Double-Blind, Placebo-Controlled, Randomized Phase III Trial of Darbepoetin Alfa in Lung Cancer Patients Receiving Chemotherapy
Background: Patients receiving chemotherapy often develop anemia. Darbepoetin alfa (Aranesp™) is an erythropoiesis-stimulating glycoprotein that has been shown, in dose-finding studies, to be safe and clinically active when administered to patients with cancer every 1, 2, or 3 weeks. This phase III...
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| creator | Vansteenkiste, Johan Pirker, Robert Massuti, Bartomeu Barata, Fernando Font, Albert Fiegl, Michael Siena, Salvatore Gateley, Jenni Tomita, Dianne Colowick, Alan B. Musil, Jaromir |
| description | Background: Patients receiving chemotherapy often develop anemia. Darbepoetin alfa (Aranesp™) is an erythropoiesis-stimulating glycoprotein that has been shown, in dose-finding studies, to be safe and clinically active when administered to patients with cancer every 1, 2, or 3 weeks. This phase III study compared the safety and efficacy of darbepoetin alfa with placebo in patients with lung cancer receiving chemotherapy. Methods: In this multicenter, double-blind, placebo-controlled study, 320 anemic patients (hemoglobin ≤11.0 g/dL) were randomly assigned to receive darbepoetin alfa or placebo injections weekly for 12 weeks. The 297 patients who completed at least the first 28 days of study were assessed for red blood cell transfusions, the primary endpoint. Patients were also assessed for hemoglobin concentration (i.e., hematopoietic response), adverse events, antibody formation to darbepoetin alfa, hospitalizations, Functional Assessment of Cancer Therapy (FACT)–Fatigue score, and disease outcome. Efficacy endpoints were assessed using Kaplan–Meier analyses, Cox proportional hazards analyses, and chi-square tests where appropriate. All statistical tests were two-sided. Results: Patients receiving darbepoetin alfa required fewer transfusions (27% versus 52%; mean difference = 25%; 95% confidence interval [CI] = 14% to 36%; P |
| doi_str_mv | 10.1093/jnci/94.16.1211 |
| format | Article |
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Darbepoetin alfa (Aranesp™) is an erythropoiesis-stimulating glycoprotein that has been shown, in dose-finding studies, to be safe and clinically active when administered to patients with cancer every 1, 2, or 3 weeks. This phase III study compared the safety and efficacy of darbepoetin alfa with placebo in patients with lung cancer receiving chemotherapy. Methods: In this multicenter, double-blind, placebo-controlled study, 320 anemic patients (hemoglobin ≤11.0 g/dL) were randomly assigned to receive darbepoetin alfa or placebo injections weekly for 12 weeks. The 297 patients who completed at least the first 28 days of study were assessed for red blood cell transfusions, the primary endpoint. Patients were also assessed for hemoglobin concentration (i.e., hematopoietic response), adverse events, antibody formation to darbepoetin alfa, hospitalizations, Functional Assessment of Cancer Therapy (FACT)–Fatigue score, and disease outcome. Efficacy endpoints were assessed using Kaplan–Meier analyses, Cox proportional hazards analyses, and chi-square tests where appropriate. All statistical tests were two-sided. Results: Patients receiving darbepoetin alfa required fewer transfusions (27% versus 52%; mean difference = 25%; 95% confidence interval [CI] = 14% to 36%; P<.001), required fewer units of blood (0.67 versus 1.92; mean difference = 1.25, 95% CI = 0.65 to 1.84; P<.001), had more hematopoietic responses (66% versus 24%; mean difference = 42%; 95% CI = 31% to 53%; P<.001), and had better improvement in FACT–Fatigue scores (56% versus 44% overall improvement; 32% versus 19% with ≥25% improvement; mean difference = 13%; 95% CI = 2% to 23%, P = .019) than patients receiving placebo. Patients receiving darbepoetin alfa did not appear to have any untoward effect in disease outcome and did not develop antibodies to the drug. Adverse events were similar between the groups. Conclusions: Patients with chemotherapy-associated anemia can safely and effectively be treated with weekly darbepoetin alfa therapy. Darbepoetin alfa decreased blood transfusion requirements, increased hemoglobin concentration, and decreased fatigue. Although no conclusions can be drawn about survival from this study, the potential salutary effect on disease outcome warrants further investigation in a prospectively designed study.