title slide — always use title case on slide titles - research to .ppt

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2017-09-02 发布于天津
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title slide — always use title case on slide titles - research to .ppt

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title slide — always use title case on slide titles - research to

Introduction A Phase III study of first-line sunitinib 50 mg/d (4 weeks on/2 weeks off) in metastatic RCC (mRCC) demonstrated improvements in ORR, PFS, OS compared to IFN-alpha (J Clin Oncol 2009;27:3584). In Phase II studies, standard-dose sunitinib (50 mg/d 4/2 schedule) has demonstrated robust clinical efficacy in cytokine-refractory mRCC (JAMA 2006;295:2516, J Urol 2007;178:1883, J Clin Oncol 2006;24:16): Overall response rates (ORR): 42% Median progression free survival (PFS): 8.2 mos Median overall survival (OS): 23.9 mos An alternative continuous dosing regimen of sunitinib may provide added treatment flexibility and lessen the incidence or severity of adverse events. Evening (PM) rather than morning (AM) administration may reduce drug-related fatigue or nausea. Current study objectives (N = 107): Assess the efficacy and tolerability of continuous sunitinib at a starting dose of 37.5 mg/d administered in the AM or PM in patients with cytokine-refractory mRCC. Post-Baseline Tumor Assessment in the Combined Patient Population Receiving At Least One-Dose of Sunitinib Most Commonly Reported (Occurring in 10% of Patients) Grade 3 Treatment-Related Adverse Events Tolerability and Health-Related Quality of Life of Continuous Sunitinib Summary and Conclusions Continuous sunitinib 37.5 mg/d may be an alternative, more flexible dosing regimen than the standard schedule (50 mg/d, 4 weeks on/2 weeks off) for patients with cytokine-refractory mRCC. Efficacy, tolerability and health-related quality of life with continuous sunitinib were comparable in the AM and PM dosing arms. Efficacy of continuous sunitinib 37.5 mg/d may be less than with the standard 50 mg/d (4/2) although 95% confidence intervals were overlapping (data shown below from combined analysis of phase II studies). ORR = 20% (vs 42%, 50 mg/d 4/2) Median PFS = 8.2 mos (vs 8.2 mos, 50 mg/d 4/2) Median OS = 19.8 mos (vs 23.9 mos, 50 mg/d 4/2) The safety profile and pharmacokinetics (data not shown) of continu