It's been six weeks since I began my
clinical trial which is organized in three-week cycles. On the first
day I received an infusion of what we can call my PD-L1 drug. Then
on the first day of cycle two, I got another infusion of the PD-L1
drug and started taking the other drug that we can call the IDO drug.
During cycle 2 I took 12 capsules of the drug (50 mg/capsule) twice
a day for a total of 504 capsules in cycle 2. On Tuesday cycle 3
began, and they changed my IDO dose to 3 tablet of the drug (200 mg
each) twice a day. I joked that I feared I'd get gelatin poisoning
from taking that many capsules during cycle 1.
About halfway through cycle 2, I
developed a light, widespread rash over my stomach, back and legs.
It was not itchy or raised, just there. On day 15, the nurse
practitioner examined the rash and put me on 10 mg/day of prednisone, a
steroid. She apparently told me to discontinue the IDO drug, but
misunderstood and continued to take it. At an exam three days later,
the rash was improved, so she said
to continue with the drug and the prednisone. Then on Tuesday (first
day of cycle 3), my oncologist looked at the rash and said I could
stop the prednisone. The rash was evaluated as a grade 3 event (on a 1-5) scale, which would make it count as a serious event; however, it had not effect on my well being.
In the
time between the Friday visit with the nurse practitioner and the
Tuesday visit with my oncologist, I read what could be taken as a
frightening article in the New Your Times. The reporter highlighted
the fact that getting two immuno therapies at the same time has been
associated with unusual, life-threatening adverse effects.
I had
already seen references to this problem, but the profiles of two
patients who had bad effects made the concern concrete. It appears
that the female patient in the article is participating in the same
trial I'm in, but at Yale. I looked at abstracts of the cited articles and verified the reported statistics; however,
the reporter did not mention that the journal articles concluded that
the adverse events were controllable.
What I
took away from the article was that the communication between the
doctors treating the adverse events and the study docs was not
optimal, so I created a card to carry in my wallet with instructions
(in case I were unconscious from an accident) and was being
taken to an ER by EMS.
I
noted that I am participating in clinical trial that can produce
unusual side effect, that I should be taken to the University of
Colorado Hospital ER, if possible, and I provided phone numbers for
the clinical trial doctors, so the ER could get in touch with them quickly. These events are rare, and I am confident
that they can be managed with prompt, accurate medical care. The
bottom line is that the potential benefit far outweighs the risk.
On
Monday, the last day of cycle 2, I had a CT scan and received the
results on Tuesday from my oncologist. I was a little hopeful that
they would be positive, because even though my fatigue and weakness
seems to fluctuate across days, it seems that my coughing and
breathing have improved. Unfortunately, the results showed no clear
improvement but no decline either, so I will continue with the trial
and have another CT in six weeks.
