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The primary efficacy endpoint was duration of severe neutropenia (<jats:styled-content style=\"fixed-case\">DSN<\/jats:styled-content>) during the first cycle of treatment. Patients who were candidates for adjuvant\/neoadjuvant <jats:styled-content style=\"fixed-case\">TC<\/jats:styled-content> chemotherapy were eligible for participation. <jats:styled-content style=\"fixed-case\">TC<\/jats:styled-content> was administered on Day 1, followed by 45, 135, or 270\u00a0<jats:italic>\u03bc<\/jats:italic>g\/kg Rolontis or 6\u00a0mg pegfilgrastim on Day 2. Complete blood counts were monitored daily when the absolute neutrophil count (<jats:styled-content style=\"fixed-case\">ANC<\/jats:styled-content>) fell to &lt;1.5\u00a0\u00d7\u00a010<jats:sup>9<\/jats:sup>\/L. Up to four cycles of <jats:styled-content style=\"fixed-case\">TC<\/jats:styled-content> were investigated. The difference in <jats:styled-content style=\"fixed-case\">DSN<\/jats:styled-content> (time from <jats:styled-content style=\"fixed-case\">ANC<\/jats:styled-content> &lt;0.5\u00a0\u00d7\u00a010<jats:sup>9<\/jats:sup>\/L to <jats:styled-content style=\"fixed-case\">ANC<\/jats:styled-content> recovery \u22652.0\u00a0\u00d7\u00a010<jats:sup>9<\/jats:sup>\/L) between the Rolontis and pegfilgrastim groups was \u22120.28\u00a0days (confidence interval [<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>]: \u22120.56, \u22120.06) at 270\u00a0<jats:italic>\u03bc<\/jats:italic>g\/kg, 0.14\u00a0days (<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>: \u22120.28, 0.64) at 135\u00a0<jats:italic>\u03bc<\/jats:italic>g\/kg, and 0.72\u00a0days (<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>: 0.19, 1.27) at 45\u00a0<jats:italic>\u03bc<\/jats:italic>g\/kg. Noninferiority to pegfilgrastim was demonstrated at 135\u00a0<jats:italic>\u03bc<\/jats:italic>g\/kg (<jats:italic>P\u00a0=\u00a0<\/jats:italic>0.002) and 270\u00a0<jats:italic>\u03bc<\/jats:italic>g\/kg (<jats:italic>P\u00a0<\/jats:italic>&lt;<jats:italic>\u00a0<\/jats:italic>.001), with superiority demonstrated at 270\u00a0<jats:italic>\u03bc<\/jats:italic>g\/kg (0.03\u00a0days; <jats:italic>P\u00a0=\u00a0<\/jats:italic>0.023). The most common treatment\u2010related adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s) were bone pain, myalgia, arthralgia, back pain, and elevated white blood cell counts, with similar incidences across groups. All doses of Rolontis were well tolerated, and no new or significant treatment\u2010related toxicities were observed. In Cycle 1, Rolontis demonstrated noninferiority at the 135\u00a0<jats:italic>\u03bc<\/jats:italic>g\/kg dose and statistical superiority in <jats:styled-content style=\"fixed-case\">DSN<\/jats:styled-content> at the 270\u00a0<jats:italic>\u03bc<\/jats:italic>g\/kg dose when compared to pegfilgrastim.<\/jats:p>","DOI":"10.1002\/cam4.1388","type":"journal-article","created":{"date-parts":[[2018,3,24]],"date-time":"2018-03-24T04:23:07Z","timestamp":1521865387000},"page":"1660-1669","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["An open\u2010label, dose\u2010ranging study of Rolontis, a novel long\u2010acting myeloid growth factor, in breast cancer"],"prefix":"10.1002","volume":"7","author":[{"given":"Jeffrey L.","family":"Vacirca","sequence":"first","affiliation":[{"name":"New York Cancer Specialists  East Setauket New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arlene","family":"Chan","sequence":"additional","affiliation":[{"name":"Breast Cancer Research Centre WA and Curtin University  Perth Western Australia Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kl\u00e1ra","family":"Mezei","sequence":"additional","affiliation":[{"name":"Szabolcs\u2010Szatm\u00e1r Bereg County Hospital and University Teaching Hospital  Ny\u00edregyh\u00e1za Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Clarence S.","family":"Adoo","sequence":"additional","affiliation":[{"name":"Arizona Center for Cancer Care  Glendale Arizona"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zsuzsanna","family":"P\u00e1pai","sequence":"additional","affiliation":[{"name":"State Health Center  Budapest Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kimberly","family":"McGregor","sequence":"additional","affiliation":[{"name":"Samaritan Hematology and Oncology Associates  Corvalis Oregon"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meena","family":"Okera","sequence":"additional","affiliation":[{"name":"Adelaide Cancer Centre  Kurralta Park South Australia Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zsolt","family":"Horv\u00e1th","sequence":"additional","affiliation":[{"name":"University of Debrecen  Debrecen Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L\u00e1szl\u00f3","family":"Landherr","sequence":"additional","affiliation":[{"name":"Uzsoki Hospital  Budapest Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jerzy","family":"Hanslik","sequence":"additional","affiliation":[{"name":"Szpital Rejonowy Dzienny Oddzial Chemioterapii  Raciborzu Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven J.","family":"Hager","sequence":"additional","affiliation":[{"name":"California Cancer Associates for Research and Excellence  Fresno California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emad N.","family":"Ibrahim","sequence":"additional","affiliation":[{"name":"Emad Ibrahim MD, Inc.  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