{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T02:04:19Z","timestamp":1791165859731,"version":"4.1.0"},"reference-count":25,"publisher":"American Medical Association (AMA)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"Importance<\/jats:title>There is substantial interest in capturing cancer treatment tolerability from the patient\u2019s perspective using patient-reported outcomes (PROs).<\/jats:p><\/jats:sec>Objective<\/jats:title>To examine whether a PRO question, item 5 from the Functional Assessment of Cancer Therapy-General General Physical Wellbeing Scale (GP5), was associated with early treatment discontinuation (ETD) due to adverse events.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>This prospective survey study was conducted from February to April 2023. Among participants in the ECOG-ACRIN E1A11 trial (a phase 3, parallel design trial conducted between 2013 and 2019), patients with newly diagnosed multiple myeloma were randomized to receive bortezomib (VRd) or carfilzomib (KRd) plus lenalidomide and dexamethasone as induction therapy. The GP5 item was administered at baseline (pretreatment) and at 1 month, 2.8 months, and 5.5 months postbaseline. Eligible participants included patients with newly diagnosed multiple myeloma treated at community oncology practices or academic medical centers in the US.<\/jats:p><\/jats:sec>Exposures<\/jats:title>GP5 response options were \u201cvery much,\u201d \u201cquite a bit,\u201d \u201csomewhat,\u201d \u201ca little bit,\u201d and \u201cnot at all.\u201d Responses at each assessment while undergoing treatment (1 month, 2.8 months, and 5.5 months) were categorized as high adverse event bother (ie, \u201cvery much,\u201d and \u201cquite a bit\u201d) and low adverse event bother (ie, \u201csomewhat,\u201d \u201ca little bit,\u201d or \u201cnot at all\u201d). In addition, change from baseline to each assessment while undergoing treatment was calculated and categorized as worsening by 1 response category and 2 or more response categories.<\/jats:p><\/jats:sec>Main Outcome and Measure<\/jats:title>ETD due to adverse events (yes vs no) was analyzed using logistic regression adjusting for treatment group, performance status, gender, race, and disease stage.<\/jats:p><\/jats:sec>Results<\/jats:title>Of the 1087 participants in the original trial, 1058 (mean [SD] age 64 [9] years; 531 receiving VrD [50.2%]; 527 receiving KRd [49.8%]) responded to item GP5 and were included in the secondary analysis. A small proportion (142 patients [13.4%]) discontinued treatment early due to AEs. For those with high adverse-effect bother, GP5 while undergoing treatment was associated with ETD at 1 month (adjusted odds ratio [aOR], 2.20; 95% CI, 1.25-3.89), 2.8 months (aOR, 3.41; 95% CI, 2.01-5.80), and 5.5 months (aOR, 4.66; 95% CI, 1.69-12.83). Worsening by 2 or more response categories on the GP5 was associated with ETD at 2.8 months (aOR, 3.02; 95% CI, 1.64-5.54) and 5.5 months (aOR, 5.49; 95% CI, 1.45-20.76).<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>In this survey study of the E1A11 trial, worse GP5 response was associated with ETD. These findings suggest that simple assessment of adverse-effect bother while receiving treatment is an efficient way to indicate treatment tolerability and ETD risk.<\/jats:p><\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2024.3854","type":"journal-article","created":{"date-parts":[[2024,3,27]],"date-time":"2024-03-27T15:34:02Z","timestamp":1711553642000},"page":"e243854","source":"Crossref","is-referenced-by-count":22,"title":["Patient-Reported Adverse Events and Early Treatment Discontinuation Among Patients With Multiple Myeloma"],"prefix":"10.1001","volume":"7","author":[{"given":"John Devin","family":"Peipert","sequence":"first","affiliation":[{"name":"Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fengmin","family":"Zhao","sequence":"additional","affiliation":[{"name":"Dana Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ju-Whei","family":"Lee","sequence":"additional","affiliation":[{"name":"Dana Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shu-en","family":"Shen","sequence":"additional","affiliation":[{"name":"Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward","family":"Ip","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathaniel","family":"O\u2019Connell","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruth C.","family":"Carlos","sequence":"additional","affiliation":[{"name":"Univeristy of Michigan Comprehensive Cancer Center, Ann Arbor"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noah","family":"Graham","sequence":"additional","affiliation":[{"name":"Dana Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary Lou","family":"Smith","sequence":"additional","affiliation":[{"name":"Research Advocacy Network, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela