Tumori Journal Abstract Book - October 2020 - 152

152	
Conclusions: Implementation of MDT and continous verification of outcomes through objective indicators results
into optimization of prostate cancer care.

H28
A phase 3 study (COSMIC-313) of
cabozantinib in combination
with nivolumab and ipilimumab
in patients with previously
untreated advanced renal cell
carcinoma of intermediate or
poor risk
De Giorgi U.1, Choueiri T.K.2, Albiges L.3, Powles T.4, Scheffold C.5,
Wang F.5, Motzer R.J.6
1

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola
FC; 2Dana-Farber Cancer Institute/Brigham and Women's Hospital and
Harvard University School of Medicine, Boston; 3Institute Gustave Roussy,
Villejuif; 4Barts Cancer Institute, Queen Mary University of London, London;
5
Exelixis, Inc., Alameda; 6Memorial Sloan Kettering Cancer Center, New York

Background: Cabozantinib (C) inhibits tyrosine kinases
involved in tumor growth, angiogenesis, and immune regulation, including MET, VEGFR, and TAM kinases
(Tyro3, AXL, MER), and may promote an immune-permissive tumor environment, resulting in enhanced response
to immune checkpoint inhibitors. C has shown preliminary
clinical activity and tolerability in combination with the
PD-1 inhibitor nivolumab (N) and as part of a triplet combination with N and the CTLA-4 inhibitor ipilimumab (I)
in patients (pts) with advanced renal cell carcinoma
(aRCC) (Nadal et al. ASCO 2018). C is approved for pts
with aRCC, and N+I is approved as a combination therapy in pts with previously untreated aRCC of intermediate
or poor risk. We present the study design of a phase 3 trial
of C+N+I vs N+I in previously untreated pts with aRCC
of IMDC intermediate or poor risk (NCT03937219).
Methods: This randomized, double-blind, controlled
phase 3 study evaluates the efficacy and safety of C+N+I
vs N+I in previously untreated pts with IMDC intermediate or poor risk aRCC. Eligible pts are randomized 1:1 to
receive C+N+I or N+I in combination with placebo,
stratified by IMDC prognostic score and geographic
region. Pts receive C (40 mg oral QD) + N (3 mg/kg IV
Q3W) x 4 doses + I (1 mg/kg IV Q3W) x 4 doses, followed by C (40 mg oral QD) + N (480 mg IV flat dose
Q4W). Control pts receive C-matched placebo and the
same treatment regimen for N+I as the experimental arm.
N will be administered for a maximum of 2 years.
Eligibility criteria include histologically confirmed metastatic or aRCC with a clear cell component, intermediate
or poor risk RCC per IMDC criteria, measurable disease
per RECIST 1.1, KPS ⩾70%, adequate organ and marrow
function and age ⩾18 years. Exclusion criteria include

Tumori Journal 106(2S)
prior systemic therapy for aRCC and uncontrolled significant illnesses. The primary endpoint is PFS per RECIST
1.1 by BICR; the secondary endpoint is OS. Additional
endpoints include ORR, safety, correlation of biomarkers
with outcomes, and pharmacokinetics of C in combination
with N+I. The first patient was enrolled in June 2019 and
enrollment is ongoing.

H29
RARE CASES OF METASTASIS TO THE
THYROID GLAND FROM RENAL CLEAR
CARCINOMA SOME YEARS AFTER
NEPHRECTOMY, AS THE FIRST AND
ONLY SITE OF METASTASIS
Ricci I.1, Intersimone D.1, Dessanti P.1, Vaira F.1, Tognoni A.1, Ferrari
A.1, Milano A.1, Negru M.E.1, Pastorino A.1, Rondini M.1, Vigani A.1,
Olcese F.1, Barillaro F.2, Camilli M.2, Conti E.2, Aschele C.3
1
ASL5 Spezzino-Ospedale Sant'andrea, La Spezia; 2ASL5 Spezzino-Ospedale
San Bartolomeo, Sarzana; 3ASL5 Spezzino-Ospedale Sant' Andrea, La Spezia

Background: Renal cell carcinoma (RCC) is known to cause
metastasis to unusual sites, which can be both synchronous or
metachronous. Thyroid gland is a rare site for metastasis but,
when it occurs, RCC is the most common primary neoplasm
and can develop many years after initial diagnosis.
Patients and methods: We retrospectively reviewed our
database of RCC patients with thyroid metastases. Our aim
was to investigate the incidence of thyroid metastasis from
RCC and describe patients' characteristics, initial presenting symptoms at the diagnosis of the thyroid metastasis,
status and size of the metastatic lesions, diagnostic and
therapeutic modalities used, the average latency time
before the detection of metastasis after nephrectomy, presence of metastatic sites other than the thyroid gland, follow-up time after detection of thyroid metastasis with the
final status of the patients.
Results: The total number of RCC patients observed from
2004 to 2019 in our institution was of about 208 cases. Out
of these, only 3 patients developed thyroid metastasis from
RCC, 1 male (a 79-year-old) and 2 females (respectively
71 and 78-year-old). The average lag time to diagnosis of
thyroid metastases was ten years for two females and three
years for male. Only one patient had symptoms. Regarding
the tests performed for the diagnosis of RCC metastases to
the thyroid gland, ultrasound of the neck was the most frequently used radiological imaging modality followed by
computed tomography and positron emission tomography.
The patients subsequently underwent fine needle aspiration cytology. Immunohistochemistry is helpful in differential diagnosis. All patients underwent radical thyroid
surgery. The histopathological examination showed metastatic RCC of clear cell type in all three cases. The subsequent follow up was negative.



Tumori Journal Abstract Book - October 2020

Table of Contents for the Digital Edition of Tumori Journal Abstract Book - October 2020

Contents
Tumori Journal Abstract Book - October 2020 - Cover1
Tumori Journal Abstract Book - October 2020 - Cover2
Tumori Journal Abstract Book - October 2020 - I
Tumori Journal Abstract Book - October 2020 - II
Tumori Journal Abstract Book - October 2020 - Contents
Tumori Journal Abstract Book - October 2020 - IV
Tumori Journal Abstract Book - October 2020 - V
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