</description><identifier>ISSN: 0027-8874</identifier><identifier>ISSN: 1460-2105</identifier><identifier>EISSN: 1460-2105</identifier><identifier>DOI: 10.1093/jnci/94.16.1211</identifier><identifier>PMID: 12189224</identifier><identifier>CODEN: JNCIEQ</identifier><language>eng</language><publisher>Cary, NC: Oxford University Press</publisher><subject><![CDATA[Adult ; Aged ; Aged, 80 and over ; Anemia ; Anemia - blood ; Anemia - chemically induced ; Anemia - complications ; Anemia - drug therapy ; Anemia - prevention & control ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Chemotherapy ; Clinical trials ; Darbepoetin alfa ; Disease Progression ; Double-Blind Method ; Drug toxicity and drugs side effects treatment ; Erythrocyte Transfusion - statistics & numerical data ; Erythropoiesis - drug effects ; Erythropoietin - analogs & derivatives ; Erythropoietin - therapeutic use ; Fatigue - etiology ; Fatigue - prevention & control ; Female ; Humans ; Length of Stay - statistics & numerical data ; Lung cancer ; Lung Neoplasms - blood ; Lung Neoplasms - drug therapy ; Male ; Medical sciences ; Middle Aged ; Patient Admission - statistics & numerical data ; Pharmaceuticals ; Pharmacology. Drug treatments ; Platinum Compounds - adverse effects ; Surveys and Questionnaires ; Survival Analysis ; Toxicity: blood ; Treatment Outcome]]></subject><ispartof>JNCI : Journal of the National Cancer Institute, 2002-08, Vol.94 (16), p.1211-1220</ispartof><rights>2003 INIST-CNRS</rights><rights>Copyright Superintendent of Documents Aug 21, 2002</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c495t-dbe68cebc4a8b66b7f79ca3051977ba545f63367253e07b766513c6ce8b1e6da3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,27905,27906</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=14915367$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12189224$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vansteenkiste, Johan</creatorcontrib><creatorcontrib>Pirker, Robert</creatorcontrib><creatorcontrib>Massuti, Bartomeu</creatorcontrib><creatorcontrib>Barata, Fernando</creatorcontrib><creatorcontrib>Font, Albert</creatorcontrib><creatorcontrib>Fiegl, Michael</creatorcontrib><creatorcontrib>Siena, Salvatore</creatorcontrib><creatorcontrib>Gateley, Jenni</creatorcontrib><creatorcontrib>Tomita, Dianne</creatorcontrib><creatorcontrib>Colowick, Alan B.</creatorcontrib><creatorcontrib>Musil, Jaromir</creatorcontrib><creatorcontrib>Aranesp 980297 Study Group</creatorcontrib><title>Double-Blind, Placebo-Controlled, Randomized Phase III Trial of Darbepoetin Alfa in Lung Cancer Patients Receiving Chemotherapy</title><title>JNCI : Journal of the National Cancer Institute</title><addtitle>JNCI J Natl Cancer Inst</addtitle><description>Background: Patients receiving chemotherapy often develop anemia. Darbepoetin alfa (Aranesp™) is an erythropoiesis-stimulating glycoprotein that has been shown, in dose-finding studies, to be safe and clinically active when administered to patients with cancer every 1, 2, or 3 weeks. This phase III study compared the safety and efficacy of darbepoetin alfa with placebo in patients with lung cancer receiving chemotherapy. Methods: In this multicenter, double-blind, placebo-controlled study, 320 anemic patients (hemoglobin ≤11.0 g/dL) were randomly assigned to receive