Phase III Open-Label Randomized Study of Cytarabine in Combination With Amonafide L-Malate or Daunorubicin As Induction Therapy for Patients With Secondary Acute Myeloid Leukemia
| Autor: | Jun Ho Jang, Miklos Egyed, Martin S. Tallman, Ante Sven Lundberg, Richard Stone, Donna Neuberg, Dominik Selleslag, Harry P. Erba, Robert K. Stuart, Emanuele Mazzola, Lloyd E. Damon, Parameswaran Venugopal, Tamas Masszi, David A. Rizzieri, Mikkael A. Sekeres, Meir Wetzler, Heinz A. Horst, Steven L. Allen, Bayard L. Powell, Arnaud Pigneux, Krzysztof Warzocha, Scott R. Solomon |
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| Rok vydání: | 2015 |
| Předmět: |
Adult
Male Cancer Research Time Factors Myeloid Daunorubicin Organophosphonates Drug resistance Pharmacology Drug Administration Schedule Young Adult Antineoplastic Combined Chemotherapy Protocols medicine Humans Secondary Acute Myeloid Leukemia Prospective Studies Infusions Intravenous Aged Aged 80 and over business.industry Adenine Remission Induction Cytarabine Induction chemotherapy Amonafide Induction Chemotherapy Middle Aged medicine.disease Leukemia Myeloid Acute Naphthalimides Leukemia Treatment Outcome medicine.anatomical_structure Oncology Female business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 33:1252-1257 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | 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/m2 continuous intravenous (IV) infusion once per day on days 1 to 7 plus either amonafide 600 mg/m2 IV over 4 hours on days 1 to 5 (A + C arm) or daunorubicin 45 mg/m2 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. |
| Databáze: | OpenAIRE |
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