OncoLog, Volume 61, Number 9, September 2016 Page: 4
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Nivolumab Shows Potential
in Treating Squamous Cell
Carcinoma of the Anal Cana
By Brandon C. Strubberg
Currently, there are no standard therapy op-
tions for patients with treatment-refractory
metastatic squamous cell carcinoma of the
anal canal (SCCA), but early results of a multi-
institutional clinical trial (No. NC19673) led by
researchers at The University of Texas MD An-
derson Cancer Center show that the immuno-
therapy drug nivolumab may be effective
against the disease."Although a rare malignancy,
SCCA is on the rise and has a strong
association with the human papillo-
mavirus (HPV) and impaired immune
function," said Cathy Eng, M.D., a pro-
fessor in the Department of Gastroin-
testinal Medical Oncology and the
national trial's principal investigator.
She added that anal cancer rates in-
crease 2%-3% each year.
About 20% of the more than 8,000
patients diagnosed with SCCA each
year in the United States present with
metastatic disease. Additionally, 20%
of patients who have early-stage SCCA
will later develop metastatic disease.
Metastatic SCCA is typically treated
with platinum-based chemotherapy;
however, such regimens have not been
fully evaluated in clinical trials for pa-
tients with metastatic SCCA, and there
is no established standard of care for
refractory metastatic disease.
Evaluating nivolumab
Nivolumab is a monoclonal anti-
body that blocks the programmed cell
death protein 1 (PD-1) by binding to
the PD-1 ligand (PD-L1). PD-1 is an
immune checkpoint that shuts down T
lymphocyte attacks when activated by
PD-L1. HPV-related anal cancer tumors
have proteins produced by the virus, sonivolumab could help the immune sys-
tem recognize and attack anal tumor
cells infected with HPV.
The ongoing phase II clinical trial
is the first study to evaluate the efficacy
of nivolumab in the treatment of refrac-
tory metastatic SCCA. Dr. Eng said
that the trial, which completed enroll-I
ment after only 5 months, addresses an
unmet need for treatment.
Patients in the trial, all of whom
have previously undergone at least one
treatment for metastatic SCCA, receive
nivolumab intravenously every 2 weeks
until they experience disease progres-
sion or unacceptable toxic effects.
It was important to researchers that
the patient population be representa-
tive of those whom SCCA typically
affects, so HIV-positive patients were
eligible provided that their CD4-posi-
tive T lymphocyte count was at least
300/pL. "Since HIV predisposes pa-
tients to compromised immune systems,
it is a well-defined risk factor for anal
cancer," said Van Morris, M.D., an
assistant professor in the Department
of Gastrointestinal Medical Oncology.
Two HIV-positive patients were en-
rolled in the trial, making it the first
completed trial of a PD-1 or PD-L1
inhibitor to include HIV-positive pa-
tients.Top: Pretreatment computed tomography scans show metastatic tumors (arrows) from
squamous cell carcinoma of the anal canal. Bottom: Scans of the same patient after 22
cycles of nivolumab show improvement. Images courtesy of Dr. Cathy Eng.4 OncoLog * September 2016
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University of Texas M.D. Anderson Cancer Center. OncoLog, Volume 61, Number 9, September 2016, periodical, September 2016; Houston, Texas. (https://texashistory.unt.edu/ark:/67531/metapth1034034/m1/4/: accessed June 17, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.