Real-life use of erythropoiesis-stimulating agents in myelodysplastic syndromes: a “Gruppo Romano Mielodisplasie (GROM)” multicenter study
The Gruppo Romano Mielodisplasie (GROM) conducted a retrospective study in 543 patients with myelodysplastic syndromes (MDS) to evaluate the safety and efficacy of erythropoiesis-stimulating agents (ESAs) in “real-life” clinical practice. The 40.000-UI/week erythropoietin (EPO)-alpha and 30.000-UI/w...
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creator | Buccisano, Francesco Piccioni, Anna Lina Nobile, Carolina Criscuolo, Marianna Niscola, Pasquale Tatarelli, Caterina Fianchi, Luana Villivà, Nicoletta Neri, Benedetta Carmosino, Ida Gumenyuk, Svitlana Mancini, Stefano Voso, Maria Teresa Maurillo, Luca Breccia, Massimo Zini, Gina Venditti, Adriano Fenu, Susanna Spiriti, Maria Antonietta Aloe Latagliata, Roberto |
description | The Gruppo Romano Mielodisplasie (GROM) conducted a retrospective study in 543 patients with myelodysplastic syndromes (MDS) to evaluate the safety and efficacy of erythropoiesis-stimulating agents (ESAs) in “real-life” clinical practice. The 40.000-UI/week erythropoietin (EPO)-alpha and 30.000-UI/week EPO-beta starting dose were defined “standard,” and 80,000 UI/week EPO-alpha and 60.000 UI/week EPO-beta were defined “high.” Response was defined according to International Working Group (IWG) 2006 criteria. At ESA’s start, median age was 74.2 years (interquartile range (IR) 67.8–79.5) and median hemoglobin was 8.9 g/dl (IR 8.2–9.6). Median time from diagnosis to ESAs start was 3.8 months (IR 0.8–13.2). ESA starting dose was “standard” in 361 patients (66.5 %) and “high” in 182 patients (33.5 %). Erythroid response was observed in 82/185 (44.3 %) transfusion dependent (TD) patients as compared with 226/329 (68.6 %) transfusion independent (TI) ones (
p
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doi_str_mv | 10.1007/s00277-016-2667-1 |
format | Article |
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p
< 0.001). At multivariate analysis, in TD patients, only endogenous EPO levels <50 mU/l were significant (
p
= 0.046), whereas in TI patients, high-dose ESAs (
p
< 0.001), abnormal creatinine levels (0.009), and endogenous EPO levels <50 mU/l (
p
= 0.014) were predictors of response. Responders showed a higher 5-year overall survival (OS) (57.8 vs. 32.2 %,
p
< 0.001) and leukemia-free survival (76.0 vs. 49.8 %,
p
< 0.001). At multivariable analysis for OS, response to ESA, low International Prognostic Scoring System (IPSS), no transfusion need, and female sex showed an independent favorable prognostic role. Our results confirm that treatment with ESAs is effective in a real-life MDS setting, particularly at high dose and in TI patients. Prospective studies are needed to define the optimal starting dose.]]></description><identifier>ISSN: 0939-5555</identifier><identifier>EISSN: 1432-0584</identifier><identifier>DOI: 10.1007/s00277-016-2667-1</identifier><identifier>PMID: 27091349</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Aged ; Aged, 80 and over ; Female ; Follow-Up Studies ; Hematinics - therapeutic use ; Hematology ; Humans ; Italy - epidemiology ; Male ; Medicine ; Medicine & Public Health ; Myelodysplastic syndromes ; Myelodysplastic Syndromes - diagnosis ; Myelodysplastic Syndromes - drug therapy ; Myelodysplastic Syndromes - mortality ; Oncology ; Original Article ; Retrospective Studies ; Survival Rate - trends</subject><ispartof>Annals of hematology, 2016-06, Vol.95 (7), p.1059-1065</ispartof><rights>Springer-Verlag Berlin Heidelberg 2016</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c372t-5bed263300cc4e8951601f406e6b7c6000c4a8862eafdba7ce5ddf0ce4a89843</citedby><cites>FETCH-LOGICAL-c372t-5bed263300cc4e8951601f406e6b7c6000c4a8862eafdba7ce5ddf0ce4a89843</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00277-016-2667-1$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00277-016-2667-1$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27091349$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Buccisano, Francesco</creatorcontrib><creatorcontrib>Piccioni, Anna