TY - JOUR
T1 - Impact of Adverse Events on Health Utility and Health-Related Quality of Life in Patients Receiving First-Line Chemotherapy for Metastatic Breast Cancer
T2 - Results from the SELECT BC Study
AU - Hagiwara, Yasuhiro
AU - Shiroiwa, Takeru
AU - Shimozuma, Kojiro
AU - Kawahara, Takuya
AU - Uemura, Yukari
AU - Watanabe, Takanori
AU - Taira, Naruto
AU - Fukuda, Takashi
AU - Ohashi, Yasuo
AU - Mukai, Hirofumi
N1 - Funding Information:
Funding The SELECT BC study was sponsored by the Comprehensive Support Project for Oncology Research (CSPOR) of the Public Health Research Foundation. The research fund was provided to CSPOR by Taiho Pharmaceutical Co., Ltd. under the study contract.
Funding Information:
This study was supported by the Comprehensive Support Project for Health Outcomes Research (CSP-HOR) of the Public Health Research Foundation. We are grateful to the SELECT BC study investigators, staff, and patients who participated. The SELECT BC study was sponsored by the Comprehensive Support Project for Oncology Research (CSPOR) of the Public Health Research Foundation. The research fund was provided to CSPOR by Taiho Pharmaceutical Co., Ltd. under the study contract. Yasuhiro Hagiwara was contractually employed by EP CRSU, and Yasuo Ohashi received consulting fees or honoraria from the Public Health Research Foundation and Taiho Pharmaceutical Co., Ltd. Takeru Shiroiwa, Kojiro Shimozuma, Takuya Kawahara, Yukari Uemura, Takanori Watanabe, Naruto Taira, Takashi Fukuda, and Hirofumi Mukai have declared no conflicts of interest.
Publisher Copyright:
© 2017, The Author(s).
PY - 2018/2/1
Y1 - 2018/2/1
N2 - Objective: The aim of this study was to investigate the impact of adverse events (AEs) on health utility and health-related quality of life (HRQOL) in patients with metastatic breast cancer undergoing first-line chemotherapy. Methods: We analyzed the data from the SELECT BC study, a multicenter, open-label, randomized, phase III study conducted in Japan, which compared first-line S-1 with taxane therapies. Heath utility and HRQOL were assessed using the EQ-5D-3L and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at baseline and 3, 6, and 12 months after treatment initiation. Health utility was calculated based on societal preferences, and AEs were reported at each cycle of the study treatment. Linear marginal mean models were used to quantify the impact of the last AEs (with 10 or more incidences) observed before HRQOL assessment on health utility and HRQOL. Results: Analysis included 380 patients and 12 (of 15) AEs. Grade 1 nausea and oral mucositis, grade 1 and 2 edema, and grade 2 fatigue, motor and sensory neuropathy, and myalgia were significantly associated with disutility, measured using the EQ-5D-3L. Grade 1 oral mucositis, grade 1 and 2 fatigue, and grade 2 sensory neuropathy were significantly associated with impaired global health status in the EORTC QLQ-C30. AEs associated with decrements in the five functioning scales included fatigue, oral mucositis, nausea, edema, motor and sensory neuropathy, and myalgia. Conclusions: We reported disutilities caused by AEs in patients with metastatic breast cancer under chemotherapy. These findings can be applied to future model-based cost-effectiveness analyses. Trial Registration Number: C000000416.
AB - Objective: The aim of this study was to investigate the impact of adverse events (AEs) on health utility and health-related quality of life (HRQOL) in patients with metastatic breast cancer undergoing first-line chemotherapy. Methods: We analyzed the data from the SELECT BC study, a multicenter, open-label, randomized, phase III study conducted in Japan, which compared first-line S-1 with taxane therapies. Heath utility and HRQOL were assessed using the EQ-5D-3L and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at baseline and 3, 6, and 12 months after treatment initiation. Health utility was calculated based on societal preferences, and AEs were reported at each cycle of the study treatment. Linear marginal mean models were used to quantify the impact of the last AEs (with 10 or more incidences) observed before HRQOL assessment on health utility and HRQOL. Results: Analysis included 380 patients and 12 (of 15) AEs. Grade 1 nausea and oral mucositis, grade 1 and 2 edema, and grade 2 fatigue, motor and sensory neuropathy, and myalgia were significantly associated with disutility, measured using the EQ-5D-3L. Grade 1 oral mucositis, grade 1 and 2 fatigue, and grade 2 sensory neuropathy were significantly associated with impaired global health status in the EORTC QLQ-C30. AEs associated with decrements in the five functioning scales included fatigue, oral mucositis, nausea, edema, motor and sensory neuropathy, and myalgia. Conclusions: We reported disutilities caused by AEs in patients with metastatic breast cancer under chemotherapy. These findings can be applied to future model-based cost-effectiveness analyses. Trial Registration Number: C000000416.
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U2 - 10.1007/s40273-017-0580-7
DO - 10.1007/s40273-017-0580-7
M3 - Article
C2 - 29043567
AN - SCOPUS:85031506629
VL - 36
SP - 215
EP - 223
JO - PharmacoEconomics
JF - PharmacoEconomics
SN - 1170-7690
IS - 2
ER -