A randomized trial comparing standard versus high-dose daunorubicin induction in patients with acute myeloid leukemia
We conducted a phase 3 randomized trial comparing 2 different doses of daunorubicin as induction chemotherapy in young adults (60 years of age or younger) with acute myeloid leukemia (AML). Of 383 patients who were analyzed, 189 received standard-dose daunorubicin (SD-DN, 45 mg/m2 per day times 3 da...
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| Veröffentlicht in: | Blood 2011-10, Vol.118 (14), p.3832-3841 |
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| creator | Lee, Je-Hwan Joo, Young-Don Kim, Hawk Bae, Sung Hwa Kim, Min Kyoung Zang, Dae Young Lee, Jung-Lim Lee, Gyeong Won Lee, Jung-Hee Park, Jae-Hoo Kim, Dae-Young Lee, Won-Sik Ryoo, Hun Mo Hyun, Myung Soo Kim, Hyo Jung Min, Young Joo Jang, Yae-Eun Lee, Kyoo-Hyung |
| description | We conducted a phase 3 randomized trial comparing 2 different doses of daunorubicin as induction chemotherapy in young adults (60 years of age or younger) with acute myeloid leukemia (AML). Of 383 patients who were analyzed, 189 received standard-dose daunorubicin (SD-DN, 45 mg/m2 per day times 3 days) and 194 received high-dose daunorubicin (HD-DN, 90 mg/m2 per day times 3 days) in addition to cytarabine (200 mg/m2 per day times 7 days) to induce complete remission (CR). The CR rates were 72.0% in the SD-DN arm and 82.5% in the HD-DN arm (P = .014). At a median follow-up of 52.6 months, overall (OS) and event-free (EFS) survival were higher in the HD-DN arm than in the SD-DN arm (OS, 46.8% vs 34.6%, P = .030; EFS, 40.8% vs 28.4%, P = .030). Differences in CR rate and both OS and EFS remained significant after adjusting for other variables (CR, hazard ratio [HR], 1.802, P = .024; OS, HR, 0.739, P = .032; EFS, HR, 0.774, P = .048). The survival benefits of HD-DN therapy were evident principally in patients with intermediate-risk cytogenetic features. The toxicity profiles were similar in the 2 arms. In conclusion, HD-DN improved both the CR rate and survival duration compared with SD-DN in young adults with AML. This study is registered at www.clinicaltrials.gov as #NCT00474006. |
| doi_str_mv | 10.1182/blood-2011-06-361410 |
| format | Article |
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Of 383 patients who were analyzed, 189 received standard-dose daunorubicin (SD-DN, 45 mg/m2 per day times 3 days) and 194 received high-dose daunorubicin (HD-DN, 90 mg/m2 per day times 3 days) in addition to cytarabine (200 mg/m2 per day times 7 days) to induce complete remission (CR). The CR rates were 72.0% in the SD-DN arm and 82.5% in the HD-DN arm (P = .014). At a median follow-up of 52.6 months, overall (OS) and event-free (EFS) survival were higher in the HD-DN arm than in the SD-DN arm (OS, 46.8% vs 34.6%, P = .030; EFS, 40.8% vs 28.4%, P = .030). Differences in CR rate and both OS and EFS remained significant after adjusting for other variables (CR, hazard ratio [HR], 1.802, P = .024; OS, HR, 0.739, P = .032; EFS, HR, 0.774, P = .048). The survival benefits of HD-DN therapy were evident principally in patients with intermediate-risk cytogenetic features. The toxicity profiles were similar in the 2 arms. In conclusion, HD-DN improved both the CR rate and survival duration compared with SD-DN in young adults with AML. This study is registered at www.clinicaltrials.gov as #NCT00474006.