Weekly Administration of Epoetin Beta for Chemotherapy-induced Anemia in Cancer Patients: Results of a Multicenter, Phase III, Randomized, Double-blind, Placebo-controlled Study
Objective The efficacy and safety of weekly administration of epoetin beta (EPO) for chemotherapy-induced anemia (CIA) patients was evaluated. Methods One hundred and twenty-two patients with lung cancer or malignant lymphoma undergoing chemotherapy were randomized to the EPO 36 000 IU group or the...
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| Veröffentlicht in: | Japanese journal of clinical oncology 2009-03, Vol.39 (3), p.163-168 |
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| creator | Tsuboi, Masahiro Ezaki, Kohji Tobinai, Kensei Ohashi, Yasuo Saijo, Nagahiro |
| description | Objective The efficacy and safety of weekly administration of epoetin beta (EPO) for chemotherapy-induced anemia (CIA) patients was evaluated. Methods One hundred and twenty-two patients with lung cancer or malignant lymphoma undergoing chemotherapy were randomized to the EPO 36 000 IU group or the placebo group. Hematological response and red blood cell (RBC) transfusion requirement were assessed. Quality of life (QOL) was assessed using the Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire. Results Mean change in hemoglobin level with EPO increased significantly over placebo (1.4 ± 1.9 g/dl versus −0.8 ± 1.5 g/dl; P < 0.001). The proportion of patients with change in hemoglobin level ≥2.0 g/dl was higher for EPO than those for placebo (P < 0.001). After 4 weeks of administration, the proportion of RBC transfusion or hemoglobin level |
| doi_str_mv | 10.1093/jjco/hyn151 |
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Methods One hundred and twenty-two patients with lung cancer or malignant lymphoma undergoing chemotherapy were randomized to the EPO 36 000 IU group or the placebo group. Hematological response and red blood cell (RBC) transfusion requirement were assessed. Quality of life (QOL) was assessed using the Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire. Results Mean change in hemoglobin level with EPO increased significantly over placebo (1.4 ± 1.9 g/dl versus −0.8 ± 1.5 g/dl; P < 0.001). The proportion of patients with change in hemoglobin level ≥2.0 g/dl was higher for EPO than those for placebo (P < 0.001). After 4 weeks of administration, the proportion of RBC transfusion or hemoglobin level <8.0 g/dl was significantly lower for EPO than those for placebo (P = 0.046). The changes in the FACT-An total Fatigue Subscale Score (FSS) were less deteriorated with EPO than those with placebo. Progressive disease (PD) did not influence the change in hemoglobin level but there was less decrease in FSS in non-PD patients. No significant differences in adverse events were observed. Thrombovascular events and pure red cell aplasia related to EPO were not observed. Retrospective analysis of survival showing the hazard ratio of EPO to placebo was 0.94. Conclusion Weekly administration of EPO 36 000 IU significantly increased hemoglobin level and ameliorated the decline of QOL in CIA patients over the 8-week administration period.</description><identifier>ISSN: 0368-2811</identifier><identifier>EISSN: 1465-3621</identifier><identifier>DOI: 10.1093/jjco/hyn151</identifier><identifier>PMID: 19164318</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Adult ; Aged ; anemia ; Anemia - blood ; Anemia - chemically induced ; Anemia - drug therapy ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Biomarkers - blood ; cancer ; chemotherapy-induced anemia ; Double-Blind Method ; Drug Administration Schedule ; erythropoietin ; Erythropoietin - administration & dosage ; Erythropoietin - adverse effects ; Female ; Hematinics - administration & dosage ; Hematinics - adverse effects ; Hemoglobins - metabolism ; Humans ; Incidence ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Prospective Studies ; Quality of Life ; Recombinant Proteins ; survival ; Treatment Outcome</subject><ispartof>Japanese journal of clinical oncology, 2009-03, Vol.39 (3), p.163-168</ispartof><rights>The Author (2009). Published by Oxford University Press. All rights reserved 2009</rights><rights>The Author (2009). Published by Oxford University Press. All rights reserved</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c407t-5ffa5d871ca498c6dacdf50bbd3f6f7d3ebea05c17cd9743bce861307313469d3</citedby><cites>FETCH-LOGICAL-c407t-5ffa5d871ca498c6dacdf50bbd3f6f7d3ebea05c17cd9743bce861307313469d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,1578,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19164318$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tsuboi, Masahiro</creatorcontrib><creatorcontrib>Ezaki, Kohji</creatorcontrib><creatorcontrib>Tobinai, Kensei</creatorcontrib><creatorcontrib>Ohashi, Yasuo</creatorcontrib><creatorcontrib>Saijo, Nagahiro</creatorcontrib><title>Weekly