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 Blood, 1 April 2007, Vol. 109, No. 7, pp. 2773-2780.
Prepublished online as a Blood First Edition Paper on November 28, 2006; DOI 10.1182/blood-2006-07-036673.

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Submitted July 20, 2006
Accepted November 12, 2006

Results of the randomized international FAB/LMB96 trial for intermediate risk B-cell non-Hodgkin's lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients

Catherine Patte*, Anne Auperin, Mary Gerrard, Jean Michon, Ross Pinkerton, Richard Sposto, Claire Weston, Martine Raphael, Sherrie L. Perkins, Keith McCarthy, and Mitchell S. Cairo

Pediatric Department, Institut Gustave Roussy, Villejuif, France
Biostatistics and Epidemiology Department, Institut Gustave Roussy, Villejuif, France
Sheffield Children's Hospital, Sheffield, United Kingdom
Pediatric Department, Institut Curie, Paris, France
Royal Marsden Hospital, Sutton, Surrey, United Kingdom
Keck School of Medicine, University of Southern California, Los Angeles, CA, United States
University of Leicester, Leicester, United Kingdom
CHU Bicetre AP-HP, University Paris Sud 11, France
University of Utah Health Sciences Center, Salt Lake City, UT, United States
Gloucestershire Hospitals, NHS Foundation Gloucestershire, United Kingdom
Morgan-Stanley Children's Hospital of New York-Presbyterian, Columbia University, New York, NY, United States

* Corresponding author; email: patte{at}igr.fr.

A previous study (LMB89) of the French Society of Pediatric Oncology for childhood mature B-cell lymphoma (B-NHL) demonstrated a 92% 3-year event-free-survival (EFS) for intermediate-risk Group B defined as "non-resected" stage I/II and CNS-negative advanced-stage III/IV (70% of cases). We performed the FAB/LMB96 trial to assess the possibility of reducing treatment in children/adolescents with intermediate-risk B-NHL without jeopardizing survival. "Early responding" (tumor response >20% at D7) patients were randomized in a factorial design between four arms, two receiving half-dose of cyclophosphamide in the 2nd induction COPADM course and two not receiving the maintenance course M1. Six hundred and fifty-seven patients were randomized (05/1996-06/2001) and 637 were analyzed. The analysis showed no significant effect of any of the treatment reductions on EFS and survival. Four-year EFS was 93.4% and 90.9% in the groups with full-dose and half-dose of cyclophosphamide (RR=1.3, P=0.40) and 91.9% and 92.5% in the groups with and without M1 (RR=1.01, P=0.98). There was no interaction between the 2 treatment reductions or between each treatment reduction and LDH level or histological subtypes (Burkitt/Burkitt-like or large B-cell). Children/adolescents with intermediate-risk B-NHL who have an early response and achieve a complete remission after the first consolidation course can be cured with a four-course treatment with a total dose of only 3.3g/m2 of cyclophosphamide and 120mg/m2 of doxorubicin.


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