@entity8779 , XXXX , and @entity8673 as induction therapy for untreated @entity3052 and high-risk myelodysplastic syndrome.

@entity1 @entity4289 @entity66 @entity8779 @entity294 @entity3052 @entity2592 @entity177 @entity1398 @entity8673
Previous studies suggest that @entity8779 / @entity2592 (ara-C)/ @entity8673 (IAP) is an active salvage regimen for @entity1 with @entity3052 . We therefore investigated this regimen in @entity1 with newly-diagnosed @entity3052 or @entity4289 (>= 10% blasts). @entity1 were eligible if the anticipated treatment-related mortality (TRM) was <10%. @entity1 received @entity8673 (1,280 mg/day po; days 1-8), @entity2592 (1.5 g/m(2) /day; days 4-7), and @entity8779 (12 mg/m(2) /day, days 4-6). Up to 3 cycles of consolidation with a shortened course was permitted. The primary endpoints were "good CR" rate (CR on day 35 without minimal @entity66 ) and TRM in the first 28 days. The study was to stop if after each cohort of 5 @entity1 (a) the Bayesian posterior probability was   <   5% that the true "good CR rate" was   >=    70% or (b) the posterior probability was >25% that the TRM rate was >= 5%. Twenty-four @entity1 were included. Conventional CR was achieved in 15 (63%) @entity1 but only 12 (50%) achieved "good CR". 4 of 12 (33%) @entity1 with "good CR" relapsed at median of 16 weeks (10.5-19). Five (21%) @entity1 had refractory disease. Survival probability at 1 year was 72% (48.7-64). Two (8.3%) @entity1 died within 28 days from @entity177 . The most common grade 3-4 adverse effects were @entity1398 (75%) and @entity294 (25%). Based on the stopping rules accrual ceased after entry of these 24 @entity1 . IAP did not meet the predefined efficacy criteria for success. Therefore, we would not recommend this regimen for phase three testing in this @entity1 subset.
