{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,17]],"date-time":"2026-01-17T09:12:59Z","timestamp":1768641179508,"version":"3.49.0"},"reference-count":22,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"8","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO Global Oncology"],"published-print":{"date-parts":[[2022,5]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p> This study evaluated the efficacy, safety, and immunogenicity of biosimilar pegfilgrastim (PegFilBS) and originator pegfilgrastim (PegFilOR) in patients with stage 2-4 breast cancer. <\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p> This phase III randomized, multicenter, evaluator-blinded, noninferiority study recruited women with stage 2-4 breast cancer in Argentina who were scheduled to receive chemotherapy. Stratification was based on the breast cancer stage. The primary end point was the duration of severe neutropenia (DSN, noninferiority margin: 1 day) in the first chemotherapy cycle. Secondary end points assessed were incidence of severe neutropenia, grade 3 neutropenia, febrile neutropenia, infections, postchemotherapy hospitalization and duration, and the incidence of adverse drug reactions (ADRs). <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> A total of 120 patients were randomly assigned to receive PegFilBS (58 patients) or PegFilOR (62 patients). Severe neutropenia occurred in 52 of 283 cycles (18.4%) for 27 patients who received PegFilBS and in 48 of 297 cycles (16.2%) for 20 patients who received PegFilOR ( P = .48). During the first cycle, severe neutropenia occurred in 16 patients who received PegFilBS (DSN: 0.78 \u00b1 1.53 days) and in 11 patients who received PegFilOR (DSN: 0.53 \u00b1 1.25 days; 95% CI, \u20130.26 to 0.76 days). In the intention-to-treat analysis, the mean DSN values were 0.90 \u00b1 1.79 days for the PegFilBS group and 0.50 \u00b1 1.21 for the PegFilOR group (95% CI, \u20130.15 to 0.95 days). No significant differences were observed for the secondary efficacy end points. Three patients experienced seven ADRs in the PegFilBS group while 10 patients experienced 31 ADRs in the PegFilOR group. The most common ADR was myalgia. <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p> Relative to PegFilOR, PegFilBS provided noninferior efficacy outcomes in Argentinian women with stage 2-4 breast cancer who were treated using myelosuppressive chemotherapy. <\/jats:p><\/jats:sec>","DOI":"10.1200\/go.21.00276","type":"journal-article","created":{"date-parts":[[2022,3,25]],"date-time":"2022-03-25T00:02:06Z","timestamp":1648166526000},"update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":2,"title":["Biosimilar Versus Originator Pegfilgrastim for Preventing Chemotherapy-Induced Neutropenia: A Phase III Randomized, Multicenter, Evaluator-Blinded, Noninferiority Study"],"prefix":"10.1200","author":[{"given":"Ruben D.","family":"Kowalyszyn","sequence":"first","affiliation":[{"name":"Centro De Investigaciones Cl\u00ednicas Cl\u00ednica Viedma S A, Viedma, Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luis E.","family":"Fein","sequence":"additional","affiliation":[{"name":"Instituto Oncol\u00f3gico de Rosario, Rosario, Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin E.","family":"Richardet","sequence":"additional","affiliation":[{"name":"Sanatorio Aconcagua, C\u00f3rdoba, Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0135-3479","authenticated-orcid":false,"given":"Mirta S.","family":"Varela","sequence":"additional","affiliation":[{"name":"COIBA, Berazategui, Buenos Aires, Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eduardo","family":"Ortiz","sequence":"additional","affiliation":[{"name":"Centro Oncol\u00f3gico Infinito, Santa Rosa, La Pampa, Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristian","family":"Micheri","sequence":"additional","affiliation":[{"name":"Instituto de Oncol\u00f3gico de Rosario, Rosario, Santa F\u00e9, Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juan J.","family":"Zarba","sequence":"additional","affiliation":[{"name":"Centro Medico San Roque, Tucum\u00e1n, Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susana","family":"Kahl","sequence":"additional","affiliation":[{"name":"Centro Investigaci\u00f3n Pergamino, Pergamino, Buenos Aires, Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3782-0929","authenticated-orcid":false,"given":"Ezequiel","family":"Klimovsky","sequence":"additional","affiliation":[{"name":"QUID