Outcomes in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with isolated deletion 5q treated with lenalidomide: a subset analysis from the MDS-004 study
Objective A subset analysis of the randomised, phase 3, MDS‐004 study to evaluate outcomes in patients with International Prognostic Scoring System (IPSS)‐defined Low‐/Intermediate (Int)‐1‐risk myelodysplastic syndromes (MDS) with isolated del(5q). Methods Patients received lenalidomide 10 mg/d (day...
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| Veröffentlicht in: | European journal of haematology 2014-11, Vol.93 (5), p.429-438 |
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| creator | Giagounidis, Aristoteles Mufti, Ghulam J. Mittelman, Moshe Sanz, Guillermo Platzbecker, Uwe Muus, Petra Selleslag, Dominik Beyne-Rauzy, Odile te Boekhorst, Peter del Cañizo, Consuelo Guerci-Bresler, Agnès Nilsson, Lars Lübbert, Michael Quesnel, Bruno Ganser, Arnold Bowen, David Schlegelberger, Brigitte Göhring, Gudrun Fu, Tommy Benettaib, Bouchra Hellström-Lindberg, Eva Fenaux, Pierre |
| description | Objective
A subset analysis of the randomised, phase 3, MDS‐004 study to evaluate outcomes in patients with International Prognostic Scoring System (IPSS)‐defined Low‐/Intermediate (Int)‐1‐risk myelodysplastic syndromes (MDS) with isolated del(5q).
Methods
Patients received lenalidomide 10 mg/d (days 1–21; n = 47) or 5 mg/d (days 1–28; n = 43) on 28‐d cycles or placebo (n = 45). From the placebo and lenalidomide 5 mg groups, 84% and 58% of patients, respectively, crossed over to lenalidomide 5 or 10 mg at 16 wk, respectively.
Results
Rates of red blood cell‐transfusion independence (RBC‐TI) ≥182 d were higher in the lenalidomide 10 mg (57.4%; P |
| doi_str_mv | 10.1111/ejh.12380 |
| format | Article |
| fullrecord | <record><control><sourceid>wiley_swepu</sourceid><recordid>TN_cdi_swepub_primary_oai_swepub_ki_se_521671</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>EJH12380</sourcerecordid><originalsourceid>FETCH-LOGICAL-i5560-3f1b50d6a654125d364be4c878f4fc7b6d419afe481b9500a8405542837d19b33</originalsourceid><addsrcrecordid>eNp1kttu1DAQhiMEokvhghdAfoF0fU7MBRLdlrZooRLlIHFjOfGEdTebhNhhm_frg-Fmy0IvsGR5NP7_b6zxJMlLgo9IXHO4Xh0RynL8KJkRiXGKJVaPkxlWmKacc3KQPPP-GmNMFcmeJgeU54RJimfJ7eUQynYDHrkGfTpeoNCbxleDd22TWuigsdAE1Jng4unR1oUVWrbbdH7RBOg3YJ0JkJK0d36NNiPUrR19VxsfXIn82Nh-ok8-59s6qi2yUEOIFZD4GQvClJsUNTSmdrbdOAuvkUF-KDwEZGJ29M6jKtJQWAH6cHKVYsyRD4MdnydPKlN7eHF_HiZf3p1-Xpyny8uzi8XbZeqEkDhlFSkEttJIwQkVlkleAC_zLK94VWaFtJwoU0FsTqEExibnWAhOc5ZZogrGDpN0x_Vb6IZCd73bmH7UrXH6PrWOEWhBicxI1C__q6-HLu4i7jsDlUaxTFEthS00p0WlVfxDrco8PtfYqpQ84t7scJEVG1_GD-lN_YD68KZxK_2j_RV5jOYyj4BX_wL2zj_jEAXznWDrahj39wTruznTcc70NGf69P35FPxtifMBbvYO06-1zFgm9LePZ3qhvh-f5Fdfdc5-A8Cj2Vc</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Outcomes in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with isolated deletion 5q treated with lenalidomide: a subset analysis from the MDS-004 study</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><source>SWEPUB Freely available online</source><creator>Giagounidis, Aristoteles ; Mufti, Ghulam J. ; Mittelman, Moshe ; Sanz, Guillermo ; Platzbecker, Uwe ; Muus, Petra ; Selleslag, Dominik ; Beyne-Rauzy, Odile ; te Boekhorst, Peter ; del Cañizo, Consuelo ; Guerci-Bresler, Agnès ; Nilsson, Lars ; Lübbert, Michael ; Quesnel, Bruno ; Ganser, Arnold ; Bowen, David ; Schlegelberger, Brigitte ; Göhring, Gudrun ; Fu, Tommy ; Benettaib, Bouchra ; Hellström-Lindberg, Eva ; Fenaux, Pierre</creator><creatorcontrib>Giagounidis, Aristoteles ; Mufti, Ghulam J. ; Mittelman, Moshe ; Sanz, Guillermo ; Platzbecker, Uwe ; Muus, Petra ; Selleslag, Dominik ; Beyne-Rauzy, Odile ; te Boekhorst, Peter ; del Cañizo, Consuelo ; Guerci-Bresler, Agnès ; Nilsson, Lars ; Lübbert, Michael ; Quesnel, Bruno ; Ganser, Arnold ; Bowen, David ; Schlegelberger, Brigitte ; Göhring, Gudrun ; Fu, Tommy ; Benettaib, Bouchra ; Hellström-Lindberg, Eva ; Fenaux, Pierre</creatorcontrib><description>Objective
A subset analysis of the randomised, phase 3, MDS‐004 study to evaluate outcomes in patients with International Prognostic Scoring System (IPSS)‐defined Low‐/Intermediate (Int)‐1‐risk myelodysplastic syndromes (MDS) with isolated del(5q).
