DOSE INTENSIFICATION WITH AUTOLOGOUS BONE-MARROW TRANSPLANTATION IN RELAPSED AND RESISTANT HODGKINS-DISEASE - RESULTS OF A BNLI RANDOMIZED TRIAL

High-dose chemotherapy and radiotherapy with autologous bone-marrow tr ansplantation (ABMT) are increasingly used for the treatment of relaps ed and resistant Hodgkin's disease, although there has been no randomi sed trial of this treatment. The British National Lymphoma Investigati on therefore undertook a randomised comparison of high-dose chemothera py (BEAM=carmustine, etoposide, cytarabine, and melphalan) plus ABMT w ith the same drugs at lower doses not requiring bone-marrow rescue (mi ni-BEAM) in patients with active Hodgkin's disease, for whom conventio nal therapy had failed. 20 patients were assigned treatment with BEAM plus ABMT and 20 mini-BEAM. All have been followed up for at least 12 months (median 34 months). 5 BEAM recipients have died (2 from causes related to ABMT and 3 from disease progression) compared with 9 mini-B EAM recipients (all disease progression). This difference was not sign ificant (p = 0.318). However, both event-free survival and progression -free survival showed significant differences in favour of BEAM plus A BMT (p = 0.025 and p = 0.005, respectively). Recruitment to the trial became increasingly difficult because patients refused randomisation a nd requested ABMT. It was therefore closed early (40 patients rather t han 66 intended). Nevertheless, we found a dose-response effect in the se patients with relapsed and resistant Hodgkin's disease. High doses facilitated by ABMT can lead to better disease-free survival.