Impact of Comorbidities on Clinical Outcomes and Quality of Life of Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Advanced Breast Cancer Treated With Palbociclib in the POLARIS Study.

Debu Tripathy, Joanne L Blum, Meghan S Karuturi, Steven McCune, Sobha Kurian, Mehdi M Moezi, Daniel M Anderson, Yan Ji, Timothy J Pluard, John Migas, Shailendra Lakhanpal, Erin Jepsen, Yao Wang, Monica Z Montelongo, Zhe Zhang, Joseph C Cappelleri, Eric Gauthier, Gabrielle B Rocque

Journal: Cancer medicine 2026;15(4):e71788

PMID: 42017805

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Abstract

BACKGROUND

Comorbidities, common in patients with advanced breast cancer (ABC), may impact survival outcomes and health-related quality of life (HRQoL). Here, we report subgroup analyses on the basis of comorbidities of patients from POLARIS (NCT03280303), a prospective, observational study of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) ABC who were treated with palbociclib plus endocrine therapy in routine clinical practice in North America.

METHODS

Real-world progression-free survival (rwPFS) and overall survival (OS) were evaluated by line of therapy (1 LOT, ≥ 2 LOT), Charlson Comorbidity Index (CCI) score (0, 1-2, and 3+), and common comorbid disorder categories (cardiovascular, psychiatric, metabolic and nutritional, and blood and lymphatic disorders). HRQoL was assessed using the global health status (GHS)/QoL subscale of the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30.

RESULTS

From January 2017 to October 2019, 1250 patients (median age, 64 years) initiated palbociclib-based therapy. Median rwPFS (95% CI) for patients with CCI scores of 0, 1-2, and 3+ were 20.3 (17.1-24.8), 24.2 (19.4-29.5), and 16.8 (11.2-20.8) months in 1 LOT and 13.7 (6.2-19.7), 13.2 (9.4-17.5), and 14.9 (8.0-21.9) months in ≥ 2 LOT, respectively. Median OS durations (95% CI) were 48.8 (37.3-not estimable [NE]), not reached (43.0-NE), and 34.8 (29.1-44.1) months in 1 LOT and 39.0 (30.6-50.5), 37.9 (26.5-42.6), and 31.6 (20.9-45.2) months in ≥ 2 LOT, respectively. Patients with blood and lymphatic disorders had shorter rwPFS and OS than those with other common comorbidities. GHS/QoL was maintained irrespective of CCI score. Patients with a CCI score of 0 had clinically meaningful and statistically significantly higher mean GHS/QoL scores than patients with a CCI score of 3+ at each assessment.

CONCLUSIONS

Patients with HR+/HER2- ABC receiving palbociclib with higher comorbidity burden, especially blood and lymphatic system disorders, had poorer clinical outcomes. GHS/QoL was preserved regardless of comorbidity burden.

TRIAL REGISTRATION

Clinical trial number: NCT03280303.

Address: Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.; Department of Oncology, Baylor-Sammons Cancer Center, Texas Oncology, US Oncology, Dallas, Texas, USA.; William S. Gibbons Cancer Research Institute, Northwest Georgia Oncology Centers Wellstar, Marietta, Georgia, USA.; Hematology/Oncology, West Virginia University Cancer Institute, Morgantown, West Virginia, USA.; Medical Oncology, Cancer Specialists of North Florida, Fleming Island, Florida, USA.; Oncology & Hematology, Health Partners Institute, Saint Paul, Minnesota, USA.; Health Partners Institute, St. Paul, Minnesota, USA.; Saint Luke's Cancer Institute, Kansas City, Missouri, USA.; Mid-Illinois Hematology & Oncology Associates Ltd, Normal, Illinois, USA.; Saint Vincent's Birmingham, Birmingham, Alabama, USA.; Novant Health, Winston-Salem, North Carolina, USA.; Oncology Medical Group, Pfizer Inc, New York, New York, USA.; Biostatistics and Medical Writing, ICON Commercialisation and Outcomes, ICON Plc., Blue Bell, Pennsylvania, USA.; Oncology Clinical Statistics, Pfizer Inc, San Diego, California, USA.; Statistical Research and Data Science Center, Pfizer Inc, Groton, Connecticut, USA.; Global Medical Affairs, Pfizer Inc, San Francisco, California, USA.; Division of Hematology/Oncology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.

DOI: 10.1002/cam4.71788

MeSH Terms: Humans, Female, Quality of Life, Breast Neoplasms, Pyridines, Piperazines, Middle Aged, Erb-b2 Receptor Tyrosine Kinases, Aged, Prospective Studies, Comorbidity, Receptors, Estrogen, Receptors, Progesterone, Antineoplastic Combined Chemotherapy Protocols, Adult, Treatment Outcome, Aged, 80 and over, Progression-Free Survival