“Compare Best % Tumor Specific Response in loco-regional disease and/or metastatic disease for the treatment regimens in the study population”
I found this interesting. First, the words ... the term distal does not show up. It’s still there by implication though, because that’s the disease that’s left over when the loco-regional part is considered separately. Loco-regional for H&N is the tumor group defined by a (required) primary tumor, plus any metastases located above the collar bone. Distal then, is then either only the metastases below the collar bone (in the collar bone is not defined) when there’s a primary tumor, OR all metastases (wherever located) if there is no primary tumor.
The term “metastatic disease” now DOES show up. This is any metastases, no matter where located, and whether or not there is a primary tumor. It’s a pure measurement. The measurement in this Trial of the response of observed metastases (without changes in definition depending on whether there is a primary tumor or not) was not part of the original Trial definition, and was not described in the September 12 webcast. It now appears that the approved Trial protocol allows metastatic disease, as a standalone indication, to be a listed outcome measure of this Trial. We must assume that this change was part of Oncolytics' re-submittal to the FDA, and that the FDA has approved this change.
I like it! Where it looked like we wouldn't have any direct reportable clinical results of above the collarbone metastases in patients that still had a primary tumor, now we will. I consider this to be a very significant (and positive) change.
We are now officially in the "metastatic disease" business.