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document
The impact on outcome of the addition of all-trans retinoic acid to intensive chemotherapy in younger patients with nonacute promyelocytic acute myeloid leukemia : overall results and results in genotypic subgroups defined by mutations in NPM1 , FLT3 , and CEBPA . We investigated the benefit of adding all-trans retinoic acid ( ATRA ) to chemotherapy for younger patients with nonacute promyelocytic acute myeloid leukemia and high-risk myelodysplastic syndrome , and considered interactions between treatment and molecular markers . Overall , 1075 patients less than 60 years of age were randomized to receive or not receive ATRA in addition to daunorubicin/Ara-C/thioguanine chemotherapy with Ara-C at standard or double standard dose . There were data on FLT3 internal tandem duplications and NPM1 mutations ( n = 592 ) , CEBPA mutations ( n = 423 ) , and MN1 expression ( n = 195 ) . The complete remission rate was 68 % with complete remission with incomplete count recovery in an additional 16 % ; 8-year overall survival was 32 % . There was no significant treatment effect for any outcome , with no significant interactions between treatment and demographics , or cytarabine randomization . Importantly , there were no interactions by FLT3/internal tandem duplications , NPM1 , or CEBPA mutation . There was a suggestion that ATRA reduced relapse in patients with lower MN1 levels , but no significant effect on overall survival . Results were consistent when restricted to patients with normal karyotype . ATRA has no overall effect on treatment outcomes in this group of patients . The study did not identify any subgroup of patients likely to derive a significant survival benefit from the addition of ATRA to chemotherapy .
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Intervention_Pharmacological
all-trans retinoic acid to intensive chemotherapy
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Intervention_Pharmacological
all-trans retinoic acid ( ATRA )
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Intervention_Pharmacological
chemotherapy
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Intervention_Pharmacological
ATRA
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Intervention_Pharmacological
daunorubicin/Ara-C/thioguanine chemotherapy with Ara-C at standard or double standard dose .
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Intervention_Pharmacological
ATRA
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Intervention_Pharmacological
ATRA to chemotherapy
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Outcome_Other
complete remission rate
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Outcome_Mortality
8-year overall survival
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Outcome_Physical
FLT3/internal tandem duplications
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Outcome_Physical
NPM1
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Outcome_Physical
CEBPA mutation
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Outcome_Physical
relapse
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Outcome_Mortality
overall survival .
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Participant_Age
younger
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Participant_Condition
nonacute promyelocytic acute myeloid leukemia
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Participant_Condition
mutations in NPM1 , FLT3 , and CEBPA
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Participant_Age
younger
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Participant_Condition
nonacute promyelocytic acute myeloid leukemia
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Participant_Condition
high-risk myelodysplastic syndrome
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Participant_Sample-size
1075
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Participant_Age
less than 60 years of age