Intermittent Intrathecal Methotrexate and Fractional Radiation (M-Imfra) plus Chemotherapy in Childhood Leukemia

Abstract

Preliminary results of our investigation concern 28 consecutive cases of children with acute lymphoblastic leukemia (ALL), treated between March 1974 and March 1978 at the Clinica Pediatrica of the Catholic University in Rome, with a slight modification of the ALL protocol II of the Children's Hospital of Michigan (M-IMFRA). This protocol includes intermittent low dosage radiation of the cranio-spinal axis, combined with single intrathecal injections of methotrexate for the prophylaxis of central nervous system leukemia. Of the initial 28 children, one did not achieve a complete remission and one died of viral pneumonitis, 4 months after admission, in complete remission and had no hematologic toxicity at the time of this infection. The evaluation of remission duration is based on the remaining 26 children with a period of observation of up to 48 months. Only 2 children, who belonged to the low risk group, have so far relapsed, and relapse was confined to the bone marrow. Median survival without evidence of recurrence is 21 months. Or the 28 patients investigated, 17 are high risk children, as judged by the WBC above 20,000/mm3, mediastinal mass and age below 18 months or above 12 years. Only minimal toxicity has been observed in all cases. We have been encouraged to continue the regimen described here by recent observations regarding the abnormal computed tomography (ACT) scans in children with ALL following CNS prophylaxis of 2,400 rad to the skull. The high incidence of CAT scan abnormalities found is of interest and suggests a reappraisal of the current approaches to CNS prophylaxis.