Elephants And Tea - December 2020 - 40

Conversation

CLINICAL TRIALS

Clinical Trials from a
Patient and Scientist
Perspective

A

M A R ISA A . C ORT E SEPE SK E , PH D, F N PB C

s a cancer researcher and nurse practitioner for over 15
years, I have worked with hundreds of cancer patients and
have been an investigator on over 50 clinical trials. I love
the science and being part of cutting-edge medicine. I've
always had this passion of working in cancer research and
helping patients get the best possible treatments available. My workdays
are long, but I am always excited to come to work the next day.
There was one moment in my life where everything just stood
still. It was September 15, 2015. I was about to celebrate my 10-year
wedding anniversary. My daughter was three years old at the time.
The day before, I had felt a lump in my right breast. I immediately
contacted the breast center at the hospital where I was working at the
time. My colleagues made sure to squeeze me into their busy schedule.
Within the matter of four hours, I had a mammogram, ultrasound
and breast biopsy. It still didn't dawn on me that it could be cancer.
I said to myself " I've always had fibrocystic breasts, I'm sure it's just
that. " The next day I received a phone call from an oncologist who
is a colleague of mine. I never thought I would hear the words, " I'm
sorry but you have invasive breast cancer " as it applied to me. I was
in a state of shock. I was unable to tell anyone about my diagnosis
and my poor husband made the phone calls to our families. The next
day, I returned to work and just put the diagnosis in the back of my
mind. I had patients and a staff who needed me. I kept moving forward, trying not to think about the tumor that was growing inside me.
On October 12, 2015, I received a double mastectomy and right
axillary node dissection. I was told that my cancer had spread to my
lymph nodes, my tumor was aggressive, and I was high risk for recurrence. At that moment, I knew that I had to throw " everything plus
the kitchen sink " at this if I was going to survive. After I completed
seven months of chemotherapy plus radiation, I felt that I wasn't done
with treatment. I wanted something more to help prevent the chance
for recurrence. Knowing that 30% of early breast cancer patients will
one day recur to metastatic disease, which is when cancer spreads to
other parts of the body such as bone, liver and lungs, haunted me.
Every single decrease in percentage of recurrence was important to
me. When I was approached with the possibility of participating
in a clinical trial it was a no brainer. The trial I was offered was the
" Combination Immunotherapy with Herceptin and the HER2 Vaccine Neuvax plus GM-CSF versus GM-CSF alone. " This trial was for

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DECEMBER 2020

patients who did not have a tumor that overly expressed HER2 but
for tumors that were low to moderately expressing HER2. I received
Herceptin every three weeks for one year while receiving the vaccine
and GM-CSF or GM-CSF alone. This study was a randomized, double blind controlled trial which means that the physician, nurse, or
myself did not know if I was receiving the vaccine and GM-CSF or
GM-CSF alone. I completed the one year of Herceptin and continued
to receive the study drug injections.
About six months after completing the Herceptin, new published
data on another trial showed that Herceptin in low to moderate
expressing HER2 did not show any difference in recurrence rates
compared to standard of care. Unfortunately, that meant the Herceptin I received probably didn't reduce my recurrence rate and the
trial was stopped.
A few months later, I received a letter in the mail and found out
that I did not receive the vaccine. I remember this feeling I had when
I read this information, at first I felt a little sad that I did not receive
the vaccine but then I realized this is the reality of participating in
the randomized trial, I had a 50/50 chance of getting the vaccine.
There was no reason to be sad, but to be proud of being a research
participant and contributing to the standard of care to be provided
to future breast cancer patients. Would I participate in a clinical trial
again? Absolutely! Since this study, I have participated in four research
studies for breast cancer; three of which were specimen collection
studies, such as donating my tumor, blood and saliva and the other
was a hypnosis study to help reduce one of the side effects from the
anti-hormonal medication I need to take to prevent a recurrence. The
only way we are going to better treat or possibly cure breast cancer
is through research.
It's been five years since I was diagnosed with breast cancer. I've
learned so many things about myself and focused on the important
things like family and friends. Clinical research is still my passion. I
have recently focused my efforts on researching cancer treatment-related cognitive deficits also known as " chemo brain. " Throughout the
years, I have educated numerous clinicians, patients and families on
the importance of participating in clinical trials. At every stage of
cancer treatment there may be a clinical trial in which a patient can
participate. Each study that is conducted brings us closer to finding
better treatments and hopefully, one day, a cure. l


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Elephants And Tea - December 2020

Table of Contents for the Digital Edition of Elephants And Tea - December 2020

Contents
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