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There is long term monitoring with RECIST data - tumor size and spread I think. Patients on SOC will have LT Recist info anyway. I assume they will also be on the lookout for any unwanted side-effects such as heart issues - can be a Herceptin issue. They are monitoring this carefully, from an earlier reply(last year) from Nick Ede . . . For this reason we are monitoring all our patients closely for changesin heart function, specifically their LVEF (left ventricular ejectionfraction). Whilst I can’t provide result details at this point in time,this monitoring is part of the safety endpoints and we have announced that notoxicities have been observed thus far.
Day 56 for each patient was when they received their 3rd dose of Cisplatin and is the last day that IMU used blood samples and serum for data, assuming that the trial info holds.
It doesn't say whether day 56 is the final day for chemo. Patients who tolerate it well and are doing OK might continue on SOC, it just isn't clear in the trial notes.
It also isn't clear if or how long the patients have continued to respond for. 9 were either stable or had partial reduction, they could still be doing ok, but we don't know. A number didn't make it to day 56 and again we don't know why, some patients can have an awful response to chemo and are unable to continue treatment.
Anyway, I'm hopeful for LT data at some point. It could take a while as the last of the 3rd cohort patients hit their day 56 not too long ago.
Cheers.
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