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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.

Publication ,  Journal Article
Stone, RM; Mazzola, E; Neuberg, D; Allen, SL; Pigneux, A; Stuart, RK; Wetzler, M; Rizzieri, D; Erba, HP; Damon, L; Jang, J-H; Tallman, MS ...
Published in: J Clin Oncol
April 10, 2015

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.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

April 10, 2015

Volume

33

Issue

11

Start / End Page

1252 / 1257

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Time Factors
  • Remission Induction
  • Prospective Studies
  • Organophosphonates
  • Oncology & Carcinogenesis
  • Naphthalimides
  • Middle Aged
  • Male
 

Citation

APA
Chicago
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Stone, R. M., Mazzola, E., Neuberg, D., Allen, S. L., Pigneux, A., Stuart, R. K., … Powell, B. (2015). 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. J Clin Oncol, 33(11), 1252–1257. https://doi.org/10.1200/JCO.2014.57.0952
Stone, Richard M., Emanuele Mazzola, Donna Neuberg, Steven L. Allen, Arnaud Pigneux, Robert K. Stuart, Meir Wetzler, et al. “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.J Clin Oncol 33, no. 11 (April 10, 2015): 1252–57. https://doi.org/10.1200/JCO.2014.57.0952.
Stone, Richard M., et al. “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.J Clin Oncol, vol. 33, no. 11, Apr. 2015, pp. 1252–57. Pubmed, doi:10.1200/JCO.2014.57.0952.
Stone RM, Mazzola E, Neuberg D, Allen SL, Pigneux A, Stuart RK, Wetzler M, Rizzieri D, Erba HP, Damon L, Jang J-H, Tallman MS, Warzocha K, Masszi T, Sekeres MA, Egyed M, Horst H-A, Selleslag D, Solomon SR, Venugopal P, Lundberg AS, Powell B. 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. J Clin Oncol. 2015 Apr 10;33(11):1252–1257.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

April 10, 2015

Volume

33

Issue

11

Start / End Page

1252 / 1257

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Time Factors
  • Remission Induction
  • Prospective Studies
  • Organophosphonates
  • Oncology & Carcinogenesis
  • Naphthalimides
  • Middle Aged
  • Male