The FOSSIL Study: FLAG or standard 7+3 induction therapy in secondary acute myeloid leukemia
•FLAG induction produces 70% overall response rates in secondary AML.•Induction mortality rate was 3% and duration of neutropenia was shorter with FLAG.•FLAG induction allowed half of all patients to proceed to consolidation therapy.•FLAG represents a highly effective, lower-cost approach to treatin...
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| Veröffentlicht in: | Leukemia research 2018-07, Vol.70, p.91-96 |
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| creator | Vulaj, Vera Perissinotti, Anthony J. Uebel, James R. Nachar, Victoria R. Scappaticci, Gianni B. Crouch, Ashley Bixby, Dale L. Burke, Patrick W. Maillard, Ivan Talpaz, Moshe Marini, Bernard L. |
| description | •FLAG induction produces 70% overall response rates in secondary AML.•Induction mortality rate was 3% and duration of neutropenia was shorter with FLAG.•FLAG induction allowed half of all patients to proceed to consolidation therapy.•FLAG represents a highly effective, lower-cost approach to treating secondary AML.
Patients with secondary acute myeloid leukemia (sAML) have poor outcomes, with CR/CRi rates of 25–35% with standard 7 + 3 induction chemotherapy, while single center non-comparative analyses suggest promising outcomes with FLAG. We conducted a single-center, retrospective cohort study assessing outcomes in treatment-naïve patients with sAML treated with fludarabine, high-dose cytarabine, and granulocyte colony-stimulating factor (FLAG, n = 40) compared with 7 + 3 (n = 66). Median patient age was 63 years (range: 27–82) in the FLAG group and 60 years (range: 21–76) in the 7 + 3 group (P = 0.968). Patients treated with FLAG achieved higher overall response rates (CR + CRi + MLFS) compared to 7 + 3 (70% vs. 48%, P = 0.043). FLAG was well tolerated, with only one induction death (30-day mortality rate, 3% vs. 8%, P = 0.405) and no cases of cerebellar toxicity. Duration of neutropenia was significantly shorter with FLAG (median 16 vs. 23 days, P |
| doi_str_mv | 10.1016/j.leukres.2018.05.011 |
| format | Article |
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Patients with secondary acute myeloid leukemia (sAML) have poor outcomes, with CR/CRi rates of 25–35% with standard 7 + 3 induction chemotherapy, while single center non-comparative analyses suggest promising outcomes with FLAG. We conducted a single-center, retrospective cohort study assessing outcomes in treatment-naïve patients with sAML treated with fludarabine, high-dose cytarabine, and granulocyte colony-stimulating factor (FLAG, n = 40) compared with 7 + 3 (n = 66). Median patient age was 63 years (range: 27–82) in the FLAG group and 60 years (range: 21–76) in the 7 + 3 group (P = 0.968). Patients treated with FLAG achieved higher overall response rates (CR + CRi + MLFS) compared to 7 + 3 (70% vs. 48%, P = 0.043). FLAG was well tolerated, with only one induction death (30-day mortality rate, 3% vs. 8%, P = 0.405) and no cases of cerebellar toxicity. Duration of neutropenia was significantly shorter with FLAG (median 16 vs. 23 days, P < 0.001). Half of the FLAG-treated patients proceeded to consolidative therapy compared with only 27% of those who received 7 + 3 (P = 0.022). Overall survival was comparable between groups (8.5 mos, FLAG vs. 9.1 mos, 7 + 3; P = 0.798). Thus, FLAG may represent a low-cost treatment strategy in sAML that produces higher response rates and promising survival outcomes with minimal treatment-related toxicity. Further studies are required to prospectively compare FLAG to the newly FDA-approved CPX-351 in sAML.</description><identifier>ISSN: 0145-2126</identifier><identifier>EISSN: 1873-5835</identifier><identifier>DOI: 10.1016/j.leukres.2018.05.011</identifier><identifier>PMID: 29908418</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>7 + 3 ; CPX-351 ; FLAG ; sAML ; Secondary acute myeloid leukemia</subject><ispartof>Leukemia research, 2018-07, Vol.70, p.91-96</ispartof><rights>2018 Elsevier Ltd</rights><rights>Copyright © 2018 Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c365t-5dcdb7a38aae0537914c94e55a94e21eb0249c2c22f83ce6f1a88d25457925973</citedby><cites>FETCH-LOGICAL-c365t-5dcdb7a38aae0537914c94e55a94e21eb0249c2c22f83ce6f1a88d25457925973</cites><orcidid>0000-0003-0436-8948 ; 0000-0002-5906-4733 ; 0000-0003-4975-1684</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.leukres.2018.05.011$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,778,782,3539,27911,27912,45982</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29908418$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vulaj, Vera</creatorcontrib><creatorcontrib>Perissinotti, Anthony J.</creatorcontrib><creatorcontrib>Uebel, James R.</creatorcontrib><creatorcontrib>Nachar, Victoria R.</creatorcontrib><creatorcontrib>Scappaticci, Gianni B.</creatorcontrib><creatorcontrib>Crouch, Ashley</creatorcontrib><creatorcontrib>Bixby, Dale L.</creatorcontrib><creatorcontrib>Burke, Patrick W.</creatorcontrib><creatorcontrib>Maillard, Ivan</creatorcontrib><creatorcontrib>Talpaz, Moshe</creatorcontrib><creatorcontrib>Marini, Bernard L.</creatorcontrib><title>The FOSSIL Study: FLAG or standard 7+3 induction therapy in secondary acute myeloid leukemia</title><title>Leukemia research</title><addtitle>Leuk Res</addtitle><description>•FLAG induction produces 70% overall response rates in secondary AML.•Induction mortality rate was 3% and duration of neutropenia was shorter with FLAG.•FLAG induction allowed half of all patients to proceed to consolidation therapy.•FLAG represents a highly effective, lower-cost approach to treating secondary AML.
