{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T04:21:55Z","timestamp":1790050915136,"version":"4.0.1"},"reference-count":29,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2024,1,9]],"date-time":"2024-01-09T00:00:00Z","timestamp":1704758400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,1,9]],"date-time":"2024-01-09T00:00:00Z","timestamp":1704758400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Support Care Cancer"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>Evaluate the safety and efficacy of efbemalenograstim alfa for neutrophil support in breast cancer patients undergoing myelosuppressive chemotherapy in a phase 2, dose-finding, open-label study (NCT01648322, ClinicalTrials.gov, 2012\u201307-19).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>232 patients received up to 4 cycles of chemotherapy, 141 patients with docetaxel\u2009+\u2009cyclophosphamide (TC) and 91 patients with docetaxel\u2009+\u2009doxorubicin\u2009+\u2009cyclophosphamide (TAC). Patients were randomized to efbemalenograstim alfa (80, 240, or 320\u00a0\u00b5g\/kg [TC]; 240\u00a0or 320\u00a0\u00b5g\/kg [TAC]) or pegfilgrastim (6\u00a0mg) on Day 2 of each cycle.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Efbemalenograstim alfa was non-inferior to pegfilgrastim in duration of moderate and severe neutropenia (absolute neutrophil count [ANC]\u2009&lt;\u20091.0\u2009\u00d7\u200910<jats:sup>9<\/jats:sup>\/L) in TAC Cycle 1 (mean [SD] of 2.1 [1.58] and 2.1 [1.46] days for 240\u00a0\u00b5g\/kg and 320\u00a0\u00b5g\/kg efbemalenograstim alfa, respectively, and 1.8 [1.28] days for pegfilgrastim), with a difference (95% CI) of 0.3 (-0.4, 1.1) days. ANC nadir occurred between Days 7\u20138 of TAC Cycle 1, with mean [SD] of 0.68 [1.064], 0.86 [1.407] and 0.78[1.283]\u2009\u00d7\u200910<jats:sup>9<\/jats:sup>\/L for 240\u00a0\u00b5g\/kg, 320\u00a0\u00b5g\/kg efbemalenograstim alfa and pegfilgrastim, respectively. Time to ANC recovery post nadir (defined as an ANC\u2009&gt;\u20092.0\u2009\u00d7\u200910<jats:sup>9<\/jats:sup>\/L after the expected ANC nadir) was 2.0\u20132.4 and 1.9\u00a0days for TAC patients treated with efbemalenograstim alfa and pegfilgrastim, respectively. No significant difference was found between any dose of efbemalenograstim alfa and pegfilgrastim in TAC Cycle 1 for incidence of moderate to severe neutropenia (76%-77% of patients) or incidence of severe neutropenia (ANC\u2009&lt;\u20090.5\u2009\u00d7\u200910<jats:sup>9<\/jats:sup>\/L; 63%-72%). Efbemalenograstim alfa exhibited similar safety profile to pegfilgrastim. Febrile neutropenia occurred in 4 (1.8%) patients, 2 patients each for 320\u00a0\u00b5g\/kg efbemalenograstim alfa and pegfilgrastim, with no event considered related to study drug.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Efbemalenograstim alfa was comparable to pegfilgrastim in efficacy and safety.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>ClinicalTrials.gov identifier<\/jats:title>\n                <jats:p>NCT01648322.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00520-023-08260-x","type":"journal-article","created":{"date-parts":[[2024,1,9]],"date-time":"2024-01-09T06:02:33Z","timestamp":1704780153000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Efbemalenograstim alfa not inferior to pegfilgrastim in providing neutrophil support in women with breast cancer undergoing myelotoxic chemotherapy: results of a phase 2 randomized, multicenter, open-label trial"],"prefix":"10.1007","volume":"32","author":[{"given":"John","family":"Glaspy","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Igor","family":"Bondarenko","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dmitrii","family":"Krasnozhon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dean","family":"Rutty","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianmin","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanyan","family":"Fu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shufang","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qingsong","family":"Hou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,1,9]]},"reference":[{"key":"8260_CR1","doi-asserted-by":"publisher","first-page":"404","DOI":"10.1186\/1471-2407-11-404","volume":"11","author":"KL Cooper","year":"2011","unstructured":"Cooper KL, Madan J, Whyte S, Stevenson MD, Akehurst RL (2011) Granulocyte colony-stimulating factors for febrile neutropenia prophylaxis following chemotherapy: systematic review and meta-analysis. 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