The Registration Trials that are ongoing are purposed not
only to find out if the strong response rates seen in the earlier phase 1 and 2
trials hold up with larger and different populations of patients, but also to
look for early signals of unanticipated side effects of adverse events.
But problems with medications can show up very late in the game.
Who would have guessed that pregnant mothers who received
DES (Diethylstilbestrol) in what turned out to be a futile attempt to reduce the risk of miscarriage
would see a problem a generation later when it was realized that their
daughters exposed in utero had an increased risk of a rare vaginal and cervical cancer.
And while a good number of the brave first patients out of the handful that entered the phase 1 trial of ibrutinib are still doing well on drug, at the
time of this writing I don’t believe that anyone has been on the medicine for
even four years, and most of us for much shorter times.
Therefore we should not be surprised as our experience grows
with the new generation of treatments heading rapidly for FDA approval when new
possible concerns pop up.
I didn’t get a chance to ask Dr. Byrd when he spoke on the
early results with ibrutinib in Stockholm at the same meeting where I too
lectured (I gave a patient’s perspective on having CLL and how my life was
impacted by both the disease and by my dramatic response to the new medicine
) about the
incidence or statistical significance of what to me was an unknown adverse
event: brittle fingernails.
That explains why my career as a hand model will never get
off the ground. My fingernails break easily and I must keep then very short at
all times to avoid them tearing. Reaching in and out of my carry-on bag with
its computer sleeve and tight pockets where I stuff my papers and medications
is like a dance in a minefield for my fingertips, and they are often the worse
for wear after my travels.
I also am certain just as we all know that when someone asks
us if our nose is itchy, our noses are more likely to itch, awareness of the
possibility of any problem increases the incidence of the problem. I will now
join the ranks of those ibrutinib subjects reporting brittle nails, though for
me the fashion consequences are much less significant compare to the women who
enjoy growing and painting their nails and who, I bet, were much more astute
and observant than me in pointing out this problem early on.
I just thought it was a consequence of
my vegan way. Maybe it is.
In the big scheme of things, jagged fingernails are not a
biggie. Sure beats pneumonia or neutropenia. Still could it be a marker of a
What’s next? Split ends? This isn’t so crazy. Many chemo
drugs not only cause your hair to fall out, but when it grows back, it grows in
curlier due to the broken bisulfide bonds.
Will our future doctors be able to walk into our exam room,
check our fingernails, and assess if we have been compliant with taking our
Time will tell, but I am pleased that so far, so few nasty
signals are popping up.
Labels: adverse events, Clinical trials, Dr. Byrd, fingernails, ibrutinib, side effects