Tuesday, June 11, 2013

Anti-PD1 (Nivolumab)..FINISHED!!! The whole story:

In keeping with the strange routine that has been my life for the past two and a half years, it was time for me to return to Moffitt in Tampa.  It is hard to believe that I have been traveling back and forth, every two weeks for the first 6 months, then every 3 months for the past 2 years!!!  Anyhow, Brent and I took off and here is my story:

"Adriaaaaaaan!  Adriaaaaan!"
"Rocky, I love you!!!!"

Wait....different Adrian, better known as Andrea, actually, but hey!! Yes, I travel to Tampa predominately in inclement weather!  Snow - check!  Ice - check!  Path of a tornado - check!  Horrible thunderstorm with devastating hail - check!!  And now, we fly toward the first hurricane of the season, planning to follow it north when we land in Atlanta the following day!  Awesome!!!!!

So, though cloudy, we drove to Atlanta before the rain set in, with pretty mild traffic and minimal stomping of his imaginary brake...though he did get in trouble a couple of times!!!...by Bentie.  Got my veggie sandwich from the Atlanta Bread Company while watching bags fly off the carts being pulled by jeep-like vehicles as they zoomed across the tarmac.  Waiting for our flight I was entertained by my fellow travelers; they never disappoint.  As B went off on an explore (don't ask me why!!) I observed a lady wearing a T-shirt of so bright an orange, that only those of us who have been exposed to UT on game day, would fail to be alarmed.  In addition to its vivid color, it bore three crosses in bright white relief with "REPENT" written above in large block letters.  Behind me, a gentleman (?) is yelling loudly at someone on his phone:  "All you want is your G@# D@^m* money!" And..."You didn't leave no damn message...I check my messages!" with lots of "a.k.a"...which I don't think he understood the meaning of, sprinkled throughout.  But, his closing was the best, after all that...."Ok, baby. I love you."  Ruthie has considered that perhaps, certain folks who look as though they are waiting on a flight, are actually paid entertainers. I think it is more like a nurse I work with recently said, "The world is full of crazy people....AND THEY DON'T STAY HOME!!!!"  We boarded our Air Tran flight and were off.  The flight wasn't nearly as bumpy as I had feared, though the landing was a little sketchy as the pilot was having to deal with some very high winds.  Once in Tampa, the rain began in earnest.  Off to Alamo to check out their fluid line up, and discovered that a bright yellow Fiat 500 was an option for our 21 bucks.  (Car rental is an amazing craziness in and of itself.  We have paid over $80.00 at times, for the cheapest possible ride!) But, happy with the price of the day, B indulged my selection, knowing to ask..."Does it smell ok?"  Hee Hee!!! Driving off into rain and pretty high winds in a vehicle, while very cute, was tiny and top heavy, having little pick-up, loose steering, and wheelbarrow tires, was probably not the wisest choice.  But, a girl's gotta have fun.  The wind definitely got my attention as we crossed the bridges and overpasses through Tampa to our hotel and then on to Pho Quyen.  So, yummy!!!

Off to Moffitt the next morning, the skies were mostly clear and the sun was shining.  However, in talking to the locals, Andrea had made her presence known with winds and high water that had caused some residents trouble before we arrived.  IV start and labs accomplished, over for our visit with Dr. Weber.  It was a happy meeting given his recent return from ASCO and my completion of the trial!!  What we learned:

Though no one can state the significance with any certainty, the fact that I remain NED, after 32 months, S/P a brain tumor is pretty remarkable.  The data for my NED arm remains unchanged since I last posted them (See "My Thoughts - posted May 29).  But, the bottom line continues unchanged:  Of 31 patients, 26 remain NED.  For a clinical benefit of 83%!!!  Weber remains in talks with the folks at BMS to try to get a clinical trial started to examine Nivolumab as an adjuvant for folks who are Stage IV NED.  They however, are concerned that there just aren't enough of us to make it profitable.  ASSHOLES!!!!  But, for what it's worth, Dr. Weber believes in it, and is continuing to try to encourage them to pursue it.

