Phase II study of FLAGM (fludarabine + high-dose cytarabine + granulocyte colony-stimulating factor + mitoxantrone) for relapsed or refractory acute myeloid leukemia
Given the poor prognosis of patients with relapsed/refractory acute myeloid leukemia (AML), better therapy is needed. Fludarabine enhances the efficacy of Ara-C (cytarabine) by increasing intracellular Ara-C-triphosphate. The FLAG (fludarabine, high-dose Ara-C, supported with granulocyte colony-stim...
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| Veröffentlicht in: | International journal of hematology 2019-04, Vol.109 (4), p.418-425 |
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| creator | Hatsumi, Nahoko Miyawaki, Shuichi Yamauchi, Takahiro Takeshita, Akihiro Komatsu, Norio Usui, Noriko Arai, Yukihiro Ishida, Fumihiro Morii, Takeshi Kano, Yasuhiko Ogura, Michinori Machida, Shinichiro Nishii, Kazuhiro Honda, Sumihisa Ohnishi, Kazunori Naoe, Tomoki |
| description | Given the poor prognosis of patients with relapsed/refractory acute myeloid leukemia (AML), better therapy is needed. Fludarabine enhances the efficacy of Ara-C (cytarabine) by increasing intracellular Ara-C-triphosphate. The FLAG (fludarabine, high-dose Ara-C, supported with granulocyte colony-stimulating factor) regimen has been tested for use in AML patients by other investigators. In the phase II study reported here, we evaluated the efficacy and toxicity of FLAGM therapy (FLAG with mitoxantrone), further intensified by adding mitoxantrone, based on the results of a phase I study by our group. The major endpoints were complete remission (CR) rate and early death. From June 2004 to February 2008, 41 patients (median age 52 years; range 18–64 years) were enrolled. Thirty (73% 95% CI 58–84%) patients achieved CR, which met the primary endpoint; there was a single case of early death from pneumonia. Two-year overall survival was 39.4% (95% CI 25.2–55.6%). Of those who achieved CR, 27 underwent allogeneic stem cell transplantation (SCT), and 12 SCT recipients showed long-term survival. Grade 3/4 non-hematological adverse events included infection (59%), nausea/vomiting (15%), diarrhea (7%), and elevated liver enzymes (7%). In conclusion, FLAGM is an effective and safe salvage therapy for patients with relapsed/refractory AML, and facilitated SCT for a large proportion of patients. |
| doi_str_mv | 10.1007/s12185-019-02606-0 |
| format | Article |
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Fludarabine enhances the efficacy of Ara-C (cytarabine) by increasing intracellular Ara-C-triphosphate. The FLAG (fludarabine, high-dose Ara-C, supported with granulocyte colony-stimulating factor) regimen has been tested for use in AML patients by other investigators. In the phase II study reported here, we evaluated the efficacy and toxicity of FLAGM therapy (FLAG with mitoxantrone), further intensified by adding mitoxantrone, based on the results of a phase I study by our group. The major endpoints were complete remission (CR) rate and early death. From June 2004 to February 2008, 41 patients (median age 52 years; range 18–64 years) were enrolled. Thirty (73% 95% CI 58–84%) patients achieved CR, which met the primary endpoint; there was a single case of early death from pneumonia. Two-year overall survival was 39.4% (95% CI 25.2–55.6%). Of those who achieved CR, 27 underwent allogeneic stem cell transplantation (SCT), and 12 SCT recipients showed long-term survival. Grade 3/4 non-hematological adverse events included infection (59%), nausea/vomiting (15%), diarrhea (7%), and elevated liver enzymes (7%). In conclusion, FLAGM is an effective and safe salvage therapy for patients with relapsed/refractory AML, and facilitated SCT for a large proportion of patients.</description><identifier>ISSN: 0925-5710</identifier><identifier>EISSN: 1865-3774</identifier><identifier>DOI: 10.1007/s12185-019-02606-0</identifier><identifier>PMID: 30725360</identifier><language>eng</language><publisher>Tokyo: Springer Japan</publisher><subject>Acute myeloid leukemia ; Colonies ; Colony-stimulating factor ; Cytarabine ; Diarrhea ; Fludarabine ; Granulocyte colony-stimulating factor ; Granulocytes ; Hematology ; Leukemia ; Leukocytes (granulocytic) ; Liver ; Medical prognosis ; Medicine ; Medicine & Public Health ; Mitoxantrone ; Myeloid leukemia ; Nausea ; Oncology ; Original Article ; Patients ; Remission ; Salvage ; Stem cell transplantation ; Stem cells ; Survival ; Therapy ; Toxicity ; Transplantation ; Vomiting</subject><ispartof>International journal of hematology, 2019-04, Vol.109 (4), p.418-425</ispartof><rights>Japanese Society of Hematology 2019</rights><rights>International Journal of Hematology is a copyright of Springer, (2019). