10549-023-07145-1

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.