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We report the patient-reported outcomes (PROs) of FAST in patients with advanced gastroesophageal adenocarcinoma.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Patients were randomized to ZOL\/EOX or EOX alone. Patients could receive\u2009\u2264\u20098 EOX cycles and remained on zolbetuximab until disease progression. PROs were collected using the EORTC QLQ-C30 and QLQ-STO22 before drug administration at day 1\/cycle 1, day 1\/cycle 5, end of EOX treatment, and q12w thereafter until disease progression. Time to deterioration (TTD), defined as the first meaningful worsening from baseline, in the individual QLQ-C30\/QLQ-STO22 scores was analyzed. Longitudinal changes in scores from baseline were analyzed using a mixed-effects model for repeated measures (MMRM).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The per protocol population included 143 (ZOL\/EOX: 69; EOX: 74) patients. Baseline QLQ-C30 and STO22 scores were comparable between arms and denoted intermediate-to-high quality of life (QoL), intermediate-to-low global health status (GHS) and low symptom burden. Descriptive analyses showed no differences between arms until end of EOX but maintenance therapy with zolbetuximab was associated with better QoL and less symptom burden thereafter. TTD for most scores favored ZOL\/EOX over EOX and reached statistical significance for GHS (<jats:italic>p<\/jats:italic>\u2009=\u20090.008). MMRM results support TTD findings; no statistically significant differences were observed between arms in any score except for nausea and vomiting (<jats:italic>p<\/jats:italic>\u2009=\u20090.0181 favoring EOX).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>ZOL\/EOX allowed patients to maintain good QoL and low symptom burden for longer than EOX alone.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10120-020-01153-6","type":"journal-article","created":{"date-parts":[[2021,3,23]],"date-time":"2021-03-23T14:04:09Z","timestamp":1616508249000},"page":"721-730","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["Patient-reported outcomes from the phase II FAST trial of zolbetuximab plus EOX compared to EOX alone as first-line treatment of patients with metastatic CLDN18.2+\u2009gastroesophageal adenocarcinoma"],"prefix":"10.1007","volume":"24","author":[{"given":"Florian","family":"Lordick","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Salah-Eddin","family":"Al-Batran","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arijit","family":"Ganguli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Morlock","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ugur","family":"Sahin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"\u00d6zlem","family":"T\u00fcreci","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,3,23]]},"reference":[{"issue":"6","key":"1153_CR1","doi-asserted-by":"publisher","first-page":"394","DOI":"10.3322\/caac.21492","volume":"68","author":"F Bray","year":"2018","unstructured":"Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. 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Salah-Eddin Al-Batran reports advisory role from Merck, Roche, Celgene, Lilly, Nordic Pharma, Bristol-Myers Squibb, MSD Sharp & Dohme; speaker role from Roche, Celgene, Lilly, Nordic Pharma, AIO gGmbH, MCI, Promedicis, Forum f\u00fcr Medizinische Fortbildung; CEO\/founder of IKF Klinische Krebsforschung GmbH; and clinical trial fees from Sanofi, Merck, Roche, Celgene, Vifor, Medac, Hospira, Lilly, German Cancer Aid (Krebshilfe), and German Research Foundation; and translational research from the Federal Ministry of Education and Research. Arijit Ganguli is an employee of Astellas Pharma, Inc. Robert Morlock is a former independent consultant with YouCareChoice supporting Astellas Pharma, Inc., and reports personal fees from Astellas Pharma, Inc., Abbot Medical Optics, Ironwood, and Genentech. Ugur Sahin reports co-founder and shareholder at Ganymed and also holds several patents, with royalties paid by Astellas; founder, chief executive officer, and shareholder of BioNTech. \u00d6zlem T\u00fcreci reports founder and chief executive officer of Ganymed until the end of 2016; currently an employee and chief medical officer of BioNTech; patents for the investigational agent, zolbetuximab, with royalties paid by Astellas; consultancy fees from Astellas Pharma.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}