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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Veröffentlicht in:Annals of hematology 2016-06, Vol.95 (7), p.1059-1065
Hauptverfasser: 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
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container_issue 7
container_start_page 1059
container_title Annals of hematology
container_volume 95
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  
doi_str_mv 10.1007/s00277-016-2667-1
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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><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 &amp; 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 &amp; 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 &amp; 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 &amp; 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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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1432-0584
language eng
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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