Friday, September 19, 2014

My melanoma stats and update on my Nivolumab trial cohort

CT's of neck, chest, abdomen and pelvis along with an MRI of the brain were all negative a couple of weeks ago.

At this point, I am:
133 months post original melanoma diagnosis in 2003
53 months Stage IV
47 months NED
45 months since starting the Nivolumab (BMS' anti-PD1)/peptide vaccine trial
15 months after my last Nivo dose

     As per routine we drove down to Atlanta and flew on to Tampa last Thursday.  It was not our strangest trip by any means, but traveling on September 11 made it a little nervy.  And whether that had anything to do with anything, the TSA peeps in Atlanta seemed a bit on edge as well. For grins and giggles, the chaos that is the Atlanta airport, that I know all the in's and out's of at this point, is under construction...inside and out.  So much so, that they are actually paying people to stand and direct "people" traffic within the terminal.  But, if I've walked it once, I can do it again, so that was OK, though parking and driving about was not so easy. I was yelled at, loudly, by one TSA lovely, to stand directly in front of his podium, rather than the three inches to his left I was inadvertently pushed into given the crowd.  After gaining his blessing, we were herded, as ever, into lines for the scanners.  As we (hundreds of us!!!) were wearily getting ready to lay our carefully zip-locked 3 ounces of shampoo and deodorant into plastic bins and shed our shoes...a commanding voice boomed overhead:  "DO NOT REMOVE ANY ITEM FROM YOUR BAG!!!!!"  "DO NOT REMOVE YOUR SHOES!!"  "I REPEAT...DO NOT REMOVE ANY ITEM FROM YOUR BAG!!!"  Now, I grant you, in a normal world, reasonable people would say, "Duh!!!?  Why on earth would I take off my shoes and unpack my bag as I am about to board a flight!!?  Are you kidding me?"  However, in our current altered reality, this admonition brought forth a great deal of confusion. But, we wonderingly complied.  All of us certain we would be slapped up side the head when we entered "the area" with our little baggies still ensconced within our luggage and our shoes on our feet. was not so.  Indeed, we simply put our bags on the conveyor with all precious liquids still hidden within and our wee little shoes still in place, and just walked through the metal detectors!!  Some folks had their hands swabbed...Lord only know why!...but B and I were even waved past that.
     The flight was rather unremarkable as was the night in Tampa, other than the fact that I did select a grey standard car-like Hyundai with some trepidation, given the memory of difficulties Ruthie and I have experienced in finding such a typical grey car-car in any parking area.  But, it was the most reasonable option.  And, sure enough, on returning to the car park after dinner I saw a line of more than 5 grey cars lined up with ours.  "It had to be grey, didn't it?" I muttered to Brent.  So, I click the remote, which I had already struggled with a bit, as it was separate from the key and there were actually two...with strangely different purposes.  (Why, Hyundai?  Why!!?)  At any rate...nothing happened.  I worked with the other remote.  Still nothing.  I decide to resort to the old fashioned key-in-lock approach.  As I was deciding upon the key to use for that (there were three!) B remarks, "It's amazing how much these Hyundai's look like Honda Accords."  In my head, I ran through this list:
1.  B knows nothing about cars.
2.  Hyundai's look nothing like Accords.
3.  Holy Shit!!
I walk to the back of the....yep, a Honda Accord!  And NOT our Hyundai, which is three grey car-cars down!!!  I can hardly get it open because I am laughing like a hyena.  Guess B knows more about cars than I thought, though he stood ready and willing to get into a car that was not his own!!!!
     Up at our usual Butt-Crack-of Dawn, in order to have labs, see Weber, and make our return flight.  To Moffitt we go, straight to the lab.  And...just for the record...honesty is NOT the best policy...something I can never seem to learn.  When finally positioned in the chair for stabbing, cute little girl asks if I have a port.  "No," I reply.  Which is met with a very disappointed face.