Lina</creatorcontrib><creatorcontrib>Nobile, Carolina</creatorcontrib><creatorcontrib>Criscuolo, Marianna</creatorcontrib><creatorcontrib>Niscola, Pasquale</creatorcontrib><creatorcontrib>Tatarelli, Caterina</creatorcontrib><creatorcontrib>Fianchi, Luana</creatorcontrib><creatorcontrib>Villivà, Nicoletta</creatorcontrib><creatorcontrib>Neri, Benedetta</creatorcontrib><creatorcontrib>Carmosino, Ida</creatorcontrib><creatorcontrib>Gumenyuk, Svitlana</creatorcontrib><creatorcontrib>Mancini, Stefano</creatorcontrib><creatorcontrib>Voso, Maria Teresa</creatorcontrib><creatorcontrib>Maurillo, Luca</creatorcontrib><creatorcontrib>Breccia, Massimo</creatorcontrib><creatorcontrib>Zini, Gina</creatorcontrib><creatorcontrib>Venditti, Adriano</creatorcontrib><creatorcontrib>Fenu, Susanna</creatorcontrib><creatorcontrib>Spiriti, Maria Antonietta Aloe</creatorcontrib><creatorcontrib>Latagliata, Roberto</creatorcontrib><creatorcontrib>GROM (Gruppo Romano Mielodisplasie)</creatorcontrib><creatorcontrib>on behalf of GROM (Gruppo Romano Mielodisplasie)</creatorcontrib><title>Real-life use of erythropoiesis-stimulating agents in myelodysplastic syndromes: a “Gruppo Romano Mielodisplasie (GROM)” multicenter study</title><title>Annals of hematology</title><addtitle>Ann Hematol</addtitle><addtitle>Ann Hematol</addtitle><description><![CDATA[The Gruppo Romano Mielodisplasie (GROM) conducted a retrospective study in 543 patients with myelodysplastic syndromes (MDS) to evaluate the safety and efficacy of erythropoiesis-stimulating agents (ESAs) in “real-life” clinical practice. The 40.000-UI/week erythropoietin (EPO)-alpha and 30.000-UI/week EPO-beta starting dose were defined “standard,” and 80,000 UI/week EPO-alpha and 60.000 UI/week EPO-beta were defined “high.” Response was defined according to International Working Group (IWG) 2006 criteria. At ESA’s start, median age was 74.2 years (interquartile range (IR) 67.8–79.5) and median hemoglobin was 8.9 g/dl (IR 8.2–9.6). Median time from diagnosis to ESAs start was 3.8 months (IR 0.8–13.2). ESA starting dose was “standard” in 361 patients (66.5 %) and “high” in 182 patients (33.5 %). Erythroid response was observed in 82/185 (44.3 %) transfusion dependent (TD) patients as compared with 226/329 (68.6 %) transfusion independent (TI) ones (
p
< 0.001). At multivariate analysis, in TD patients, only endogenous EPO levels <50 mU/l were significant (
p
= 0.046), whereas in TI patients, high-dose ESAs (
p
< 0.001), abnormal creatinine levels (0.009), and endogenous EPO levels <50 mU/l (
p
= 0.014) were predictors of response. Responders showed a higher 5-year overall survival (OS) (57.8 vs. 32.2 %,
p
< 0.001) and leukemia-free survival (76.0 vs. 49.8 %,
p
< 0.001). At multivariable analysis for OS, response to ESA, low International Prognostic Scoring System (IPSS), no transfusion need, and female sex showed an independent favorable prognostic role. Our results confirm that treatment with ESAs is effective in a real-life MDS setting, particularly at high dose and in TI patients. Prospective studies are needed to define the optimal starting dose.]]></description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Hematinics - therapeutic use</subject><subject>Hematology</subject><subject>Humans</subject><subject>Italy - epidemiology</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Myelodysplastic syndromes</subject><subject>Myelodysplastic Syndromes - diagnosis</subject><subject>Myelodysplastic Syndromes - drug therapy</subject><subject>Myelodysplastic Syndromes - mortality</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Retrospective Studies</subject><subject>Survival Rate - trends</subject><issn>0939-5555</issn><issn>1432-0584</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kUFu1DAUhi1ERYeWA7BBltiUhemzk9gJO1TBgNSq0qh7y5O8DK6SOPgli-x6Ak4Al-tJ8HQKQkj1xtLz93-2_DP2WsJ7CWDOCUAZI0BqobQ2Qj5jK5lnSkBR5s_ZCqqsEkVax-wl0S2AVGWuXrBjZaCSWV6t2I8Nuk50vkU-E_LQcozL9C2GMXgkT4Im38-dm_yw426Hw0TcD7xfsAvNQmPnElBzWoYmhh7pA3f8_u7nOs7jGPgm9G4I_Mrvaf9Ae-Rn68311bv7u188mVM6STFymuZmOWVHresIXz3uJ-zm86ebiy_i8nr99eLjpagzoyZRbLFROssA6jrHsiqkBtnmoFFvTa0hzXNXllqha5utMzUWTdNCjWlalXl2ws4O2jGG7zPSZHtPNXadGzDMZKVJPydVrnVC3_6H3oY5DulxD5SETINJlDxQdQxEEVs7Rt-7uFgJdt-VPXRlU1d235WVKfPm0Txve2z-Jv6UkwB1ACgdDTuM_1z9pPU3vv-jXg</recordid><startdate>20160601</startdate><enddate>20160601</enddate><creator>Buccisano, Francesco</creator><creator>Piccioni, Anna