RANDOMIZED STUDY ON HYDROXYUREA ALONE VERSUS HYDROXYUREA COMBINED WITH LOW-DOSE INTERFERON-ALPHA-2B FOR CHRONIC MYELOID-LEUKEMIA

Interferon-alpha (IFN-alpha) is considered the standard therapy for ch ronic myeloid leukemia (CML) patients not suitable for allogeneic stem cell transplantation. From 1987 through 1992, 195 patients in the Ben elux with recent untreated CML were randomized between low-dose IFN-al pha 2b (3 MIU, 5 days/wk) or hydroxyurea alone (control group). The wh ite blood cell count had to be kept less than 10 x 10(9)/L in both arm s; to this end, the IFN group received additional hydroxyurea, if nece ssary. The complete hematologic responses at 6 months in the IFN group were 62%, versus 38% in the control group. In the IFN group, a comple te hematologic response at 6 months predicted a better survival (P =.0 01), but such a tendency was also seen in the control group (P =.07). Cytogenetic responses in the IFN group yielded 9% complete responders, 7% partial responders (<35% Ph+), and 24% minor responders (36% to 95 % Ph+), The quality of cytogenetic response within the first 24 months was highly predictive for survival (P =.002), Twenty-four patients di scontinued IFN-a because of side effects, but they did this at a long median interval of 17.6 months: the remaining patients did not require dose adaptations. Although the hematologic and cytogenetic responses in the IFN group were higher than in the control group, the duration o f chronic phase from randomization was not statistically different wit h 53 and 44 months in the IFN and control group, respectively. Also, n o advantage for survival calculated from diagnosis was seen for the IF N group (median, 64 months) compared with the control group (median, 6 8 months). (C) 1998 by The American Society of Hematology.