{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T09:12:20Z","timestamp":1791623540799,"version":"4.3.4"},"reference-count":22,"publisher":"Wiley","issue":"20","license":[{"start":{"date-parts":[[2023,10,12]],"date-time":"2023-10-12T00:00:00Z","timestamp":1697068800000},"content-version":"vor","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Pegfilgrastim is indicated to decrease the incidence of chemotherapy\u2010induced febrile neutropenia. It is the first granulocyte\u2010colony stimulating factor approved for prophylactic use regardless of carcinoma type and is marketed in Japan as G\u2010LASTA (Kyowa Kirin Co., Ltd., Tokyo, Japan). MD\u2010110 is a biosimilar of pegfilgrastim. This phase III, multicenter, open\u2010label, single\u2010arm study investigated the efficacy and safety of MD\u2010110 in early\u2010stage breast cancer patients receiving neoadjuvant or adjuvant myelosuppressive chemotherapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A total of 101 patients received the study drug. Each patient received docetaxel 75 mg\/m<jats:sup>2<\/jats:sup> and cyclophosphamide 600 mg\/m<jats:sup>2<\/jats:sup> (TC) for four cycles on day 1 of each cycle. MD\u2010110 (3.6\u2009mg) was administered subcutaneously on day 2 of each cycle. The primary efficacy endpoint was the duration of severe neutropenia during cycle 1 (days with absolute neutrophil count &lt; 500\/mm<jats:sup>3<\/jats:sup>). The safety endpoints were adverse events and the presence of antidrug antibodies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The mean (SD) duration of severe neutropenia for MD\u2010110 was 0.2 (0.4) days. The upper limit of the two\u2010sided 95% confidence interval for the mean duration of severe neutropenia was 0.2\u2009days, below the predefined threshold of 3.0\u2009days. The incidence of febrile neutropenia, the secondary efficacy endpoint, was 6.9% (7\/101). Adverse events, occurring in more than 50% of patients, were alopecia, constipation, and malaise, which are common side effects of TC chemotherapy. Antidrug antibodies were negative in all patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>MD\u2010110 was effective against chemotherapy\u2010induced neutropenia. No additional safety concern, compared with the originator, was observed in patients with breast cancer receiving TC chemotherapy.(JapicCTI\u2010205230).<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.6519","type":"journal-article","created":{"date-parts":[[2023,10,12]],"date-time":"2023-10-12T16:54:30Z","timestamp":1697129670000},"page":"20242-20250","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Efficacy and safety of pegfilgrastim biosimilar <scp>MD<\/scp>\u2010110 in patients with breast cancer receiving chemotherapy: Single\u2010arm phase <scp>III<\/scp>"],"prefix":"10.1002","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8417-5291","authenticated-orcid":false,"given":"Toshimi","family":"Takano","sequence":"first","affiliation":[{"name":"Breast Medical Oncology The Cancer Institute Hospital of Japanese Foundation for Cancer Research  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitsuya","family":"Ito","sequence":"additional","affiliation":[{"name":"Department of Breast Surgery Hiroshima City Hiroshima Citizens Hospital  Hiroshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1835-1266","authenticated-orcid":false,"given":"Takayuki","family":"Kadoya","sequence":"additional","affiliation":[{"name":"Department of Breast Surgery Hiroshima University Hospital  Hiroshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8449-7170","authenticated-orcid":false,"given":"Tomofumi","family":"Osako","sequence":"additional","affiliation":[{"name":"Breast Center Kumamoto Shinto General Hospital  Kumamoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3442-8972","authenticated-orcid":false,"given":"Tomoyuki","family":"Aruga","sequence":"additional","affiliation":[{"name":"Department of Breast Surgery Tokyo Metropolitan Center and Infectious Diseases Center Komagome Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7302-0278","authenticated-orcid":false,"given":"Norikazu","family":"Masuda","sequence":"additional","affiliation":[{"name":"Department of Surgery, Breast Oncology National Hospital Organization Osaka National Hospital  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiko","family":"Miyaki","sequence":"additional","affiliation":[{"name":"Department of Breast Surgery Chiba Cancer Center  Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6732-8527","authenticated-orcid":false,"given":"Naoki","family":"Niikura","sequence":"additional","affiliation":[{"name":"Department of Breast Oncology Tokai University Hospital  Isehara Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisuke","family":"Shimizu","sequence":"additional","affiliation":[{"name":"Breast Center Yokohama City Minato Red Cross Hospital  Yokohama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuichi","family":"Yokoyama","sequence":"additional","affiliation":[{"name":"Mochida Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manabu","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Mochida Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masato","family":"Tomomitsu","sequence":"additional","affiliation":[{"name":"Mochida Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8147-8062","authenticated-orcid":false,"given":"Kenjiro","family":"Aogi","sequence":"additional","affiliation":[{"name":"Department of Breast Surgery National Hospital Organization Shikoku Cancer Center  Matsuyama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,10,12]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdw325"},{"key":"e_1_2_11_3_1","volume-title":"Japanese Society of Medical Oncology. 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