Increased remissions from one course for intermediate-dose @entity2592 and XXXX in elderly @entity3052 when combined with @entity8778 . A randomized population-based phase II study.

@entity1 @entity8778 @entity137 @entity882 @entity8779 @entity2592 @entity3052 @entity11402
@entity8778 has single-drug activity in @entity3052 ( @entity3052 ), and may enhance the formation of the active metabolite ( @entity11402 ) of @entity2592 ( @entity2592 ). To evaluate the feasibility of adding intermittent @entity8778 to intermediate-dose ara-C (1 g/m2/2 h) b.i.d. for 4 d with @entity8779 (CCI), we performed a 2:1 randomized phase II trial in @entity3052 @entity1 aged over 60 years. Primary endpoints were time to recovery from cytopenia and need for supportive care following the first course. Sixty-three @entity1 (median 71 years, range 60-84 years) were included, constituting 72% of all eligible @entity1 . @entity137 was limited, with no differences between the treatment arms. The early toxic death rate was 11%. The median time to recovery from neutropenia and @entity882 was 22 and 17 d from the start of course no. 1, respectively, and the requirement for platelet and red cell transfusions was four and eight units respectively. @entity1 had a median of 8 d with fever over 38 degrees C, and 17 d with intravenous antibiotic treatment. The overall complete remission (CR) rate was 62%, with 51% CR from one course of CCI in comparison with 35% for the two-drug therapy (P = 0.014). The median survival with a 2-year follow-up was 14 months, and the 2-year survival was over 30%, with no differences between the treatment arms. Considering the median age and our population-based approach, the overall results are encouraging.
