Re: 6.5 months Median survival for Cap plus Placebo arm 1-Dec-11 04:46 pm
The 6.5 month median survival data he referred to was the median survival time for the 5FU refractory subset of the Peri-cap Phase II trials. He was not saying that based on that number you should assume 6.5 months in this trial that has more than ten times as many drug taking patients. There were only 38 patients enrolled in the Phase II with only half of them receiving Perifosine. The 5 FU refractory patients are a subset of that number . With fewer than 20 patients, no statistician would ever suggest that we should extrapolate that number to be used as an exact reference point in a trial involving 230 drug taking patients anymore than they would say that you should use exactly 13.9 months as the exact survival expectation for the perifosine arm. He was only making the point that the 6.5 figure was basically consistent with the historical results of earlier large trials involving patients with late stage colorectal cancer -- most notably the erbitux trial, where the median overall survival time was 5.5 months. Based on historical data from large trials, a model that uses 6 months appears to be conservative, and as the threads have indicated, a 6 month control median survival with a 3 month survival benefit for the peri arm is consistent with 163 deaths in early August and suggests that the 360th even will occur early in the second week of January.We'll see soon enough.