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c465t-dc496d882c1ba949977740abfd6391fba0f1eebbe9633fb0c32ed165071f558d3</citedby><cites>FETCH-LOGICAL-c465t-dc496d882c1ba949977740abfd6391fba0f1eebbe9633fb0c32ed165071f558d3</cites><orcidid>0000-0002-1173-4216</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12185-019-02606-0$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12185-019-02606-0$$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/30725360$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hatsumi, Nahoko</creatorcontrib><creatorcontrib>Miyawaki, Shuichi</creatorcontrib><creatorcontrib>Yamauchi, Takahiro</creatorcontrib><creatorcontrib>Takeshita, Akihiro</creatorcontrib><creatorcontrib>Komatsu, Norio</creatorcontrib><creatorcontrib>Usui, Noriko</creatorcontrib><creatorcontrib>Arai, Yukihiro</creatorcontrib><creatorcontrib>Ishida, Fumihiro</creatorcontrib><creatorcontrib>Morii, Takeshi</creatorcontrib><creatorcontrib>Kano, Yasuhiko</creatorcontrib><creatorcontrib>Ogura, Michinori</creatorcontrib><creatorcontrib>Machida, Shinichiro</creatorcontrib><creatorcontrib>Nishii, Kazuhiro</creatorcontrib><creatorcontrib>Honda, Sumihisa</creatorcontrib><creatorcontrib>Ohnishi, Kazunori</creatorcontrib><creatorcontrib>Naoe, Tomoki</creatorcontrib><creatorcontrib>Japan Adult Leukemia Study Group (JALSG)</creatorcontrib><creatorcontrib>The Japan Adult Leukemia Study Group (JALSG)</creatorcontrib><title>Phase II study of FLAGM (fludarabine + high-dose cytarabine + granulocyte colony-stimulating factor + mitoxantrone) for relapsed or refractory acute myeloid leukemia</title><title>International journal of hematology</title><addtitle>Int J Hematol</addtitle><addtitle>Int J Hematol</addtitle><description>Given the poor prognosis of patients with relapsed/refractory acute myeloid leukemia (AML), better therapy is needed. Fludarabine enhances the efficacy of Ara-C (cytarabine) by increasing intracellular Ara-C-triphosphate. The FLAG (fludarabine, high-dose Ara-C, supported with granulocyte colony-stimulating factor) regimen has been tested for use in AML patients by other investigators. In the phase II study reported here, we evaluated the efficacy and toxicity of FLAGM therapy (FLAG with mitoxantrone), further intensified by adding mitoxantrone, based on the results of a phase I study by our group. The major endpoints were complete remission (CR) rate and early death. From June 2004 to February 2008, 41 patients (median age 52 years; range 18–64 years) were enrolled. Thirty (73% 95% CI 58–84%) patients achieved CR, which met the primary endpoint; there was a single case of early death from pneumonia. Two-year overall survival was 39.4% (95% CI 25.2–55.6%). Of those who achieved CR, 27 underwent allogeneic stem cell transplantation (SCT), and 12 SCT recipients showed long-term survival. Grade 3/4 non-hematological adverse events included infection (59%), nausea/vomiting (15%), diarrhea (7%), and elevated liver enzymes (7%). In conclusion, FLAGM is an effective and safe salvage therapy for patients with relapsed/refractory AML, and facilitated SCT for a large proportion of patients.</description><subject>Acute myeloid leukemia</subject><subject>Colonies</subject><subject>Colony-stimulating factor</subject><subject>Cytarabine</subject><subject>Diarrhea</subject><subject>Fludarabine</subject><subject>Granulocyte colony-stimulating factor</subject><subject>Granulocytes</subject><subject>Hematology</subject><subject>Leukemia</subject><subject>Leukocytes (granulocytic)</subject><subject>Liver</subject><subject>Medical prognosis</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Mitoxantrone</subject><subject>Myeloid leukemia</subject><subject>Nausea</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Patients</subject><subject>Remission</subject><subject>Salvage</subject><subject>Stem cell transplantation</subject><subject>Stem cells</subject><subject>Survival</subject><subject>Therapy</subject><subject>Toxicity</subject><subject>Transplantation</subject><subject>Vomiting</subject><issn>0925-5710</issn><issn>1865-3774</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>BENPR</sourceid><recordid>eNp9kU2O1DAQhS0EYpqBC7BAltiAkKEcx3ayHI2YoaVGsIC15cR2d4YkbvwjkR3bOc5ciZNguhsQGxZWWX5fvbLqIfSUwmsKIN9EWtGGE6AtgUqAIHAPrWgjOGFS1vfRCtqKEy4pnKFHMd4AUAm1fIjOGMiKMwErdPdxp6PF6zWOKZsFe4evNhfX7_ELN2ajg-6G2f74fvuqnN2w3RHjC94v6V9pG_ScR1_ei-hHPy8kpmHKo07DvMVO98mHEzsNyX_Tcwp-ti-x8wEHO-p9tAYf7i4c6AXrPhe7abGjHwwebf5ip0E_Rg-cHqN9cqrn6PPV20-X78jmw_X68mJD-lrwRExft8I0TdXTTrd128qyE9CdM4K11HUaHLW262wrGHMd9KyyhgoOkjrOG8PO0fOj7z74r9nGpG58DnMZqSoqBZd1WzeFqo5UH3yM5fNqH4ZJh0VRUL9SUseUVElJHVJSUJqenaxzN1nzp-V3LAVgRyAWad7a8Hf2f2x_Apj1pkw</recordid><startdate>20190401</startdate><enddate>20190401</enddate><creator>Hatsumi, Nahoko</creator><creator>Miyawaki, 