J.","family":"Raper","sequence":"additional","affiliation":[{"name":"Gillings School of Global Public Health, Department of Health Policy and Management, University of North Carolina at Chapel Hill"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"Weiss","sequence":"additional","affiliation":[{"name":"ThedaCare Cancer Center, Appleton, Wisconsin"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaji K.","family":"Kumar","sequence":"additional","affiliation":[{"name":"Mayo Clinic, Rochester, Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S. Vincent","family":"Rajkumar","sequence":"additional","affiliation":[{"name":"Mayo Clinic, Rochester, Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Cella","sequence":"additional","affiliation":[{"name":"Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Gray","sequence":"additional","affiliation":[{"name":"Dana Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynne I.","family":"Wagner","sequence":"additional","affiliation":[{"name":"Gillings School of Global Public Health, Department of Health Policy and Management, University of North Carolina at Chapel Hill"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2024,3,27]]},"reference":[{"issue":"6","key":"zoi240171r2","doi-asserted-by":"publisher","first-page":"742","DOI":"10.1016\/j.jval.2017.09.009","article-title":"Informing the tolerability of cancer treatments using patient-reported outcome measures: summary of an FDA and critical path institute workshop.","volume":"21","author":"Kluetz","year":"2018","journal-title":"Value Health"},{"issue":"8","key":"zoi240171r3","doi-asserted-by":"publisher","first-page":"1780","DOI":"10.1158\/1078-0432.CCR-17-2555","article-title":"Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections.","volume":"24","author":"Kim","year":"2018","journal-title":"Clin Cancer Res"},{"key":"zoi240171r7","doi-asserted-by":"publisher","first-page":"79","DOI":"10.1186\/1477-7525-1-79","article-title":"The functional assessment of chronic illness therapy (FACIT) measurement system: properties, applications, and interpretation.","volume":"1","author":"Webster","year":"2003","journal-title":"Health Qual Life Outcomes"},{"issue":"3","key":"zoi240171r8","doi-asserted-by":"publisher","first-page":"570","DOI":"10.1200\/JCO.1993.11.3.570","article-title":"The functional assessment of cancer therapy scale: development and validation of the general measure.","volume":"11","author":"Cella","year":"1993","journal-title":"J Clin Oncol"},{"issue":"5","key":"zoi240171r9","doi-asserted-by":"publisher","first-page":"991","DOI":"10.1002\/cncr.v124.5","article-title":"Validity and usefulness of a single-item measure of patient-reported bother from side effects of cancer therapy.","volume":"124","author":"Pearman","year":"2018","journal-title":"Cancer"},{"issue":"4","key":"zoi240171r10","doi-asserted-by":"publisher","first-page":"3613","DOI":"10.1007\/s00520-022-06802-3","article-title":"Validity of a single-item indicator of treatment side effect bother in a diverse sample of cancer patients.","volume":"30","author":"Griffiths","year":"2022","journal-title":"Support Care Cancer"},{"issue":"3","key":"zoi240171r11","doi-asserted-by":"publisher","first-page":"537","DOI":"10.1007\/s10549-018-4713-2","article-title":"Patient-reported predictors of early treatment discontinuation: treatment-related symptoms and health-related quality of life among postmenopausal women with primary breast cancer randomized to anastrozole or exemestane on NCIC Clinical Trials Group (CCTG) MA.27 (E1Z03).","volume":"169","author":"Wagner","year":"2018","journal-title":"Breast Cancer Res Treat"},{"issue":"10","key":"zoi240171r12","doi-asserted-by":"publisher","first-page":"1317","DOI":"10.1016\/S1470-2045(20)30452-6","article-title":"Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial.","volume":"21","author":"Kumar","year":"2020","journal-title":"Lancet Oncol"},{"issue":"4","key":"zoi240171r13","doi-asserted-by":"publisher","first-page":"821","DOI":"10.1016\/j.clinthera.2016.03.011","article-title":"Methods for implementing and reporting patient-reported outcome (PRO) measures of symptomatic adverse events in cancer clinical trials.","volume":"38","author":"Basch","year":"2016","journal-title":"Clin Ther"},{"issue":"2","key":"zoi240171r14","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2019.3332","article-title":"Assessment of adverse events from the patient perspective in a phase 3 metastatic castration-resistant prostate cancer clinical trial.","volume":"6","author":"Dueck","year":"2020","journal-title":"JAMA Oncol"},{"issue":"11","key":"zoi240171r16","doi-asserted-by":"publisher","first-page":"e563","DOI":"10.1016\/S2352-3026(18)30051-6","article-title":"Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies.","volume":"5","author":"Thanarajasingam","year":"2018","journal-title":"Lancet Haematol"},{"issue":"36","key":"zoi240171r17","doi-asserted-by":"publisher","first-page":"67","DOI":"10.1200\/EDBK_159514","article-title":"Patient-reported