Lina</creator><creator>Nobile, Carolina</creator><creator>Criscuolo, Marianna</creator><creator>Niscola, Pasquale</creator><creator>Tatarelli, Caterina</creator><creator>Fianchi, Luana</creator><creator>Villivà, Nicoletta</creator><creator>Neri, Benedetta</creator><creator>Carmosino, Ida</creator><creator>Gumenyuk, Svitlana</creator><creator>Mancini, Stefano</creator><creator>Voso, Maria Teresa</creator><creator>Maurillo, Luca</creator><creator>Breccia, Massimo</creator><creator>Zini, Gina</creator><creator>Venditti, Adriano</creator><creator>Fenu, Susanna</creator><creator>Spiriti, Maria Antonietta Aloe</creator><creator>Latagliata, Roberto</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><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>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20160601</creationdate><title>Real-life use of erythropoiesis-stimulating agents in myelodysplastic syndromes: a “Gruppo Romano Mielodisplasie (GROM)” multicenter study</title><author>Buccisano, Francesco ; Piccioni, Anna Lina ; Nobile, Carolina ; Criscuolo, Marianna ; Niscola, Pasquale ; Tatarelli, Caterina ; Fianchi, Luana ; Villivà, Nicoletta ; Neri, Benedetta ; Carmosino, Ida ; Gumenyuk, Svitlana ; Mancini, Stefano ; Voso, Maria Teresa ; Maurillo, Luca ; Breccia, Massimo ; Zini, Gina ; Venditti, Adriano ; Fenu, Susanna ; Spiriti, Maria Antonietta Aloe ; Latagliata, Roberto</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c372t-5bed263300cc4e8951601f406e6b7c6000c4a8862eafdba7ce5ddf0ce4a89843</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Hematinics - therapeutic use</topic><topic>Hematology</topic><topic>Humans</topic><topic>Italy - epidemiology</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Myelodysplastic syndromes</topic><topic>Myelodysplastic Syndromes - diagnosis</topic><topic>Myelodysplastic Syndromes - drug therapy</topic><topic>Myelodysplastic Syndromes - mortality</topic><topic>Oncology</topic><topic>Original Article</topic><topic>Retrospective Studies</topic><topic>Survival Rate - trends</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Buccisano, Francesco</creatorcontrib><creatorcontrib>Piccioni, Anna Lina</creatorcontrib><creatorcontrib>Nobile, Carolina</creatorcontrib><creatorcontrib>Criscuolo, Marianna</creatorcontrib><creatorcontrib>Niscola, Pasquale</creatorcontrib><creatorcontrib>Tatarelli, Caterina</creatorcontrib><creatorcontrib>Fianchi, Luana</creatorcontrib><creatorcontrib>Villivà, Nicoletta</creatorcontrib><creatorcontrib>Neri, Benedetta</creatorcontrib><creatorcontrib>Carmosino, Ida</creatorcontrib><creatorcontrib>Gumenyuk, Svitlana</creatorcontrib><creatorcontrib>Mancini, Stefano</creatorcontrib><creatorcontrib>Voso, Maria Teresa</creatorcontrib><creatorcontrib>Maurillo, Luca</creatorcontrib><creatorcontrib>Breccia, Massimo</creatorcontrib><creatorcontrib>Zini, Gina</creatorcontrib><creatorcontrib>Venditti, Adriano</creatorcontrib><creatorcontrib>Fenu, Susanna</creatorcontrib><creatorcontrib>Spiriti, Maria Antonietta Aloe</creatorcontrib><creatorcontrib>Latagliata, Roberto</creatorcontrib><creatorcontrib>GROM (Gruppo Romano Mielodisplasie)</creatorcontrib><creatorcontrib>on behalf of GROM (Gruppo Romano Mielodisplasie)</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Annals of hematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Buccisano, Francesco</au><au>Piccioni, Anna Lina</au><au>Nobile, Carolina</au><au>Criscuolo, Marianna</au><au>Niscola, Pasquale</au><au>Tatarelli, Caterina</au><au>Fianchi, Luana</au><au>Villivà, Nicoletta</au><au>Neri, Benedetta</au><au>Carmosino, Ida</au><au>Gumenyuk, Svitlana</au><au>Mancini, Stefano</au><au>Voso, Maria Teresa</au><au>Maurillo, Luca</au><au>Breccia, Massimo</au><au>Zini, Gina</au><au>Venditti, Adriano</au><au>Fenu, Susanna</au><au>Spiriti, Maria