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Neuropsychological Outcomes From a Randomized Trial of Triple Intrathecal Chemotherapy Compared With 18 Gy Cranial Radiation As CNS Treatment in Acute Lymphoblastic Leukemia: Findings From Dana-Farber Cancer Institute ALL Consortium Protocol 95-01

Deborah P. Waber, Jennifer Turek, Lori Catania, Kristen Stevenson, Philippe Robaey, Ivonne Romero, Heather Adams, Cheryl Alyman, Christine Jandet-Brunet, Donna S. Neuberg, Stephen E. Sallan, Lewis B. Silverman

From the Division of Psychology, Department of Psychiatry, Children's Hospital; Departments of Psychiatry and Pediatrics, Harvard Medical School; Divisions of Hematology and Oncology, Department of Medicine, Children's Hospital and Departments of Pediatric Oncology, Biostatistics, and Computational Biology, Dana-Farber Cancer Institute, Boston, MA; Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, NY; Division of Pediatric Hematology/Oncology, McMaster University, Hamilton, Ontario; Departments of Pediatric Hematology/Oncology, Division of Hematology/Oncology, Hôpital Sainte Justine, Montreal; Division of Psychology, Department of Pediatric Hematology/Oncology, Centre Mère-Enfant, Quebec, Canada; and the Interamerican University, San Germán, Puerto Rico

Address reprint requests to Deborah P. Waber, PhD, Department of Psychiatry, Children's Hospital, 300 Longwood Ave, Boston, MA 02115; e-mail: deborah.waber{at}childrens.harvard.edu

Purpose We evaluated late neuropsychological toxicity in children treated for standard-risk acute lymphoblastic leukemia (ALL) who were randomly assigned to receive either cranial radiation therapy (CRT) with double intrathecal (IT) chemotherapy or intensive triple IT chemotherapy (no CRT) as CNS-directed therapy.

Patients and Methods Between 1996 and 2000, 164 children with standard-risk ALL treated on Dana-Farber Cancer Institute Consortium Protocol 95-01 were randomly assigned to receive either 18 Gy CRT delivered in twice daily fractions (0.9 Gy) with double IT therapy (methotrexate and cytarabine) or intensive triple IT drug (methotrexate, cytarabine and hydrocortisone) without CRT. Neuropsychological testing was completed at a median 6 years postdiagnosis for 79 children (CRT, n = 39; triple IT, n = 40), all of whom were in continuous complete remission.

Results Cognitive function for both groups was solidly in the average range, with no consistent group differences in basic cognitive skills. Children treated on the CRT plus double IT arm did, however, exhibit less fluent output and were less effective at modulating their behavior by parent report.

Conclusion This randomized trial revealed only subtle differences 6 years after diagnosis between children who received CNS therapy as CRT plus double IT drug or as intensive triple IT drug. In most situations where comparable therapeutic efficacy can be achieved without CRT, it is preferable to do so. Where therapeutically necessary, however, CRT at lower doses may not add risk for significant neurotoxicity.

Supported by Grant No. 2 P01 CA 68484 from the National Cancer Institute, the Michael J. Garil Fund for Leukemia Research, and by Mental Retardation Center Grant No. P30-HD18655.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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