     "Oh, I see."  Bit of a pause.  "Have you ever have lymph nodes removed from your arms?"  
     "Yes," I say.  "Complete lymphadenectomies, bilaterally." 
     "Then, do you have a standing order?"
     "For, what?  Drawing lab?  I have no idea.  But, I've been having it drawn here for the past four years!"
     That is met with a look of extreme consternation.  "Well, I have to have an order.  You should not have blood drawn in your arm if you have had lymph nodes removed!"
     I reply, "You're absolutely correct.  Nor blood pressures, or finger sticks, or pretty much anything.  However, like many of the patients here, I would imagine, I seem to have run out of options."
    Well, I'll have to see about this!"
     "OK."  And, off she goes.  A bit later, she returns with a rather jolly lady.  B has been standing rather dejectedly this whole time.  The lady explains that Moffitt lab services has a new policy that requires the oncology doc to give permission for their patients to be stuck post lymph node removal, but happily says she'll just call Weber for the order and we are shooed back into the waiting room.  It is clear to me that the surgeons have pitched a fit, and some lab supervisor, or VP of laboratory services, as they like to be called, caught shit because someone was stuck against their surgeon's orders, without an oncology order, and developed lymphedema.  Whether that unfortunate development was really due to that stick is certainly debatable, but they do not intend to be the peeps with their ass on the line any further!  All speculation on my part, of course...but given my years on both sides of the aisle in this weird world...I'm pretty certain that's how that all went down. 
     "Great!" says B.  "That's one way to let Weber know you're in Tampa!"
     How this is all my fault, I do not know...oh, yeah - I told the truth.  Anyhow, after a bit of a wait, we are waved back into the stabbing area by the jolly lady.  She is quite funny and entertaining, and very good at her job.  Weber, it appeared, had given her the order, along with a good deal to say on the subject as well.  She offered the donkey (aka B) a "stool specimen" so he could take a load off.  The woman can certainly recognize a donkey on the edge when she sees one.  B was taken aback,  as he is the one generally cracking those sorts of jokes.  After a few more laughs we were back out and on our way upstairs to Weber's office.  Sign-in remains bizarre.  How many places within one building and a gigantic computer system must one show id and have them repeatedly scanned in?  Oh!  And the lady checking me in?  Actually asked for my "ids"...not 'I' period 'D' in the letters...but my "ids" though that is a - id and ego!!!  I almost allowed my id to take over....but having dealt with her before when she complained endlessly about how hard she had been working, because "all morning there had been patients, standing wall-to-wall in the waiting room" and I had replied, "Wow!  That must have been nice for the cancer patients!"...a remark that had completely no meaning for her and slowed her complaints not at all....I merely handed her my license.  My ego in control.  Freud would be so pleased.
     After a bit of a wait, while a tiny little wheel chair bound old lady spoke in a  non-stop mono-tone, "Yep.  She used to take care of me and then she passed.  But, Martha would come up to the house and we would....mumble, mumble....and then she passed.  And, you remember so-and-so, we always went to church...mumble, mumble...but then he passed."  All this to her 300 pound female companion, who was making full use of the "love seat" sized straight chairs you see in waiting rooms these days, and managed to put on a full face of make-up, from foundation to blush to eye liner to mascara while waiting and making the occasional, "Umm huh" to her talkative friend.  It was all quite impressive.
    Completely new set of MA's to do BP and such.  But, Jennifer, Weber's right-hand nurse, the most amazing woman in that office, who has been a God-send to us on many occasions....especially when we were just starting the trial and trying to coordinate all the visits and the every two week regimen...poked her head in to say hi.  A bright light for us and many others I am sure.