</description><identifier>ISSN: 0006-4971</identifier><identifier>EISSN: 1528-0020</identifier><identifier>DOI: 10.1182/blood-2011-06-361410</identifier><identifier>PMID: 21828126</identifier><language>eng</language><publisher>Washington, DC: Elsevier Inc</publisher><subject>Adolescent ; Adult ; Antibiotics, Antineoplastic - administration & dosage ; Antibiotics, Antineoplastic - therapeutic use ; Biological and medical sciences ; Daunorubicin - administration & dosage ; Daunorubicin - therapeutic use ; Disease-Free Survival ; Female ; Follow-Up Studies ; Hematologic and hematopoietic diseases ; Humans ; Leukemia, Myeloid, Acute - diagnosis ; Leukemia, Myeloid, Acute - drug therapy ; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis ; Male ; Medical sciences ; Middle Aged ; Prognosis ; Remission Induction ; Treatment Outcome ; Young Adult</subject><ispartof>Blood, 2011-10, Vol.118 (14), p.3832-3841</ispartof><rights>2011 American Society of Hematology</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c437t-4ca3bd2ac82b63f820221996b06d7b95381dfed8e2227fb3d24d32657f6e38813</citedby><cites>FETCH-LOGICAL-c437t-4ca3bd2ac82b63f820221996b06d7b95381dfed8e2227fb3d24d32657f6e38813</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24595530$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21828126$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lee, Je-Hwan</creatorcontrib><creatorcontrib>Joo, Young-Don</creatorcontrib><creatorcontrib>Kim, Hawk</creatorcontrib><creatorcontrib>Bae, Sung Hwa</creatorcontrib><creatorcontrib>Kim, Min Kyoung</creatorcontrib><creatorcontrib>Zang, Dae Young</creatorcontrib><creatorcontrib>Lee, Jung-Lim</creatorcontrib><creatorcontrib>Lee, Gyeong Won</creatorcontrib><creatorcontrib>Lee, Jung-Hee</creatorcontrib><creatorcontrib>Park, Jae-Hoo</creatorcontrib><creatorcontrib>Kim, Dae-Young</creatorcontrib><creatorcontrib>Lee, Won-Sik</creatorcontrib><creatorcontrib>Ryoo, Hun Mo</creatorcontrib><creatorcontrib>Hyun, Myung Soo</creatorcontrib><creatorcontrib>Kim, Hyo Jung</creatorcontrib><creatorcontrib>Min, Young Joo</creatorcontrib><creatorcontrib>Jang, Yae-Eun</creatorcontrib><creatorcontrib>Lee, Kyoo-Hyung</creatorcontrib><creatorcontrib>Cooperative Study Group A for Hematology</creatorcontrib><creatorcontrib>for the Cooperative Study Group A for Hematology</creatorcontrib><title>A randomized trial comparing standard versus high-dose daunorubicin induction in patients with acute myeloid leukemia</title><title>Blood</title><addtitle>Blood</addtitle><description>We conducted a phase 3 randomized trial comparing 2 different doses of daunorubicin as induction chemotherapy in young adults (60 years of age or younger) with acute myeloid leukemia (AML). Of 383 patients who were analyzed, 189 received standard-dose daunorubicin (SD-DN, 45 mg/m2 per day times 3 days) and 194 received high-dose daunorubicin (HD-DN, 90 mg/m2 per day times 3 days) in addition to cytarabine (200 mg/m2 per day times 7 days) to induce complete remission (CR). The CR rates were 72.0% in the SD-DN arm and 82.5% in the HD-DN arm (P = .014). At a median follow-up of 52.6 months, overall (OS) and event-free (EFS) survival were higher in the HD-DN arm than in the SD-DN arm (OS, 46.8% vs 34.6%, P = .030; EFS, 40.8% vs 28.4%, P = .030). Differences in CR rate and both OS and EFS remained significant after adjusting for other variables (CR, hazard ratio [HR], 1.802, P = .024; OS, HR, 0.739, P = .032; EFS, HR, 0.774, P = .048). The survival benefits of HD-DN therapy were evident principally in patients with intermediate-risk cytogenetic features. The toxicity profiles were similar in the 2 arms. In conclusion, HD-DN improved both the CR rate and survival duration compared with SD-DN in young adults with AML. This study is registered at www.clinicaltrials.gov as #NCT00474006.