{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T11:01:14Z","timestamp":1791975674853,"version":"4.4.0"},"reference-count":24,"publisher":"Springer Science and Business Media LLC","issue":"12","license":[{"start":{"date-parts":[[2025,11,22]],"date-time":"2025-11-22T00:00:00Z","timestamp":1763769600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,11,22]],"date-time":"2025-11-22T00:00:00Z","timestamp":1763769600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Kyowa Kirin Co., Ltd., Tokyo, Japan"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Support Care Cancer"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>We performed post-marketing surveillance of the safety and effectiveness of 3.6\u00a0mg pegfilgrastim to prevent chemotherapy-induced febrile neutropenia (FN) in real-world conditions in Japan.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients were registered between June 2015 and May 2017 and followed prospectively. Pegfilgrastim was administered once every chemotherapy cycle (maximum 6 cycles). Use of pegfilgrastim, safety, and effectiveness in reducing FN were evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>From 300 institutions, 1,597 patients were registered and 1,479 patients were analyzed. Pegfilgrastim was given as primary prophylaxis (750 patients), as secondary prophylaxis (727 patients), or for therapeutic purposes (2 patients). The most common primary diseases were breast cancer (51.4%) and non-Hodgkin lymphoma (25.6%). Adverse events (AEs) occurred in 36.4% of patients and adverse drug reactions (ADR) in 18.5%. Common ADRs included back pain (3.6%), pyrexia (3.1%), arthralgia (2.1%), hepatic function abnormal (1.5%), myalgia (1.4%), and bone pain (1.0%). All back and\/or bone pain-related ADRs were non-serious and well-controlled with non-steroidal anti-inflammatory drugs. Docetaxel-cyclophosphamide therapy among breast cancer patients was a factor influencing bone and\/or back pain-related AEs by multivariate logistic regression analysis (odds ratios vs. fluorouracil-epirubicin-cyclophosphamide therapy: 2.32, P\u2009=\u20090.031).<\/jats:p>\n                    <jats:p>FN was observed in 5.3% (primary prophylaxis) and 2.5% (secondary prophylaxis) of the effectiveness analysis set in cycle 1 and decreased with increasing cycles.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This survey confirmed that both primary and secondary prophylaxis using pegfilgrastim reduced FN in the real-world setting. No new safety concerns were identified.<\/jats:p>\n                    <jats:p>This survey was retrospectively registered on 26 April 2024 in the University Hospital Medical Information Network Clinical Trial Registry (UMIN000054267).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00520-025-10042-6","type":"journal-article","created":{"date-parts":[[2025,11,22]],"date-time":"2025-11-22T05:26:28Z","timestamp":1763789188000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["The safety and effectiveness of pegfilgrastim to reduce cancer chemotherapy-induced febrile neutropenia in real-world practice in Japan: a post-marketing surveillance study"],"prefix":"10.1007","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8647-5098","authenticated-orcid":false,"given":"Nobuhiro","family":"Shibata","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Kuwazawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoharu","family":"Yasukawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manabu","family":"Iwabuchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6732-8030","authenticated-orcid":false,"given":"Shigehira","family":"Saji","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,11,22]]},"reference":[{"key":"10042_CR1","doi-asserted-by":"publisher","first-page":"190","DOI":"10.1016\/j.critrevonc.2013.12.006","volume":"90","author":"GH Lyman","year":"2014","unstructured":"Lyman GH, Abella E, Pettengell R (2014) Risk factors for febrile neutropenia among patients with cancer receiving chemotherapy: a systematic review. 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Accessed 01 December 2024."}],"container-title":["Supportive Care in Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00520-025-10042-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00520-025-10042-6\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00520-025-10042-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,17]],"date-time":"2025-12-17T05:32:30Z","timestamp":1765949550000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00520-025-10042-6"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,22]]},"references-count":24,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["10042"],"URL":"https:\/\/doi.org\/10.1007\/s00520-025-10042-6","relation":{},"ISSN":["0941-4355","1433-7339"],"issn-type":[{"value":"0941-4355","type":"print"},{"value":"1433-7339","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,22]]},"assertion":[{"value":"12 March 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 October 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 November 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This survey was conducted in compliance with the Ministerial Ordinance on Post-Marketing Surveillance and Testing of Drugs (GPSP) in Japan (Ministry of Health, Labour and Welfare Ordinance No. 171 dated December 20, 2004) upon approval of the heads of each institution. All institutions that provided the data agreed for the survey results to be published.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"A post-marketing surveillance study is exempt from obtaining informed consent by the ordinance.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"NS received consulting fees for serving on the advisory board from Kyowa Kirin Co., Ltd. and Daiichi Sankyo Co., Ltd.; honoraria from Kyowa Kirin Co., Ltd., MSD K.K., Daiichi Sankyo Co., Ltd., Chugai Pharmaceutical Co., Ltd., Pfizer Japan Inc., Eisai Co., Ltd., Taiho Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Nippon Kayaku Co., Ltd., Merck Biopharma Co., Ltd., and Bristol-Myers Squibb K.K.; and research funding from Daiichi Sankyo Co., Ltd. MSD K.K., and AstraZeneca K.K. SS received lecture fees from Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., MSD K.K., Novartis Pharma K.K., Eisai Co., Ltd., Takeda Pharmaceutical Company Ltd., Daiichi Sankyo Co., Ltd., Eli Lilly Japan K.K., AstraZeneca K.K., Pfizer Japan Inc., Taiho Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., Gilead Sciences, Inc., Exact Sciences K.K. and research grants from Taiho Pharmaceutical Co., Ltd., Eisai Co., Ltd., Chugai Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Ltd., MSD K.K., AstraZeneca K.K., Daiichi Sankyo Co., Ltd., Gilead Sciences, Inc., Eli Lilly Japan K.K., Sanofi K.K.; had an advisory role for Chugai Pharmaceutical Co., Ltd., AstraZeneca K.K., Eli Lilly Japan K.K., Pfizer Japan Inc., Kyowa Kirin Co., Ltd., Daiichi Sankyo Co., Ltd., MSD K.K.; and was an executive board member of JBCRG (Japan Breast Cancer Research Group), JBCS (Japan Breast Cancer Society), JSMO (Japanese Society of Medical Oncology) and BIG (Breast International Group). HK, TY, and MI are employees of Kyowa Kirin Co., Ltd.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"1115"}}