Administration of Epoetin Beta for Chemotherapy-induced Anemia in Cancer Patients: Results of a Multicenter, Phase III, Randomized, Double-blind, Placebo-controlled Study</title><title>Japanese journal of clinical oncology</title><addtitle>Jpn J Clin Oncol</addtitle><description>Objective The efficacy and safety of weekly administration of epoetin beta (EPO) for chemotherapy-induced anemia (CIA) patients was evaluated. Methods One hundred and twenty-two patients with lung cancer or malignant lymphoma undergoing chemotherapy were randomized to the EPO 36 000 IU group or the placebo group. Hematological response and red blood cell (RBC) transfusion requirement were assessed. Quality of life (QOL) was assessed using the Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire. Results Mean change in hemoglobin level with EPO increased significantly over placebo (1.4 ± 1.9 g/dl versus −0.8 ± 1.5 g/dl; P < 0.001). The proportion of patients with change in hemoglobin level ≥2.0 g/dl was higher for EPO than those for placebo (P < 0.001). After 4 weeks of administration, the proportion of RBC transfusion or hemoglobin level <8.0 g/dl was significantly lower for EPO than those for placebo (P = 0.046). The changes in the FACT-An total Fatigue Subscale Score (FSS) were less deteriorated with EPO than those with placebo. Progressive disease (PD) did not influence the change in hemoglobin level but there was less decrease in FSS in non-PD patients. No significant differences in adverse events were observed. Thrombovascular events and pure red cell aplasia related to EPO were not observed. Retrospective analysis of survival showing the hazard ratio of EPO to placebo was 0.94. Conclusion Weekly administration of EPO 36 000 IU significantly increased hemoglobin level and ameliorated the decline of QOL in CIA patients over the 8-week administration period.</description><subject>Adult</subject><subject>Aged</subject><subject>anemia</subject><subject>Anemia - blood</subject><subject>Anemia - chemically induced</subject><subject>Anemia - drug therapy</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Biomarkers - blood</subject><subject>cancer</subject><subject>chemotherapy-induced anemia</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>erythropoietin</subject><subject>Erythropoietin - administration & dosage</subject><subject>Erythropoietin - adverse effects</subject><subject>Female</subject><subject>Hematinics - administration & dosage</subject><subject>Hematinics - adverse effects</subject><subject>Hemoglobins - metabolism</subject><subject>Humans</subject><subject>Incidence</subject><subject>Kaplan-Meier Estimate</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Quality of Life</subject><subject>Recombinant Proteins</subject><subject>survival</subject><subject>Treatment Outcome</subject><issn>0368-2811</issn><issn>1465-3621</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkUFv0zAUgC0EYmVw4o4sDlxoNrtO4mS3UgarGKIqIKZdLMd-UdMldrAdiexf7R_OVSo4cnpPep--d_gQek3JGSUlO9_vlT3fjYZm9Ama0TTPEpYv6FM0IywvkkVB6Ql64f2eEJIVKX-OTmhJ85TRYoYefgHctSNe6q4xjQ9OhsYabGt82VsIjcEfIEhcW4dXO-hs2IGT_Zg0Rg8KNF4a6BqJI7eSRoHDmygAE_wF3oIf2uAPLom_xrVR8QBujjc76QGv1-s53kqjbdfcg57jj3aoWkiqNsoj1EoFlU2UNcHZto3PvodBjy_Rs1q2Hl4d5yn6-enyx-oquf72eb1aXicqJTwkWV3LTBecKpmWhcq1VLrOSFVpVuc11wwqkCRTlCtd8pRVCoqcMsIZZWleanaK3k7e3tnfA_gg9nZwJr4UC8opSYtFFqH3E6Sc9d5BLXrXdNKNghJxqCMOdcRUJ9Jvjsqh6kD_Y485IvBuAuzQ_8eUTGBMBn_-otLdiZwznomrm1ux2d584bfbVHD2CFsjq1Y</recordid><startdate>20090301</startdate><enddate>20090301</enddate><creator>Tsuboi, Masahiro</creator><creator>Ezaki, Kohji</creator><creator>Tobinai, Kensei</creator><creator>Ohashi, Yasuo</creator><creator>Saijo, Nagahiro</creator><general>Oxford University Press</general><general>Oxford Publishing Limited (England)</general><scope>BSCLL</scope><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>7T5</scope><scope>7T7</scope><scope>7TM</scope><scope>7TO</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>P64</scope></search><sort><creationdate>20090301</creationdate><title>Weekly Administration of Epoetin Beta for Chemotherapy-induced Anemia in Cancer Patients: Results of a Multicenter, Phase III, Randomized, Double-blind, Placebo-controlled Study</title><author>Tsuboi, Masahiro ; Ezaki, Kohji ; Tobinai, Kensei ; Ohashi, Yasuo ; Saijo, Nagahiro</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c407t-5ffa5d871ca498c6dacdf50bbd3f6f7d3ebea05c17cd9743bce861307313469d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Adult</topic><topic>Aged</topic><topic>anemia</topic><topic>Anemia - blood</topic><topic>Anemia - chemically induced</topic><topic>Anemia - drug therapy</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Biomarkers - blood</topic><topic>cancer</topic><topic>chemotherapy-induced anemia</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>erythropoietin</topic><topic>Erythropoietin - administration & dosage</topic><topic>Erythropoietin - adverse effects</topic><topic>Female</topic><topic>Hematinics - administration & dosage</topic><topic>Hematinics - adverse effects</topic><topic>Hemoglobins - metabolism</topic><topic>Humans</topic><topic>Incidence</topic><topic>Kaplan-Meier Estimate</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Quality of Life</topic><topic>Recombinant Proteins</topic><topic>survival</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tsuboi, Masahiro</creatorcontrib><creatorcontrib>Ezaki, Kohji</creatorcontrib><creatorcontrib>Tobinai, Kensei</creatorcontrib><creatorcontrib>Ohashi, Yasuo</creatorcontrib><creatorcontrib>Saijo, Nagahiro</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors 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>Biotechnology and BioEngineering Abstracts</collection><jtitle>Japanese journal of clinical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tsuboi, Masahiro</au><au>Ezaki, Kohji</au><au>Tobinai, Kensei</au><au>Ohashi, Yasuo</au><au>Saijo, Nagahiro</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Weekly Administration of Epoetin Beta for Chemotherapy-induced Anemia in Cancer Patients: Results of a Multicenter, Phase III, Randomized, Double-blind, Placebo-controlled Study</atitle><jtitle>Japanese journal of clinical oncology</jtitle><addtitle>Jpn J Clin Oncol</addtitle><date>2009-03-01</date><risdate>2009</risdate><volume>39</volume><issue>3</issue><spage>163</spage><epage>168</epage><pages>163-168</pages><issn>0368-2811</issn><eissn>1465-3621</eissn><abstract>Objective The efficacy and safety of weekly administration of epoetin beta (EPO) for chemotherapy-induced anemia (CIA) patients was evaluated. Methods One hundred and twenty-two patients with lung cancer or malignant lymphoma undergoing chemotherapy were randomized to the EPO 36 000 IU group or the placebo group. Hematological response and red blood cell (RBC) transfusion requirement were assessed. Quality of life (QOL) was assessed using the Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire. Results Mean change in hemoglobin level with EPO increased significantly over placebo (1.4 ± 1.9 g/dl versus −0.8 ± 1.5 g/dl; P < 0.001). The proportion of patients with change in hemoglobin level ≥2.0 g/dl was higher for EPO than those for placebo (P < 0.001). After 4 weeks of administration, the proportion of RBC transfusion or hemoglobin level <8.0 g/dl was significantly lower for EPO than those for placebo (P = 0.046). The changes in the FACT-An total Fatigue Subscale Score (FSS) were less deteriorated with EPO than those with placebo. Progressive disease (PD) did not influence the change in hemoglobin level but there was less decrease in FSS in non-PD patients. No significant differences in adverse events were observed. Thrombovascular events and pure red cell aplasia related to EPO were not observed. Retrospective analysis of survival showing the hazard ratio of EPO to placebo was 0.94. Conclusion Weekly administration of EPO 36 000 IU significantly increased hemoglobin level and ameliorated the decline of QOL in CIA patients over the 8-week administration period.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>19164318</pmid><doi>10.1093/jjco/hyn151</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Japanese journal of clinical oncology, 2009-03, Vol.39 (3), p.163-168 |
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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Adult Aged anemia Anemia - blood Anemia - chemically induced Anemia - drug therapy Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Biomarkers - blood cancer chemotherapy-induced anemia Double-Blind Method Drug Administration Schedule erythropoietin Erythropoietin - administration & dosage Erythropoietin - adverse effects Female Hematinics - administration & dosage Hematinics - adverse effects Hemoglobins - metabolism Humans Incidence Kaplan-Meier Estimate Male Middle Aged Prospective Studies Quality of Life Recombinant Proteins survival Treatment Outcome |
| title | Weekly Administration of Epoetin Beta for Chemotherapy-induced Anemia in Cancer Patients: Results of a Multicenter, Phase III, Randomized, Double-blind, Placebo-controlled Study |
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