SURVIVAL, DISEASE-FREE SURVIVAL AND ADVERSE-EFFECTS OF CONDITIONING FOR ALLOGENEIC BONE-MARROW TRANSPLANTATION WITH BUSULFAN CYCLOPHOSPHAMIDE VS TOTAL-BODY IRRADIATION - A METAANALYSIS/

Randomized, prospective studies comparing BUCY to TBI conditioning reg imens for allogeneic bone marrow transplantation have yielded conflict ing results. We investigated the overall survival, the disease-free su rvival and the toxicities of BUCY vs TBI-based regimens by conducting a meta-analysis of all published, randomized, prospective trials compa ring these regimens. Five studies were analyzed. We evaluated six endp oints: survival, disease-free survival, veno-occlusive disease (VOD) o f the liver, acute GVHD, chronic GVHD, and interstitial pneumonitis. W e combined individual study results using a random effects model. Surv ival and disease-free survival were better with TBI-based regimens tha n with BUCY, but these differences were not statistically significant (survival odds ratio 1.4, 95% confidence interval 0.9-2.2, P = 0.09; d isease-free survival odds ratio 1.2, 95% confidence interval 0.7 - 2.1 , P = 0.44). A power analysis indicated that BUCY was unlikely to have a clinically relevant survival or disease-free survival advantage. Th e power analysis could not exclude the possibility of such an advantag e for TBI-based regimens. A significantly greater incidence of VOD occ urred with BUCY (odds ratio 2.5, 95% confidence interval 1.2 - 5.2, P = 0.02). For the other side-effects, there were no significant differe nces. We concluded that TBI-based regimens cause less VOD than BUCY an d are at least as good for survival and disease-free survival.