{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T19:32:07Z","timestamp":1785353527391,"version":"3.55.0"},"reference-count":33,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T00:00:00Z","timestamp":1767916800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T00:00:00Z","timestamp":1767916800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100001249","name":"University of Tasmania","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100001249","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>There is widespread interest among patients, clinicians, regulators and other constituents in post-treatment patient-reported cancer data. Side effect bother is a patient-reported outcome (PRO) that can capture an important aspect of tolerability. In this study, we examined side effect bother at cancer treatment discontinuation and post-discontinuation in commercial cancer trials. We sought to understand completion rates, the extent of bother and its association with other PROs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>Data were evaluated from three trials in patients with solid tumours (renal cell carcinoma and breast cancer). Side effect bother was measured with the Functional Assessment of Chronic Illness Therapy (FACIT) GP5 item. Symptom items were drawn from FACIT and function items were drawn from the EQ-5D-3L. FACIT items, including the GP5, are on a 0\u20134 scale (higher\u2009=\u2009worse symptoms\/bother), and were dichotomised as 0\u20131 (\u201clow\u201d) vs 2\u20134 (\u201cmoderate\u201d). EQ-5D-3L items were characterised as no problems (1) and some problems (2\u20133). Descriptive and correlation analyses were conducted separately for each trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among patients who received treatment, completion rates at discontinuation for most items were at least 70%, and 52% to 78% at follow up. More than 20% of patients had high side effect bother at and after discontinuation, and similar percentages were seen for symptom items and functioning problems. GP5 and most items were at least somewhat correlated (\u2265\u20090.2 in nearly all evaluations).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion and Conclusions<\/jats:title>\n                    <jats:p>Persistent side effect bother and symptomatic and functional detriments at and after discontinuation suggest capturing this information post-treatment can inform understanding of tolerability, particularly with improved PRO completion.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s43441-025-00906-8","type":"journal-article","created":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T16:35:50Z","timestamp":1767976550000},"page":"575-590","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Patient-Perceived Overall Side Effect Bother at and After Cancer Treatment Discontinuation: An Analysis Using Commercial Cancer Trial Data"],"prefix":"10.1007","volume":"60","author":[{"given":"Jessica","family":"Roydhouse","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monique","family":"Breslin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Zola","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ethan","family":"Basch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melanie","family":"Calvert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Cella","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary Lou","family":"Smith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gita","family":"Thanarajasingam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John Devin","family":"Peipert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,1,9]]},"reference":[{"issue":"11","key":"906_CR1","doi-asserted-by":"publisher","first-page":"681","DOI":"10.1038\/s41571-022-00685-3","volume":"19","author":"NM Kuderer","year":"2022","unstructured":"Kuderer NM, Desai A, Lustberg MB, Lyman GH. 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MJC receives funding outside the submitted work from the National Institute for Health and Care Research (NIHR), UK Research and Innovation (UKRI), NIHR Birmingham Biomedical Research Centre (BRC), NIHR ARC West Midlands, LifeArc, European Regional Development Fund, Innovate UK (part of UKRI), Merck, GSK and Gilead. MC has received personal fees from Aparito Ltd, Boehringer Ingelheim, CIS Oncology, Halfloop, ICON, Merck, Pfizer and Vertex outside the submitted work. JDP receives funding outside the submitted work from the United States Food and Drug Administration, UK Research and Innovation, and LifeArc. He has received personal fees from Orphalan SA, Ionis Pharmaceuticals, Beta6, and DayOne Pharmaceuticals. JR receives funding outside the submitted work to her institution from the Patient-Centered Outcomes Research Institute, Prostate Cancer Foundation of Australia, EuroQol Foundation, Cancer Council of Tasmania, Gilead Sciences, Movember Foundation, and Pfizer Inc. Outside the submitted work, she is an Editor-in-Chief of Quality of Life Research. MB receives funding outside the submitted work to her institution from Gilead Sciences. EB receives funds as a scientific advisor for Navigating Cancer, Resilience Health, and Thyme Care; he receives research funding to his institution from the National Cancer Institute and from the Patient-Centered Outcomes Research Institute. DC is President of FACIT.org, which licenses and distributes questionnaires that include item GP5. MLS, GT and AZ have no competing interests to report.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}