Methods
Patients received lenalidomide 10 mg/d (days 1–21; n = 47) or 5 mg/d (days 1–28; n = 43) on 28‐d cycles or placebo (n = 45). From the placebo and lenalidomide 5 mg groups, 84% and 58% of patients, respectively, crossed over to lenalidomide 5 or 10 mg at 16 wk, respectively.
Results
Rates of red blood cell‐transfusion independence (RBC‐TI) ≥182 d were higher in the lenalidomide 10 mg (57.4%; P < 0.0001) and 5 mg (37.2%; P = 0.0001) groups vs. placebo (2.2%). Cytogenetic response rates (major + minor responses) were 56.8% (P < 0.0001), 23.1% (P = 0.0299) and 0%, respectively. Two‐year cumulative risk of acute myeloid leukaemia progression was 12.6%, 17.4% and 16.7% in the lenalidomide 10 mg, 5 mg, and placebo groups, respectively. In a 6‐month landmark analysis, overall survival was longer in lenalidomide‐treated patients with RBC‐TI ≥182 d vs. non‐responders (P = 0.0072). The most common grade 3–4 adverse event was myelosuppression.
Conclusions
These data support the clinical benefits and acceptable safety profile of lenalidomide in transfusion‐dependent patients with IPSS‐defined Low‐/Int‐1‐risk MDS with isolated del(5q).</description><identifier>ISSN: 0902-4441</identifier><identifier>ISSN: 1600-0609</identifier><identifier>EISSN: 1600-0609</identifier><identifier>DOI: 10.1111/ejh.12380</identifier><identifier>PMID: 24813620</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>acute myeloid leukaemia ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents - therapeutic use ; Chromosome Deletion ; Chromosomes, Human, Pair 5 ; Clinical Medicine ; Cytogenetic Analysis ; del(5q) ; Disease Progression ; Drug Administration Schedule ; Erythrocyte Transfusion ; Female ; Hematologi ; Hematology ; Humans ; Klinisk medicin ; lenalidomide ; Leukemia, Myeloid, Acute - genetics ; Leukemia, Myeloid, Acute - mortality ; Leukemia, Myeloid, Acute - pathology ; Leukemia, Myeloid, Acute - therapy ; Male ; Medical and Health Sciences ; Medicin och hälsovetenskap ; Middle Aged ; myelodysplastic ; myelodysplastic syndromes ; Myelodysplastic Syndromes - genetics ; Myelodysplastic Syndromes - mortality ; Myelodysplastic Syndromes - pathology ; Myelodysplastic Syndromes - therapy ; Original ; Retrospective Studies ; Risk ; Survival Analysis ; syndromes ; Thalidomide - analogs & derivatives ; Thalidomide - therapeutic use ; transfusion independence ; Treatment Outcome</subject><ispartof>European journal of haematology, 2014-11, Vol.93 (5), p.429-438</ispartof><rights>2014 The Authors. Published by John Wiley & Sons Ltd.</rights><rights>2014 The Authors. European Journal of Haematology Published by John Wiley & Sons Ltd.</rights><rights>2014 The Authors. Published by John Wiley & Sons Ltd. 