Patients with secondary acute myeloid leukemia (sAML) have poor outcomes, with CR/CRi rates of 25–35% with standard 7 + 3 induction chemotherapy, while single center non-comparative analyses suggest promising outcomes with FLAG. We conducted a single-center, retrospective cohort study assessing outcomes in treatment-naïve patients with sAML treated with fludarabine, high-dose cytarabine, and granulocyte colony-stimulating factor (FLAG, n = 40) compared with 7 + 3 (n = 66). Median patient age was 63 years (range: 27–82) in the FLAG group and 60 years (range: 21–76) in the 7 + 3 group (P = 0.968). Patients treated with FLAG achieved higher overall response rates (CR + CRi + MLFS) compared to 7 + 3 (70% vs. 48%, P = 0.043). FLAG was well tolerated, with only one induction death (30-day mortality rate, 3% vs. 8%, P = 0.405) and no cases of cerebellar toxicity. Duration of neutropenia was significantly shorter with FLAG (median 16 vs. 23 days, P < 0.001). Half of the FLAG-treated patients proceeded to consolidative therapy compared with only 27% of those who received 7 + 3 (P = 0.022). Overall survival was comparable between groups (8.5 mos, FLAG vs. 9.1 mos, 7 + 3; P = 0.798). Thus, FLAG may represent a low-cost treatment strategy in sAML that produces higher response rates and promising survival outcomes with minimal treatment-related toxicity. Further studies are required to prospectively compare FLAG to the newly FDA-approved CPX-351 in sAML.</description><subject>7 + 3</subject><subject>CPX-351</subject><subject>FLAG</subject><subject>sAML</subject><subject>Secondary acute myeloid leukemia</subject><issn>0145-2126</issn><issn>1873-5835</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><recordid>eNqFkFtLIzEUgIOsaNf1Jyh5XJAZT5LJTOLLIrJVodCH1reFkCanmDqXmswI_fdOad1XX86Bw3duHyFXDHIGrLzd5DUObxFTzoGpHGQOjJ2QCVOVyKQS8geZACtkxhkvz8nPlDYAIDXTZ-Scaw2qYGpC_i1fkU7ni8XzjC76we_u6HR2_0i7SFNvW2-jp9WNoKH1g-tD19L-FaPd7sYKTei6PbKj1g090maHdRc83V-GTbC_yOna1gkvj_mCvEz_Lh-estn88fnhfpY5Uco-k975VWWFshZBikqzwukCpbRj5AxXwAvtuON8rYTDcs2sUp7LQlaaS12JC_L7MHcbu_cBU2-akBzWtW2xG5LhIEuhuQIYUXlAXexSirg22xia8QXDwOzFmo05ijV7sQakGcWOfdfHFcOqQf-_68vkCPw5ADg--hEwmuQCtg59iOh647vwzYpPxmSK8A</recordid><startdate>201807</startdate><enddate>201807</enddate><creator>Vulaj, Vera</creator><creator>Perissinotti, Anthony J.</creator><creator>Uebel, James R.</creator><creator>Nachar, Victoria R.</creator><creator>Scappaticci, Gianni B.</creator><creator>Crouch, Ashley</creator><creator>Bixby, Dale L.</creator><creator>Burke, Patrick W.</creator><creator>Maillard, Ivan</creator><creator>Talpaz, Moshe</creator><creator>Marini, Bernard L.</creator><general>Elsevier Ltd</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-0436-8948</orcidid><orcidid>https://orcid.org/0000-0002-5906-4733</orcidid><orcidid>https://orcid.org/0000-0003-4975-1684</orcidid></search><sort><creationdate>201807</creationdate><title>The FOSSIL Study: FLAG or standard 7+3 induction therapy in secondary acute myeloid leukemia</title><author>Vulaj, Vera ; Perissinotti, Anthony J. ; Uebel, James R. ; Nachar, Victoria R. ; Scappaticci, Gianni B. ; Crouch, Ashley ; Bixby, Dale L. ; Burke, Patrick W. ; Maillard, Ivan ; Talpaz, Moshe ; Marini, Bernard L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c365t-5dcdb7a38aae0537914c94e55a94e21eb0249c2c22f83ce6f1a88d25457925973</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>7 + 3</topic><topic>CPX-351</topic><topic>FLAG</topic><topic>sAML</topic><topic>Secondary acute myeloid leukemia</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vulaj, Vera</creatorcontrib><creatorcontrib>Perissinotti, Anthony J.