Prophylaxis of chemotherapy‐induced neutropenia and febrile neutropenia with lipegfilgrastim in patients with non‐Hodgkin lymphoma (NADIR study)
Objective The prospective non‐interventional study (NIS) NADIR was designed to evaluate both effectiveness and safety of prophylactic use of lipegfilgrastim (Lonquex®), a glycopegylated granulocyte colony‐stimulating factor, in cancer patients with different tumor entities undergoing chemotherapy in...
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| Veröffentlicht in: | European journal of haematology 2019-02, Vol.102 (2), p.174-181 |
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| container_title | European journal of haematology |
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| creator | Wolff, Thomas Schulz, Holger Losem, Christoph Reichert, Dietmar Hurtz, Hans‐Jürgen Sandner, Reiner Harde, Johanna Grebhardt, Sina Potthoff, Karin Mueller, Udo Fietz, Thomas |
| description | Objective
The prospective non‐interventional study (NIS) NADIR was designed to evaluate both effectiveness and safety of prophylactic use of lipegfilgrastim (Lonquex®), a glycopegylated granulocyte colony‐stimulating 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‐associated complications.
Method
NADIR was a national, multicenter, prospective NIS.
Results
Here, we present the data on patients with non‐Hodgkin lymphoma (NHL). Final analysis comprised 337 NHL patients having received ≥1 administration of lipegfilgrastim. Primary prophylaxis with lipegfilgrastim was documented in 78.7% of patients with high risk to develop FN. In total, ≥1 severe neutropenia (grade 3/4) was reported in 115 (34.1%) patients and ≥1 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.
Conclusion
Prophylaxis or therapeutic intention with lipegfilgrastim in NHL patients in routine clinical practice showed similar effectiveness and safety as demonstrated in the pivotal trials. |
| doi_str_mv | 10.1111/ejh.13189 |
| format | Article |
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The prospective non‐interventional study (NIS) NADIR was designed to evaluate both effectiveness and safety of prophylactic use of lipegfilgrastim (Lonquex®), a glycopegylated granulocyte colony‐stimulating 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‐associated complications.
Method
NADIR was a national, multicenter, prospective NIS.
Results
Here, we present the data on patients with non‐Hodgkin lymphoma (NHL). Final analysis comprised 337 NHL patients having received ≥1 administration of lipegfilgrastim. Primary prophylaxis with lipegfilgrastim was documented in 78.7% of patients with high risk to develop FN. In total, ≥1 severe neutropenia (grade 3/4) was reported in 115 (34.1%) patients and ≥1 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.
Conclusion
Prophylaxis or therapeutic intention with lipegfilgrastim in NHL patients in routine clinical practice showed similar effectiveness and safety as demonstrated in the pivotal trials.</description><identifier>ISSN: 0902-4441</identifier><identifier>EISSN: 1600-0609</identifier><identifier>DOI: 10.1111/ejh.13189</identifier><identifier>PMID: 30347466</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Cancer ; Chemotherapy ; Chemotherapy-Induced Febrile Neutropenia - diagnosis ; Chemotherapy-Induced Febrile Neutropenia - prevention & control ; chemotherapy‐induced febrile neutropenia ; Clinical medicine ; Clinical trials ; Comorbidity ; Febrile Neutropenia - diagnosis ; Febrile Neutropenia - etiology ; Febrile Neutropenia - prevention & control ; Female ; Filgrastim - administration & dosage ; Filgrastim - therapeutic use ; granulocyte colony‐stimulating factor ; Humans ; Incidence ; Leukocytes (granulocytic) ; Leukocytosis ; lipegfilgrastim ; Lymphoma ; Lymphoma, Non-Hodgkin - complications ; Lymphoma, Non-Hodgkin - diagnosis ; Lymphoma, Non-Hodgkin - drug therapy ; Male ; Middle Aged ; Myalgia ; Neutropenia ; non‐Hodgkin lymphoma ; Pain ; Polyethylene Glycols - administration & dosage ; Polyethylene Glycols - therapeutic use ; primary prophylaxis ; Prophylaxis ; Prospective Studies ; routine clinical practice ; Treatment Outcome ; Young Adult</subject><ispartof>European journal of haematology, 2019-02, Vol.102 (2), p.174-181</ispartof><rights>2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd</rights><rights>2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.