Sunday, June 16, 2013
Love Potion...or Patient...#9!!!!!
She jumped down, turned around and gave me a wink.
She said, "I'll mix it up right here in the sink."
It smelled like turpentine and looked like India ink!
I held my nose, I closed my eyes...
I took a drink!
At the end of my visit in Tampa last week, it suddenly hit me. Which patient had I been? So, I asked one of the clinical coordinators. With a little smile, she tilted my chart so I could see the front. There, in black magic marker: #9. However, she noted, a couple patients had passed (I knew of two) and "several" had dropped out or been assigned numbers but for a variety of reasons had not participated. (These patients may have decided against it or had labs/scans that in the end didn't meet criteria. I knew of one who had been ahead of me, but had to drop out due to progression, but then spontaneously resolved). "In fact," she continued, "the first patient returning for the 3-month post infusion follow-up is here today." Wow! I don't know why it hit me so strangely. But, when you count it up...I am #9 minus 2 = 7, then minus the one who progressed = 6, minus the one returning that day = 5, minus Lynn Luc = 4, then maybe minus one who didn't make it in due to unfortunate results = probably patient #3!!!! I felt rather startled!
Cognitively, that was not such a surprise. I knew I was in the first cohort of the NED arm of the study and there were to be only 10 patients per arm...at the start. I also knew the rough history of anti- PD1....
Once upon a time (2005), in a land far, far away...(Japan), ONO Pharmaceutical generated ONO4538, an anti-PD1 monoclonal antibody, in research collaboration with Medarex (who called the product, MDX1106). In 2009, the big, getting ever bigger, (? benevolent) King of the World, Bristol-Myers Squibb (BMS) acquired the rights to develop ONO4538/MDX1106/BMS936558 in North America. In an additional agreement in 2011, BMS attained the rights to the product in the rest of the world...except Japan, Korea, and Taiwan...where ONO retained exclusive development rights and is conducting Phase II studies with ONO4538 in non small cell lung cancer and melanoma and Phase III studies in renal cell carcinoma currently. However, no results of either of those studies can be found.
Thus began the exploration of BMS 936558 in the Americas! There was a study by Sznol at Yale (that I can't manage to lay my hands on) that included approximately 15 patients with melanoma.
In 2009: Phase II experience with MDX1106 (ONO4538) an anti PD1 monoclonal antibody in patients with selected refractory or relapsed malignancies. Journal of Clinical Oncology, Topalian, et al. John Hopkins. Where 21 patients, 8 of whom had melanoma, were treated with a 10 mg/kg dose.
In 2010: Phase I study of single agent anti-programmed death-1 (MDX 1106) in refractory solid tumors: Safety, clinical activity, pharmacodynamics, and immunologic correlates. Journal of Clinical Oncology, Brahmer, Topalian, et al. 39 patients, 10 with melanoma, with data tallied as of January 2010 had been treated with said drug. (Keep in mind this may simply be an extension of the study noted above.)
In 2012: Safety, Activity, and Immune Correlates of Anti-Pd1 Antibody in Cancer. New England Journal of Medicine, Hodi, Sznol, McDermott, et al, from a variety of centers. 296 patients were treated. 94 of those had melanoma. Patients with non-small cell lung cancer, renal cell carcinoma, and melanoma showed some response.
But, back to Patient #9. As best as I can find and add, apart from the uncountable, unknowable Japanese study, I am actually roughly patient #36 (or perhaps patient #28!!!), since I embarked on this adventure before those in the Hodi study or the growing numbers in the various arms of my current study. So...knowing all this...why did I feel so discombobulated at hearing I was Patient #9 (or #3) in my study????
I don't really know. Except, when you go to your doctor every 2 weeks, or every 3 months, being scanned, leukophoresised, poked, prodded, and given more bug juice...a much more apt moniker in my mind than Nivolumab!!!!... and you ask: "So, how are things going?" "What is the data looking like?" "Has anybody else had this rash, done that thing?" "How are they, anyway?" You somehow, despite KNOWING: He doesn't know!!!!!...value the few points and details you can glean. When the real truth is, especially at first, the main response was only, "Hmmm. This stuff is WEIRD!!!"
I didn't know if it was day or night.
I started kissing everything in sight.
But, when I kissed a cop at 34th and Vine,
He broke my little bottle of....
Love Potion #9!