darbepoetin alfa or placebo injections weekly for 12 weeks. The 297 patients who completed at least the first 28 days of study were assessed for red blood cell transfusions, the primary endpoint. Patients were also assessed for hemoglobin concentration (i.e., hematopoietic response), adverse events, antibody formation to darbepoetin alfa, hospitalizations, Functional Assessment of Cancer Therapy (FACT)–Fatigue score, and disease outcome. Efficacy endpoints were assessed using Kaplan–Meier analyses, Cox proportional hazards analyses, and chi-square tests where appropriate. All statistical tests were two-sided. Results: Patients receiving darbepoetin alfa required fewer transfusions (27% versus 52%; mean difference = 25%; 95% confidence interval [CI] = 14% to 36%; P<.001), required fewer units of blood (0.67 versus 1.92; mean difference = 1.25, 95% CI = 0.65 to 1.84; P<.001), had more hematopoietic responses (66% versus 24%; mean difference = 42%; 95% CI = 31% to 53%; P<.001), and had better improvement in FACT–Fatigue scores (56% versus 44% overall improvement; 32% versus 19% with ≥25% improvement; mean difference = 13%; 95% CI = 2% to 23%, P = .019) than patients receiving placebo. Patients receiving darbepoetin alfa did not appear to have any untoward effect in disease outcome and did not develop antibodies to the drug. Adverse events were similar between the groups. Conclusions: Patients with chemotherapy-associated anemia can safely and effectively be treated with weekly darbepoetin alfa therapy. Darbepoetin alfa decreased blood transfusion requirements, increased hemoglobin concentration, and decreased fatigue. Although no conclusions can be drawn about survival from this study, the potential salutary effect on disease outcome warrants further investigation in a prospectively designed study.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anemia</subject><subject>Anemia - blood</subject><subject>Anemia - chemically induced</subject><subject>Anemia - complications</subject><subject>Anemia - drug therapy</subject><subject>Anemia - prevention & control</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Chemotherapy</subject><subject>Clinical trials</subject><subject>Darbepoetin alfa</subject><subject>Disease Progression</subject><subject>Double-Blind Method</subject><subject>Drug toxicity and drugs side effects treatment</subject><subject>Erythrocyte Transfusion - statistics & numerical data</subject><subject>Erythropoiesis - drug effects</subject><subject>Erythropoietin - analogs & derivatives</subject><subject>Erythropoietin - therapeutic use</subject><subject>Fatigue - etiology</subject><subject>Fatigue - prevention & control</subject><subject>Female</subject><subject>Humans</subject><subject>Length of Stay - statistics & numerical data</subject><subject>Lung cancer</subject><subject>Lung Neoplasms - blood</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Patient Admission - statistics & numerical data</subject><subject>Pharmaceuticals</subject><subject>Pharmacology. Drug treatments</subject><subject>Platinum Compounds - adverse effects</subject><subject>Surveys and Questionnaires</subject><subject>Survival Analysis</subject><subject>Toxicity: blood</subject><subject>Treatment Outcome</subject><issn>0027-8874</issn><issn>1460-2105</issn><issn>1460-2105</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkM1v0zAYhy0EYmVw5oYsJG6ktWPHjo9bBqyoiGoaE-Ji2c4b6pLGxU4Q48K_jqtWzJdX8u95P_Qg9JKSOSWKLbaD8wvF51TMaUnpIzSjXJCipKR6jGaElLKoa8nP0LOUtiQ_VfKn6CyztSpLPkN_r8Jkeyguez-0b_G6Nw5sKJowjDH0PeS_GzO0Yef_QIvXG5MAL5dLfBu96XHo8JWJFvYBRj_gi74zONfVNHzHjRkcRLw2o4dhTPgGHPhf_pBsYBfGDUSzv3-OnnSmT_DiVM_Rl_fvbpvrYvX5w7K5WBWOq2osWguizpc5bmorhJWdVM4wUlElpTUVrzrBmJBlxYBIK4WoKHPCQW0piNawc_T6OHcfw88J0qi3YYpDXqnLbIsIxesMLY6QiyGlCJ3eR78z8V5Tog--9cG3VlxToQ--c8er09jJ7qB94E-CM_DmBJjkTN_FbMWnB44rWuW7M1ccOZ9G-P0_N_GHzqms9PXXb_quYR_J3SXVn9g_pQ6YEA</recordid><startdate>20020821</startdate><enddate>20020821</enddate><creator>Vansteenkiste, Johan</creator><creator>Pirker, Robert</creator><creator>Massuti, Bartomeu</creator><creator>Barata, Fernando</creator><creator>Font, Albert</creator><creator>Fiegl, Michael</creator><creator>Siena, Salvatore</creator><creator>Gateley, Jenni</creator><creator>Tomita, Dianne</creator><creator>Colowick, Alan B.