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Delay of the Diagnostic Lumbar Puncture and Intrathecal Chemotherapy in Children With Acute Lymphoblastic Leukemia Who Undergo Routine Corticosteroid Testing: Tokyo Children’s Cancer Study Group Study L89-12

From the Tokyo Children’s Cancer Study Group; Department of Pediatric Hematology-Oncology, Institute of Medical Science, and Department of Pediatrics, University of Tokyo; Department of Pediatrics, Juntendo University; Department of Pediatrics, Tokyo Medical and Dental University; First Department of Pediatrics, Toho University; Department of Hematology-Oncology, Tokyo Metropolitan Kiyose Children’s Hospital; Department of Pediatrics, Jikei University; Department of Pediatrics, Nippon Medical School; Department of Pediatrics, Keio University; and Departments of Environmental Epidemiology and Hematology, National Children’s Hospital, Tokyo; Department of Pediatrics, Ibaraki Children’s Hospital, Mito; Department of Hematology-Oncology, Saitama Children’s Medical Center, Iwatsuki; Department of Pediatrics, Yokohama City University; and Department of Oncology, Kanagawa Children’s Medical Center, Yokohama; Department of Hematology-Oncology, Chiba Children’s Hospital; and Department of Pediatrics, Chiba University, Chiba; Department of Pediatrics, University of Shinshu, Matsumoto; Department of Pediatrics, Dokkyo Medical School, Tochigi; and Department of Pediatrics, Yamanashi Medical University, Kofu, Japan.

Address reprint requests to Atsushi Manabe, MD, Department of Pediatric Hematology-Oncology, Institute of Medical Science, University of Tokyo, 4-6-1, Shirokanedai, Minato-ku, Tokyo 108-8639, Japan; email: manabe{at}ims.u-tokyo.ac.jp

PURPOSE: To determine the effects of eliminating initial lumbar punctures in 418 consecutively treated children with acute lymphoblastic leukemia (ALL).

PATIENTS AND METHODS: Patients were enrolled onto a trial conducted in central Japan between 1989 and 1992. Treatment consisted of standard four-drug induction therapy followed by a risk-based intensification phase, reinduction therapy, late intensification, and remission maintenance therapy (total of 104 weeks). The initial lumbar puncture, with an intrathecal injection of chemotherapy, was performed after 1 week of prednisolone sensitivity testing (day 8). End points included response to prednisolone, CNS status at the time of the day 8 lumbar puncture, subsequent adverse events in CNS and bone marrow, and event-free survival (EFS).

RESULTS: The remission induction rate was 93.1% with a 6-year EFS rate (± SE) of 68.7% ± 2.4%, which is similar to historical results for patients who received their diagnostic lumbar puncture and first instillation of intrathecal chemotherapy on day 0. Overall, 84.5% of the patients had good responses to prednisolone, whereas 15.5% had poor responses. Clinical outcome was strikingly better for the good responders (6-year EFS, 74.1% ± 2.5% compared with 40.1% ± 6.4% for patients with poor responses), suggesting that omission of intrathecal chemotherapy did not alter the predictive value of drug sensitivity testing. Eighteen patients experienced CNS relapse as their first adverse event (cumulative risk, 5.1%; 95% confidence interval, 2.7% to 7.4%), coincident with reports from groups using conventional strategies of CNS clinical management. Bleeding into the CSF at the time of the day 8 lumbar puncture was apparent in 29 cases (8.1%), but leukemic blasts were identified in only two.

CONCLUSION: Delay of the initial lumbar puncture and intrathecal injection of chemotherapy seems to be feasible in children with ALL. Further controlled evaluations are needed to establish the validity of this conclusion.

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