So....Here's the important stuff ~ WHAT WE LEARNED ~ (as best as I can tell you!!!)

Of the 33 patients in my NED cohort (the first batch of which were given Nivo 1mg/kg [me], the next had 3 mg/kg, with the last getting 10mg/kg...all of us with peptide vaccines...every 2 weeks for 6 months...and then our set dose of Nivo alone every 3 months for the next 2 years) most are doing well.  10 have relapsed.  Most within the first 6 months.  5 of those have passed.  The last two of those who relapsed had their new tumor surgically removed and remain NED currently.  I am not clear about what treatment the other three were given and what their current condition is.  None of the brain met folks have relapsed so far.  And at this point, if you do the expected math, 16 of us should be dead, rather than the poor 5 we have already lost.

20 additional NED melanoma patients were added in cohort 4, to my trial.  They were given Nivo at 1mg/kg along with ipi at 3mg/kg.  Their clinical response was very good, but 1/2 of them had to stop the trial due to side effects.

A new cohort #5 has been created.  It will accept 1,500 resected melanoma patients, from Stage III B/C to Stage IV.  Due to the high incidence of side effects with the prior combo....the dosages were flipped.  These patients will now be given Nivo at 3mg/kg and Ipi at 1 mg/kg.  Side effects remain a concern, especially for those at Stage IIIB as their risk for their melanoma is less than that of NED patients Staged IIIC/IV, and such side effects always have to be weighed against risk of disease, but should be decreased for everyone with this particular dosing plan.  There is no HLA typing requirement as no vaccines will be given.

Here is a link to the trial on the NIH website:  Ipi/nivo combo for NED melanoma patients!!!!

Questions asked:
     Sadly, as it has been for some time, the questions I have, have no absolute answers. I, and my fellow ratties, ARE the answer.  But, I asked a few none-the-less.  The one of most importance =
"Having completed anti-PD1, is my immune system permanently changed, or was the change temporary?"
After some discussion and recognition that no one really knows the answer to this...the answer was:
"Yes, it is most likely that your immune system has been altered permanently via your central memory T cells."
     The good news, if this is indeed the case, is that, theoretically, my memory T cells will be around for a good while and continue to kill off any horrid little melanoma cells fluttering about. (Their life span and function will have to wait for a different post as this one is over-long already!!!)  On the down side, a forever changed immune system could continue to put me at greater risk for immune stimulated disease processes...but what's a girl to do?  And mostly...time will tell all.
     One other bit of good proven by those lovely graphs where melanoma patients seem to fall precipitously downward, into the pit of despair....there is a leveling off.  And...theoretically, that occurs....just about....NOW!!

Around 5 years out.  Which is where I and my other ratties are rapidly headed.  It's just that a little Jiminy Cricket inside me knows....I once, almost, made it out 5 years....only to go round the mulberry bush again.  Granted, that was when I was only status post melanoma lesion and node removal.  I have the cherry trees to prove it.  So.....we shall see.  We shall see.

More about me, my labs, and those good old memory cells later.  Love to the ratties! - c


  1. Haha! You didn't tell me about the "id" lady ~ that is a new one! And I wanted to let you know what was on the news just this morning! Atlanta is the busiest airport in the world, not the United States, the WORLD! I know you are surprised by this information!

  2. No kidding. Here is some data I posted in 2012...

    "Seriously, Atlanta has been recognized as the world's busiest airport in passengers since 1998 and in landings and take-offs as well, since 2005, with 92 million passengers moving through in 2011 and almost 1 million flights (923,991 to be exact). Meanwhile, Tampa dealt with 33,000 flights and 16,732,051 passengers last year (see wikipedia if you don't believe me!!!). Despite these facts, getting through security in Atlanta is a piece of cake compared to Tampa ..."

    Though, I have to say....B and I both noticed that on our return flight...the Tampa TSA peeps seem to have been given a happy pill. Two actually smiled and chatted!!! What's up with that??? On the down side, our return flight was basically canceled as the plane didn't show up and they had to send a different one....and that was just, "Oh well, these things happen..." We just had to waste several hours of our lives and get stuck in Atlanta rush hour traffic though we had planned our flight in order to avoid it. Other poor travelers missed their connecting flights to lord only knows what opportunities and obligations! The airline had no concern about that. Now if YOU miss YOUR is absolutely NOT business as usual, these things happen!!! You will pay big time!!! How is it we allow an industry to treat paying customers this way??????

    Oh, well....don't suppose anyone is going to listen to little ol me....but I've got that airport licked, huh??? Even know when to get off the! ;>)