Cancer medicine · 2026
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.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Tripathy Debu, Blum Joanne L, Karuturi Meghan S, McCune Steven, Kurian Sobha, Moezi Mehdi M, Anderson Daniel M, Ji Yan, Pluard Timothy J, Migas John, Lakhanpal Shailendra, Jepsen Erin, Wang Yao, Montelongo Monica Z, Zhang Zhe, Cappelleri Joseph C, Gauthier Eric, Rocque Gabrielle B
Аннотация
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.
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.
Предметные рубрики MeSH
AdultAgedFemaleHumansMiddle AgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsComorbidityErb-b2 Receptor Tyrosine KinasesPiperazinesProgression-Free SurvivalProspective StudiesProtein Kinase InhibitorsPyridinesQuality of LifeReceptors, EstrogenReceptors, ProgesteroneTreatment Outcome