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Antibiotics, Antineoplastic - administration & dosage</subject><subject>Antibiotics, Antineoplastic - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Daunorubicin - administration & dosage</subject><subject>Daunorubicin - therapeutic use</subject><subject>Disease-Free Survival</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Hematologic and hematopoietic diseases</subject><subject>Humans</subject><subject>Leukemia, Myeloid, Acute - diagnosis</subject><subject>Leukemia, Myeloid, Acute - drug therapy</subject><subject>Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Prognosis</subject><subject>Remission Induction</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0006-4971</issn><issn>1528-0020</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kE1v1DAQhi1ERbeFf4CQL4hTwB-J41yQqgoKUqVeytly7El3IIkXf7Rqfz1edoEbpxlpnnln9BDymrP3nGvxYZxD8I1gnDdMNVLxlrNnZMM7oRvGBHtONozVSTv0_JScpfSdMd5K0b0gp6IGaC7UhpQLGu3qw4JP4GmOaGfqwrKzEdc7mnKd2ejpPcRUEt3i3bbxIQH1tqwhlhEdrhRXX1zGsO_ozmaENSf6gHlLrSsZ6PIIc0BPZyg_YEH7kpxMdk7w6ljPybfPn24vvzTXN1dfLy-uG9fKPjets3L0wjotRiUnLZgQfBjUyJTvx6GTmvsJvAYhRD-N0ovWS6G6flIgtebynLw75O5i-FkgZbNgcjDPdoVQkhmY5G0vOatkeyBdDClFmMwu4mLjo-HM7H2b377N3rdhyhx817U3xwNlXMD_XfojuAJvj4BNzs5Tle0w_ePabug6uQ_6eOCg6rhHiCa5qtGBxwguGx_w_5_8Ak3loEk</recordid><startdate>20111006</startdate><enddate>20111006</enddate><creator>Lee, Je-Hwan</creator><creator>Joo, Young-Don</creator><creator>Kim, Hawk</creator><creator>Bae, Sung Hwa</creator><creator>Kim, Min Kyoung</creator><creator>Zang, Dae Young</creator><creator>Lee, Jung-Lim</creator><creator>Lee, Gyeong Won</creator><creator>Lee, Jung-Hee</creator><creator>Park, Jae-Hoo</creator><creator>Kim, Dae-Young</creator><creator>Lee, Won-Sik</creator><creator>Ryoo, Hun Mo</creator><creator>Hyun, Myung Soo</creator><creator>Kim, Hyo Jung</creator><creator>Min, Young Joo</creator><creator>Jang, Yae-Eun</creator><creator>Lee, Kyoo-Hyung</creator><general>Elsevier Inc</general><general>Americain Society of Hematology</general><scope>6I.</scope><scope>AAFTH</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>7X8</scope></search><sort><creationdate>20111006</creationdate><title>A randomized trial comparing standard versus high-dose daunorubicin induction in patients with acute myeloid leukemia</title><author>Lee, Je-Hwan ; Joo, Young-Don ; Kim, Hawk ; Bae, Sung Hwa ; Kim, Min Kyoung ; Zang, Dae Young ; Lee, Jung-Lim ; Lee, Gyeong Won ; Lee, Jung-Hee ; Park, Jae-Hoo ; Kim, Dae-Young ; Lee, Won-Sik ; Ryoo, Hun Mo ; Hyun, Myung Soo ; Kim, Hyo Jung ; Min, Young Joo ; Jang, Yae-Eun ; Lee, Kyoo-Hyung</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c437t-4ca3bd2ac82b63f820221996b06d7b95381dfed8e2227fb3d24d32657f6e38813</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Antibiotics, Antineoplastic - administration & dosage</topic><topic>Antibiotics, Antineoplastic - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Daunorubicin - administration & dosage</topic><topic>Daunorubicin - therapeutic use</topic><topic>Disease-Free Survival</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Hematologic and hematopoietic diseases</topic><topic>Humans</topic><topic>Leukemia, Myeloid, Acute - diagnosis</topic><topic>Leukemia, Myeloid, Acute - drug therapy</topic><topic>Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Prognosis</topic><topic>Remission Induction</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lee, Je-Hwan</creatorcontrib><creatorcontrib>Joo, Young-Don</creatorcontrib><creatorcontrib>Kim, Hawk</creatorcontrib><creatorcontrib>Bae, Sung Hwa</creatorcontrib><creatorcontrib>Kim, Min Kyoung</creatorcontrib><creatorcontrib>Zang, Dae Young</creatorcontrib><creatorcontrib>Lee, Jung-Lim</creatorcontrib><creatorcontrib>Lee, Gyeong Won</creatorcontrib><creatorcontrib>Lee, Jung-Hee</creatorcontrib><creatorcontrib>Park, Jae-Hoo</creatorcontrib><creatorcontrib>Kim, Dae-Young</creatorcontrib><creatorcontrib>Lee, Won-Sik</creatorcontrib><creatorcontrib>Ryoo, Hun