Dibromomannitol in the treatment of chronic granulocytic leukemia: a
prospective randomized comparison with busulfan
GP Canellos, RC Young, PE Neiman and VT DeVita
Dibromomannitol (DBM) is a new agent for the treatment of chronic
granulocytic leukemia. A propsective evaluation of the drug was undertaken
in a randomized comparison with busulfan. Forty previously untreated,
Philadelphia chromosome-positive cases were treated, with 20 patients in
each treatment group. The protocol provided for continuous maintenance
therapy after remission induction, with a crossover to the opposite drug in
patients who became refractory to the primary agent but are without
evidence of blastic tranformation. There were 14 remissions in the DBM
group and 15 in those treated with busulfan. The rate of decrease of the
elevated leukocyte count was more rapid with DBM, but prolonged disease
control off treatment occurred in only three of 14 cases as opposed to nine
of fifteen busulfan-treated patients who required a median delay of 12 mo
before maintenance could be initiated. Hypoplasia occurred in one DBM
patient and two busulfan cases. Following recovery, crossover to the
opposite drug in two cases again resulted in hypopllasia. Increased skin
pigmentation, amenorrhea, pulmonary fibrosis, and cytologic dysplasia,
commonly associated with busulfan adminstration, were also noted with DBM.
The median duration of disease control with busulfan was 34 mo and 26 mo
with DBM. There was no signigicant difference in the incidence of blastic
transformation, and median survival for both groups was 44 mo. DBM appears
to be as effective as busulfan in the treatment of the chronic phase of CGL
but with a more predictable myelosuppressive action. The principal
advantage of busulfan over DBM is the fact that more than half the
busulfan-treated patients experienced prolonged disease control off
treatment.
Volume 45,
Issue 2,
pp. 197-203,
02/01/1975
Copyright © 1975 by The American Society of Hematology