{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T09:12:22Z","timestamp":1791623542764,"version":"4.3.4"},"reference-count":14,"publisher":"Korean Cancer Association","issue":"3","license":[{"start":{"date-parts":[[2023,1,19]],"date-time":"2023-01-19T00:00:00Z","timestamp":1674086400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/3.0\/"}],"content-domain":{"domain":["e-crt.org"],"crossmark-restriction":true},"short-container-title":["Cancer Res Treat"],"published-print":{"date-parts":[[2023,7,15]]},"abstract":"<jats:p>Purpose We investigated the consistent efficacy and safety of eflapegrastim, a novel long-acting granulocyte-colony stimulating factor (G-CSF), in Koreans and Asians compared with the pooled population of two global phase 3 trials.Materials and Methods Two phase 3 trials (ADVANCE and RECOVER) evaluated the efficacy and safety of fixed-dose eflapegrastim (13.2 mg\/0.6 mL [3.6 mg G-CSF equivalent]) compared to pegfilgrastim (6 mg based on G-CSF) in breast cancer patients who received neoadjuvant or adjuvant docetaxel\/cyclophosphamide. The primary objective was to demonstrate non-inferiority of eflapegrastim compared to pegfilgrastim in mean duration of severe neutropenia (DSN) in cycle 1, in Korean and Asian subpopulations.Results Among a total of 643 patients randomized to eflapegrastim (n=314) or pegfilgrastim (n=329), 54 Asians (29 to eflapegrastim and 25 to pegfilgrastim) including 28 Koreans (14 to both eflapegrastim and pegfilgrastim) were enrolled. The primary endpoint, DSN in cycle 1 in the eflapegrastim arm was non-inferior to the pegfilgrastim arm in Koreans and Asians. The DSN difference between the eflapegrastim and pegfilgrastim arms was consistent across populations: \u20130.120 days (95% confidence interval [CI], \u20130.227 to \u20130.016), \u20130.288 (95% CI, \u20130.714 to 0.143), and \u20130.267 (95% CI, \u20130.697 to 0.110) for pooled population, Koreans and Asians, respectively. There were few treatment-related adverse events that caused discontinuation of eflapegrastim (1.9%) or pegfilgrastim (1.5%) in total and no notable trends or differences across patient populations.Conclusion This study may suggest that eflapegrastim showed non-inferior efficacy and similar safety compared to pegfilgrastim in Koreans and Asians, consistently with those of pooled population.<\/jats:p>","DOI":"10.4143\/crt.2022.987","type":"journal-article","created":{"date-parts":[[2023,1,19]],"date-time":"2023-01-19T00:58:46Z","timestamp":1674089926000},"page":"766-777","update-policy":"https:\/\/doi.org\/10.4143\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Eflapegrastim versus Pegfilgrastim for Chemotherapy-Induced Neutropenia in Korean and Asian Patients with Early Breast Cancer: Results from the Two Phase III ADVANCE and RECOVER Studies"],"prefix":"10.4143","volume":"55","author":[{"given":"Yong 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Treatment"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/e-crt.org\/upload\/pdf\/crt-2022-987.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/e-crt.org\/journal\/view.php?doi=10.4143\/crt.2022.987","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/e-crt.org\/upload\/pdf\/crt-2022-987.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,25]],"date-time":"2023-08-25T04:17:50Z","timestamp":1692937070000},"score":1,"resource":{"primary":{"URL":"http:\/\/e-crt.org\/journal\/view.php?doi=10.4143\/crt.2022.987"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,7,15]]},"references-count":14,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2023,7]]}},"URL":"https:\/\/doi.org\/10.4143\/crt.2022.987","relation":{},"ISSN":["1598-2998","2005-9256"],"issn-type":[{"value":"1598-2998","type":"print"},{"value":"2005-9256","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,7,15]]},"assertion":[{"value":"2022-08-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication 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