</rights><rights>Copyright © 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3539-f58f8e49679600ad1ae183c2d3e0d7bd8ad2f0f3afd0e5fd8f86364a6847565a3</citedby><cites>FETCH-LOGICAL-c3539-f58f8e49679600ad1ae183c2d3e0d7bd8ad2f0f3afd0e5fd8f86364a6847565a3</cites><orcidid>0000-0003-1015-9624</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fejh.13189$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fejh.13189$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30347466$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Wolff, Thomas</creatorcontrib><creatorcontrib>Schulz, Holger</creatorcontrib><creatorcontrib>Losem, Christoph</creatorcontrib><creatorcontrib>Reichert, Dietmar</creatorcontrib><creatorcontrib>Hurtz, Hans‐Jürgen</creatorcontrib><creatorcontrib>Sandner, Reiner</creatorcontrib><creatorcontrib>Harde, Johanna</creatorcontrib><creatorcontrib>Grebhardt, Sina</creatorcontrib><creatorcontrib>Potthoff, Karin</creatorcontrib><creatorcontrib>Mueller, Udo</creatorcontrib><creatorcontrib>Fietz, Thomas</creatorcontrib><title>Prophylaxis of chemotherapy‐induced neutropenia and febrile neutropenia with lipegfilgrastim in patients with non‐Hodgkin lymphoma (NADIR study)</title><title>European journal of haematology</title><addtitle>Eur J Haematol</addtitle><description>Objective
The prospective non‐interventional study (NIS) NADIR was designed to evaluate both effectiveness and safety of prophylactic use of lipegfilgrastim (Lonquex®), a glycopegylated granulocyte colony‐stimulating 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‐associated complications.
Method
NADIR was a national, multicenter, prospective NIS.
Results
Here, we present the data on patients with non‐Hodgkin lymphoma (NHL). Final analysis comprised 337 NHL patients having received ≥1 administration of lipegfilgrastim. Primary prophylaxis with lipegfilgrastim was documented in 78.7% of patients with high risk to develop FN. In total, ≥1 severe neutropenia (grade 3/4) was reported in 115 (34.1%) patients and ≥1 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.
Conclusion
Prophylaxis or therapeutic intention with lipegfilgrastim in NHL patients in routine clinical practice showed similar effectiveness and safety as demonstrated in the pivotal trials.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Cancer</subject><subject>Chemotherapy</subject><subject>Chemotherapy-Induced Febrile Neutropenia - diagnosis</subject><subject>Chemotherapy-Induced Febrile Neutropenia - prevention & control</subject><subject>chemotherapy‐induced febrile neutropenia</subject><subject>Clinical medicine</subject><subject>Clinical trials</subject><subject>Comorbidity</subject><subject>Febrile Neutropenia - diagnosis</subject><subject>Febrile Neutropenia - etiology</subject><subject>Febrile Neutropenia - prevention & control</subject><subject>Female</subject><subject>Filgrastim - administration & dosage</subject><subject>Filgrastim - therapeutic use</subject><subject>granulocyte colony‐stimulating factor</subject><subject>Humans</subject><subject>Incidence</subject><subject>Leukocytes (granulocytic)</subject><subject>Leukocytosis</subject><subject>lipegfilgrastim</subject><subject>Lymphoma</subject><subject>Lymphoma, Non-Hodgkin - complications</subject><subject>Lymphoma, Non-Hodgkin - diagnosis</subject><subject>Lymphoma, Non-Hodgkin - drug therapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Myalgia</subject><subject>Neutropenia</subject><subject>non‐Hodgkin lymphoma</subject><subject>Pain</subject><subject>Polyethylene Glycols - administration & dosage</subject><subject>Polyethylene Glycols - therapeutic use</subject><subject>primary prophylaxis</subject><subject>Prophylaxis</subject><subject>Prospective Studies</subject><subject>routine clinical practice</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0902-4441</issn><issn>1600-0609</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp10UFO3DAUBmALFcGUdsEFKkvdwCJgx46TLBGlDAi1VdWuI0_8PPE0sYOdiGbHEVhwQk6CIVCpleqNJfvTLz__CO1TckTjOoZNc0QZLcottKCCkIQIUr5BC1KSNOGc0130NoQNISQtab6DdhlhPOdCLND9N-_6ZmrlbxOw07huoHNDA17208PtnbFqrEFhC-MQIVgjsbQKa1h508Jf5zdmaHBrelhr0669DIPpsLG4l4MBO4QZWGdj7tKp9a94105d37hO4oMvJ58uvuMwjGo6fIe2tWwDvH_Z99DPz2c_TpfJ1dfzi9OTq6RmGSsTnRW6AF6KvIxDS0Ul0ILVqWJAVL5ShVSpJppJrQhkWkUtmOBSFDzPRCbZHjqYc3vvrkcIQ9WZUEPbSgtuDFVKWc7zQlAW6cd_6MaN3sbXRSWEyApWkqgOZ1V7F4IHXfXedNJPFSXVU1VVrKp6riraDy-J46oD9Ue-dhPB8Qxu4k9P_0-qzi6Xc-QjG0aiGA</recordid><startdate>201902</startdate><enddate>201902</enddate><creator>Wolff, Thomas</creator><creator>Schulz, Holger</creator><creator>Losem, Christoph</creator><creator>Reichert, Dietmar</creator><creator>Hurtz, Hans‐Jürgen</creator><creator>Sandner, Reiner</creator><creator>Harde, Johanna</creator><creator>Grebhardt, Sina</creator><creator>Potthoff, Karin</creator><creator>Mueller, Udo</creator><creator>Fietz, Thomas</creator><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QG</scope><scope>7T5</scope><scope>7TM</scope><scope>7TO</scope><scope>H94</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-1015-9624</orcidid></search><sort><creationdate>201902</creationdate><title>Prophylaxis of chemotherapy‐induced neutropenia and febrile neutropenia with lipegfilgrastim in patients with non‐Hodgkin lymphoma (NADIR study)</title><author>Wolff, Thomas ; Schulz, Holger ; Losem, Christoph ; Reichert, Dietmar ; Hurtz, Hans‐Jürgen ; Sandner, Reiner ; Harde, Johanna ; Grebhardt, Sina ; Potthoff, Karin ; Mueller, Udo ; Fietz, Thomas</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3539-f58f8e49679600ad1ae183c2d3e0d7bd8ad2f0f3afd0e5fd8f86364a6847565a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Cancer</topic><topic>Chemotherapy</topic><topic>Chemotherapy-Induced Febrile Neutropenia - diagnosis</topic><topic>Chemotherapy-Induced Febrile Neutropenia - prevention & control</topic><topic>chemotherapy‐induced febrile neutropenia</topic><topic>Clinical medicine</topic><topic>Clinical trials</topic><topic>Comorbidity</topic><topic>Febrile Neutropenia - diagnosis</topic><topic>Febrile Neutropenia - etiology</topic><topic>Febrile Neutropenia - prevention & control</topic><topic>Female</topic><topic>Filgrastim - administration & dosage</topic><topic>Filgrastim - therapeutic use</topic><topic>granulocyte colony‐stimulating factor</topic><topic>Humans</topic><topic>Incidence</topic><topic>Leukocytes (granulocytic)</topic><topic>Leukocytosis</topic><topic>lipegfilgrastim</topic><topic>Lymphoma</topic><topic>Lymphoma, Non-Hodgkin - complications</topic><topic>Lymphoma, Non-Hodgkin - diagnosis</topic><topic>Lymphoma, Non-Hodgkin - drug therapy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Myalgia</topic><topic>Neutropenia</topic><topic>non‐Hodgkin lymphoma</topic><topic>Pain</topic><topic>Polyethylene Glycols - administration & dosage</topic><topic>Polyethylene Glycols - therapeutic use</topic><topic>primary prophylaxis</topic><topic>Prophylaxis</topic><topic>Prospective Studies</topic><topic>routine clinical