Conflict of interest: Nothing to report.
No advantage of a rotational continuation phase in acute lymphoblastic leukemia in childhood treated with a BFM back-bone therapy†
Article first published online: 10 MAR 2011
Copyright © 2011 Wiley-Liss, Inc.
Pediatric Blood & Cancer
Volume 57, Issue 1, pages 47–55, 15 July 2011
How to Cite
Felice, M. S., Rossi, J. G., Gallego, M. S., Alfaro, E. M., Zubizarreta, P. A., Fraquelli, L. E., Alonso, C. N., Guitter, M. R. and Scopinaro, M. J. (2011), No advantage of a rotational continuation phase in acute lymphoblastic leukemia in childhood treated with a BFM back-bone therapy. Pediatr. Blood Cancer, 57: 47–55. doi: 10.1002/pbc.23097
- Issue published online: 9 MAY 2011
- Article first published online: 10 MAR 2011
- Manuscript Accepted: 26 JAN 2011
- Manuscript Received: 27 APR 2010
- acute lymphoblastic leukemia;
- BFM back-bone;
- continuation phase;
- maintenance phase;
- randomized studies;
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.
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.
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.
In protocols with initial BFM-based strategy, a more intensive continuation phase did not benefit any risk group of patients. Pediatr Blood Cancer 2011;57:47–55. © 2011 Wiley-Liss, Inc.