{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T15:36:23Z","timestamp":1792164983087,"version":"4.4.0"},"reference-count":4,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"12","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2024,4,20]]},"abstract":"<jats:p> Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. <\/jats:p><jats:p> The primary joint efficacy analysis of the Anthracyclines in Early Breast Cancer (ABC) trials reported in 2017 failed to demonstrate nonanthracycline adjuvant therapy was noninferior to anthracycline-based regimens in high-risk, early breast cancer. Full analyses of the studies had proceeded when the prespecified futility boundary was crossed at a planned futility analysis for the ability to demonstrate noninferiority of a nonanthracycline regimen with continued follow-up. These results were presented with 3.3 years of median follow-up. This manuscript reports results of the final analyses of the study efficacy end points conducted with 6.9 years of median follow-up. Long-term analysis of invasive disease-free survival (IDFS), the primary end point of the ABC trials, remains consistent with the original results, as noninferiority of the nonanthracycline regimens could not be declared on the basis of the original criteria. The secondary end point of recurrence-free interval, which excluded deaths not due to breast cancer as events, favored anthracycline-based regimens, and tests for heterogeneity were significant for hormone receptor status ( P = .02) favoring anthracycline regimens for the hormone receptor\u2013negative cohorts. There was no difference in overall survival, and review of the type of IDFS events in the groups suggested reductions in cancer recurrences achieved with anthracycline regimens were offset by late leukemias and deaths unrelated to breast cancer. <\/jats:p>","DOI":"10.1200\/jco.23.01428","type":"journal-article","created":{"date-parts":[[2024,2,9]],"date-time":"2024-02-09T21:01:11Z","timestamp":1707512471000},"page":"1344-1349","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":30,"title":["Long-Term Follow-Up of the Anthracyclines in Early Breast Cancer Trials (USOR 06-090, NSABP B-46-I\/USOR 07132, and NSABP B-49 [NRG Oncology])"],"prefix":"10.1200","volume":"42","clinical-trial-number":[{"clinical-trial-number":"nct00887536","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct00493870","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01547741","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2379-5702","authenticated-orcid":false,"suffix":"Jr","given":"Charles E.","family":"Geyer","sequence":"first","affiliation":[{"name":"NSABP Foundation\/NRG Oncology, Pittsburgh, PA"},{"name":"UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7951-6645","authenticated-orcid":false,"given":"Joanne L.","family":"Blum","sequence":"additional","affiliation":[{"name":"Baylor-Sammons Cancer Center, Texas Oncology, US Oncology Research, Dallas, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7965-7333","authenticated-orcid":false,"given":"Greg","family":"Yothers","sequence":"additional","affiliation":[{"name":"NRG Oncology SDMC, Department of Biostatistics, and University of Pittsburgh School of Public Health, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lina","family":"Asmar","sequence":"additional","affiliation":[{"name":"USOR, McKesson Specialty Health, The Woodlands, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6516-8021","authenticated-orcid":false,"given":"Patrick J.","family":"Flynn","sequence":"additional","affiliation":[{"name":"Minnesota Community Oncology Research Consortium (MSORC), Stone Lake, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8491-5392","authenticated-orcid":false,"given":"Nicholas J.","family":"Robert","sequence":"additional","affiliation":[{"name":"Ontada, Irving, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9829-1242","authenticated-orcid":false,"given":"Judith O.","family":"Hopkins","sequence":"additional","affiliation":[{"name":"Novant Health (Forsyth Medical) Cancer Institute, Southeast Clinical Oncology Research (SCOR) NCORP, Winston Salem, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joyce A.","family":"O'Shaughnessy","sequence":"additional","affiliation":[{"name":"Baylor University Medical Center, Texas Oncology, US Oncology Research, Dallas, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6179-6407","authenticated-orcid":false,"given":"Priya","family":"Rastogi","sequence":"additional","affiliation":[{"name":"NSABP Foundation\/NRG Oncology, Pittsburgh, PA"},{"name":"UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA"},{"name":"UPMC Magee-Womens Hospital, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shannon L.","family":"Puhalla","sequence":"additional","affiliation":[{"name":"NSABP Foundation\/NRG Oncology, Pittsburgh, PA"},{"name":"UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christie J.","family":"Hilton","sequence":"additional","affiliation":[{"name":"NSABP Foundation\/NRG Oncology, Pittsburgh, PA"},{"name":"Allegheny Health Network, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chau T.","family":"Dang","sequence":"additional","affiliation":[{"name":"Memorial Sloan Kettering Cancer Center, West Harrison, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4234-4448","authenticated-orcid":false,"given":"Henry Leonidas","family":"G\u00f3mez","sequence":"additional","affiliation":[{"name":"National Institute of Neoplastic Diseases, Lima, Peru"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Svetislava J.","family":"Vukelja","sequence":"additional","affiliation":[{"name":"US Oncology Tyler Cancer Center, Tyler, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan P.","family":"Lyss","sequence":"additional","affiliation":[{"name":"Heartland Cancer Research NCORP-Missouri Baptist Medical Center, St Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Devchand","family":"Paul","sequence":"additional","affiliation":[{"name":"USOR, McKesson Specialty Health, The Woodlands, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8080-7960","authenticated-orcid":false,"given":"Adam M.","family":"Brufsky","sequence":"additional","affiliation":[{"name":"UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA"},{"name":"UPMC Magee-Womens Hospital, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda H.","family":"Colangelo","sequence":"additional","affiliation":[{"name":"NRG Oncology SDMC, Department of Biostatistics, and University of Pittsburgh School of Public Health, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1320-3830","authenticated-orcid":false,"given":"Sandra M.","family":"Swain","sequence":"additional","affiliation":[{"name":"NSABP Foundation\/NRG Oncology, Pittsburgh, PA"},{"name":"Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, MedStar Health, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9476-2553","authenticated-orcid":false,"given":"Eleftherios P.","family":"Mamounas","sequence":"additional","affiliation":[{"name":"NSABP Foundation\/NRG Oncology, Pittsburgh, PA"},{"name":"Orlando Health Cancer Institute, Orlando, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7156-1110","authenticated-orcid":false,"given":"Norman","family":"Wolmark","sequence":"additional","affiliation":[{"name":"NSABP Foundation\/NRG Oncology, Pittsburgh, PA"},{"name":"UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"b1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2016.71.4147"},{"key":"b2","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1958.10501452"},{"key":"b3","doi-asserted-by":"publisher","DOI":"10.1002\/0471249688"},{"key":"b4","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(23)00285-4"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.23.01428","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,4,17]],"date-time":"2024-04-17T22:01:36Z","timestamp":1713391296000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.23.01428"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4,20]]},"references-count":4,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2024,4,20]]}},"alternative-id":["10.1200\/JCO.23.01428"],"URL":"https:\/\/doi.org\/10.1200\/jco.23.01428","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,4,20]]},"assertion":[{"value":"2023-07-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-10-03","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-12-07","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-02-09","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}