III期VISTA临床研究.pptVIP

* Descriptive P-values (stratified log-rank test) for the comparisons of duration of response: All responding patients – 0.001 Patients achieving CR – 0.097 The latter comparison does not result in a P-value indicating statistical significance as only 12 patients in the melphalan–prednisone arm achieved a complete response and not all of these patients have progressed. DOR p value 0.0012 for all responders, and 0.03 for patients with CR * Median TTP by algorithm was 20.7 months with VMP and 15.2 months with MP (HR 0.54, P0.001) In a post-hoc analysis using modified International Uniform Response Criteria (Facon), median TTP with VMP was not reached at 27 months * * Palumbo Lancet 2006 study measured OS from diagnosis, and excluded 76 patients (23%) who had less than 6 months of follow-up * * VMP demonstrated consistently good efficacy in subgroups of patients with poor prognostic characteristics: age ≥75 years impaired renal function (creatinine clearance 60 mL/min) high-risk cytogenetics (t(4;14), t(14;16), or 17p deletion by FISH) In elderly patients vs younger patients: CR rate was slightly lower (26% vs 32%), TTP was identical, OS was slightly poorer (P=0.17) In patients with CrCl60 mL/min vs ≥60 mL/min: CR rate (28% vs 32%), TTP, and OS appeared unaffected In patients with high-risk vs standard-risk cytogenetics: CR rate was identical (28% vs 28%), TTP and OS were similar * * 29 (28%) of 102 CR VMP patients obtained CR during their weekly therapy * VMP: nervous system 4%, blood and lymphatic (mostly thrombocytopenia) 3%, general disorders (mostly fatigue) 3%; MP: nervous system 0%, blood and lymphatic (mostly thrombocytopenia) 8%, general disorders (mostly fatigue) 0% 45% on VMP vs 41 % on MP completed planned 9 cycles; 14% on VMP and 10% on MP are still on therapy 12% of patients on VMP discontinued bortezomib due to PN (9% in APEX). Hematologic toxicities similar with VMP and MP Rate of thrombocytopenia (52% vs 47%) similar Low rate of severe bleeding ev