Venous Thromboembolism and Mortality Associated With Recombinant Erythropoietin and Darbepoetin Administration for the Treatment of Cancer-Associated Anemia
CONTEXT The erythropoiesis-stimulating agents (ESAs) erythropoietin and darbepoetin are licensed to treat chemotherapy-associated anemia in patients with nonmyeloid malignancies. Although systematic overviews of trials have identified venous thromboembolism (VTE) risks, none have identified mortalit...
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| Veröffentlicht in: | JAMA : the journal of the American Medical Association 2008-02, Vol.299 (8), p.914-924 |
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| creator | Bennett, Charles L Silver, Samuel M Djulbegovic, Benjamin Samaras, Athena T Blau, C. Anthony Gleason, Kara J Barnato, Sara E Elverman, Kathleen M Courtney, D. Mark McKoy, June M Edwards, Beatrice J Tigue, Cara C Raisch, Dennis W Yarnold, Paul R Dorr, David A Kuzel, Timothy M Tallman, Martin S Trifilio, Steven M West, Dennis P Lai, Stephen Y Henke, Michael |
| description | CONTEXT The erythropoiesis-stimulating agents (ESAs) erythropoietin and darbepoetin are licensed to treat chemotherapy-associated anemia in patients with nonmyeloid malignancies. Although systematic overviews of trials have identified venous thromboembolism (VTE) risks, none have identified mortality risks with ESAs. OBJECTIVE To evaluate VTE and mortality rates associated with ESA administration for the treatment of anemia among patients with cancer. DATA SOURCES A published overview from the Cochrane Collaboration (search dates: January 1, 1985-April 1, 2005) and MEDLINE and EMBASE databases (key words: clinical trial, erythropoietin, darbepoetin, and oncology), the public Web site of the US Food and Drug Administration and ESA manufacturers, and safety advisories (search dates: April 1, 2005-January 17, 2008). STUDY SELECTION Phase 3 trials comparing ESAs with placebo or standard of care for the treatment of anemia among patients with cancer. DATA EXTRACTION Mortality rates, VTE rates, and 95% confidence intervals (CIs)
were extracted by 3 reviewers from 51 clinical trials with 13 611
patients that included survival information and 38 clinical trials with 8172 patients that included information on VTE. DATA SYNTHESIS Patients with cancer who received ESAs had increased VTE risks (334 VTE events among 4610 patients treated with ESA vs 173 VTE events among 3562 control patients; 7.5% vs 4.9%; relative risk, 1.57; 95%
CI, 1.31-1.87) and increased mortality risks (hazard ratio, 1.10;
95% CI, 1.01-1.20). CONCLUSIONS Erythropoiesis-stimulating agent administration to patients with cancer is associated with increased risks of VTE and mortality.
Our findings, in conjunction with basic science studies on erythropoietin and erythropoietin receptors in solid cancers, raise concern about the safety of ESA administration to patients with cancer. |
| doi_str_mv | 10.1001/jama.299.8.914 |
| format | Article |
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were extracted by 3 reviewers from 51 clinical trials with 13 611
patients that included survival information and 38 clinical trials with 8172 patients that included information on VTE. DATA SYNTHESIS Patients with cancer who received ESAs had increased VTE risks (334 VTE events among 4610 patients treated with ESA vs 173 VTE events among 3562 control patients; 7.5% vs 4.9%; relative risk, 1.57; 95%
CI, 1.31-1.87) and increased mortality risks (hazard ratio, 1.10;
95% CI, 1.01-1.20). CONCLUSIONS Erythropoiesis-stimulating agent administration to patients with cancer is associated with increased risks of VTE and mortality.
