{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,17]],"date-time":"2026-02-17T12:36:27Z","timestamp":1771331787231,"version":"3.50.1"},"reference-count":22,"publisher":"Wiley","issue":"S2","license":[{"start":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T00:00:00Z","timestamp":1761091200000},"content-version":"vor","delay-in-days":7,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["acsjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2025,10,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Overall side\u2010effect impact, the aggregated experience of multiple toxicities, can be captured with the single Functional Assessment of Cancer Therapy (FACT) item GP5 (\u201cI am bothered by side effects of treatment\u201d). The objective of this study was to evaluate the ability of item GP5 to indicate treatment tolerability by examining its association with early treatment discontinuation (ETD) due to adverse events (AEs) in four cancer trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The authors analyzed data from four clinical trials coordinated by the ECOG\u2010ACRIN Cancer Research Group, covering breast cancer (E1Z11, all patients received anastrozole; E1Z03, compared anastrozole vs. exemestane), melanoma (E1609, compared ipilimumab vs. high\u2010dose interferon \u03b1), and chronic lymphocytic leukemia (E1912, compared ibrutinib\u2013rituximab bs. standard chemoimmunotherapy). In each trial, GP5 responses were categorized as severe bother (i.e., \u201cvery much\u201d\/\u201cquite a bit\u201d) versus moderate\/low bother (\u201csomewhat\u201d\/\u201ca little bit\u201d\/\u201cnot at all\u201d).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>At 3 months, significant associations were observed in each trial, indicating approximately 2.8\u20136.8 times greater odds of ETD among patients reporting severe bother (E1Z03: adjusted odds ratio [aOR], 2.82; 95% confidence interval [95% CI], 1.10\u20137.28; E1Z11: aOR, 4.10; 95% CI, 1.69\u201310.00; E1609: aOR, 6.77; 95% CI, 2.88\u201315.92; E1912: aOR, 4.15; 95% CI, 1.64\u201310.49).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These results support prior research demonstrating an association between severe side\u2010effect bother, as reported on responses to the GP5 item, and ETD among patients with newly diagnosed multiple myeloma. The consistent association between GP5 responses and ETD suggests the GP5's ability\u00a0to capture how well patients tolerate treatment, especially when side\u2010effect bother is observed early in the course of treatment, and signals an opportunity to develop interventions to promote treatment adherence.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cncr.70084","type":"journal-article","created":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T14:40:07Z","timestamp":1761144007000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Overall side\u2010effect bother consistently associated with early treatment discontinuation due to adverse events in four clinical trials with various cancer types and treatments"],"prefix":"10.1002","volume":"131","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5762-7881","authenticated-orcid":false,"given":"John Devin","family":"Peipert","sequence":"first","affiliation":[{"name":"Centre for Patient Reported Outcomes Research Department of Applied Health Sciences University of Birmingham  Edgbaston Birmingham UK"},{"name":"Department of Medical Social Sciences Feinberg School of Medicine  Chicago Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-0956-5861","authenticated-orcid":false,"given":"Shaili","family":"Ganatra","sequence":"additional","affiliation":[{"name":"Department of Medical Social Sciences Feinberg School of Medicine  Chicago Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9826-3703","authenticated-orcid":false,"given":"Fengmin","family":"Zhao","sequence":"additional","affiliation":[{"name":"Eastern Cooperative Oncology Group\u2010American College of Radiology Imaging Network Biostatistics Center Dana\u2010Farber Cancer Institute  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ju\u2010Whei","family":"Lee","sequence":"additional","affiliation":[{"name":"Eastern Cooperative Oncology Group\u2010American College of Radiology Imaging Network Biostatistics Center Dana\u2010Farber Cancer Institute  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessica","family":"Roydhouse","sequence":"additional","affiliation":[{"name":"Menzies Institute for Medical Research University of Tasmania  Hobart Tasmania Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4811-4205","authenticated-orcid":false,"given":"Edward H.","family":"Ip","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Data Science Wake Forest University School of Medicine  Winston\u2010Salem North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nathaniel","family":"O\u2019Connell","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Data Science Wake Forest University School of Medicine  Winston\u2010Salem North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruth C.","family":"Carlos","sequence":"additional","affiliation":[{"name":"Department of Radiology Columbia University Vagelos College of Physicians and Surgeons  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noah","family":"Graham","sequence":"additional","affiliation":[{"name":"Eastern Cooperative Oncology Group\u2010American College of Radiology Imaging Network Biostatistics Center Dana\u2010Farber Cancer Institute  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mary Lou","family":"Smith","sequence":"additional","affiliation":[{"name":"Research