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></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.12380$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fejh.12380$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,550,776,780,881,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24813620$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://lup.lub.lu.se/record/4876016$$DView record from Swedish Publication Index$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:129991163$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Giagounidis, Aristoteles</creatorcontrib><creatorcontrib>Mufti, Ghulam J.</creatorcontrib><creatorcontrib>Mittelman, Moshe</creatorcontrib><creatorcontrib>Sanz, Guillermo</creatorcontrib><creatorcontrib>Platzbecker, Uwe</creatorcontrib><creatorcontrib>Muus, Petra</creatorcontrib><creatorcontrib>Selleslag, Dominik</creatorcontrib><creatorcontrib>Beyne-Rauzy, Odile</creatorcontrib><creatorcontrib>te Boekhorst, Peter</creatorcontrib><creatorcontrib>del Cañizo, Consuelo</creatorcontrib><creatorcontrib>Guerci-Bresler, Agnès</creatorcontrib><creatorcontrib>Nilsson, Lars</creatorcontrib><creatorcontrib>Lübbert, Michael</creatorcontrib><creatorcontrib>Quesnel, Bruno</creatorcontrib><creatorcontrib>Ganser, Arnold</creatorcontrib><creatorcontrib>Bowen, David</creatorcontrib><creatorcontrib>Schlegelberger, Brigitte</creatorcontrib><creatorcontrib>Göhring, Gudrun</creatorcontrib><creatorcontrib>Fu, Tommy</creatorcontrib><creatorcontrib>Benettaib, Bouchra</creatorcontrib><creatorcontrib>Hellström-Lindberg, Eva</creatorcontrib><creatorcontrib>Fenaux, Pierre</creatorcontrib><title>Outcomes in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with isolated deletion 5q treated with lenalidomide: a subset analysis from the MDS-004 study</title><title>European journal of haematology</title><addtitle>Eur J Haematol</addtitle><description>Objective
A subset analysis of the randomised, phase 3, MDS‐004 study to evaluate outcomes in patients with International Prognostic Scoring System (IPSS)‐defined Low‐/Intermediate (Int)‐1‐risk myelodysplastic syndromes (MDS) with isolated del(5q).
Methods
Patients received lenalidomide 10 mg/d (days 1–21; n = 47) or 5 mg/d (days 1–28; n = 43) on 28‐d cycles or placebo (n = 45). From the placebo and lenalidomide 5 mg groups, 84% and 58% of patients, respectively, crossed over to lenalidomide 5 or 10 mg at 16 wk, respectively.
Results
Rates of red blood cell‐transfusion independence (RBC‐TI) ≥182 d were higher in the lenalidomide 10 mg (57.4%; P < 0.0001) and 5 mg (37.2%; P = 0.0001) groups vs. placebo (2.2%). Cytogenetic response rates (major + minor responses) were 56.8% (P < 0.0001), 23.1% (P = 0.0299) and 0%, respectively. Two‐year cumulative risk of acute myeloid leukaemia progression was 12.6%, 17.4% and 16.7% in the lenalidomide 10 mg, 5 mg, and placebo groups, respectively. In a 6‐month landmark analysis, overall survival was longer in lenalidomide‐treated patients with RBC‐TI ≥182 d vs. non‐responders (P = 0.0072). The most common grade 3–4 adverse event was myelosuppression.