</creatorcontrib><creatorcontrib>Uebel, James R.</creatorcontrib><creatorcontrib>Nachar, Victoria R.</creatorcontrib><creatorcontrib>Scappaticci, Gianni B.</creatorcontrib><creatorcontrib>Crouch, Ashley</creatorcontrib><creatorcontrib>Bixby, Dale L.</creatorcontrib><creatorcontrib>Burke, Patrick W.</creatorcontrib><creatorcontrib>Maillard, Ivan</creatorcontrib><creatorcontrib>Talpaz, Moshe</creatorcontrib><creatorcontrib>Marini, Bernard L.</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Leukemia research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vulaj, Vera</au><au>Perissinotti, Anthony J.</au><au>Uebel, James R.</au><au>Nachar, Victoria R.</au><au>Scappaticci, Gianni B.</au><au>Crouch, Ashley</au><au>Bixby, Dale L.</au><au>Burke, Patrick W.</au><au>Maillard, Ivan</au><au>Talpaz, Moshe</au><au>Marini, Bernard L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The FOSSIL Study: FLAG or standard 7+3 induction therapy in secondary acute myeloid leukemia</atitle><jtitle>Leukemia research</jtitle><addtitle>Leuk Res</addtitle><date>2018-07</date><risdate>2018</risdate><volume>70</volume><spage>91</spage><epage>96</epage><pages>91-96</pages><issn>0145-2126</issn><eissn>1873-5835</eissn><abstract>•FLAG induction produces 70% overall response rates in secondary AML.•Induction mortality rate was 3% and duration of neutropenia was shorter with FLAG.•FLAG induction allowed half of all patients to proceed to consolidation therapy.•FLAG represents a highly effective, lower-cost approach to treating secondary AML.
Patients with secondary acute myeloid leukemia (sAML) have poor outcomes, with CR/CRi rates of 25–35% with standard 7 + 3 induction chemotherapy, while single center non-comparative analyses suggest promising outcomes with FLAG. We conducted a single-center, retrospective cohort study assessing outcomes in treatment-naïve patients with sAML treated with fludarabine, high-dose cytarabine, and granulocyte colony-stimulating factor (FLAG, n = 40) compared with 7 + 3 (n = 66). Median patient age was 63 years (range: 27–82) in the FLAG group and 60 years (range: 21–76) in the 7 + 3 group (P = 0.968). Patients treated with FLAG achieved higher overall response rates (CR + CRi + MLFS) compared to 7 + 3 (70% vs. 48%, P = 0.043). FLAG was well tolerated, with only one induction death (30-day mortality rate, 3% vs. 8%, P = 0.405) and no cases of cerebellar toxicity. Duration of neutropenia was significantly shorter with FLAG (median 16 vs. 23 days, P < 0.001). Half of the FLAG-treated patients proceeded to consolidative therapy compared with only 27% of those who received 7 + 3 (P = 0.022). Overall survival was comparable between groups (8.5 mos, FLAG vs. 9.1 mos, 7 + 3; P = 0.798). Thus, FLAG may represent a low-cost treatment strategy in sAML that produces higher response rates and promising survival outcomes with minimal treatment-related toxicity. Further studies are required to prospectively compare FLAG to the newly FDA-approved CPX-351 in sAML.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>29908418</pmid><doi>10.1016/j.leukres.2018.05.011</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0003-0436-8948</orcidid><orcidid>https://orcid.org/0000-0002-5906-4733</orcidid><orcidid>https://orcid.org/0000-0003-4975-1684</orcidid></addata></record> |
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| subjects | 7 + 3 CPX-351 FLAG sAML Secondary acute myeloid leukemia |
| title | The FOSSIL Study: FLAG or standard 7+3 induction therapy in secondary acute myeloid leukemia |
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