Stone, Richard M; Mazzola, Emanuele; Neuberg, Donna; Allen, Steven L; Pigneux, Arnaud; Stuart, Robert K; Wetzler, Meir; Rizzieri, David; Erba, Harry P; Damon, Lloyd; Jang, Jun-Ho; Tallman, Martin S; Warzocha, Krzysztof; Masszi, Tamas; Sekeres, Mikkael A; Egyed, Miklos; Horst, Heinz-August; Selleslag, Dominik; Solomon, Scott R; Venugopal, Parameswaran; Lundberg, Ante S; Powell, Bayard
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
2015Apr ; 33 ( 11 ) :1252-7.
PMID : 25732165
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Stone, Richard M -
Mazzola, Emanuele -
Neuberg, Donna -
Allen, Steven L -
Pigneux, Arnaud -
Stuart, Robert K -
Wetzler, Meir -
Rizzieri, David -
Erba, Harry P -
Damon, Lloyd -
Jang, Jun-Ho -
Tallman, Martin S -
Warzocha, Krzysztof -
Masszi, Tamas -
Sekeres, Mikkael A -
Egyed, Miklos -
Horst, Heinz-August -
Selleslag, Dominik -
Solomon, Scott R -
Venugopal, Parameswaran -
Lundberg, Ante S -
Powell, Bayard -
ABSTRACT
PURPOSE: Secondary acute myeloid leukemia (sAML), defined as AML arising after a prior myelodysplastic syndrome or after antineoplastic therapy, responds poorly to current therapies. It is often associated with adverse karyotypic abnormalities and overexpression of proteins that mediate drug resistance. We performed a phase III trial to determine whether induction therapy with cytarabine and amonafide L-malate, a DNA intercalator and non-ATP-dependent topoisomerase II inhibitor that evades drug resistance mechanisms, yielded a superior complete remission rate than standard therapy with cytarabine and daunorubicin in sAML. PATIENTS AND
METHODS: Patients with previously untreated sAML were randomly assigned at a one-to-one ratio to cytarabine 200 mg/m(2) continuous intravenous (IV) infusion once per day on days 1 to 7 plus either amonafide 600 mg/m(2) IV over 4 hours on days 1 to 5 (A + C arm) or daunorubicin 45 mg/m(2) IV over 30 minutes once per day on days 1 to 3 (D + C arm).
RESULTS: The complete remission (CR) rate was 46% (99 of 216 patients) in A + C arm and 45% (97 of 217 patients) in D + C arm (P = .81). The 30- and 60-day mortality rates were 19% and 28% in A + C arm and 13% and 21% in D + C arm, respectively. CONCLUSION: Induction treatment with A + C did not improve the CR rate compared with D + C in patients with sAML. CI - ??2015 by American Society of Clinical Oncology.
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MESH
Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use, Cytarabine/administration & dosage, Daunorubicin/administration & dosage, Drug Administration Schedule, Female, Humans, *Induction Chemotherapy, Infusions, Intravenous, Leukemia, Myeloid, Acute/*drug therapy/mortality/pathology, Male, Middle Aged, Naphthalimides/administration & dosage, Prospective Studies, Remission Induction, Time Factors, Treatment Outcome, Young Adult
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