Conclusions
These data support the clinical benefits and acceptable safety profile of lenalidomide in transfusion‐dependent patients with IPSS‐defined Low‐/Int‐1‐risk MDS with isolated del(5q).</description><subject>acute myeloid leukaemia</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Chromosome Deletion</subject><subject>Chromosomes, Human, Pair 5</subject><subject>Clinical Medicine</subject><subject>Cytogenetic Analysis</subject><subject>del(5q)</subject><subject>Disease Progression</subject><subject>Drug Administration Schedule</subject><subject>Erythrocyte Transfusion</subject><subject>Female</subject><subject>Hematologi</subject><subject>Hematology</subject><subject>Humans</subject><subject>Klinisk medicin</subject><subject>lenalidomide</subject><subject>Leukemia, Myeloid, Acute - genetics</subject><subject>Leukemia, Myeloid, Acute - mortality</subject><subject>Leukemia, Myeloid, Acute - pathology</subject><subject>Leukemia, Myeloid, Acute - therapy</subject><subject>Male</subject><subject>Medical and Health Sciences</subject><subject>Medicin och hälsovetenskap</subject><subject>Middle Aged</subject><subject>myelodysplastic</subject><subject>myelodysplastic syndromes</subject><subject>Myelodysplastic Syndromes - genetics</subject><subject>Myelodysplastic Syndromes - mortality</subject><subject>Myelodysplastic Syndromes - pathology</subject><subject>Myelodysplastic Syndromes - therapy</subject><subject>Original</subject><subject>Retrospective Studies</subject><subject>Risk</subject><subject>Survival Analysis</subject><subject>syndromes</subject><subject>Thalidomide - analogs & derivatives</subject><subject>Thalidomide - therapeutic use</subject><subject>transfusion independence</subject><subject>Treatment Outcome</subject><issn>0902-4441</issn><issn>1600-0609</issn><issn>1600-0609</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><sourceid>D8T</sourceid><recordid>eNp1kttu1DAQhiMEokvhghdAfoF0fU7MBRLdlrZooRLlIHFjOfGEdTebhNhhm_frg-Fmy0IvsGR5NP7_b6zxJMlLgo9IXHO4Xh0RynL8KJkRiXGKJVaPkxlWmKacc3KQPPP-GmNMFcmeJgeU54RJimfJ7eUQynYDHrkGfTpeoNCbxleDd22TWuigsdAE1Jng4unR1oUVWrbbdH7RBOg3YJ0JkJK0d36NNiPUrR19VxsfXIn82Nh-ok8-59s6qi2yUEOIFZD4GQvClJsUNTSmdrbdOAuvkUF-KDwEZGJ29M6jKtJQWAH6cHKVYsyRD4MdnydPKlN7eHF_HiZf3p1-Xpyny8uzi8XbZeqEkDhlFSkEttJIwQkVlkleAC_zLK94VWaFtJwoU0FsTqEExibnWAhOc5ZZogrGDpN0x_Vb6IZCd73bmH7UrXH6PrWOEWhBicxI1C__q6-HLu4i7jsDlUaxTFEthS00p0WlVfxDrco8PtfYqpQ84t7scJEVG1_GD-lN_YD68KZxK_2j_RV5jOYyj4BX_wL2zj_jEAXznWDrahj39wTruznTcc70NGf69P35FPxtifMBbvYO06-1zFgm9LePZ3qhvh-f5Fdfdc5-A8Cj2Vc</recordid><startdate>201411</startdate><enddate>201411</enddate><creator>Giagounidis, Aristoteles</creator><creator>Mufti, Ghulam J.</creator><creator>Mittelman, Moshe</creator><creator>Sanz, Guillermo</creator><creator>Platzbecker, Uwe</creator><creator>Muus, Petra</creator><creator>Selleslag, Dominik</creator><creator>Beyne-Rauzy, Odile</creator><creator>te Boekhorst, Peter</creator><creator>del Cañizo, Consuelo</creator><creator>Guerci-Bresler, Agnès</creator><creator>Nilsson, Lars</creator><creator>Lübbert, Michael</creator><creator>Quesnel, Bruno</creator><creator>Ganser, Arnold</creator><creator>Bowen, David</creator><creator>Schlegelberger, Brigitte</creator><creator>Göhring, Gudrun</creator><creator>Fu, Tommy</creator><creator>Benettaib, Bouchra</creator><creator>Hellström-Lindberg, Eva</creator><creator>Fenaux, Pierre</creator><general>Blackwell Publishing Ltd</general><general>BlackWell Publishing Ltd</general><scope>BSCLL</scope><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>5PM</scope><scope>ADTPV</scope><scope>AOWAS</scope><scope>D95</scope><scope>D8T</scope><scope>ZZAVC</scope></search><sort><creationdate>201411</creationdate><title>Outcomes in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with isolated deletion 5q treated with lenalidomide: a subset analysis from the MDS-004 study</title><author>Giagounidis, Aristoteles ; Mufti, Ghulam J. ; Mittelman, Moshe ; Sanz, Guillermo ; Platzbecker, Uwe ; Muus, Petra ; Selleslag, Dominik ; Beyne-Rauzy, Odile ; te Boekhorst, Peter ; del Cañizo, Consuelo ; Guerci-Bresler, Agnès ; Nilsson, Lars ; Lübbert, Michael ; Quesnel, Bruno ; Ganser, Arnold ; Bowen, David ; Schlegelberger, Brigitte ; Göhring, Gudrun ; Fu, Tommy ; Benettaib, Bouchra ; Hellström-Lindberg, Eva ; Fenaux, Pierre</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-i5560-3f1b50d6a654125d364be4c878f4fc7b6d419afe481b9500a8405542837d19b33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>acute