</creator><creator>Musil, Jaromir</creator><general>Oxford University Press</general><general>Oxford Publishing Limited (England)</general><scope>BSCLL</scope><scope>IQODW</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>7TO</scope><scope>7U7</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope></search><sort><creationdate>20020821</creationdate><title>Double-Blind, Placebo-Controlled, Randomized Phase III Trial of Darbepoetin Alfa in Lung Cancer Patients Receiving Chemotherapy</title><author>Vansteenkiste, Johan ; Pirker, Robert ; Massuti, Bartomeu ; Barata, Fernando ; Font, Albert ; Fiegl, Michael ; Siena, Salvatore ; Gateley, Jenni ; Tomita, Dianne ; Colowick, Alan B. ; Musil, Jaromir</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c495t-dbe68cebc4a8b66b7f79ca3051977ba545f63367253e07b766513c6ce8b1e6da3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anemia</topic><topic>Anemia - blood</topic><topic>Anemia - chemically induced</topic><topic>Anemia - complications</topic><topic>Anemia - drug therapy</topic><topic>Anemia - prevention & control</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Chemotherapy</topic><topic>Clinical trials</topic><topic>Darbepoetin alfa</topic><topic>Disease Progression</topic><topic>Double-Blind Method</topic><topic>Drug toxicity and drugs side effects treatment</topic><topic>Erythrocyte Transfusion - statistics & numerical data</topic><topic>Erythropoiesis - drug effects</topic><topic>Erythropoietin - analogs & derivatives</topic><topic>Erythropoietin - therapeutic use</topic><topic>Fatigue - etiology</topic><topic>Fatigue - prevention & control</topic><topic>Female</topic><topic>Humans</topic><topic>Length of Stay - statistics & numerical data</topic><topic>Lung cancer</topic><topic>Lung Neoplasms - blood</topic><topic>Lung Neoplasms - drug therapy</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Patient Admission - statistics & numerical data</topic><topic>Pharmaceuticals</topic><topic>Pharmacology. Drug treatments</topic><topic>Platinum Compounds - adverse effects</topic><topic>Surveys and Questionnaires</topic><topic>Survival Analysis</topic><topic>Toxicity: blood</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vansteenkiste, Johan</creatorcontrib><creatorcontrib>Pirker, Robert</creatorcontrib><creatorcontrib>Massuti, Bartomeu</creatorcontrib><creatorcontrib>Barata, Fernando</creatorcontrib><creatorcontrib>Font, Albert</creatorcontrib><creatorcontrib>Fiegl, Michael</creatorcontrib><creatorcontrib>Siena, Salvatore</creatorcontrib><creatorcontrib>Gateley, Jenni</creatorcontrib><creatorcontrib>Tomita, Dianne</creatorcontrib><creatorcontrib>Colowick, Alan B.</creatorcontrib><creatorcontrib>Musil, Jaromir</creatorcontrib><creatorcontrib>Aranesp 980297 Study Group</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><jtitle>JNCI : Journal of the National Cancer Institute</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vansteenkiste, Johan</au><au>Pirker, Robert</au><au>Massuti, Bartomeu</au><au>Barata, Fernando</au><au>Font, Albert</au><au>Fiegl, Michael</au><au>Siena, Salvatore</au><au>Gateley, Jenni</au><au>Tomita, Dianne</au><au>Colowick, Alan B.