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Mitoxantrone and Cytarabine Induction, High-Dose Cytarabine, and Etoposide Intensification for Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia: Children’s Cancer Group Study 2951

From the M.D. Anderson Cancer Center, Houston, TX; LifeSource Upper Midwest Organ Procurement Organization, Inc, St Paul; University of Minnesota, Minneapolis, MN; University of Southern California Keck School of Medicine, Los Angeles; Children’s Oncology Group, Arcadia, CA; Johns Hopkins Hospital, Baltimore, MD; Children’s Mercy Hospital and Clinics, Kansas City, MO; Cancer Institute of New Jersey, New Brunswick, NJ; Indiana University, Riley Children’s Hospital, Indianapolis, IN; University of Nebraska Medical Center, Omaha, NE; and Pediatric Hematology/Oncology, Vanderbilt University Medical Center, Nashville, TN.

Address reprint requests to Robert J. Wells, MD, Children’s Oncology Group, 440 E Huntington Dr, Suite 300, PO Box 60012, Arcadia, CA 91066-6012; email: rjwells{at}mdanderson.org.

Purpose: To evaluate the response rate, survival, and toxicity of mitoxantrone and cytarabine induction, high-dose cytarabine and etoposide intensification, and further consolidation/maintenance therapies, including bone marrow transplantation, in children with relapsed, refractory, or secondary acute myeloid leukemia (AML). To evaluate response to 2-chlorodeoxyadenosine (2-CDA) and etoposide (VP-16) in patients who did not respond to mitoxantrone and cytarabine.

Patients and Methods: Patients with relapsed/refractory AML (n = 101) and secondary AML (n = 13) were entered.

Results: Mitoxantrone and cytarabine induction achieved a remission rate of 76% for relapsed/refractory patients and 77% for patients with secondary AML, with a 3% induction mortality rate. Cytarabine and etoposide intensification exceeded the acceptable toxic death rate of 10%. The response rate of 2-CDA/VP-16 was 8%. Two-year overall survival was estimated at 24% and was better than historical control data. Patients with secondary AML had similar outcomes to relapsed or refractory patients. Initial remission longer than 1 year was the most important prognostic factor for patients with primary AML (2-year survival rate, 75%), whereas for patients with primary AML, with less than 12 months of initial remission, survival was 13% and was similar to that of refractory patients (6%).

Conclusion: Mitoxantrone and cytarabine induction is effective with reasonable toxicity in patients with relapsed/refractory or secondary AML. The cytarabine and etoposide intensification regimen should be abandoned because of toxicity. Patients with relapsed AML with initial remissions longer than 1 year have a relatively good prognosis.

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