PMID- 29043567 OWN - NLM STAT- MEDLINE DCOM- 20190614 LR - 20190614 IS - 1179-2027 (Electronic) IS - 1170-7690 (Print) IS - 1170-7690 (Linking) VI - 36 IP - 2 DP - 2018 Feb TI - Impact of Adverse Events on Health Utility and Health-Related Quality of Life in Patients Receiving First-Line Chemotherapy for Metastatic Breast Cancer: Results from the SELECT BC Study. PG - 215-223 LID - 10.1007/s40273-017-0580-7 [doi] 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. FAU - Hagiwara, Yasuhiro AU - Hagiwara Y AUID- ORCID: 0000-0003-3792-5368 AD - Department of Biostatistics, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. hagiwara@epistat.m.u-tokyo.ac.jp. FAU - Shiroiwa, Takeru AU - Shiroiwa T AD - Department of Health and Welfare Services, National Institute of Public Health, Wako, Japan. FAU - Shimozuma, Kojiro AU - Shimozuma K AD - Department of Biomedical Sciences, College of Life Sciences, Ritsumeikan University, Kusatsu, Japan. FAU - Kawahara, Takuya AU - Kawahara T AD - Biostatistics Division, Clinical Research Support Center, The University of Tokyo Hospital, Tokyo, Japan. FAU - Uemura, Yukari AU - Uemura Y AD - Biostatistics Division, Clinical Research Support Center, The University of Tokyo Hospital, Tokyo, Japan. FAU - Watanabe, Takanori AU - Watanabe T AD - Department of Breast Surgery, National Hospital Organization Sendai Medical Center, Sendai, Japan. FAU - Taira, Naruto AU - Taira N AD - Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan. FAU - Fukuda, Takashi AU - Fukuda T AD - Department of Health and Welfare Services, National Institute of Public Health, Wako, Japan. FAU - Ohashi, Yasuo AU - Ohashi Y AD - Department of Integrated Science and Engineering for Sustainable Society, Faculty of Science and Engineering, Chuo University, Tokyo, Japan. FAU - Mukai, Hirofumi AU - Mukai H AD - Department of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan. LA - eng PT - Clinical Trial, Phase III PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - New Zealand TA - Pharmacoeconomics JT - PharmacoEconomics JID - 9212404 RN - 0 (Antineoplastic Agents) RN - 0 (Drug Combinations) RN - 0 (Taxoids) RN - 150863-82-4 (S 1 (combination)) RN - 1548R74NSZ (Tegafur) RN - 5VT6420TIG (Oxonic Acid) MH - Aged MH - Antineoplastic Agents/administration & dosage/*adverse effects MH - Breast Neoplasms/*drug therapy/pathology MH - Drug Combinations MH - Female MH - Health Status MH - Humans MH - Japan MH - Middle Aged MH - Neoplasm Metastasis MH - Oxonic Acid/administration & dosage/*adverse effects MH - Quality of Life MH - Surveys and Questionnaires MH - Taxoids/administration & dosage/*adverse effects MH - Tegafur/administration & dosage/*adverse effects MH - Time Factors PMC - PMC5805818 COIS- 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. CONFLICT OF INTEREST: 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. ETHICAL APPROVAL: The SELECT BC study was conducted in accordance with the Declaration of Helsinki and the Ethical Guidelines for Clinical Research of the Japanese Ministry of Health, Labor and Welfare. The study protocol was approved by an independent Ethics Committee for each participating site. All participants provided written informed consent. DATA AVAILABILITY STATEMENT: The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request. EDAT- 2017/10/19 06:00 MHDA- 2019/06/15 06:00 PMCR- 2017/10/17 CRDT- 2017/10/19 06:00 PHST- 2017/10/19 06:00 [pubmed] PHST- 2019/06/15 06:00 [medline] PHST- 2017/10/19 06:00 [entrez] PHST- 2017/10/17 00:00 [pmc-release] AID - 10.1007/s40273-017-0580-7 [pii] AID - 580 [pii] AID - 10.1007/s40273-017-0580-7 [doi] PST - ppublish SO - Pharmacoeconomics. 2018 Feb;36(2):215-223. doi: 10.1007/s40273-017-0580-7.