Practice Update: Oncology

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Cabozantinib Is Safe and Effective for Metastatic Renal Cell
Carcinoma in Real-World Practice
Cabozantinib has been found to be safe and effective in a large unselected population with metastatic renal cell
carcinoma treated in everyday clinical practice.
This finding of a study performed in
patients in the Italian ExpandedAccess
Programwas reported at the European
Society for Medical Oncology (ESMO) 2017
Congress, from September 8–12.
Giuseppe Procopio, MD, of the Fondazi-
one Istituto di Ricovero e Cura a Carattere
Scientifico, Milan, Italy, explained that final
results of the randomized phase III Cabo-
zantinib vs Everolimus in advanced Renal
Cell Carcinoma (METEOR) trial confirmed
a survival benefit of cabozantinib over
everolimus in patients with advanced clear-
cell renal cell carcinoma.
“Our goal was to validate clinical data
reported for cabozantinib in the phase III
trial in an unselected population for the first
time,” said Dr. Procopio.
Subjects had progressed after receiving at
least one previous antiangiogenic inhibi-
tor. The Italian Expanded Access Program
provided the opportunity to treat patients
in real-world clinical practice.
Dr. Procopio and colleagues set out to eval-
uate the safety and activity of cabozantinib
in a large unselected population.
Data were collected from 91 patients
treated with cabozantinib across 23 Ital-
ian hospitals. Cabozantinib was available
on physician request from September to
December 2016. Patients were age 18
years and older, and harbored measura-
ble metastatic renal cell carcinoma.
They were Eastern Cooperative Oncology
Group performance status 0–2. They had
relapsed after one or more prior systemic
treatments. Of these patients, 73 suffered
from clear cell renal cell carcinoma, while
the other 18 had non–clear-cell histology
(type II papillary and chromophobe).
The most frequent sites of disease were
lung 58% (n=53), lymph nodes 45% (n=41),
bone 31% (n=28), liver 16% (n=15), and brain
5% (n=5). A total of 42 (46%) of patients har-
bored two or more sites of disease.
Cabozantinib was administered orally at
60 mg once a day in 28 day-cycles. Dose
reductions to 40 or 20 mg were allowed
if toxicity was encountered. Patients were
monitored for adverse events using the
National Cancer Institute Common Termi-
nology Criteria for Adverse Events v4.0.
Cabozantinib was administered second
line in 28 (30%) patients, third line in 18
(19%) patients, and as further lines in the
remaining 45 (51%). At the time of the
analysis, grade 3 and 4 adverse events
were observed in 21% of patients. Among
91 patients, only five (5%) discontinued
treatment due to adverse events.
The best overall response was partial in
28 cases (31%), whereas 23 (25%) patients
achieved stable disease and 23 (25%), pro-
gressive disease. A total of 17 patients (18%)
have not reached the first assessment of
response. After a median follow-up of 4
months, median progression-free survival
was 3.5 months irrespective of the line of
treatment.
Dr. Procopio concluded that cabozantinib
was found to be safe and active in this
large unselected population of patients
with metastatic renal cell carcinoma who
were treated in everyday clinical practice.
“The results may support physicians in
their decision making in everyday clinical
practice,” he added. “Our study included
special populations, including the elderly,
and those with rare histology, brain metas-
tasis, and poor prognosis.”
“In the future, we hope to evaluate cabo-
zantinib early in the first-line setting. We
also hope to characterize definitively the
role of predictive biomarkers, such as MET.”
PracticeUpdate Editorial Team
© ESMO 2017 Congress
ESMO 2017 23
VOL. 1 • NO. 3 • 2017