LATAM Consulting SRL, CABA, Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea A.","family":"Federico","sequence":"additional","affiliation":[{"name":"QUID LATAM Consulting SRL, CABA, Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jorge H.","family":"Cassini","sequence":"additional","affiliation":[{"name":"Hospital Aeronautico Central, CABA, Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gustavo","family":"Cortese","sequence":"additional","affiliation":[{"name":"Hospital de Cl\u00ednicas \u201cJos\u00e9 de San Mart\u00edn,\u201d CABA, Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7633-8687","authenticated-orcid":false,"given":"Nestor","family":"Lago","sequence":"additional","affiliation":[{"name":"Gema Biotech SAU, CABA, Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"233","reference":[{"key":"b1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.21847"},{"key":"b2","volume-title":"Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. Guidance on Similar Medicinal Products Containing Recombinant Granulocyte-Colony Stimulating Factor. EMEA\/CHMP\/BMWP\/31329\/2005","author":"Committee for Medicinal Products for Human Use (CHMP)","year":"2006"},{"key":"b3","doi-asserted-by":"publisher","DOI":"10.1084\/jem.165.4.941"},{"key":"b4","doi-asserted-by":"publisher","DOI":"10.1126\/science.2420009"},{"key":"b5","doi-asserted-by":"publisher","DOI":"10.1038\/332647a0"},{"key":"b6","doi-asserted-by":"publisher","DOI":"10.1016\/0006-291X(87)91430-6"},{"key":"b7","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2006.06.4451"},{"key":"b8","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdq195"},{"key":"b9","volume-title":"NCCN Guidelines Version 1.2011 Myeloid Growth Factors","author":"Crawford J","year":"2011"},{"key":"b10","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-011-1375-6"},{"key":"b11","doi-asserted-by":"publisher","DOI":"10.1007\/s10549-015-3531-z"},{"key":"b12","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2015.0118"},{"key":"b13","doi-asserted-by":"publisher","DOI":"10.1002\/cam4.454"},{"key":"b14","volume-title":"WHO Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)","author":"World Health Organization","year":"2009"},{"key":"b15","doi-asserted-by":"publisher","DOI":"10.1111\/1756-185X.13461"},{"key":"b17","doi-asserted-by":"publisher","DOI":"10.6061\/clinics\/2016(10)06"},{"key":"b18","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejbt.2016.10.003"},{"key":"b19","volume-title":"ANMAT Resolution 7729\/11. Regulation for Biosimilar Products. ANMAT, Minister of Health, Buenos Aires, Argentina, 2011"},{"key":"b20","volume-title":"Assessment Report Fulphila. Procedure No. EMEA\/H\/C\/004915\/0000 EMEA","author":"Committee for Medicinal Products for Human Use","year":"2018"},{"key":"b21","volume-title":"Assessment Report Ziextenzo Procedure No. EMEA\/H\/C\/004802\/0000 EMA\/706001\/2018","author":"Committee for Medicinal Products for Human Use","year":"2018"},{"key":"b22","volume-title":"Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-clinical and Clinical Issues","author":"Committee for Medicinal Products for Human Use (CHMP)","year":"2014"},{"key":"b23","unstructured":"US Department of Health and Human Services, Food and Drugs Administration: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product Guidance for Industry. Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Silver Spring, MD, 2015"}],"container-title":["JCO Global Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/GO.21.00276","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,29]],"date-time":"2022-05-29T11:02:01Z","timestamp":1653822121000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/GO.21.00276"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,5]]},"references-count":22,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2022,5]]}},"alternative-id":["10.1200\/GO.21.00276"],"URL":"https:\/\/doi.org\/10.1200\/go.21.00276","relation":{},"ISSN":["2687-8941"],"issn-type":[{"value":"2687-8941","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,5]]},"assertion":[{"value":"2021-07-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-12-05","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-02-05","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-03-24","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e2100276"}}