SANCTUARY THERAPY - A RANDOMIZED TRIAL OF 724 CHILDREN WITH PREVIOUSLY UNTREATED ACUTE LYMPHOBLASTIC-LEUKEMIA - A REPORT FROM CHILDRENS CANCER STUDY-GROUP

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  • 1 January 1982
    • journal article
    • research article
    • Vol. 42  (2) , 674-680
Abstract
Between 1972 and 1974, Childrens Cancer Study Group enrolled 724 children with newly diagnosed acute lymphoblastic leukemia on a single randomized clinical trial. Study CCG-101 was designed to test 4 types of presymptomatic CNS and sanctuary therapies consisting of 2400 rad craniospinal radiation therapy (RT) plus 1200 rad extended-field RT, which included the liver, spleen, kidneys, lower abdomen and gonads; 2400 rad craniospinal RT; 24000 rad cranial RT plus intrathecal methotrexate (i.t. MTX); and i.t. MTX alone. Patients all received a 28-day induction course of vincristine, prednisolone and L-asparaginase and were maintained subsequently on a regimen consisting of daily 6-mercaptopurine, weekly MTX and monthly pulses of vincristine and prednisone. Patients treated with 6 doses of i.t. MTX alone had a significantly higher incidence of CNS relapse than did patients treated with 2400 rad and craniospinal RT plus 1200-rad abdominal RT, 2400-rad craniospinal RT or 2400-rad cranial RT plus i.t. MTX. There was no significant difference in marrow remission duration or survival of the treatment groups. There appears to be a benefit with regard to length of bone marrow remission and survival for patients with initial white blood counts .gtoreq. 20,000/mm3 treated with cranial RT plus i.t. MTX. The majority of the patients remaining on study have now discontinued maintenance therapy. The 8-yr overall estimated survival rate on this study is 56% and the disease-free survival rate is 52%.

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