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Two-sided P values http://www.selleckchem.com/products/epz015666.html (VAD). The median age of the 213 patients was 55 years (range 27�C71), and there were 110 males. Most patients had advanced disease at diagnosis (77% Durie-Salmon stage III, 71% ISS in stages II/III). Chromosome 13 deletion was present in 34% of the 150 patients tested. Among the 213 patients, 123 (58%) underwent the scheduled ASCT, and 108 (51% of the enrolled patients and 88% of the patients who underwent ASCT) were randomly assigned to maintenance therapy: 52 in arm A and 56 in arm B (Fig. 1). Ninety patients did not undergo ASCT for the following reasons: early death (n = 44, including 36 deaths during VAD treatment phase and 8 during stem cell mobilization phase), lost in follow-up (n = 22), progression after VAD (n = 14), refusal (n = 4), not eligible for ASCT due to poor lung or cardiac function (n = 4), and protocol violation (n = 2). Among the 123 ASCT recipients, 14 were not randomized for the following reasons: death (n = 7), disease progression (n = 5), concomitant myelodysplasia (n = 1), psychosis (n = 1), and protocol violation (n = 1). Table I shows a comparison of the baseline characteristics http://www.selleckchem.com/products/smoothened-agonist-sag-hcl.html of the 108 randomized patients. The two groups were comparable except for a higher median age in arm A (55 vs. 52 years; P = 0.052) and for a higher proportion of ISS stage III in arm http://www.selleck.cn/products/SP600125.html A (30 vs. 13%; P = 0.04). There were no differences in response rates (CR and VGPR) between the groups 12 months after the initiation maintenance therapy and at the last follow-up (Table II) in intention to treat analysis. After a median follow-up of 27 months, the estimated OS at 2 years was 70% in arm A (95% confidence interval [CI] 60�C80) and 85% in arm B (95% CI 80�C90; P = 0.27; Fig. 2A). The 2-year PFS was 30% in arm A (95% CI 22�C38) and 64% in arm B (95% CI 57�C71; P = 0.002; Fig. 2B), with median PFS of 19 months (range 15�C22) and 36 months (range 22�C49), respectively. We looked at OS and PFS in good (CR and VGPR) and poor (below VGPR) responders after ASCT. The estimated OS at 2 years did not differ among good and poor responders (83% in arm A and 89% in arm B, P = 0.41, for good responders; 66% in arm A and 82% in arm B, P = 0.29, for poor responders). In contrast, patients who did not achieve a CR or VGPR, the estimated PFS at 2 years was significantly different between the two treatment groups (19% in arm A and 59% in arm B; P = 0.002; Fig. 3B). This difference was not observed in patients with CR or VGPR (Fig. 3A).
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