Our findings, in conjunction with basic science studies on erythropoietin and erythropoietin receptors in solid cancers, raise concern about the safety of ESA administration to patients with cancer.</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.299.8.914</identifier><identifier>PMID: 18314434</identifier><identifier>CODEN: JAMAAP</identifier><language>eng</language><publisher>Chicago, IL: American Medical Association</publisher><subject>Anemia ; Anemia - drug therapy ; Anemia - etiology ; Biological and medical sciences ; Blood and lymphatic vessels ; Cancer ; Cardiology. Vascular system ; Chemotherapy ; Clinical outcomes ; Clinical Trials, Phase III as Topic ; Darbepoetin alfa ; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous ; Epidemiology ; Erythropoietin - adverse effects ; Erythropoietin - analogs & derivatives ; General aspects ; Hematinics - adverse effects ; Humans ; Medical research ; Medical sciences ; Medical treatment ; Mortality ; Neoplasms - complications ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; Recombinant Proteins ; Risk ; Survival Rate ; Venous Thromboembolism - epidemiology</subject><ispartof>JAMA : the journal of the American Medical Association, 2008-02, Vol.299 (8), p.914-924</ispartof><rights>2008 INIST-CNRS</rights><rights>Copyright American Medical Association Feb 27, 2008</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a329t-52c7de55073416535574b83962e4ebb37dd1729a0abfc036428490b8f8a60d073</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.299.8.914$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.299.8.914$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,315,782,786,3342,27931,27932,76497,76500</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20134190$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18314434$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bennett, Charles L</creatorcontrib><creatorcontrib>Silver, Samuel M</creatorcontrib><creatorcontrib>Djulbegovic, Benjamin</creatorcontrib><creatorcontrib>Samaras, Athena T</creatorcontrib><creatorcontrib>Blau, C. Anthony</creatorcontrib><creatorcontrib>Gleason, Kara J</creatorcontrib><creatorcontrib>Barnato, Sara E</creatorcontrib><creatorcontrib>Elverman, Kathleen M</creatorcontrib><creatorcontrib>Courtney, D. Mark</creatorcontrib><creatorcontrib>McKoy, June M</creatorcontrib><creatorcontrib>Edwards, Beatrice J</creatorcontrib><creatorcontrib>Tigue, Cara C</creatorcontrib><creatorcontrib>Raisch, Dennis W</creatorcontrib><creatorcontrib>Yarnold, Paul R</creatorcontrib><creatorcontrib>Dorr, David A</creatorcontrib><creatorcontrib>Kuzel, Timothy M</creatorcontrib><creatorcontrib>Tallman, Martin S</creatorcontrib><creatorcontrib>Trifilio, Steven M</creatorcontrib><creatorcontrib>West, Dennis P</creatorcontrib><creatorcontrib>Lai, Stephen Y</creatorcontrib><creatorcontrib>Henke, Michael</creatorcontrib><title>Venous Thromboembolism and Mortality Associated With Recombinant Erythropoietin and Darbepoetin Administration for the Treatment of Cancer-Associated Anemia</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>CONTEXT The erythropoiesis-stimulating agents (ESAs) erythropoietin and darbepoetin are licensed to treat chemotherapy-associated anemia in patients with nonmyeloid malignancies. Although systematic overviews of trials have identified venous thromboembolism (VTE) risks, none have identified mortality risks with ESAs. OBJECTIVE To evaluate VTE and mortality rates associated with ESA administration for the treatment of anemia among patients with cancer. DATA SOURCES A published overview from the Cochrane Collaboration (search dates: January 1, 1985-April 1, 2005) and MEDLINE and EMBASE databases (key words: clinical trial, erythropoietin, darbepoetin, and oncology), the public Web site of the US Food and Drug Administration and ESA manufacturers, and safety advisories (search dates: April 1, 2005-January 17, 2008). STUDY SELECTION Phase 3 trials comparing ESAs with placebo or standard of care for the treatment of anemia among patients with cancer. DATA EXTRACTION Mortality rates, VTE rates, and 95% confidence intervals (CIs)
were extracted by 3 reviewers from 51 clinical trials with 13 611
patients that included survival information and 38 clinical trials with 8172 patients that included information on VTE. DATA SYNTHESIS Patients with cancer who received ESAs had increased VTE risks (334 VTE events among 4610 patients treated with ESA vs 173 VTE events among 3562 control patients; 7.5% vs 4.9%; relative risk, 1.57; 95%
CI, 1.31-1.87) and increased mortality risks (hazard ratio, 1.10;
95% CI, 1.01-1.20). CONCLUSIONS Erythropoiesis-stimulating agent administration to patients with cancer is associated with increased risks of VTE and mortality.
