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PURPOSE Sunitinib has shown antitumor activity with a manageable safety profile as metastatic renal cell carcinoma (RCC) treatment, when given by the standard intermittent schedule as well as a continuous daily dosing (CDD) schedule. A trial was conducted to compare the schedules. PATIENTS AND METHODS Patients with treatment-naive, clear cell advanced RCC(More)
BACKGROUND Sunitinib at 50 mg/day on the 4-weeks-on-2-weeks-off schedule is the current approved regimen for advanced/metastatic renal cell carcinoma (mRCC). Escudier et al reported that continuous, once-daily dosing with sunitinib 37.5 mg had a manageable safety profile and significant antitumor activity as second-line mRCC therapy. In this prospective,(More)
BACKGROUND We retrospectively analyzed sunitinib outcome as a function of age in metastatic renal cell carcinoma (mRCC) patients. METHODS Data were pooled from 1059 patients in six trials. Kaplan-Meier estimates of progression-free survival (PFS) and overall survival (OS) were compared by log-rank test between patients aged <70 (n=857; 81%) and ≥70(More)
BACKGROUND The prevalence, efficacy, and risk for addiction for persons receiving opioids for chronic back pain are unclear. PURPOSE To determine the prevalence of opioid treatment, whether opioid medications are effective, and the prevalence of substance use disorders among patients receiving opioid medications for chronic back pain. DATA SOURCES(More)
LBA308 Background: In a randomized phase III trial, sunitinib 50 mg/d on Schedule 4/2 (4 wk on treatment [Tx], 2 wk off) showed superior progression-free survival (primary endpoint) to IFN-α (11 vs. 5 mo; p<0.001) as first-line metastatic renal cell carcinoma (mRCC) therapy with a median overall survival (OS) of >2 yr (Motzer 2009). Continuous dosing of(More)
We prospectively assessed the effect of oral methadone on the corrected QT interval (QTc) among 160 patients free of structural heart disease and measured serum methadone concentrations and simultaneous QTc intervals in a subset of 44 participants. Mean +/- SD QTc increased by 12.4 +/- 23 ms (p <0.001) at 6 months, by 10.7 +/- 30 ms (p <0.001) at 12 months,(More)
STUDY OBJECTIVE To evaluate the effects of methadone on QT-interval dispersion. DESIGN Single-center, prospective, cohort study. SETTING Methadone maintenance treatment facility. PATIENTS One hundred eighteen patients who were newly admitted to the facility. Intervention. Twelve-lead electrocardiograms (ECGs) were performed in patients at both(More)
The potential of immunoconjugates of cytotoxic drugs for the treatment of cancer has not yet been realized owing to the difficulty of delivering therapeutic concentrations of these drugs to the target cells. In an effort to overcome this problem we have synthesized maytansinoids that have 100- to 1000-fold higher cytotoxic potency than clinically used(More)
CONTEXT Cocaine dependence, which affects 2.5 million Americans annually, has no US Food and Drug Administration-approved pharmacotherapy. OBJECTIVES To evaluate the immunogenicity, safety, and efficacy of a novel cocaine vaccine to treat cocaine dependence. DESIGN A 24-week, phase 2b, randomized, double-blind, placebo-controlled trial with efficacy(More)