Anti-PD1 info

We had a later appointment time on this visit, but saw all our usual folks at the CRU.  Had our original nurse again and she always does a good job. IV was started easily and boatloads of lab was drawn. Walked over to the office to wait to see Dr. Weber. There, all new check-in staff, save one, were registering patients.  The turnover there is pretty impressive.  At any rate, our person, new to us, had trouble finding me in the computer, despite the fact that I've been going there a year now, had already been checked in that very day in the CRU, and was in possession of an arm band and an IV. Oh well, that was not the disturbing portion, rather it was her lamenting that she was so glad it was Friday since she had had such a busy two weeks and was sooooo tired.  Why, just last Friday there had been standing room only in the waiting room...ALL DAY...and it had just worn her out! Brent's eyes took on that worried...oh, dear....here she goes look....  But, I resisted... then....so I'll just say it here.... "Really, honey????!!!!!  You poor thing.  Just think, you still had a chair for you fat arse while cancer patients STOOD in your waiting room....having a gay old time, I'm sure!!!!"  I'm telling you, I am going to write a book....What NOT to say to Cancer Patients, So You Don't Look Like a Complete Schmuck!!!!

We were soon placed in our usual exam room only to be visited by the hands down, most obnoxious, infuriating, insensitive, jerk I have EVER met masquerading as a medical professional.  Worry not....explanation to all that on next entry.  I pass over it now, as I did most of it then...to get to the real reason we were there...the acquisition of information about me and my fellow anti-PD1 lab rats!!!  Dr. Weber arrived and Jerk M.D. (MD in this case stands for "mentally deficient") was silenced.

Because there were new developments on my CT scan (the notation of enlarging inguinal nodes and the granulomas in my anterior thighs) and some obscure spot in my left cerebellum according to my local radiologist (Who was very nice and spoke with Brent at length about all her findings...yet was still convinced that there are three places in my brain that appear to have been irradiated mets....now with no activity...but absolutely there in her opinion and explained away by nothing else...though Brent assured her that there was only the one lesion in the right frontal lobe that had actually been treated...plus, we and Weber have long known about the granulomas and inguinal nodes that developed as sequelae to my vaccines which Brent eplained as well.) Dr. Weber is going to have them reviewed at the meeting of the Moffitt Tumor Board on Wednesday.  He said he didn't think anything was a problem but thought it would be a good idea to review them.  He said he would let us know if there were any findings, stated that he felt that I was doing well, and gave the ok for my infusion.

Here is my best report of what he said regarding the trial in general:

All three groups (1, 3, and 10mg/kg) of the NON-resected arm are currently in process. The number of patients in the last, 10mg/kg group, was not made absolutely clear, but I deduce it is full with its requisite 10 because of other numbers sited later.  The 1 and 3mg/kg groups are full and the 10mg/kg group for the RESECTED arm will begin in January.

When asked what exactly made up a "handful of patients with vitiligo", we were told "3 or 4 out of 50". (That is part of the information that leads us to believe that all 3 goups of the nonresected arm are filled at 30 with 20 more from the first two groups of the resected...for a total of 50 patients enrolled currently.) SO...those numbers for the development of vitiligo are roughly 8%.  In other studies with biologic therapies, the rate of vitiligo runs about 3%, including the last data reported with Yervoy (ipi). Although, there was one IL2 study that demonstrated a rate of vitiligo development at about 25%.

We already know that 2 patients were taken off my study group early on. One individual developed swelling of the optic nerve on the 3mg/kg group, though I don't know if they were resected or non.  We also know that 4 people "failed" anti-PD1 and Dr. Weber placed them on ipi.  2 of them responded. He seems to feel that some people will respond to anti-PD1 and others will respond to ipi.  He also seems to think that for some, being primed with one, will allow for increased response to the other if given subsequently.  I imagine it as a venn diagram with individual responders to the individual drugs on either side and the center circle containing those who do well when they are combined. 

I asked what sort of study he would like to do regarding anti-PD1 next.  Dr. Weber replied that he would like to do a "sandwich study" with patients getting a couple months of anti-PD1 followed by ipi then finish up with some prescribed quantity of anti-PD1.  He said he didn't know if he could get it going, but he had been pretty good at getting funding so far....so....maybe...

And our final question was about overall response....he told us that there had been "10 responders out of 26".  We can only assume that that would be a count from the NONresected side.  Because, there were 30 minus the 4 who failed.  Plus, how do you tell if I, or anybody else in the REsected side is responding.  The only thing you can tell about us is if we were to DEVELOP something...then we are NOT responding....OR...if in 10 years we are still disease free....then....Yep! We responded!!!! At any rate, "10 responders out of 26" is roughly 40% which is consistent with the only other phase I anti-PD1 study data available, completed by Snzol at Yale. The caveat is, my study included vaccines and I don't think anyone knows what implication that will have on the final results, if any.

Walked back over to the CRU...got my CHAIR!!!! and infusion with no misadventures.  Back to the airport, managed to snag a ride on the 4:20 flight rather than the 6:30 one we were slated for.  Had a great dinner at a little Cuban place with Roo and drove back home for a good chat with Freddie who was home with the pups waiting for us!!!  Can't believe I have been doing this for a full year!!!!  Especially, the 6 months of every other week visits!!!  Oh, well....done 'til March!!!! - c