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Treatment of Childhood Acute Lymphoblastic Leukemia: Results of Dana-Farber ALL Consortium Protocol 87-01

From the Division of Hematology/Oncology, Hopital Sainte Justine, Montreal, Quebec; Division of Pediatric Hematology/Oncology, McMaster University, Hamilton, Ontario, Canada; Departments of Pediatric Oncology and Biostatistical Science, Dana-Farber Cancer Institute; Divisions of Hematology/Oncology and Radiation Oncology and Department of Medicine, Children’s Hospital, Harvard Medical School, Boston, MA; Department of Pediatrics, Mt Sinai Medical Center, New York; Division of Pediatric Hematology/Oncology and Division of Pediatric Cardiology, University of Rochester Medical Center, Rochester, NY; Division of Pediatric Oncology, San Jorge Children’s Hospital, San Juan, Puerto Rico; Division of Pediatric Hematology/Oncology, Maine Children’s Cancer Program and Barbara Bush Children’s Hospital at Maine Medical Center, Portland, ME; Division of Pediatric Oncology, Ochsner Clinic, New Orleans, LA; and Department of Pediatrics, Stanford University School of Medicine, Stanford, CA.

Address reprint requests to Stephen E. Sallan, MD, Dana-Farber Cancer Institute, 44 Binney St, Boston, MA 02115; email: stephen_sallan{at}dfci.harvard.edu

PURPOSE: To improve efficacy and reduce toxic- ity of treatment for children with acute lymphoblas- tic leukemia.

PATIENTS AND METHODS: Patients from all risk groups, including infants and those with T-cell disease, were treated between 1987 and 1991. Standard-risk (SR) patients did not receive cranial irradiation, whereas high-risk (HR) and very high-risk (VHR) patients participated in a randomized comparison of 18 Gy of cranial irradiation conventionally fractionated versus two fractions per day (hyperfractionated).

RESULTS: At a median follow-up of 9.2 years, the 9-year event-free survival (EFS ± SE) was 75% ± 2% for all 369 patients, 77% ± 4% for the 142 SR patients, and 73% ± 3% for the 227 HR/VHR patients (P = .37 comparing SR and HR/VHR). The CNS, with or without concomitant bone marrow involvement, was the first site of relapse in 19 (13%) of the 142 SR patients: 16 (20%) of 79 SR boys and three (5%) of 63 SR girls. This high incidence of relapses necessitated a recall of SR boys for additional therapy. CNS relapse occurred in only two (1%) of 227 HR and VHR patients. There were no outcome differences found among randomized treatment groups. Nine-year overall survival was 84% ± 2% for the entire population, 93% ± 2% for SR children, and 79% ± 3% for HR and VHR children (P < .01 comparing SR and HR/VHR).

CONCLUSION: A high overall survival outcome was obtained for SR patients despite the high risk of CNS relapse for SR boys, which was presumed to be associated with eliminating cranial radiation without intensifying systemic or intrathecal chemotherapy. For HR/VHR patients, inability to salvage after relapse (nearly all of which were in the bone marrow) remains a significant clinical problem.

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