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Re: sunstar post# 104755

Sunday, 12/16/2012 1:51:51 PM

Sunday, December 16, 2012 1:51:51 PM

Post# of 346678
You should note that the first link is to the abstract about the preliminary results of the
trial presented at ASCO in 2009, and the second is the paper on the final results of the trial
published in 2011. If you click on the second link you can read the paper. Note that it was
open label, not randomized, and had no control arm. The OS results of 12.2 months is for
the arm which was found to have the maximum tolerated dose (MTD), which had 44 patients.
The OS for all 67 patients at the three dosages was 10.3 months. An important piece of
information is that 50% of the 44 patients had ECOG status = 0, and the other 50% had
ECOG status = 1. So the patient group is somewhat biased towards healthier patients,
which is exactly why a control arm needs to be included.
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