myeloid leukaemia</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Chromosome Deletion</topic><topic>Chromosomes, Human, Pair 5</topic><topic>Clinical Medicine</topic><topic>Cytogenetic Analysis</topic><topic>del(5q)</topic><topic>Disease Progression</topic><topic>Drug Administration Schedule</topic><topic>Erythrocyte Transfusion</topic><topic>Female</topic><topic>Hematologi</topic><topic>Hematology</topic><topic>Humans</topic><topic>Klinisk medicin</topic><topic>lenalidomide</topic><topic>Leukemia, Myeloid, Acute - genetics</topic><topic>Leukemia, Myeloid, Acute - mortality</topic><topic>Leukemia, Myeloid, Acute - pathology</topic><topic>Leukemia, Myeloid, Acute - therapy</topic><topic>Male</topic><topic>Medical and Health Sciences</topic><topic>Medicin och hälsovetenskap</topic><topic>Middle Aged</topic><topic>myelodysplastic</topic><topic>myelodysplastic syndromes</topic><topic>Myelodysplastic Syndromes - genetics</topic><topic>Myelodysplastic Syndromes - mortality</topic><topic>Myelodysplastic Syndromes - pathology</topic><topic>Myelodysplastic Syndromes - therapy</topic><topic>Original</topic><topic>Retrospective Studies</topic><topic>Risk</topic><topic>Survival Analysis</topic><topic>syndromes</topic><topic>Thalidomide - analogs & derivatives</topic><topic>Thalidomide - therapeutic use</topic><topic>transfusion independence</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Giagounidis, Aristoteles</creatorcontrib><creatorcontrib>Mufti, Ghulam J.</creatorcontrib><creatorcontrib>Mittelman, Moshe</creatorcontrib><creatorcontrib>Sanz, Guillermo</creatorcontrib><creatorcontrib>Platzbecker, Uwe</creatorcontrib><creatorcontrib>Muus, Petra</creatorcontrib><creatorcontrib>Selleslag, Dominik</creatorcontrib><creatorcontrib>Beyne-Rauzy, Odile</creatorcontrib><creatorcontrib>te Boekhorst, Peter</creatorcontrib><creatorcontrib>del Cañizo, Consuelo</creatorcontrib><creatorcontrib>Guerci-Bresler, Agnès</creatorcontrib><creatorcontrib>Nilsson, Lars</creatorcontrib><creatorcontrib>Lübbert, Michael</creatorcontrib><creatorcontrib>Quesnel, Bruno</creatorcontrib><creatorcontrib>Ganser, Arnold</creatorcontrib><creatorcontrib>Bowen, David</creatorcontrib><creatorcontrib>Schlegelberger, Brigitte</creatorcontrib><creatorcontrib>Göhring, Gudrun</creatorcontrib><creatorcontrib>Fu, Tommy</creatorcontrib><creatorcontrib>Benettaib, Bouchra</creatorcontrib><creatorcontrib>Hellström-Lindberg, Eva</creatorcontrib><creatorcontrib>Fenaux, Pierre</creatorcontrib><collection>Istex</collection><collection>Wiley Online Library Open Access</collection><collection>Wiley Free Content</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>PubMed Central (Full Participant titles)</collection><collection>SwePub</collection><collection>SwePub Articles</collection><collection>SWEPUB Lunds universitet</collection><collection>SWEPUB Freely available online</collection><collection>SwePub Articles full text</collection><jtitle>European journal of haematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Giagounidis, Aristoteles</au><au>Mufti, Ghulam J.</au><au>Mittelman, Moshe</au><au>Sanz, Guillermo</au><au>Platzbecker, Uwe</au><au>Muus, Petra</au><au>Selleslag, Dominik</au><au>Beyne-Rauzy, Odile</au><au>te Boekhorst, Peter</au><au>del Cañizo, Consuelo</au><au>Guerci-Bresler, Agnès</au><au>Nilsson, Lars</au><au>Lübbert, Michael</au><au>Quesnel, Bruno</au><au>Ganser, Arnold</au><au>Bowen, David</au><au>Schlegelberger, Brigitte</au><au>Göhring, Gudrun</au><au>Fu, Tommy</au><au>Benettaib, Bouchra</au><au>Hellström-Lindberg, Eva</au><au>Fenaux, Pierre</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Outcomes in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with isolated deletion 5q treated with lenalidomide: a subset analysis from the MDS-004 study</atitle><jtitle>European journal of haematology</jtitle><addtitle>Eur J Haematol</addtitle><date>2014-11</date><risdate>2014</risdate><volume>93</volume><issue>5</issue><spage>429</spage><epage>438</epage><pages>429-438</pages><issn>0902-4441</issn><issn>1600-0609</issn><eissn>1600-0609</eissn><abstract>Objective
A subset analysis of the randomised, phase 3, MDS‐004 study to evaluate outcomes in patients with International Prognostic Scoring System (IPSS)‐defined Low‐/Intermediate (Int)‐1‐risk myelodysplastic syndromes (MDS) with isolated del(5q).
