[Randomized controlled study of methyl 6-[3-(2-chloroethyl)-3-nitrosoureido]-6-deoxy-alpha-D-glucopyranoside (MCNU) in comparison with busulfan for chronic myelogenous leukemia].

UNLABELLED:In a randomized controlled study, the efficacy of MCNU was compared with that of Busulfan in 95 patients with chronic myelogenous leukemia. Of the patients studied, 95 were entered among whom 77 were evaluable. These comprised 40 for an MCNU group (M) and 37 for a Busulfan group (B). No significant difference was found statistically between the two groups with regard to background factors, i.e., male-to-female ratio, age, white blood cell counts, platelet counts, splenomegaly or Ph1 chromosome. RESULTS:CR rate was 83% for M and 68% for B, and the number of days to CR was 88 for M and 155 for B. Blastic crisis was noted in 31% of M patients and 33% of B patients and the number of days to blastic crisis was 542.6 and 581.9, respectively for the two groups. Deaths accounted for 28% and 29% for each of M and B. Side effects were observed in 31% of M cases and 15% of B cases. A significant difference was observed only in the period to CR. MCNU showed almost equal efficacy to that of Busulfan but was superior to Busulfan in patients who required rapid response. Side effects were mild and transient. Despite its delivery by intravenous injection, the administration of MCNU is deemed convenient, considering the long interval possible between treatments, being comparable in this respect with oral Busulfan. MCNU therefore seems a very effective drug for chronic myelogenous leukemia.