</au><au>Musil, Jaromir</au><aucorp>Aranesp 980297 Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Double-Blind, Placebo-Controlled, Randomized Phase III Trial of Darbepoetin Alfa in Lung Cancer Patients Receiving Chemotherapy</atitle><jtitle>JNCI : Journal of the National Cancer Institute</jtitle><addtitle>JNCI J Natl Cancer Inst</addtitle><date>2002-08-21</date><risdate>2002</risdate><volume>94</volume><issue>16</issue><spage>1211</spage><epage>1220</epage><pages>1211-1220</pages><issn>0027-8874</issn><issn>1460-2105</issn><eissn>1460-2105</eissn><coden>JNCIEQ</coden><abstract>Background: Patients receiving chemotherapy often develop anemia. Darbepoetin alfa (Aranesp™) is an erythropoiesis-stimulating glycoprotein that has been shown, in dose-finding studies, to be safe and clinically active when administered to patients with cancer every 1, 2, or 3 weeks. This phase III study compared the safety and efficacy of darbepoetin alfa with placebo in patients with lung cancer receiving chemotherapy. Methods: In this multicenter, double-blind, placebo-controlled study, 320 anemic patients (hemoglobin ≤11.0 g/dL) were randomly assigned to receive darbepoetin alfa or placebo injections weekly for 12 weeks. The 297 patients who completed at least the first 28 days of study were assessed for red blood cell transfusions, the primary endpoint. Patients were also assessed for hemoglobin concentration (i.e., hematopoietic response), adverse events, antibody formation to darbepoetin alfa, hospitalizations, Functional Assessment of Cancer Therapy (FACT)–Fatigue score, and disease outcome. Efficacy endpoints were assessed using Kaplan–Meier analyses, Cox proportional hazards analyses, and chi-square tests where appropriate. All statistical tests were two-sided. Results: Patients receiving darbepoetin alfa required fewer transfusions (27% versus 52%; mean difference = 25%; 95% confidence interval [CI] = 14% to 36%; P<.001), required fewer units of blood (0.67 versus 1.92; mean difference = 1.25, 95% CI = 0.65 to 1.84; P<.001), had more hematopoietic responses (66% versus 24%; mean difference = 42%; 95% CI = 31% to 53%; P<.001), and had better improvement in FACT–Fatigue scores (56% versus 44% overall improvement; 32% versus 19% with ≥25% improvement; mean difference = 13%; 95% CI = 2% to 23%, P = .019) than patients receiving placebo. Patients receiving darbepoetin alfa did not appear to have any untoward effect in disease outcome and did not develop antibodies to the drug. Adverse events were similar between the groups. Conclusions: Patients with chemotherapy-associated anemia can safely and effectively be treated with weekly darbepoetin alfa therapy. Darbepoetin alfa decreased blood transfusion requirements, increased hemoglobin concentration, and decreased fatigue. Although no conclusions can be drawn about survival from this study, the potential salutary effect on disease outcome warrants further investigation in a prospectively designed study.</abstract><cop>Cary, NC</cop><pub>Oxford University Press</pub><pmid>12189224</pmid><doi>10.1093/jnci/94.16.1211</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Aged, 80 and over Anemia Anemia - blood Anemia - chemically induced Anemia - complications Anemia - drug therapy Anemia - prevention & control Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Chemotherapy Clinical trials Darbepoetin alfa Disease Progression Double-Blind Method Drug toxicity and drugs side effects treatment Erythrocyte Transfusion - statistics & numerical data Erythropoiesis - drug effects Erythropoietin - analogs & derivatives Erythropoietin - therapeutic use Fatigue - etiology Fatigue - prevention & control Female Humans Length of Stay - statistics & numerical data Lung cancer Lung Neoplasms - blood Lung Neoplasms - drug therapy Male Medical sciences Middle Aged Patient Admission - statistics & numerical data Pharmaceuticals Pharmacology. Drug treatments Platinum Compounds - adverse effects Surveys and Questionnaires Survival Analysis Toxicity: blood Treatment Outcome |
| title | Double-Blind, Placebo-Controlled, Randomized Phase III Trial of Darbepoetin Alfa in Lung Cancer Patients Receiving Chemotherapy |
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