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No advantage of a rotational continuation phase in acute lymphoblastic leukemia in childhood treated with a BFM back-bone therapy.

Author(s): Felice MS, Rossi JG, Gallego MS, Alfaro EM, Zubizarreta PA, Fraquelli LE, Alonso CN, Guitter MR, Scopinaro MJ

Affiliation(s): Department of Hematology-Oncology, Hospital de Pediatria Prof. Dr. Juan P. Garrahan, Buenos Aires, Argentina. marisa_felice@yahoo.com.ar

Publication date & source: 2011-07-15, Pediatr Blood Cancer., 57(1):47-55. Epub 2011 Mar 10.

Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial

BACKGROUND: Our aim was to compare two different schedules of maintenance in pediatric acute lymphoblastic leukemia (ALL) treated with a BFM-based therapy, in a randomized study: an Arm with 6-MP + MTX (with or without vincristine and dexamethasone pulses) versus a more intensive continuation phase. PROCEDURE: From January 1996 to November 2002, 429 eligible children with ALL were enrolled in a protocol with BFM-based back-bone, followed by a randomized continuation phase in standard (SRG) and intermediate (IRG) risk groups. Patients were randomized between Arms A and B for SRG and B or C for IRG. Arms A and C consisted of 6-MP and MTX and in Arm C, six pulses of VCR and dexamethasone were added. Arm B combined four pairs of drugs rotated weekly. All risk-groups received maintenance until completing 2 years of therapy from diagnosis. RESULTS: With a median follow-up of 138 (range: 96-178) months, the overall pEFS (SE) was 72 (6)% for all patients and the different risk groups showed: SRG: 85 (3)%, IRG: 71 (1)%, and HRG: 42 (7)% (P-value </= 0.0001). The pDFS (SE) according to the assigned arm of maintenance was, for Arm A: 89 (3)% and for Arm B: 85 (4)% in SRG, and, for Arm B: 77 (4)% and for Arm C: 75 (4)% in IRG, at 10 years follow-up. There were no statistically significant differences in outcome between arms of maintenance for both risk groups. CONCLUSIONS: In protocols with initial BFM-based strategy, a more intensive continuation phase did not benefit any risk group of patients. Copyright (c) 2011 Wiley-Liss, Inc.

Page last updated: 2011-12-09

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