Mo</creatorcontrib><creatorcontrib>Hyun, Myung Soo</creatorcontrib><creatorcontrib>Kim, Hyo Jung</creatorcontrib><creatorcontrib>Min, Young Joo</creatorcontrib><creatorcontrib>Jang, Yae-Eun</creatorcontrib><creatorcontrib>Lee, Kyoo-Hyung</creatorcontrib><creatorcontrib>Cooperative Study Group A for Hematology</creatorcontrib><creatorcontrib>for the Cooperative Study Group A for Hematology</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</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>MEDLINE - Academic</collection><jtitle>Blood</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lee, Je-Hwan</au><au>Joo, Young-Don</au><au>Kim, Hawk</au><au>Bae, Sung Hwa</au><au>Kim, Min Kyoung</au><au>Zang, Dae Young</au><au>Lee, Jung-Lim</au><au>Lee, Gyeong Won</au><au>Lee, Jung-Hee</au><au>Park, Jae-Hoo</au><au>Kim, Dae-Young</au><au>Lee, Won-Sik</au><au>Ryoo, Hun Mo</au><au>Hyun, Myung Soo</au><au>Kim, Hyo Jung</au><au>Min, Young Joo</au><au>Jang, Yae-Eun</au><au>Lee, Kyoo-Hyung</au><aucorp>Cooperative Study Group A for Hematology</aucorp><aucorp>for the Cooperative Study Group A for Hematology</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized trial comparing standard versus high-dose daunorubicin induction in patients with acute myeloid leukemia</atitle><jtitle>Blood</jtitle><addtitle>Blood</addtitle><date>2011-10-06</date><risdate>2011</risdate><volume>118</volume><issue>14</issue><spage>3832</spage><epage>3841</epage><pages>3832-3841</pages><issn>0006-4971</issn><eissn>1528-0020</eissn><abstract>We conducted a phase 3 randomized trial comparing 2 different doses of daunorubicin as induction chemotherapy in young adults (60 years of age or younger) with acute myeloid leukemia (AML). Of 383 patients who were analyzed, 189 received standard-dose daunorubicin (SD-DN, 45 mg/m2 per day times 3 days) and 194 received high-dose daunorubicin (HD-DN, 90 mg/m2 per day times 3 days) in addition to cytarabine (200 mg/m2 per day times 7 days) to induce complete remission (CR). The CR rates were 72.0% in the SD-DN arm and 82.5% in the HD-DN arm (P = .014). At a median follow-up of 52.6 months, overall (OS) and event-free (EFS) survival were higher in the HD-DN arm than in the SD-DN arm (OS, 46.8% vs 34.6%, P = .030; EFS, 40.8% vs 28.4%, P = .030). Differences in CR rate and both OS and EFS remained significant after adjusting for other variables (CR, hazard ratio [HR], 1.802, P = .024; OS, HR, 0.739, P = .032; EFS, HR, 0.774, P = .048). The survival benefits of HD-DN therapy were evident principally in patients with intermediate-risk cytogenetic features. The toxicity profiles were similar in the 2 arms. In conclusion, HD-DN improved both the CR rate and survival duration compared with SD-DN in young adults with AML. This study is registered at www.clinicaltrials.gov as #NCT00474006.</abstract><cop>Washington, DC</cop><pub>Elsevier Inc</pub><pmid>21828126</pmid><doi>10.1182/blood-2011-06-361410</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adult Antibiotics, Antineoplastic - administration & dosage Antibiotics, Antineoplastic - therapeutic use Biological and medical sciences Daunorubicin - administration & dosage Daunorubicin - therapeutic use Disease-Free Survival Female Follow-Up Studies Hematologic and hematopoietic diseases Humans Leukemia, Myeloid, Acute - diagnosis Leukemia, Myeloid, Acute - drug therapy Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis Male Medical sciences Middle Aged Prognosis Remission Induction Treatment Outcome Young Adult |
| title | A randomized trial comparing standard versus high-dose daunorubicin induction in patients with acute myeloid leukemia |
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