Outcomes of Older Women With Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor–Negative Metastatic Breast Cancer Treated With a CDK4/6 Inhibitor and an Aromatase Inhibitor: An FDA Pooled Analysis

Autor: Rajeshwari Sridhara, Kirsten B. Goldberg, Tatiana M. Prowell, Laleh Amiri-Kordestani, Amna Ibrahim, Shenghui Tang, Julia A. Beaver, Belinda L. King-Kallimanis, Jennifer J Gao, Erik Bloomquist, Harpreet Singh, Suparna Wedam, Marc R. Theoret, Richard Pazdur, Lynn J. Howie, Jacqueline Sanchez, Paul G. Kluetz
Rok vydání: 2019
Předmět:
0301 basic medicine
Oncology
Cancer Research
medicine.medical_specialty
medicine.drug_class
Breast Neoplasms
03 medical and health sciences
0302 clinical medicine
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Progression-free survival
Receptor
Protein Kinase Inhibitors
Aged
Randomized Controlled Trials as Topic
Aged
80 and over
Aromatase inhibitor
Aromatase Inhibitors
United States Food and Drug Administration
Kinase
business.industry
Editorials
Cyclin-Dependent Kinase 4
Cyclin-Dependent Kinase 6
Middle Aged
medicine.disease
Metastatic breast cancer
Progression-Free Survival
United States
Treatment Outcome
030104 developmental biology
Pooled analysis
Receptors
Estrogen
Hormone receptor
030220 oncology & carcinogenesis
Human epidermal growth factor receptor
Female
Receptors
Progesterone
business
Zdroj: J Clin Oncol
ISSN: 1527-7755
0732-183X
DOI: 10.1200/jco.18.02217
Popis: PURPOSE Many older women will be treated with a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and an aromatase inhibitor (AI), given US Food and Drug Administration approval of three agents in this class. The current pooled analysis examines the efficacy and safety of this combination in older women. PATIENTS AND METHODS We pooled data from three randomized controlled studies (N = 1,827) of different CDK4/6 inhibitors in combination with an AI for initial treatment of postmenopausal women with hormone receptor–positive, human epidermal growth factor receptor 2–negative metastatic breast cancer. The effect of age on progression-free survival was evaluated using Kaplan-Meier estimates and a Cox proportional hazards regression model. RESULTS For patients age 75 years or older (n = 198) who were treated with a CDK4/6 inhibitor and an AI, hazard ratio was 0.49 (95% CI, 0.31 to 0.76) with an estimated median progression-free survival of 31.1 months (95% CI, 20.2 months to not reached) versus 13.7 months (95% CI, 10.9 months to 24.9 months) for those treated with an AI. Incidence of grade 3 to 4 adverse events was 88.8% in patients age 75 years and older and 73.4% in patients younger than age 75 years. Patients age 75 years or older reported a decline in quality-of-life measures using the EQ-5D regardless of treatment with AI alone or with the addition of a CDK4/6 inhibitor. CONCLUSION There was similar efficacy with a CDK4/6 inhibitor in combination with an AI compared with AI alone for first-line treatment of hormone receptor–positive, human epidermal growth factor receptor 2–negative metastatic breast cancer in older women compared with younger patients. Patients older than age 75 years experienced higher rates of toxicity, dose modifications, and a decrease from baseline in quality-of-life measures.
Databáze: OpenAIRE
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