Our findings, in conjunction with basic science studies on erythropoietin and erythropoietin receptors in solid cancers, raise concern about the safety of ESA administration to patients with cancer.</description><subject>Anemia</subject><subject>Anemia - drug therapy</subject><subject>Anemia - etiology</subject><subject>Biological and medical sciences</subject><subject>Blood and lymphatic vessels</subject><subject>Cancer</subject><subject>Cardiology. Vascular system</subject><subject>Chemotherapy</subject><subject>Clinical outcomes</subject><subject>Clinical Trials, Phase III as Topic</subject><subject>Darbepoetin alfa</subject><subject>Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous</subject><subject>Epidemiology</subject><subject>Erythropoietin - adverse effects</subject><subject>Erythropoietin - analogs & derivatives</subject><subject>General aspects</subject><subject>Hematinics - adverse effects</subject><subject>Humans</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Medical treatment</subject><subject>Mortality</subject><subject>Neoplasms - complications</subject><subject>Public health. Hygiene</subject><subject>Public health. Hygiene-occupational medicine</subject><subject>Recombinant Proteins</subject><subject>Risk</subject><subject>Survival Rate</subject><subject>Venous Thromboembolism - epidemiology</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkV9rFDEUxYNY7Fp9FXyRULBvs-bvTPK4rNUWKoKs-jjcmbnDZplJ1iT7sN-lH9bQrlIauITA79ybew4h7zhbcsb4px3MsBTWLs3ScvWCLLiWppLampdkwZg1VaOMOievU9qxcrhsXpFzbiRXSqoFuf-FPhwS3WxjmLuApSaXZgp-oN9CzDC5fKSrlELvIONAf7u8pT-wL7Tz4DO9jsdcxPvgMDv_IPwMscN9eHivhtl5l3KE7IKnY4g0b5FuIkKesejDSNfge4zVkykrj7ODN-RshCnh29N9QX5-ud6sb6q7719v16u7CqSwudKibwbUmjVS8VpLrRvVGWlrgQq7TjbDwBthgUE39kzWShhlWWdGAzUbiuqCXD323cfw54Apt7NLPU4TeCzmtILpWgpmCnj5DNyFQ_Tlb63gXMmaa16gDyfo0M04tPvoZojH9p_pBfh4AiD1MI2xrO_Sf06UkBS3rHDvH7mS8ZMuJWEp_wJAaJrj</recordid><startdate>20080227</startdate><enddate>20080227</enddate><creator>Bennett, Charles L</creator><creator>Silver, Samuel M</creator><creator>Djulbegovic, Benjamin</creator><creator>Samaras, Athena T</creator><creator>Blau, C. Anthony</creator><creator>Gleason, Kara J</creator><creator>Barnato, Sara E</creator><creator>Elverman, Kathleen M</creator><creator>Courtney, D. Mark</creator><creator>McKoy, June M</creator><creator>Edwards, Beatrice J</creator><creator>Tigue, Cara C</creator><creator>Raisch, Dennis W</creator><creator>Yarnold, Paul R</creator><creator>Dorr, David A</creator><creator>Kuzel, Timothy M</creator><creator>Tallman, Martin S</creator><creator>Trifilio, Steven M</creator><creator>West, Dennis P</creator><creator>Lai, Stephen Y</creator><creator>Henke, Michael</creator><general>American Medical Association</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7T2</scope><scope>7U1</scope><scope>7U2</scope></search><sort><creationdate>20080227</creationdate><title>Venous Thromboembolism and Mortality Associated With Recombinant Erythropoietin and Darbepoetin Administration for the Treatment of Cancer-Associated Anemia</title><author>Bennett, Charles L ; Silver, Samuel M ; Djulbegovic, Benjamin ; Samaras, Athena T ; Blau, C. Anthony ; Gleason, Kara J ; Barnato, Sara E ; Elverman, Kathleen M ; Courtney, D. Mark ; McKoy, June M ; Edwards, Beatrice J ; Tigue, Cara C ; Raisch, Dennis W ; Yarnold, Paul R ; Dorr, David A ; Kuzel, Timothy M ; Tallman, Martin S ; Trifilio, Steven M ; West, Dennis P ; Lai, Stephen Y ; Henke, Michael</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a329t-52c7de55073416535574b83962e4ebb37dd1729a0abfc036428490b8f8a60d073</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Anemia</topic><topic>Anemia - drug therapy</topic><topic>Anemia - etiology</topic><topic>Biological and medical sciences</topic><topic>Blood and lymphatic vessels</topic><topic>Cancer</topic><topic>Cardiology. Vascular system</topic><topic>Chemotherapy</topic><topic>Clinical outcomes</topic><topic>Clinical Trials, Phase III as Topic</topic><topic>Darbepoetin alfa</topic><topic>Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous</topic><topic>Epidemiology</topic><topic>Erythropoietin - adverse effects</topic><topic>Erythropoietin - analogs & derivatives</topic><topic>General aspects</topic><topic>Hematinics - adverse effects</topic><topic>Humans</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Medical treatment</topic><topic>Mortality</topic><topic>Neoplasms - complications</topic><topic>Public health. Hygiene</topic><topic>Public health. Hygiene-occupational medicine</topic><topic>Recombinant Proteins</topic><topic>Risk</topic><topic>Survival Rate</topic><topic>Venous Thromboembolism - epidemiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bennett, Charles L</creatorcontrib><creatorcontrib>Silver, Samuel M</creatorcontrib><creatorcontrib>Djulbegovic, Benjamin</creatorcontrib><creatorcontrib>Samaras, Athena T</creatorcontrib><creatorcontrib>Blau, C. Anthony</creatorcontrib><creatorcontrib>Gleason, Kara