{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T21:58:43Z","timestamp":1790373523015,"version":"4.1.0"},"reference-count":6,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T00:00:00Z","timestamp":1790294400000},"content-version":"vor","delay-in-days":16,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"National Institutes of Health\/National Cancer Institute","award":["P30CA016672"],"award-info":[{"award-number":["P30CA016672"]}]},{"name":"Andrew Sabin Family Foundation Fellowship","id":[{"id":"https:\/\/ror.org\/02h7p8r46","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,9,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Designing phase III oncology trials to demonstrate overall survival (OS) superiority may be challenging due to sample size, follow-up time, resources, and costs as compared to trials evaluating intermediate endpoints, which may or may not be reliable surrogates of OS. In this study, we investigate at scale the relative gains in OS achieved in modern phase III oncology trials using OS primary endpoints in OPTIMA, a prospectively registered, pre-specified meta-analysis leveraging a large assembly of reconstructed individual patient-level data (PROSPERO: CRD420251162778). After screening 1184 trials and excluding 937 without an OS primary endpoint, 159 trials enrolling 104\u2009740 patients met the inclusion criteria. In the two-stage Cox model, randomization to the experimental arm was associated with improvement in OS (random effects HR, 0.87; 95% CI, 0.85\u20130.89; P\u2009&amp;lt;\u2009.0001). In the one-stage Cox model stratified by trial identity, OS was also longer with the experimental arm (HR, 0.88; 95% CI, 0.85\u20130.90; P\u2009&amp;lt;\u2009.0001). Taken together, the data from OPTIMA should encourage renewed enthusiasm among trialists, funders, regulatory agencies, and policymakers for prioritizing phase III oncology trials evaluating OS primary endpoints.<\/jats:p>","DOI":"10.1093\/oncolo\/oyag157","type":"journal-article","created":{"date-parts":[[2026,4,22]],"date-time":"2026-04-22T11:51:49Z","timestamp":1776858709000},"source":"Crossref","is-referenced-by-count":0,"title":["Overall survival in oncology phase III trials: an individual patient level meta-analysis (OPTIMA)"],"prefix":"10.1093","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5115-1691","authenticated-orcid":false,"given":"Alexander D","family":"Sherry","sequence":"first","affiliation":[{"name":"Department of Radiation Oncology, Mayo Clinic , Rochester, MN 55905,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-2061-1633","authenticated-orcid":false,"given":"Noah","family":"Meimoun","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center , Houston, TX 77030,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-4072-1442","authenticated-orcid":false,"given":"Avital M","family":"Miller","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center , Houston, TX 77030,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center , Houston, TX 77030,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimi","family":"Chauhan","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Mayo Clinic , Rochester, MN 55905,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1521-0495","authenticated-orcid":false,"given":"Ramez","family":"Kouzy","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center , Houston, TX 77030,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4183-9120","authenticated-orcid":false,"given":"Timothy A","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center , Houston, TX 77030,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6505-8308","authenticated-orcid":false,"given":"Pavlos","family":"Msaouel","sequence":"additional","affiliation":[{"name":"Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center , Houston, TX 77030,","place":["United States"]},{"name":"Department of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center , Houston, TX 77030,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5472-5344","authenticated-orcid":false,"given":"Ethan B","family":"Ludmir","sequence":"additional","affiliation":[{"name":"Department of Gastrointestinal Radiation Oncology, The University of Texas MD Anderson Cancer Center , Houston, TX 77030,","place":["United States"]},{"name":"Department of Biostatistics, The University of Texas MD Anderson Cancer Center , Houston, TX 77030,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,9,25]]},"reference":[{"key":"2026092517012094300_oyag157-B1","doi-asserted-by":"publisher","first-page":"728","DOI":"10.1001\/jamaoncol.2021.0379","article-title":"Evolution of the randomized clinical trial in the era of precision oncology","volume":"7","author":"Del Paggio","year":"2021","journal-title":"JAMA Oncol"},{"key":"2026092517012094300_oyag157-B2","doi-asserted-by":"publisher","first-page":"718","DOI":"10.1001\/jamaoncol.2025.1002","article-title":"Overall survival and quality-of-life superiority in modern phase 3 oncology trials: a meta-epidemiological analysis","volume":"11","author":"Sherry","year":"2025","journal-title":"JAMA Oncol"},{"key":"2026092517012094300_oyag157-B3","doi-asserted-by":"publisher","first-page":"1554","DOI":"10.1001\/jamaoncol.2025.4346","article-title":"Rethinking end points in modern oncology 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curves","volume":"12","author":"Guyot","year":"2012","journal-title":"BMC Med Res Methodol"}],"container-title":["The 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