Health-Related Quality of Life in MONARCH 3: Abemaciclib plus an Aromatase Inhibitor as Initial Therapy in HR+, HER2− Advanced Breast Cancer

The oncologist

article

Matthew P. Goetz¹  M. Corona Gainford²  Gregory L. Price²  Stephen Johnston³  Miguel Martin⁴  Eriko Tokunaga⁵  In Hae Park⁶  Jens Huober⁷  Masakazu Toi⁸  Clemens Stoffregen²  Sarah Shekarriz²  Valerie Andre² 

[1]Division of Medical Oncology, Mayo Clinic

[2]Eli Lilly & Co.

[3]The Royal Marsden NHS Foundation Trust, United Kingdom

[4]Instituto de Investigacion Sanitaria Gregorio Marañon, Universidad Complutense

[5]National Hospital Organization, Kyushu Cancer Center

[6]National Cancer Center

[7]Breast Center, Universitätsklinikum Ulm

[8]Department of Surgery, Graduate School of Medicine, Kyoto University

关键词: Abemaciclib;    Advanced breast cancer;    Cyclin-dependent kinase 4/6 inhibitor;    Health-related quality of life;    Patient-reported outcomes;   

DOI  :  10.1634/theoncologist.2020-0084

学科分类：地质学

来源: AlphaMed Press Incorporated

【 摘 要 】

Background MONARCH 3, a phase III trial (NCT02246621) of postmenopausal women with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2−) advanced breast cancer (ABC), previously demonstrated significantly improved progression-free survival in patients receiving abemaciclib plus a nonsteroidal aromatase inhibitor (NSAI). This study evaluated patient-reported outcomes, including global health-related quality of life (HRQoL), functioning, and symptoms. Methods Patients were randomly assigned 2:1 to receive abemaciclib (150 mg twice daily; n = 328) or placebo ( n = 165), plus 1 mg anastrozole or 2.5 mg letrozole daily. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Breast Cancer–Specific Quality of Life Questionnaire HRQoL instruments were administered at baseline, every two cycles during cycles 2 through 19 (each cycle being 28 days), every three cycles thereafter, and once at a short-term posttherapy follow-up visit (approximately 30 days after discontinuation). Longitudinal mixed regression and Cox proportional hazards models evaluated postbaseline change and time to sustained deterioration (TTSD), respectively. Results Baseline scores were similar between treatment arms. Although select scores statistically favored the placebo arm, global HRQoL, most symptoms, and functioning scales did not meet the threshold for clinically meaningful differences between treatment arms. Only diarrhea favored the placebo arm with statistically and clinically meaningful differences. There were no TTSD differences between treatment arms for global HRQoL, most symptoms (except diarrhea), or functioning. Conclusion Over a 2-year period, there were no clinically meaningful differences in global HRQoL, functioning, and most symptoms for patients receiving abemaciclib plus NSAI compared with NSAI alone. Only diarrhea favored the placebo arm, consistent with prior safety data, which has been shown to be manageable and reversible. Combined with clinical efficacy, results support treatment with abemaciclib plus NSAI for postmenopausal women with HR+, HER2− ABC. Implications for Practice The addition of abemaciclib to a nonsteroidal aromatase inhibitor (NSAI) was not associated with a clinically meaningful detriment in patient-reported global health-related quality of life, functioning, and most symptoms in postmenopausal women with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2−) advanced breast cancer (ABC). Prior studies have also demonstrated clinical efficacy of abemaciclib plus NSAI compared with NSAI alone, including improved progression-free survival and objective response rate. These results also complement previously reported toxicity data, as measured by investigator-assessed adverse events. Taken together, these results support treatment with abemaciclib plus NSAI for postmenopausal women with HR+, HER2− ABC.

【 授权许可】

CC BY|CC BY-NC