My anti-PD1/vaccine trial "results"

I am now more than 21 months into my Stage IV, NED (resected), 1mg/kg anti-PD1 (MDX-1106 or BMS-936558...your choice) trial with peptide vaccines at Moffitt.  For those of you just tuning in:  I have been considered a Stage IV melanoma patient for 35 months and was first diagnosed with melanoma in 2003.  I have never had any treatments other than this one and surgeries.

We did our usual Thurs/Fri trip to Tampa and all was well.  There was the fun, the silly, and the sad as usual, but for now, here are the things we learned.

OUTCOMES at this point in my cohort:  So far, it seems, as I reported in June, two patients died early on in the trial.  One of the deaths was subsequent to brain mets that had not been noted when they entered the trial and I am not certain of the cause of death in the second. In total, 6 patients out of the 29, have progressed. One, whom I've mentioned before, experienced spontaneous regression while being watched to determine treatment, and continues to remain stable with NO ADDITIONAL TREATMENT given as yet.  The other 5 are reported to be doing well on regimens of ipi (now yervoy) or BRAF inhibitors. The remaining 21 of us....carry on.

Dr. Weber remained positive about these results, saying, basically, that given the expectations of survival in this high-risk group we were "doing better than predicted" and based on historical data, after 6 months, at least half of us in this group would have been expected to relapse.  In other words, at least 15 of us would have been expected to relapse prior to this point in the study.  (See slide on next post.)

Sadly, these outcomes remain "excellent" in melanoma world.  Dr. Weber has already determined in prior work, that ipi as an adjuvant treatment for Stage IV, resected melanoma patients, produces at least a 60% survival over 5 years, so one could expect that anti-PD1 therapy which has triple the response rate of ipi, would have similar or better results.  Obviously, we lab rats have yet to prove that out.

For more on that point, check out the article:
Extended dose ipilimumab with a peptide vaccine:  immune correlates associated with clinical benefits in patients with resected high-risk stage IIIC/IV melanoma.  Journal of Clinical Cancer Research, 2011, February 15.  Authors:  Sarniak, A.A., Weber, J.S. (and others).

Which basically states, "Adjunct [ipi] following resection of melanoma at high risk of relapse appeared to be associated with improved outcome compared to historical reports."  (See set of slides in upcoming post.)

The only other solid point we discovered about my trial in particular was in regard to the vaccine component.  I asked Weber why he had decided to use the vaccines in addition to anti-PD1 in my trial as well as in some of the new ones at Moffitt.  He stated that he was just using them to generate antigen specific T-cells so that they can be utilized as indicators of the effects of anti-PD1 on T-cells.  When I asked how that was working out, he replied that the dosage levels (1, 3, and 10mg/kg in my group) showed no increased effect on T-cells as the dosage increased.  A little disconcerting for folks thinking they might get more benefit with greater quantities of medication.  (Although this was already being proven in the prior study of anti-PD1 that I reported on earlier.) Also a bit disconcerting for those of us who thought perhaps we would acquire a double whammy with which to attack our melanoma with the combined effect of the vaccines and anti-PD1. These same vaccines were used in combination with ipi in a prior study and demonstrated no effect.  However, Brent continues to hope that for some folks, a positive effect from the peptide vaccines is there...if hard to calculate...since they did work for the mice!!!

See slides...next.... c

21 months....melanoma free

CT scans (neck, chest, and pelvis) along with an MRI of the brain done yesterday, show "no substantial change" from the last scans, (way to CYA my little radiologist friend!) leaving me NED for 21 months now. Good news, obviously. That means I will head to Tampa next week for more anti-PD1 and a visit to the World of Weber. Brent and I will try to procure as much info as possible and share it here on our return.  Lately, there has been a dearth of information on the coming availability of anti-PD1 or any other substantial melanoma news in the literature. Though it does seem that both the BMS and Merck products are producing positive effects in melanoma patients, both companies are refusing to comment on when their drugs will be seeking FDA approval, nor are they offering their treatments for compassionate use. Both do have trials on-going and are doing more bit by bit. Amplimune appears to be recruiting for their anti-PD1 product and have some trials in which brain mets are not an eliminating factor. Apart from those tidbits, I have little more to offer. Perhaps I will have more to share next week.  To celebrate, B and I did errands yesterday and tons of yard work today! Did run a couple miles with the monster before pruning roses, weeding flower beds, and ripping out B's done tomatoes. Oh, well...it's the little things!  Love - c

To new peeps and old...

...much love! To my newly found, old peeps (and I refer to our duration of friendship over time only!!), it has been great to hear from you! I can hardly believe it has been 30 years since those high school days. I wish each and every one of you my very best and continued success in all that you do.  To my old peeps who have blessed me with their tolerance for my daily shenanigans, day after day after day, I give my thanks for the blessings you bring to my life. To the peeps I have grown to know and who continue to join my life along the way, I can only hope that I provide some light and support for you, as you have for me. To the peeps I have accumulated in other countries, using Google Translate and other devices to read these words...my apologies. My crazy descriptors give English speakers pause, so I know my jargon must be difficult for you at times. I hope I have helped you find information you needed in your search. To those who want to battle melanoma in every corner, in every way...I'm your girl.

To you all:  push hard, love each other, and don't forget to breathe. Love - c

24 years, 24 years, then he finds out melanoma isn't his!!!!

Happy anniversary, baby.  To a most uxorious man! Sorry about the melanoma thing, dude!!! - les

PS What DO you think Kanye and Kim chat about???

Great week! Busy week!

I had such a great week or so with my punkins!  We were busy in K'ville setting up Rosie's place and visiting her favorite haunts plus exercising, eating, and hanging with Fred.  Back here, we went through her things that remained, packed, did yard work, hemmed a skirt, potted plants, crocheted a throw, cooked, shopped, hung out, and EXERCISED!!  Roo had me running, sprinting, doing insanity workouts... It was INSANE....and WONDERFUL!  She got to visit with dear friends and have a dinner with them, too! Freddo came in and chilled with us, then got Rosie packed up and took her and the rest of her things back to her apartment. There they have already started getting ready for new semesters and new jobs!!  Good luck bingaheads!!!  You both make me very proud.  Love - mommy

Ready Set GO!

Rosie's new digs!!!  View of her living room...

Pretty yellow and red pots she's been collecting!

She IS... Beauty. Full!

Pretty poppy print fabric for pillows from Ruthie!

Isn't it wonderful when 3 different people in 3 different places can see the same vision?!!!

Yellow toaster, red kettle, poppy salt and pepper shakers, red magnetized spice jars? CHECK!

Purple cozy bed.

Pretty purple bath!

Went up to K'ville to stay with Rosie and help her set up her new place last week.  We worked hard getting it together, but I also got to got see her farmer's market, favorite gardens, and running paths.  Plus, we had great eats and fun with Fred-o who rules as the Scrabble KING!!!!!

La Cucina!!!.....or....a leap of faith!

Before, and pretty much as it has been for 15 years!!!

The morning of de/re-construction begins!

Oh, my!!!!

It's raining men!!!  Hallelujah!

Ta Dah!!!!

We're cooking with gas!

How great are Ruthie's pots??  It's blue!  Celestial blue even...no kidding, that's the name of the stone!  Hee hee!

At this point in my life, it is very easy for me to do ANYTHING for others.  For myself, it seems a bit of a gamble, to plan for the future, to expect to see things through for the duration.  But, what the heck?!!!  Here we go!  Thanks to Bent, Ruthie, and Rosie for having the patience to hear me jabber and to encourage me to live large...right now.  Much love - c