Monday, March 19, 2012

Death in the PCI-32765 trial

I guess I should share what I have just confirmed today from the trial staff.

One "young" participant in the trial in my cohort recently died of viral pneumonia. What I found out is that he had no PCI-32765 and only a couple of doses of ofatumumab. He had other "medical problems" and seems to have had iffy immunity prior to going into the trial. Long term steroids may have been a factor. So the PCI-32765 or ibrutinib was clearly NOT the culprit.

Still, he took a chance, entered the trial and died. I am sure he had to do something and this was his best choice. Mine too.

Tragedy is suffering without meaning. What is the meaning of this loss? So sad to lose this stranger just a few steps ahead of me in this journey.

Clinical trials are full of incalculable risks. How do you want your danger served up: known or unknown?

Infection risk seemed to be very underplayed. Immune suppression is built into mechanism of action of both the ofatumumab and the PCI-32765 and can't be tweaked out. We are playing with powerful weapons that are not quickly turned off and on. Although they are targeted therapy, the targets do more than just slow down the cancer cells. The collateral damage may miss the marrow and the liver and the lungs and the T-cells (unintended targets of other small molecules and MABs), but both trial drugs hit the humoral immune system and the ibrutinib probably does something nasty to the some patients' platelets too.

Still, I needed to something and this trail still makes the most sense

CLL sucks. Cancer sucks.

Options are good.

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4 Comments:

Anonymous Anonymous said...

Thinking of you Brian at this difficult time. Be strong, your instincts are good.

Thinking also of the warrior, may his memory be for a blessing

regards from sunny old London town
Susan

March 20, 2012 at 8:27 AM  
Anonymous jcleri@aol.com said...

I'm with you.....options are good and I agree with you that this is one your couldn't pass up on. Our love and prayers remain with you for total and complete healing.

J

March 20, 2012 at 9:18 AM  
Anonymous Anonymous said...

Good on you, Brian! Alison.

March 21, 2012 at 8:12 PM  
Anonymous Anonymous said...

A friend of mine also got Pneumonia on ofatumumab and was in the hospital for a month. She later died of CLL, but I don't know the particulars.

March 30, 2012 at 10:46 AM  

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