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Shuichi ; Yamauchi, Takahiro ; Takeshita, Akihiro ; Komatsu, Norio ; Usui, Noriko ; Arai, Yukihiro ; Ishida, Fumihiro ; Morii, Takeshi ; Kano, Yasuhiko ; Ogura, Michinori ; Machida, Shinichiro ; Nishii, Kazuhiro ; Honda, Sumihisa ; Ohnishi, Kazunori ; Naoe, Tomoki</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c465t-dc496d882c1ba949977740abfd6391fba0f1eebbe9633fb0c32ed165071f558d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Acute myeloid leukemia</topic><topic>Colonies</topic><topic>Colony-stimulating factor</topic><topic>Cytarabine</topic><topic>Diarrhea</topic><topic>Fludarabine</topic><topic>Granulocyte colony-stimulating factor</topic><topic>Granulocytes</topic><topic>Hematology</topic><topic>Leukemia</topic><topic>Leukocytes (granulocytic)</topic><topic>Liver</topic><topic>Medical prognosis</topic><topic>Medicine</topic><topic>Medicine & Public 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Study Group (JALSG)</aucorp><aucorp>The Japan Adult Leukemia Study Group (JALSG)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase II study of FLAGM (fludarabine + high-dose cytarabine + granulocyte colony-stimulating factor + mitoxantrone) for relapsed or refractory acute myeloid leukemia</atitle><jtitle>International journal of hematology</jtitle><stitle>Int J Hematol</stitle><addtitle>Int J Hematol</addtitle><date>2019-04-01</date><risdate>2019</risdate><volume>109</volume><issue>4</issue><spage>418</spage><epage>425</epage><pages>418-425</pages><issn>0925-5710</issn><eissn>1865-3774</eissn><abstract>Given the poor prognosis of patients with relapsed/refractory acute myeloid leukemia (AML), better therapy is needed. Fludarabine enhances the efficacy of Ara-C (cytarabine) by increasing intracellular Ara-C-triphosphate. The FLAG (fludarabine, high-dose Ara-C, supported with granulocyte colony-stimulating factor) regimen has been tested for use in AML patients by other investigators. In the phase II study reported here, we evaluated the efficacy and toxicity of FLAGM therapy (FLAG with mitoxantrone), further intensified by adding mitoxantrone, based on the results of a phase I study by our group. The major endpoints were complete remission (CR) rate and early death. From June 2004 to February 2008, 41 patients (median age 52 years; range 18–64 years) were enrolled. Thirty (73% 95% CI 58–84%) patients achieved CR, which met the primary endpoint; there was a single case of early death from pneumonia. Two-year overall survival was 39.4% (95% CI 25.2–55.6%). Of those who achieved CR, 27 underwent allogeneic stem cell transplantation (SCT), and 12 SCT recipients showed long-term survival. Grade 3/4 non-hematological adverse events included infection (59%), nausea/vomiting (15%), diarrhea (7%), and elevated liver enzymes (7%). In conclusion, FLAGM is an effective and safe salvage therapy for patients with relapsed/refractory AML, and facilitated SCT for a large proportion of patients.</abstract><cop>Tokyo</cop><pub>Springer Japan</pub><pmid>30725360</pmid><doi>10.1007/s12185-019-02606-0</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-1173-4216</orcidid></addata></record> |
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| ispartof | International journal of hematology, 2019-04, Vol.109 (4), p.418-425 |
| issn | 0925-5710 1865-3774 |
| language | eng |
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| source | Springer Online Journals Complete |
| subjects | Acute myeloid leukemia Colonies Colony-stimulating factor Cytarabine Diarrhea Fludarabine Granulocyte colony-stimulating factor Granulocytes Hematology Leukemia Leukocytes (granulocytic) Liver Medical prognosis Medicine Medicine & Public Health Mitoxantrone Myeloid leukemia Nausea Oncology Original Article Patients Remission Salvage Stem cell transplantation Stem cells Survival Therapy Toxicity Transplantation Vomiting |
| title | Phase II study of FLAGM (fludarabine + high-dose cytarabine + granulocyte colony-stimulating factor + mitoxantrone) for relapsed or refractory acute myeloid leukemia |
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