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Although nivolumab monotherapy has been an established treatment option in this setting, HRQoL data remain limited. This study aimed to examine associations between symptomatic adverse events (AEs) and HRQoL deterioration and to evaluate the feasibility of home-based electronic patient-reported outcome (ePRO) monitoring.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This prospective observational study enrolled patients aged \u2265\u200920\u00a0years with an ECOG performance status of 0\u20132 who were scheduled to receive later-line nivolumab monotherapy in clinical practice. Patients self-reported symptomatic AEs using PRO-CTCAE and assessed HRQoL weekly using FACT-Ga via a smartphone-based ePRO system for 12\u00a0weeks. The association between symptom deterioration and HRQoL decline was analyzed using a general linear model. Digital literacy and impressions of ePRO were also surveyed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among 29 evaluable patients, 20 completed the 12-week monitoring period. Median time to HRQoL deterioration was 9\u00a0weeks. Several symptomatic AEs, including stomatitis, dysgeusia, pain, malaise, and depression, showed nominal associations with HRQoL decline in unadjusted exploratory analyses (all nominal\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0&lt;\u00a00.05). Despite 37.9% of patients not regularly using smartphones, adherence to ePRO reporting was high, with only 0.95% missing data.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Exploratory analyses suggested potential associations between specific symptomatic AEs and HRQoL deterioration during later-line nivolumab therapy for advanced gastric cancer. ePRO monitoring achieved high data completeness, although patient acceptability was limited. These findings support further evaluation of ePRO as a tool for timely symptom recognition, alongside strategies to improve acceptability.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10147-026-03213-w","type":"journal-article","created":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T08:16:26Z","timestamp":1792570586000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Electronic patient-reported outcome monitoring and quality of life during later-line nivolumab therapy for advanced gastric cancer"],"prefix":"10.1007","author":[{"given":"Yoshiki","family":"Horie","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shunsuke","family":"Oyamada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hisato","family":"Kawakami","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Soichi","family":"Fumita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoki","family":"Izawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tempei","family":"Miyaji","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Kawaguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuhiro","family":"Yamaguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takako Eguchi","family":"Nakajima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,10,21]]},"reference":[{"key":"3213_CR1","unstructured":"Cancer Information Service NCCJapan Cancer registry and statistics (article in Japanese) (2022). https:\/\/ganjoho.jp\/reg_stat\/statistics\/stat\/summary.html. 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She also received lecture fees from multiple companies including Pfizer, Ono Pharmaceutical, and Chugai Pharmaceutical. Dr. Yamaguchi has received institutional research funding and consultancy fees from multiple pharmaceutical and technology companies, and participated on a data safety monitoring board for Incyte Biosciences. Dr. Kawaguchi declares no conflicts of interest. Dr. Miyaji reports institutional research funding from Ono Pharmaceutical and Medidata Solutions, lecture honoraria from Welby, Inc., and stock ownership in Meaningful Outcome Consulting, Inc. Dr. Kawakami reports institutional grants or contracts from Hitachi, Ono Pharmaceutical Co., Ltd., Ascent Development Services, Kobayashi Pharmaceutical Co., Ltd., Medpace Japan K.K., Astellas Inc., Bristol-Myers Squibb K.K., MSD K.K., ICON Clinical Research GK, Nippon Boehringer Ingelheim Co., Ltd., and Amgen. He also reports personal consulting fees from Daiichi Sankyo Co., Ltd., AbbVie GK, Astellas Pharma Inc., and Chugai Pharmaceutical Co., Ltd.; personal honoraria from Bristol-Myers Squibb Co., Ltd., Eli Lilly Japan K.K., Ono Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., Amgen, Astellas Pharma Inc., AstraZeneca K.K., Bayer Yakuhin Ltd., MSD K.K., Chugai Pharmaceutical Co., Ltd., Merck Biopharma Co., Ltd., Takata Pharmaceutical, Otsuka Pharmaceutical Co., Ltd., GlaxoSmithKline K.K., Novartis International AG, BeOne Medicine Japan, and Miyarisan Pharmaceutical Co., Ltd.; and participation on a data safety monitoring board or advisory board for AbbVie. Dr. Izawa reports research funding from Taiho Pharmaceutical.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study was performed in line with the principles of the Declaration of Helsinki, and was reviewed and approved by the independent Ethics Committee of St.Marianna University School of Medicine (Approval Number: 4281) based on the Ethical Guidelines for Medical Research Involving Human Subjects in Japan.","order":2,"name":"Ethics","label":"Ethical approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Written informed consent was obtained from all patients in this study.","order":3,"name":"Ethics","label":"Consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}}]}}