Phase II study of FLAGM (fludarabine + high-dose cytarabine + granulocyte colony-stimulating factor + mitoxantrone) for relapsed or refractory acute ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2019-02-06

AUTHORS

Nahoko Hatsumi, Shuichi Miyawaki, Takahiro Yamauchi, Akihiro Takeshita, Norio Komatsu, Noriko Usui, Yukihiro Arai, Fumihiro Ishida, Takeshi Morii, Yasuhiko Kano, Michinori Ogura, Shinichiro Machida, Kazuhiro Nishii, Sumihisa Honda, Kazunori Ohnishi, Tomoki Naoe,

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. More... »

PAGES

418-425

Journal

TITLE

International Journal of Hematology

ISSUE

4

VOLUME

109

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12185-019-02606-0

DOI

http://dx.doi.org/10.1007/s12185-019-02606-0

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1111933579

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30725360


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26 schema: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.
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35 FLAG regimen
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37 FLAGM therapy
38 Grade 3/4 non-hematological adverse events
39 II study
40 SCT recipients
41 Two-year overall survival
42 acute myeloid leukemia
43 adverse events
44 allogeneic stem cell transplantation
45 ara
46 best therapy
47 cases
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49 complete remission rate
50 conclusion
51 death
52 diarrhea
53 early death
54 efficacy
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56 elevated liver enzymes
57 endpoint
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59 events
60 group
61 infection
62 intracellular ara
63 investigators
64 large proportion
65 leukemia
66 liver enzymes
67 long-term survival
68 major endpoints
69 mitoxantrone
70 myeloid leukemia
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73 overall survival
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82 rate
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84 refractory acute myeloid leukemia
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88 safe salvage therapy
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