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Blood, 1 February 2007, Vol. 109, No. 3, pp. 896-904.
Prepublished online as a Blood First Edition Paper on September 26, 2006; DOI 10.1182/blood-2006-06-027714.
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Submitted June 12, 2006
Accepted September 18, 2006
Results of the Dana-Farber Cancer Institute ALL Consortium Protocol 95-01 for children with acute lymphoblastic leukemia
Albert Moghrabi*, Donna E. Levy, Barbara L. Asselin, Ronald Barr, Luis Clavell, Craig Hurwitz, Yvan Samson, Marshall Schorin, Virginia K. Dalton, Steven E. Lipshultz, Donna S. Neuberg, Richard D. Gelber, Harvey J. Cohen, Stephen E. Sallan, and Lewis B. Silverman
Division of Hematology and Oncology, Sainte-Justine Hospital, Montreal, Quebec, Canada
Dana-Farber Cancer Institute, Boston, MA
Division of Pediatric Hematology/Oncology, University of Rochester Medical Center, Rochester, NY
Division of Pediatric Hematology/Oncology, McMaster University, Hamilton, Ontario, Canada
Division of Pediatric Oncology, San Jorge Children's Hospital, San Juan, Puerto Rico
Department of Pediatric Hematology/Oncology, Maine Children's Cancer Program, Scarborough, ME
Centre Hospitalier Universitaire de Quebec, Quebec City, Quebec, Canada
Section of Pediatric Hematology Oncology, Tulane Hospital for Children, New Orleans, LA
Department of Pediatrics, Leonard M. Miller School of Medicine, University of Miami, Miami, FL
Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA
* Corresponding author; email: albert.moghrabi{at}umontreal.ca.
The DFCI Childhood ALL Consortium Protocol 95-01 was designed to minimize therapy-related morbidity for children with newly diagnosed ALL without compromising efficacy. Patients participated in randomized comparisons of 1) doxorubicin given with or without dexrazoxane, a cardioprotectant (high risk patients), 2) intensive intrathecal chemotherapy and cranial radiation (standard risk patients), and 3) Erwinia and E.coli asparaginase (all patients). Between 1996 and 2000, 491 patients (ages 0-18 years) were enrolled (272 standard risk and 219 high risk). With 5.7 years median follow-up, the estimated 5-year event-free survival (EFS) for all patients was 82±2%. Dexrazoxane did not significantly impact the 5-year EFS of high risk patients (p=0.99), and there was no significant difference in outcome of standard risk patients based on type of central nervous system (CNS) treatment (p=0.26). Compared with E.coli asparaginase, Erwinia asparaginase was associated with a lower incidence of toxicity (10% versus 24%), but also an inferior 5-year EFS (78±4% versus 89±3, p=0.01). We conclude that 1) dexrazoxane does not interfere with the anti-leukemic effect of doxorubicin, 2) intensive intrathecal chemotherapy is as effective as cranial radiation in preventing CNS relapse in standard risk patients, and 3) once-weekly Erwinia is less toxic than E.coli asparaginase, but also less efficacious.
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