VACOP-B VERSUS VACOP-B PLUS AUTOLOGOUS BONE-MARROW TRANSPLANTATION FOR ADVANCED DIFFUSE NON-HODGKINS-LYMPHOMA - RESULTS OF A PROSPECTIVE RANDOMIZED TRIAL BY THE NON-HODGKINS-LYMPHOMA COOPERATIVE STUDY-GROUP

Purpose: The aim of this multicenter randomized study was to compare c onventional therapy with conventional plus high-dose therapy (HDT) and autologous bone marrow transplantation (ABMT) as front-line treatment for poor-prognosis non-Hodgkin's lymphoma (NHL). Patients and Methods : Between October 1991 and June 1995, 124 patients, aged 15 to 60 year s, with diffuse intermediate- to high-grade NHL (Working Formulation c riteria), stages II bulky (greater than or equal to 10 cm), III, or IV were enrolled. Sixty-one patients were randomized to receive etoposid e, doxorubicin, cylclophasphamide, vincristine, prednisone, and bleomy cin (VACOP-B) for 12 weeks and cisplatin, cytarabine, and dexamethason e (DHAP) as a salvage regimen (arm A), and 63 to receive VACOP-B for 1 2 weeks plus HDT and ABMT (Arm B). Results: There was no significant d ifference in terms of complete remissions (CRS) in the two groups: 75% in arm A, and 73% in arm B. The median follow-up observation time was 42 months. The 6-year survival probability was 65% in both arms. Ther e was no difference in disease-free survival (DFS) or progression-free survival (PFS) between the two groups. DFS was 60% and 80% (P =.1) an d PFS was 48% and 60% (P =.4) for arms A and B, respectively. Procedur e feasibility was the major problem. In arm B, 29% of: enrolled patien ts did not undergo HDT and ABMT, A statistical improvement in terms of DFS (P =.008) and a favorable trend in terms of PFS (P =.08) far inte rmediate-/high- plus high-risk group patients assigned to HDT and ABMT was observed. Conclusion: In this study conventional chemotherapy fol lowed by HDT and ABMT as front-line therapy seems no more successful t han conventional treatment in terms of overall results. However, our r esults suggest that controlled studies of HDT plus ABMT should be prop osed for higher risk patients. J Clin Oncol 16:2796-2802, (C) 1998 by American Society of Clinical Oncology.