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Re: iwfal post# 128000

Saturday, 10/08/2011 2:03:11 PM

Saturday, October 08, 2011 2:03:11 PM

Post# of 252299
KERX/AEZS Phase II trial

The phase II trial enrolled patients with other solid tumors as well. The JCO paper reports that an unplanned interim analysis was carried out because of limited resources. At the time, they had 25 CRC patients and I'm assuming this was the only group where they saw a benefit. So they then enrolled an additional 13 CRC patients to bring the final number to 38.

Three of the patients were not evaluable for response, so I think they are excluded from the TTP analyses. However, the OS analysis reported in JCO includes all 38 patients, IIRC.

There's no mention of controlling for multiple comparisons (since this was essentially like conducting a subgroup analysis in a larger trial), but as you've mentioned, the p-values are quite low.

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