Skip Navigation LinksHome > July 2014 - Volume 36 - Issue 5 > Dose Intensification of Methotrexate and Cytarabine During I...
Journal of Pediatric Hematology/Oncology:
doi: 10.1097/MPH.0000000000000131
Original Articles

Dose Intensification of Methotrexate and Cytarabine During Intensified Continuation Chemotherapy for High-risk B-Precursor Acute Lymphoblastic Leukemia: POG 9406: A Report From the Children’s Oncology Group

Tower, Richard L. MD*; Jones, Tamekia L. PhD; Camitta, Bruce M. MD*; Asselin, Barbara L. MD; Bell, Beverly A. MD§; Chauvenet, Allen MD, PhD; Devidas, Meenakshi PhD; Halperin, Edward C. MD#; Pullen, Jeanette MD**; Shuster, Jonathan J. PhD††; Winick, Naomi MD‡‡; Kurtzberg, Joanne MD§§

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Abstract

Purpose:

To determine the efficacy and toxicity of higher dose versus standard dose intravenous methotrexate (MTX) and pulses of high-dose cytosine arabinoside with asparaginase versus standard dose cytosine arabinoside and teniposide during intensified continuation therapy for higher risk pediatric B-precursor acute lymphoblastic leukemia (ALL).

Patients and Methods:

From 1994 to 1999, the Pediatric Oncology Group conducted a randomized phase III clinical trial in higher risk pediatric B-precursor ALL. A total of 784 patients were randomized in a 2×2 factorial design to receive MTX 1 g/m2 versus 2.5 g/m2 and to cytosine arabinoside/teniposide versus high-dose cytosine arabinoside/asparaginase during intensified continuation therapy.

Results:

Patients receiving standard dose MTX had a 5-year disease-free survival (DFS) of 71.8±2.4%; patients receiving higher dose MTX had a 5-year DFS of 71.7±2.4% (P=0.55). Outcomes on cytosine arabinoside/teniposide (DFS of 70.4±2.4) were similar to higher dose cytosine arabinoside/asparaginase (DFS of 73.1±2.3%) (P=0.41). Overall survival rates were not different between MTX doses or cytosine arabinoside/teniposide versus cytosine arabinoside/asparaginase.

Conclusions:

Increasing MTX dosing to 2.5 g/m2 did not improve outcomes in higher risk pediatric B-precursor ALL. Giving high-dose cytarabine and asparaginase pulses instead of standard dose cytarabine and teniposide produced nonsignificant differences in outcomes, allowing for teniposide to be removed from ALL therapy.

Copyright © 2014 by Lippincott Williams & Wilkins

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