Raf Inhibitors progression permanently increased corticosteroid requirement

patients was estimated to provide 86% power with use of a 1 sided a of 0.1 for this comparison of the median survival using a parametric model, assuming Finibax a hazard ratio of 1.5 . As described in the protocol, we recognized that a smaller hazard ratio might still be of interest, and thus, an analysis was planned using historical control information from prior University of California, San Francisco studies to estimate the potential therapeutic benefit, adjusting for age, sex, and extent of resection. Enrollment was expected to occur over a 12 15 month period, with follow up for all patients of at least 15 months. Six patients treated using the same dosing regimen during the initial phase I trial were included for a total of 66 patients.
If the discontinuation rate because of toxicity was ≥20% and the lower bound for the 1 tailed 95% confidence interval was .10%, the treatment strategy would not have been considered to be feasible and the study would be stopped. Efficacy and safety analyses were conducted on the full analysis set, which included data Rapamycin clinical trial from all patients who received at least 1 dose of the study drug. OS and PFS were estimated using the Kaplan Meier method.27 OS was defined as the time from the date of study registration to date of death from any cause. PFS was defined as the time from the date of study registration to the date of first observed progressive disease based on radiologic assessment, nonreversible neurologic progression, permanently increased corticosteroid requirement, or death from any cause, whichever came first.
The comparative analysis of OS and PFS used a Cox proportional hazards model that included age, KPS, and extent of resection. For all efficacy analyses, 95% CIs were braf inhibitor to be included with all point estimates. For the final analysis, survival data were compared with results from 3 earlier prospective phase II clinical trials that treated similar patient populations with other chemotherapy agents in combination with temozolomide during and after RT. All trials were conducted at the University of California, San Francisco. The first study used thalidomide with temozolomide plus RT;28 the second study used cis retinoic acid with temozolomide plus RT;29 the third study used erlotinib with temozolomide plus RT.
30 An exploratory analysis of biologic correlative data using Cox proportional hazard models was performed Telaprevir solubility to increase our knowledge of how the potential benefit of enzastaurin might be influenced by genetic characteristics of the tumor. Results Patient Characteristics A total of 66 eligible patients were registered affirmative team from September 2006 through October 2008. Table 1 shows the baseline characteristics for the current trial and for the other historical control groups. Median age for ETRT was 57 years; median KPS was 90 ; median survival follow up for 19 censored patients at the time of analysis was 103 weeks . The historical control group included 193 patients treated in the 3 prior phase II studies. Median age for the combined historical control group was 54 years; median KPS was 90 . For the historical group, 14 patients were censored with median survival follow up time of 234 weeks . The extent of surgical resection was similar among the current and historical groups.