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Thursday, June 27, 2013 11:55:28 AM
On the one hand, we are comparing a phase ii result with a chart of phase iii results. Benefits are almost always smaller in phase iii studies with more patients.
On the other hand, it is possible that the secondline treatments these patients moved into (maybe just control, maybe both arms) have improved since what was available in the earlier studies, and that is part of why the control mos was higher. Maybe they moved into other clinical trials. That is why it is important to compare treatment arms to their controls, and not just look at mos of the treatment arms. (Note, I don't think this could be the whole story about why the control arm was so good, since it wouldn't explain the abnormally high pfs or orr data)
Notice also that unlike the pancreatic trial which showed no meaningful benefit, they did not point to future sub-group analysis. In the pancreatic, they probably knew that there was an imbalance in ecog status. Here, in an open label trial, it would seem that there were no obvious subgroups to mine.
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