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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CLINICAL TRIALS AND OBSERVATIONS
Results of the Dana-Farber Cancer Institute ALL Consortium Protocol 95-01 for children with acute lymphoblastic leukemia
Albert Moghrabi1,
Donna E. Levy2,
Barbara Asselin3,
Ronald Barr4,
Luis Clavell5,
Craig Hurwitz6,
Yvan Samson7,
Marshall Schorin8,
Virginia K. Dalton2,
Steven E. Lipshultz9,
Donna S. Neuberg2,
Richard D. Gelber2,
Harvey J. Cohen10,
Stephen E. Sallan2,11, and
Lewis B. Silverman2,11
1 Division of Hematology and Oncology, Sainte-Justine Hospital, University of Montreal, Montreal, QC, Canada;
2 Departments of Pediatric Oncology, Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA;
3 Division of Pediatric Hematology/Oncology, University of Rochester Medical Center, Rochester, NY;
4 Division of Pediatric Hematology/Oncology, McMaster University, Hamilton, ON, Canada;
5 Division of Pediatric Oncology, San Jorge Children's Hospital, San Juan, Puerto Rico;
6 Department of Pediatric Hematology/Oncology, Maine Children's Cancer Program, Scarborough, ME;
7 Centre Hospitalier Universitaire de Quebec, Quebec City, QC, Canada;
8 Section of Pediatric Hematology Oncology, Tulane Hospital for Children, New Orleans, LA;
9 Department of Pediatrics, Leonard M. Miller School of Medicine, University of Miami, Holtz Children's Hospital of the University of Miami-Jackson Memorial Medical Center; Batchelor Children's Research Institute, Mailman Institute for Child Development, and the Sylvester Comprehensive Cancer Center, Miami, FL;
10 Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA;
11 Division of Hematology/Oncology, Children's Hospital, Boston, MA
The Dana-Farber Cancer Institute (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 Escherichia coli asparaginase (all patients). Between 1996 and 2000, 491 patients (aged 0-18 years) were enrolled (272 standard risk and 219 high risk). With a median of 5.7 years of follow-up, the estimated 5-year event-free survival (EFS) for all patients was 82% ± 2%. Dexrazoxane did not have a significant impact on the 5-year EFS of high-risk patients (P = .99), and there was no significant difference in outcome of standard-risk patients based on type of central nervous system (CNS) treatment (P = .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 = .01). We conclude that (1) dexrazoxane does not interfere with the antileukemic 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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