outcomes in cancer clinical trials: measuring symptomatic adverse events with the national cancer institute\u2019s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).","volume":"35","author":"Kluetz","year":"2016","journal-title":"Am Soc Clin Oncol Educ Book"},{"key":"zoi240171r18","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2020.38.18_suppl.LBA3","article-title":"Carfilzomib, lenalidomide, and dexamethasone (KRd) versus bortezomib, lenalidomide, and dexamethasone (VRd) for initial therapy of newly diagnosed multiple myeloma (NDMM): Results of ENDURANCE (E1A11) phase III trial.","volume":"38","author":"Kumar","year":"2020","journal-title":"J Clin Oncol"},{"issue":"9","key":"zoi240171r19","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/dju244","article-title":"Development of the National Cancer Institute\u2019s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).","volume":"106","author":"Basch","year":"2014","journal-title":"J Natl Cancer Inst"},{"issue":"32","key":"zoi240171r20","doi-asserted-by":"publisher","first-page":"3770","DOI":"10.1200\/JCO.21.02017","article-title":"Linking the European organisation for research and treatment of cancer item library to the common terminology criteria for adverse events.","volume":"40","author":"Gilbert","year":"2022","journal-title":"J Clin Oncol"},{"issue":"6","key":"zoi240171r22","doi-asserted-by":"publisher","DOI":"10.1200\/CCI.22.00061","article-title":"Real-world symptom monitoring with patient-reported outcome measures: what can we use this data for?","volume":"6","author":"King-Kallimanis","year":"2022","journal-title":"JCO Clin Cancer Inform"},{"issue":"6","key":"zoi240171r23","doi-asserted-by":"publisher","first-page":"557","DOI":"10.1200\/JCO.2015.63.0830","article-title":"Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial.","volume":"34","author":"Basch","year":"2016","journal-title":"J Clin Oncol"},{"issue":"1","key":"zoi240171r24","doi-asserted-by":"publisher","first-page":"37","DOI":"10.1007\/s00520-022-07484-7","article-title":"How do patients interpret and respond to a single-item global indicator of cancer treatment tolerability?","volume":"31","author":"Peipert","year":"2022","journal-title":"Support Care Cancer"},{"issue":"3","key":"zoi240171r25","doi-asserted-by":"publisher","first-page":"332","DOI":"10.1177\/1740774520910389","article-title":"Exploration of baseline patient-reported side effect bother from cancer therapy.","volume":"17","author":"Roydhouse","year":"2020","journal-title":"Clin Trials"},{"key":"zoi240171r6","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1007\/978-3-030-84702-9_6","volume-title":"Handbook of Quality of Life in Cancer","author":"Webster","year":"2022","edition":"1st ed"},{"key":"zoi240171r15","author":"Rosanbalm","year":"2015"},{"key":"zoi240171r1","unstructured":"Basch? E, Campbell? A, Hudgens? S, . Broadening the definition of tolerability in cancer clinical trials to capture the patient experience: a Friends of Cancer Research white paper. Friends of Cancer Research. 2020. Accessed February 19, 2024. https:\/\/friendsofcancerresearch.org\/wp-content\/uploads\/Comparative-Tolerability-Whitepaper_FINAL.pdf"},{"key":"zoi240171r4","unstructured":"National Cancer Institute. Common terminology criteria for adverse events (CTCAE). Published November 27, 2017. Updated March 25, 2020. Accessed June 11, 2020. https:\/\/ctep.cancer.gov\/protocolDevelopment\/electronic_applications\/ctc.htm"},{"key":"zoi240171r5","unstructured":"United States Department of Health and Human Services Food and Drug Administration. Core patient-reported outcomes in cancer clinical trials: guidance for industry. June 2021. Accessed February 19, 2024. https:\/\/www.fda.gov\/media\/149994\/download"},{"key":"zoi240171r21","unstructured":"Friends of Cancer Research. Supporting a patient-centric approach to dose optimization in oncology: the essential role of patient-reported outcomes (PROs): a friends of cancer research white paper. 2022. Accessed February 19, 2024. https:\/\/friendsofcancerresearch.org\/wp-content\/uploads\/Supporting_Patient-Centric_Approach_Dose_Optimization_Oncology-PROs.pdf"}],"container-title":["JAMA Network Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/articlepdf\/2816820\/peipert_2024_oi_240171_1710960179.51062.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,3,27]],"date-time":"2024-03-27T15:34:06Z","timestamp":1711553646000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/fullarticle\/2816820"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,3,27]]},"references-count":25,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2024,3,4]]}},"URL":"https:\/\/doi.org\/10.1001\/jamanetworkopen.2024.3854","relation":{},"ISSN":["2574-3805"],"issn-type":[{"value":"2574-3805","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,3,27]]}}}