{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T07:52:54Z","timestamp":1740124374923,"version":"3.37.3"},"reference-count":24,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2018,11,23]],"date-time":"2018-11-23T00:00:00Z","timestamp":1542931200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"TEVA GmbH, Germany"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["European J of Haematology"],"published-print":{"date-parts":[[2019,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>The prospective non\u2010interventional study (NIS) NADIR was designed to evaluate both effectiveness and safety of prophylactic use of lipegfilgrastim (Lonquex<jats:sup>\u00ae<\/jats:sup>), a glycopegylated granulocyte colony\u2010stimulating factor, in cancer patients with different tumor entities undergoing chemotherapy in routine clinical practice. The primary objective was incidence of severe neutropenia, febrile neutropenia (FN), and neutropenia\u2010associated complications.<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>NADIR was a national, multicenter, prospective NIS.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Here, we present the data on patients with non\u2010Hodgkin lymphoma (NHL). Final analysis comprised 337 NHL patients having received \u22651 administration of lipegfilgrastim. Primary prophylaxis with lipegfilgrastim was documented in 78.7% of patients with high risk to develop FN. In total, \u22651 severe neutropenia (grade 3\/4) was reported in 115 (34.1%) patients and \u22651 event of FN documented in 15 (4.5%) patients. Grade 3\/4 infections were reported in 22 (6.5%) patients overall. Most frequently reported adverse events (AEs) related to lipegfilgrastim in total were bone pain (5.4%), leukocytosis (2.1%), back pain (1.8%), platelet count decreased (1.2%), and myalgia (1.2%). Fatal serious AEs were documented in 9 (2.7%) patients; none were attributable to lipegfilgrastim.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Prophylaxis or therapeutic intention with lipegfilgrastim in NHL patients in routine clinical practice showed similar effectiveness and safety as demonstrated in the pivotal trials.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ejh.13189","type":"journal-article","created":{"date-parts":[[2018,10,22]],"date-time":"2018-10-22T22:03:17Z","timestamp":1540245797000},"page":"174-181","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Prophylaxis of chemotherapy\u2010induced neutropenia and febrile neutropenia with lipegfilgrastim in patients with non\u2010Hodgkin lymphoma (NADIR study)"],"prefix":"10.1111","volume":"102","author":[{"given":"Thomas","family":"Wolff","sequence":"first","affiliation":[{"name":"Outpatient Center for Oncology Lerchenfeld Hamburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Holger","family":"Schulz","sequence":"additional","affiliation":[{"name":"Outpatient Center for Internal Oncology and Hematology Frechen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christoph","family":"Losem","sequence":"additional","affiliation":[{"name":"Outpatient Center for Hematology and Oncology Neuss Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dietmar","family":"Reichert","sequence":"additional","affiliation":[{"name":"Outpatient Center for Oncology Westerstede Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hans\u2010J\u00fcrgen","family":"Hurtz","sequence":"additional","affiliation":[{"name":"Outpatient Center for Internal Medicine, Hematology, Oncology and Gastroenterology Halle Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Reiner","family":"Sandner","sequence":"additional","affiliation":[{"name":"Outpatient Center for Internal Medicine, Oncology and Internal Hematology Passau Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Johanna","family":"Harde","sequence":"additional","affiliation":[{"name":"iOMEDICO AG  Freiburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sina","family":"Grebhardt","sequence":"additional","affiliation":[{"name":"iOMEDICO AG  Freiburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1015-9624","authenticated-orcid":false,"given":"Karin","family":"Potthoff","sequence":"additional","affiliation":[{"name":"iOMEDICO AG  Freiburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Udo","family":"Mueller","sequence":"additional","affiliation":[{"name":"TEVA GmbH Ulm Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Fietz","sequence":"additional","affiliation":[{"name":"Outpatient Center for Hematology, Oncology and Gastroenterology Singen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,11,23]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdq196"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdw325"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2010.10.013"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2407-11-404"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2008.11.021"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2407-13-11"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-010-0816-y"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdt226"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10549-016-3954-1"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.11827"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2002-10-3238"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2407-10-642"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-012-1589-2"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-016-3468-8"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2407-13-386"},{"key":"e_1_2_7_17_1","doi-asserted-by":"crossref","unstructured":"VolovatC BondarenkoIM GladkovOA Els\u00e4sserR BuchnerA BiasPet al.Phase III randomized double\u2010blind placebo\u2010controlled multicenter study of lipegfilgrastim in patients with non\u2010small cell lung cancer receiving myelosuppressive therapy. SpringerPlus [Internet].2015Dec;4(1).https:\/\/www.springerplus.com\/content\/4\/1\/316. Accessed March 27 2017.","DOI":"10.1186\/s40064-015-1067-7"},{"key":"e_1_2_7_18_1","unstructured":"Lonquex \u2010 Summary of Product Characteristics (SPC) \u2010 (eMC) [Internet].https:\/\/www.medicines.org.uk\/emc\/medicine\/28948. Accessed September 19 2017."},{"issue":"3","key":"e_1_2_7_19_1","first-page":"292","article-title":"Prophylaxis of chemotherapy\u2010induced neutropenia with Lipegfilgrastim in patients with Non\u2010Hodgkin\u2010Lymphoma (NHL): results from an interim analysis of the non\u2010interventional study NADIR [Prophylaxe von Chemotherapie\u2010induzierten Neutropenien mit Lipegfilgrastim bei Non\u2010Hodgkin\u2010Lymphom (NHL)\u2010Patienten: Ergebnisse einer Interimsanalyse der nicht\u2010interventionellen Studie NADIR]","volume":"39","author":"Fietz T","year":"2016","journal-title":"Oncol Res Treat"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1159\/000381631"},{"issue":"9","key":"e_1_2_7_21_1","doi-asserted-by":"crossref","first-page":"1709","DOI":"10.1093\/annonc\/mdu035","article-title":"Prophylaxis of infectious complications with colony\u2010stimulating factors in adult cancer patients undergoing chemotherapy\u2010evidence\u2010based guidelines from the Infectious Diseases Working Party AGIHO of the German Society for Haematology and Medical Oncology (DGHO)","volume":"25","author":"Vehreschild JJ","year":"2014","journal-title":"Ann Oncol Off J Eur Soc Med Oncol"},{"key":"e_1_2_7_22_1","unstructured":"Common Terminology Criteria for Adverse Events (CTCAE)\u2013 CTCAE_4.03_2010\u201006\u201014_QuickReference_8.5x11.pdf [Internet].https:\/\/evs.nci.nih.gov\/ftp1\/CTCAE\/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf. 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