A randomized trial of combined modality therapy of childhood non-Hodgkin's lymphoma.
From 1975 to 1978, 69 children with non-Hodgkin's lymphoma were staged and treated in a randomized protocol to determine the contribution of involved-field radiotherapy (IF-RT) to an effective drug regimen in Stages III-IV and the efficacy of prophylactic treatment of the central nervous system with cranial irradiation and intrathecal methotrexate in Stage II-IV. Induction therapy for Stages I-II was vincristine, prednisone, cyclophosphamide and IF-RT (3000-3500 rad). Stages III-IV received the same three drugs plus adriamycin, and were randomized to received or not receive IF-RT. The complete remission rate was 88%. After randomization to receive CNS prophylaxis or not, all children received oral mercaptopurine and methotrexate for 18 months. The two-year actuarial estimate of disease-free survival for all responders is 55% and is significantly influenced by stage. (Ninety percent disease-free survival for Stages I-II, versus 38.8% for III-IV, P less than .05).  We observed no benefit but added toxicity from IF-RT in Stages III-IV. Efforts at CNS prophylaxis in high-risk children are warranted, since only 1 of 18 children randomized to receive prophylaxis developed CNS disease as the site of first relapse, whereas 4 of 16 receiving no prophylaxis did so.
D000293:Adolescent; D000328:Adult; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001853:Bone Marrow / Q000187:drug effects; D002493:Central Nervous System Diseases / Q000517:prevention & control; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008223:Lymphoma / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D008297:Male; D009367:Neoplasm Staging; D011897:Random Allocation; D012075:Remission, Spontaneous; D013997:Time Factors
D000970:Antineoplastic Agents