Author(s)
Hu XC1, Zhang QY2, Sun T3, Yin YM4, Li HP5, Yan M6, Tong ZS7, Oppermann CP8, Liu YP9, Han RB10, Wang N10, Zhang YL10, Zhang WL10, Jiang ZF11
1Fudan University Shanghai Cancer Center, Shanghai, China, 2Harbin Medical University Cancer Hospital, Harbin, China, 3Cancer Hospital of China Medical University/Liaoning Cancer Hospital, Shenyang, China, 4Jiangsu Province Hospital, Nanjing, China, 5Peking University Cancer Hospital & Institute, Beijing, China, 6The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China, 7Tianjin Medical University Cancer Institute and Hospital, Tianjin, China, 8Hospital Mãe de Deus/AESC, Porto Alegre, Brazil, 9First Affiliated Hospital of China Medical University, Shenyang, China, 10Eli Lilly and Company, Shanghai, China, 11Fifth Medical Center of Chinese PLA General Hospital, Beijing, China
OBJECTIVES In the phase III MONARCH plus trial, abemaciclib combined with NSAI (Cohort A) or fulvestrant (Cohort B) provided a significant and clinically meaningful PFS improvement comparing to placebo combined with NSAI or fulvestrant in predominantly Chinese postmenopausal women with HR+/HER2- ABC without new safety signals observed. Here we assess patient-reported outcomes (PRO) including pain, global health, functioning, and symptoms. METHODS The study details were previously reported. Data from the modified Brief Pain Inventory short form (mBPI-sf) and European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C-30) were collected at baseline, cycle 2 (C2), every 2 cycles from C3 - C13, and then every 3 cycles until post-discontinuation follow-up. Change from baseline for mBPI-sf and EORTC QLQ-C30 were analyzed by mixed model with repeated measures for each cohort separately. Within each cohort, differences of change from baseline (for each and across all visits) between arms were analyzed. RESULTS PRO completion rates for both cohorts were >94.0% at baseline, >70.9% on treatment, and >74.2% at follow-up visits. In both cohorts, baseline scores for each questionnaire were similar between treatment arms. No clinical or statistical significance between-arms differences were observed in change from baseline in the mBPI-sf “worst pain” score, or the global health status and functioning scores in the EORTC QLQ-C30. As compared to NSAI or fulvestrant control arms, diarrhea was the only symptom for which there was a clinically meaningful and statistically significant worsening in the abemaciclib arms. In both cohorts, although patients in the abemaciclib arms reported a statistically significant worsening of appetite loss, there was no clinically meaningful difference. CONCLUSIONS Abemaciclib combined with NSAI or fulvestrant did not show statistically significant and clinically meaningful differences in pain, global health, functioning, or most symptoms compared to NSAI or fulvestrant arm. ClinicalTrials.gov: NCT02763566
Conference/Value in Health Info
2020-11, ISPOR Europe 2020, Milan, Italy
Value in Health, Volume 23, Issue S2 (December 2020)
Code
PCN32
Topic
Clinical Outcomes, Methodological & Statistical Research, Organizational Practices, Patient-Centered Research
Topic Subcategory
Clinical Outcomes Assessment, Industry, Patient-reported Outcomes & Quality of Life Outcomes, PRO & Related Methods
Disease
Oncology