Methods
Patients received lenalidomide 10 mg/d (days 1–21; n = 47) or 5 mg/d (days 1–28; n = 43) on 28‐d cycles or placebo (n = 45). From the placebo and lenalidomide 5 mg groups, 84% and 58% of patients, respectively, crossed over to lenalidomide 5 or 10 mg at 16 wk, respectively.
Results
Rates of red blood cell‐transfusion independence (RBC‐TI) ≥182 d were higher in the lenalidomide 10 mg (57.4%; P < 0.0001) and 5 mg (37.2%; P = 0.0001) groups vs. placebo (2.2%). Cytogenetic response rates (major + minor responses) were 56.8% (P < 0.0001), 23.1% (P = 0.0299) and 0%, respectively. Two‐year cumulative risk of acute myeloid leukaemia progression was 12.6%, 17.4% and 16.7% in the lenalidomide 10 mg, 5 mg, and placebo groups, respectively. In a 6‐month landmark analysis, overall survival was longer in lenalidomide‐treated patients with RBC‐TI ≥182 d vs. non‐responders (P = 0.0072). The most common grade 3–4 adverse event was myelosuppression.
Conclusions
These data support the clinical benefits and acceptable safety profile of lenalidomide in transfusion‐dependent patients with IPSS‐defined Low‐/Int‐1‐risk MDS with isolated del(5q).</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>24813620</pmid><doi>10.1111/ejh.12380</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0902-4441 |
| ispartof | European journal of haematology, 2014-11, Vol.93 (5), p.429-438 |
| issn | 0902-4441 1600-0609 1600-0609 |
| language | eng |
| recordid | cdi_swepub_primary_oai_swepub_ki_se_521671 |
| source | MEDLINE; Wiley Online Library Journals Frontfile Complete; SWEPUB Freely available online |
| subjects | acute myeloid leukaemia Adult Aged Aged, 80 and over Antineoplastic Agents - therapeutic use Chromosome Deletion Chromosomes, Human, Pair 5 Clinical Medicine Cytogenetic Analysis del(5q) Disease Progression Drug Administration Schedule Erythrocyte Transfusion Female Hematologi Hematology Humans Klinisk medicin lenalidomide Leukemia, Myeloid, Acute - genetics Leukemia, Myeloid, Acute - mortality Leukemia, Myeloid, Acute - pathology Leukemia, Myeloid, Acute - therapy Male Medical and Health Sciences Medicin och hälsovetenskap Middle Aged myelodysplastic myelodysplastic syndromes Myelodysplastic Syndromes - genetics Myelodysplastic Syndromes - mortality Myelodysplastic Syndromes - pathology Myelodysplastic Syndromes - therapy Original Retrospective Studies Risk Survival Analysis syndromes Thalidomide - analogs & derivatives Thalidomide - therapeutic use transfusion independence Treatment Outcome |
| title | Outcomes in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with isolated deletion 5q treated with lenalidomide: a subset analysis from the MDS-004 study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-23T14%3A45%3A17IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-wiley_swepu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Outcomes%20in%20RBC%20transfusion-dependent%20patients%20with%20Low-/Intermediate-1-risk%20myelodysplastic%20syndromes%20with%20isolated%20deletion%205q%20treated%20with%20lenalidomide:%20a%20subset%20analysis%20from%20the%20MDS-004%20study&rft.jtitle=European%20journal%20of%20haematology&rft.au=Giagounidis,%20Aristoteles&rft.date=2014-11&rft.volume=93&rft.issue=5&rft.spage=429&rft.epage=438&rft.pages=429-438&rft.issn=0902-4441&rft.eissn=1600-0609&rft_id=info:doi/10.1111/ejh.12380&rft_dat=%3Cwiley_swepu%3EEJH12380%3C/wiley_swepu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_id=info:pmid/24813620&rfr_iscdi=true |