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 aCDK4/6 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.
RCT Entities:
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, humanepidermal 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, humanepidermal 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.
Authors: Harold J Burstein; Mark R Somerfield; Debra L Barton; Ali Dorris; Lesley J Fallowfield; Dharamvir Jain; Stephen R D Johnston; Larissa A Korde; Jennifer K Litton; Erin R Macrae; Lindsay L Peterson; Praveen Vikas; Rachel L Yung; Hope S Rugo Journal: J Clin Oncol Date: 2021-07-29 Impact factor: 44.544
Authors: Marcus Schmidt; Hans Lenhard; Arnd Hoenig; Yvette Zimmerman; Jan Krijgh; Monique Jansen; Herjan J T Coelingh Bennink Journal: J Cancer Res Clin Oncol Date: 2020-11-26 Impact factor: 4.553
Authors: Matthew P Goetz; Meena Okera; Hans Wildiers; Mario Campone; Eva-Maria Grischke; Luis Manso; Valérie A M André; Nadia Chouaki; Belén San Antonio; Masakazu Toi; George W Sledge Journal: Breast Cancer Res Treat Date: 2021-01-03 Impact factor: 4.872
Authors: Laura B Oswald; Brandy Arredondo; Mika Kadono; Dinorah Martinez-Tyson; Cathy D Meade; Frank Penedo; Michael H Antoni; Hatem Soliman; Ricardo L B Costa; Heather S L Jim Journal: Cancer Med Date: 2021-06-24 Impact factor: 4.452