Advocacy Network  Chicago Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ilana F.","family":"Gareen","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and the Center for Statistical Sciences Brown University School of Public Health  Providence Rhode Island USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ahmad A.","family":"Tarhini","sequence":"additional","affiliation":[{"name":"Department of Oncologic Sciences H. Lee Moffitt Cancer Center Research Institute University of South Florida Morsani College of Medicine  Tampa Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tait","family":"Shanafelt","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Stanford University School of Medicine  Stanford California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vered","family":"Stearns","sequence":"additional","affiliation":[{"name":"Department of Medicine Division of Hematology and Medical Oncology Weill Cornell Medicine  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pamela J.","family":"Raper","sequence":"additional","affiliation":[{"name":"Department of Health Policy and Management Gillings School of Global Public Health University of North Carolina at Chapel Hill  Chapel Hill North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Cella","sequence":"additional","affiliation":[{"name":"Department of Medical Social Sciences Feinberg School of Medicine  Chicago Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Gray","sequence":"additional","affiliation":[{"name":"Eastern Cooperative Oncology Group\u2010American College of Radiology Imaging Network Biostatistics Center Dana\u2010Farber Cancer Institute  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lynne I.","family":"Wagner","sequence":"additional","affiliation":[{"name":"Department of Health Policy and Management Gillings School of Global Public Health University of North Carolina at Chapel Hill  Chapel Hill North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,10,22]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/s1470\u20102045(06)70910\u2010x"},{"key":"e_1_2_9_3_1","unstructured":"BaschE CampbellA HudgensS et\u00a0al.Broadening the definition of tolerability in cancer clinical trials to better measure the patient experience. Friends of Cancer Research.2018. Accessed October 25 2024.https:\/\/friendsofcancerresearch.org\/wp\u2010content\/uploads\/Comparative\u2010Tolerability\u2010Whitepaper_FINAL.pdf"},{"key":"e_1_2_9_4_1","unstructured":"US Food and Drug Administration (FDA).Core Patient\u2010Reported Outcomes in Cancer Clinical Trials: Guidance for Industry. FDA\u2010Docket Number: 2020\u2010D\u20102303. FDA.2024. Accessed October 25 2024.https:\/\/www.fda.gov\/regulatory\u2010information\/search\u2010fda\u2010guidance\u2010documents\/core\u2010patient\u2010reported\u2010outcomes\u2010cancer\u2010clinical\u2010trials"},{"key":"e_1_2_9_5_1","unstructured":"US National Cancer Institute (NCI).Cancer Treatment Tolerability Consortium.NCI.2024. Accessed October 25 2024.https:\/\/prevention.cancer.gov\/major\u2010programs\/cancer\u2010treatment\u2010tolerability\u2010consortium"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2017.09.009"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.31133"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11136\u2010023\u201003426\u2010w"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520\u2010024\u201008775\u2010x"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520\u2010022\u201006802\u20103"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520\u2010022\u201007484\u20107"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10549\u2010018\u20104713\u20102"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2024.3854"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078\u20100432.CCR\u201023\u20102137"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1200\/jco.2012.44.7805"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1200\/jco.19.01381"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11136\u2010022\u201003226\u20108"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2021014960"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1080\/10543406.2024.2313060"},{"key":"e_1_2_9_20_1","unstructured":"Eli Lilly and Company.Retevmo (selpercatinib) [package insert]. Eli Lilly and Company.2024."},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1200\/jco.23.00377"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520\u2010021\u201006700\u20100"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1200\/jco.21.00195"}],"container-title":["Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/acsjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cncr.70084","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,29]],"date-time":"2025-11-29T14:47:05Z","timestamp":1764427625000},"score":1,"resource":{"primary":{"URL":"https:\/\/acsjournals.onlinelibrary.wiley.com\/doi\/10.1002\/cncr.70084"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,15]]},"references-count":22,"journal-issue":{"issue":"S2","published-print":{"date-parts":[[2025,10,15]]}},"alternative-id":["10.1002\/cncr.70084"],"URL":"https:\/\/doi.org\/10.1002\/cncr.70084","archive":["Portico"],"relation":{},"ISSN":["0008-543X","1097-0142"],"issn-type":[{"value":"0008-543X","type":"print"},{"value":"1097-0142","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,15]]},"assertion":[{"value":"2025-04-10","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-08-26","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-22","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70084"}}