practice</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Wolff, Thomas</creatorcontrib><creatorcontrib>Schulz, Holger</creatorcontrib><creatorcontrib>Losem, Christoph</creatorcontrib><creatorcontrib>Reichert, Dietmar</creatorcontrib><creatorcontrib>Hurtz, Hans‐Jürgen</creatorcontrib><creatorcontrib>Sandner, Reiner</creatorcontrib><creatorcontrib>Harde, Johanna</creatorcontrib><creatorcontrib>Grebhardt, Sina</creatorcontrib><creatorcontrib>Potthoff, Karin</creatorcontrib><creatorcontrib>Mueller, Udo</creatorcontrib><creatorcontrib>Fietz, Thomas</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Animal Behavior Abstracts</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>European journal of haematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Wolff, Thomas</au><au>Schulz, Holger</au><au>Losem, Christoph</au><au>Reichert, Dietmar</au><au>Hurtz, Hans‐Jürgen</au><au>Sandner, Reiner</au><au>Harde, Johanna</au><au>Grebhardt, Sina</au><au>Potthoff, Karin</au><au>Mueller, Udo</au><au>Fietz, Thomas</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prophylaxis of chemotherapy‐induced neutropenia and febrile neutropenia with lipegfilgrastim in patients with non‐Hodgkin lymphoma (NADIR study)</atitle><jtitle>European journal of haematology</jtitle><addtitle>Eur J Haematol</addtitle><date>2019-02</date><risdate>2019</risdate><volume>102</volume><issue>2</issue><spage>174</spage><epage>181</epage><pages>174-181</pages><issn>0902-4441</issn><eissn>1600-0609</eissn><abstract>Objective
The prospective non‐interventional study (NIS) NADIR was designed to evaluate both effectiveness and safety of prophylactic use of lipegfilgrastim (Lonquex®), a glycopegylated granulocyte colony‐stimulating 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‐associated complications.
Method
NADIR was a national, multicenter, prospective NIS.
Results
Here, we present the data on patients with non‐Hodgkin lymphoma (NHL). Final analysis comprised 337 NHL patients having received ≥1 administration of lipegfilgrastim. Primary prophylaxis with lipegfilgrastim was documented in 78.7% of patients with high risk to develop FN. In total, ≥1 severe neutropenia (grade 3/4) was reported in 115 (34.1%) patients and ≥1 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.
Conclusion
Prophylaxis or therapeutic intention with lipegfilgrastim in NHL patients in routine clinical practice showed similar effectiveness and safety as demonstrated in the pivotal trials.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>30347466</pmid><doi>10.1111/ejh.13189</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0003-1015-9624</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0902-4441 |
| ispartof | European journal of haematology, 2019-02, Vol.102 (2), p.174-181 |
| issn | 0902-4441 1600-0609 |
| language | eng |
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| source | MEDLINE; Wiley Journals |
| subjects | Adolescent Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Cancer Chemotherapy Chemotherapy-Induced Febrile Neutropenia - diagnosis Chemotherapy-Induced Febrile Neutropenia - prevention & control chemotherapy‐induced febrile neutropenia Clinical medicine Clinical trials Comorbidity Febrile Neutropenia - diagnosis Febrile Neutropenia - etiology Febrile Neutropenia - prevention & control Female Filgrastim - administration & dosage Filgrastim - therapeutic use granulocyte colony‐stimulating factor Humans Incidence Leukocytes (granulocytic) Leukocytosis lipegfilgrastim Lymphoma Lymphoma, Non-Hodgkin - complications Lymphoma, Non-Hodgkin - diagnosis Lymphoma, Non-Hodgkin - drug therapy Male Middle Aged Myalgia Neutropenia non‐Hodgkin lymphoma Pain Polyethylene Glycols - administration & dosage Polyethylene Glycols - therapeutic use primary prophylaxis Prophylaxis Prospective Studies routine clinical practice Treatment Outcome Young Adult |
| title | Prophylaxis of chemotherapy‐induced neutropenia and febrile neutropenia with lipegfilgrastim in patients with non‐Hodgkin lymphoma (NADIR study) |
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