J</creatorcontrib><creatorcontrib>Barnato, Sara E</creatorcontrib><creatorcontrib>Elverman, Kathleen M</creatorcontrib><creatorcontrib>Courtney, D. Mark</creatorcontrib><creatorcontrib>McKoy, June M</creatorcontrib><creatorcontrib>Edwards, Beatrice J</creatorcontrib><creatorcontrib>Tigue, Cara C</creatorcontrib><creatorcontrib>Raisch, Dennis W</creatorcontrib><creatorcontrib>Yarnold, Paul R</creatorcontrib><creatorcontrib>Dorr, David A</creatorcontrib><creatorcontrib>Kuzel, Timothy M</creatorcontrib><creatorcontrib>Tallman, Martin S</creatorcontrib><creatorcontrib>Trifilio, Steven M</creatorcontrib><creatorcontrib>West, Dennis P</creatorcontrib><creatorcontrib>Lai, Stephen Y</creatorcontrib><creatorcontrib>Henke, Michael</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Physical Education Index</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Risk Abstracts</collection><collection>Safety Science and Risk</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bennett, Charles L</au><au>Silver, Samuel M</au><au>Djulbegovic, Benjamin</au><au>Samaras, Athena T</au><au>Blau, C. Anthony</au><au>Gleason, Kara J</au><au>Barnato, Sara E</au><au>Elverman, Kathleen M</au><au>Courtney, D. Mark</au><au>McKoy, June M</au><au>Edwards, Beatrice J</au><au>Tigue, Cara C</au><au>Raisch, Dennis W</au><au>Yarnold, Paul R</au><au>Dorr, David A</au><au>Kuzel, Timothy M</au><au>Tallman, Martin S</au><au>Trifilio, Steven M</au><au>West, Dennis P</au><au>Lai, Stephen Y</au><au>Henke, Michael</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Venous Thromboembolism and Mortality Associated With Recombinant Erythropoietin and Darbepoetin Administration for the Treatment of Cancer-Associated Anemia</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2008-02-27</date><risdate>2008</risdate><volume>299</volume><issue>8</issue><spage>914</spage><epage>924</epage><pages>914-924</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><coden>JAMAAP</coden><abstract>CONTEXT The erythropoiesis-stimulating agents (ESAs) erythropoietin and darbepoetin are licensed to treat chemotherapy-associated anemia in patients with nonmyeloid malignancies. Although systematic overviews of trials have identified venous thromboembolism (VTE) risks, none have identified mortality risks with ESAs. OBJECTIVE To evaluate VTE and mortality rates associated with ESA administration for the treatment of anemia among patients with cancer. DATA SOURCES A published overview from the Cochrane Collaboration (search dates: January 1, 1985-April 1, 2005) and MEDLINE and EMBASE databases (key words: clinical trial, erythropoietin, darbepoetin, and oncology), the public Web site of the US Food and Drug Administration and ESA manufacturers, and safety advisories (search dates: April 1, 2005-January 17, 2008). STUDY SELECTION Phase 3 trials comparing ESAs with placebo or standard of care for the treatment of anemia among patients with cancer. DATA EXTRACTION Mortality rates, VTE rates, and 95% confidence intervals (CIs)
were extracted by 3 reviewers from 51 clinical trials with 13 611
patients that included survival information and 38 clinical trials with 8172 patients that included information on VTE. DATA SYNTHESIS Patients with cancer who received ESAs had increased VTE risks (334 VTE events among 4610 patients treated with ESA vs 173 VTE events among 3562 control patients; 7.5% vs 4.9%; relative risk, 1.57; 95%
CI, 1.31-1.87) and increased mortality risks (hazard ratio, 1.10;
95% CI, 1.01-1.20). CONCLUSIONS Erythropoiesis-stimulating agent administration to patients with cancer is associated with increased risks of VTE and mortality.
Our findings, in conjunction with basic science studies on erythropoietin and erythropoietin receptors in solid cancers, raise concern about the safety of ESA administration to patients with cancer.</abstract><cop>Chicago, IL</cop><pub>American Medical Association</pub><pmid>18314434</pmid><doi>10.1001/jama.299.8.914</doi><tpages>11</tpages></addata></record> |
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| source | MEDLINE; American Medical Association Journals |
| subjects | Anemia Anemia - drug therapy Anemia - etiology Biological and medical sciences Blood and lymphatic vessels Cancer Cardiology. Vascular system Chemotherapy Clinical outcomes Clinical Trials, Phase III as Topic Darbepoetin alfa Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous Epidemiology Erythropoietin - adverse effects Erythropoietin - analogs & derivatives General aspects Hematinics - adverse effects Humans Medical research Medical sciences Medical treatment Mortality Neoplasms - complications Public health. Hygiene Public health. Hygiene-occupational medicine Recombinant Proteins Risk Survival Rate Venous Thromboembolism - epidemiology |
| title | Venous Thromboembolism and Mortality Associated With Recombinant Erythropoietin and Darbepoetin Administration for the Treatment of Cancer-Associated Anemia |
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