Antonietta Aloe</au><au>Latagliata, Roberto</au><aucorp>GROM (Gruppo Romano Mielodisplasie)</aucorp><aucorp>on behalf of GROM (Gruppo Romano Mielodisplasie)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Real-life use of erythropoiesis-stimulating agents in myelodysplastic syndromes: a “Gruppo Romano Mielodisplasie (GROM)” multicenter study</atitle><jtitle>Annals of hematology</jtitle><stitle>Ann Hematol</stitle><addtitle>Ann Hematol</addtitle><date>2016-06-01</date><risdate>2016</risdate><volume>95</volume><issue>7</issue><spage>1059</spage><epage>1065</epage><pages>1059-1065</pages><issn>0939-5555</issn><eissn>1432-0584</eissn><abstract><![CDATA[The Gruppo Romano Mielodisplasie (GROM) conducted a retrospective study in 543 patients with myelodysplastic syndromes (MDS) to evaluate the safety and efficacy of erythropoiesis-stimulating agents (ESAs) in “real-life” clinical practice. The 40.000-UI/week erythropoietin (EPO)-alpha and 30.000-UI/week EPO-beta starting dose were defined “standard,” and 80,000 UI/week EPO-alpha and 60.000 UI/week EPO-beta were defined “high.” Response was defined according to International Working Group (IWG) 2006 criteria. At ESA’s start, median age was 74.2 years (interquartile range (IR) 67.8–79.5) and median hemoglobin was 8.9 g/dl (IR 8.2–9.6). Median time from diagnosis to ESAs start was 3.8 months (IR 0.8–13.2). ESA starting dose was “standard” in 361 patients (66.5 %) and “high” in 182 patients (33.5 %). Erythroid response was observed in 82/185 (44.3 %) transfusion dependent (TD) patients as compared with 226/329 (68.6 %) transfusion independent (TI) ones (
p
< 0.001). At multivariate analysis, in TD patients, only endogenous EPO levels <50 mU/l were significant (
p
= 0.046), whereas in TI patients, high-dose ESAs (
p
< 0.001), abnormal creatinine levels (0.009), and endogenous EPO levels <50 mU/l (
p
= 0.014) were predictors of response. Responders showed a higher 5-year overall survival (OS) (57.8 vs. 32.2 %,
p
< 0.001) and leukemia-free survival (76.0 vs. 49.8 %,
p
< 0.001). At multivariable analysis for OS, response to ESA, low International Prognostic Scoring System (IPSS), no transfusion need, and female sex showed an independent favorable prognostic role. Our results confirm that treatment with ESAs is effective in a real-life MDS setting, particularly at high dose and in TI patients. Prospective studies are needed to define the optimal starting dose.]]></abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>27091349</pmid><doi>10.1007/s00277-016-2667-1</doi><tpages>7</tpages></addata></record> |
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ispartof | Annals of hematology, 2016-06, Vol.95 (7), p.1059-1065 |
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source | MEDLINE; SpringerLink Journals |
subjects | Aged Aged, 80 and over Female Follow-Up Studies Hematinics - therapeutic use Hematology Humans Italy - epidemiology Male Medicine Medicine & Public Health Myelodysplastic syndromes Myelodysplastic Syndromes - diagnosis Myelodysplastic Syndromes - drug therapy Myelodysplastic Syndromes - mortality Oncology Original Article Retrospective Studies Survival Rate - trends |
title | Real-life use of erythropoiesis-stimulating agents in myelodysplastic syndromes: a “Gruppo Romano Mielodisplasie (GROM)” multicenter study |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-15T16%3A01%3A34IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Real-life%20use%20of%20erythropoiesis-stimulating%20agents%20in%20myelodysplastic%20syndromes:%20a%20%E2%80%9CGruppo%20Romano%20Mielodisplasie%20(GROM)%E2%80%9D%20multicenter%20study&rft.jtitle=Annals%20of%20hematology&rft.au=Buccisano,%20Francesco&rft.aucorp=GROM%20(Gruppo%20Romano%20Mielodisplasie)&rft.date=2016-06-01&rft.volume=95&rft.issue=7&rft.spage=1059&rft.epage=1065&rft.pages=1059-1065&rft.issn=0939-5555&rft.eissn=1432-0584&rft_id=info:doi/10.1007/s00277-016-2667-1&rft_dat=%3Cproquest_cross%3E1793912466%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1793103607&rft_id=info:pmid/27091349&rfr_iscdi=true |