{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T08:49:06Z","timestamp":1791535746398,"version":"4.3.4"},"reference-count":38,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T00:00:00Z","timestamp":1788912000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,10,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>(Neo)adjuvant systemic treatments aim to improve overall survival by reducing recurrence risk; however, there can be challenges, such as reliance on surrogate endpoints, censoring, loss to follow-up, and impact on quality of life. We examine the design, reporting, and outcomes of US Food and Drug Administration\u2013approved drugs for solid tumors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We searched Food and Drug Administration (neo)adjuvant approvals for solid tumors 2010-2023 with time-to-event endpoints. Trial characteristics, endpoints, and censoring were evaluated descriptively. Statistical designs and sample size calculations were assessed for reproducibility and transparency.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 24 studies supporting 25 approvals met inclusion criteria. Common tumor types included melanoma (7 of 24, 29%), breast (6 of 24, 25%), and non-small cell lung cancer (6 of 24, 25%). Among 21 trials reporting overall survival, 52% (11 of 21) showed benefit at any time, but only 36% (4 of 11) reported overall survival benefits at the time of approval and\/or primary publication. In 21 (88%) trials the expected number of events could be reproduced, in 11 (46%) trials sample size calculations could be attempted (though calculations often differed), and only 14 (58%) stated expected absolute numerical outcomes. Censoring rules were applied inconsistently; only 36% defined rules adequately. Quality-of-life outcomes were reported in 79%, with 31% reporting clinically meaningful declines in one or more domains.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>(Neo)adjuvant trials often lack transparency in sample size justifications and censoring rules. Approximately half demonstrated an overall survival improvement at any time, and one-third showed a decline in quality of life. Greater standardization in trial designs and reporting is needed to ensure trials align with patient and health-care priorities.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jnci\/djag133","type":"journal-article","created":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T11:39:47Z","timestamp":1788867587000},"page":"1963-1970","source":"Crossref","is-referenced-by-count":0,"title":["(Neo)adjuvant approvals for solid tumors by the US Food and Drug Administration 2010-2023"],"prefix":"10.1093","volume":"118","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1510-2355","authenticated-orcid":false,"given":"Consolacion Molto","family":"Valiente","sequence":"first","affiliation":[{"name":"Department of Oncology, R. S. 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Ontario,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8356-0019","authenticated-orcid":false,"given":"Janet","family":"Dancey","sequence":"additional","affiliation":[{"name":"Canadian Cancer Trials Group, Queen\u2019s University , Kingston, Ontario,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7444-8594","authenticated-orcid":false,"given":"Bishal","family":"Gyawali","sequence":"additional","affiliation":[{"name":"Department of Oncology, Queen\u2019s University , Kingston, Ontario,","place":["Canada"]},{"name":"Division of Cancer Care and Epidemiology, Queen\u2019s Cancer Research Institute , Kingston,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1505-0575","authenticated-orcid":false,"given":"Christopher 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