Random gleanings:
  • There has been at least one case report of a patient who did recur after having been treated with Nivolumab, who was retreated and responded again.
  • Relapses in treated folks have occurred at the site of resected tumors.  Though, interestingly, "all of the patients with brain mets are alive and free of disease, which is very surprising since those are the highest risk patients".
  • When asked about the effect of Nivolumab in the brain...we were told that it probably does not work particularly well, but after the brain is irradiated, it can definitely prevent tumors from returning because it gives you the absconal effect, in that once an inflammatory environment is created, the drug will work...much like what they are finding out about the use of ipi after SRS for brain mets.
  • Folks in Tampa seem to think that BMS will beat Merck to market with their anti-PD1 product, by a few months, and the wait time will be around 18 months. (I hope it is even sooner!)
  • After hearing, and presenting data at ASCO, folks in Tampa felt that sequential therapy, anti-PD1 followed by ipi, will probably be the most successful sequential strategy in melanoma treatment and that sadly, side effects are likely to be very difficult to deal with when ipi and anti-PD1 are given together, even at dosage levels of 1mg/kg anti-PD1 with 3mg/kg of ipi.
  • There are more check point drugs in the pipeline, like BMS-663513, an agonist of the CD137 immune regulatory protein, for instance.  How they will do is yet to be seen.
  • AND...I have it from Dr. Weber himself:  Peptide vaccines are not going to be used (in their current form at least) in any more trials at Moffitt!  Thank goodness!!!  If we can't implement what we learn from all the ratties, then what is the point????!!!

NEXT STEP:  So, now that I've spent 2 1/2 years doing this business, what's a girl to do?  The new plan for folks in my trial (the protocol is in process of being amended....again!) once we have completed our doses of anti-PD1 as I have, is to have scans and return as usual, 3 months after our last dose, for a final visit and labs with Dr. Weber.  Then, patients can continue to see him, or their local oncologist, on a schedule of every 6 months to a year.  He noted that he would like to continue to receive lab and scan reports from his trial participants via mail, recognizing that costs of continuing to go to Tampa for simple follow-up, in both time and treasure, can be prohibitive.

So after giving Bentie a twirl in the hall, with applause from one of the lab techs, we were off to the airport, where for no extra charge (Are you listening Delta?  NO EXTRA CHARGE!!!) we were allowed to board an earlier flight.  And, yep.  Andrea, or at least her heavy surrounding rains, were in Atlanta, along with rush hour traffic, just waiting on us.  After stop and go in pouring rain, we bailed and landed at the It's OK! restaurant!  It was wonderful.  Could there have been a restaurant better named for our adventure????  I don't think so.  Had me a veggie plate with mac 'n cheese, collards, black eyed peas, and squash casserole.  That's what I'm talkin' about!  Check them out if you're in Atlanta!!

One more nugget, Love Potion #9, to follow soon.  It's OK! - c


  1. It is always such an adventure! But, all in all, it ended pretty well with the info from Dr. Weber!

  2. I am happy you are NED!! I did my last infusion April 5 ( one day before my birthday!)....Had my follow up visit on July 12...it was weird to go and just have scans, blood work and dr visit and NO infusion of Nivolumab , no injections of any thing! I don't know what patient I was, but I guess I could ask lol! But I now move on to 6 month check ups and won't be flying back down to Moffitt until January 9/10 for next check-up, scans and blood work....Never ever thought I would be on this side of it all. It was over 4 years ago I was DX'ed with Stage 4 and of that I have been NED for 3 years and 4 months. Trial nurse said on April 5th I am officially in "remission" (new word!)...Dr. W did his congrats on being disease free! Whoa...now my chore is to figure out how to get my life back on track!- :o)

  3. Congrats!!!! I wish you well in all you do, for many years to come!!!!