Tumori Journal Abstract Book - October 2020 - 59

C - Gastrointestinal (non-Colorectal) Cancers	
Results: Four sequences were identified: Sorafenib (Sor)
followed by either regorafenib or cabozantinib (Sor-TKI),
or chemotherapy (CT, capecitabine and/or cyclophosphamide, Sor-CT) or anti-PD1 agents (Sor-IO) and IO succeeded by Sor (IO-Sor).
Among the 77 pts enrolled, 28 received Sor-TKI, 34
Sor-CT, 6 Sor-IO and 9 IO-Sor: all of them were homogeneous in terms of baseline performance status, BCLC
stage, Child Pugh score, macrovascular invasion, disease's
etiology and extent (all p>0.05).
PFS1+2 was significantly different according to sequences
(p=0.01), with the highest value observed in Sor-TKI and
the lowest in IO-Sor (17.2 and 7.8 months, respectively),
while no differences were shown in OS (p=0.34).
Looking at baseline characteristics across the sequences,
AFP>400 was associated with poorer PFS1+2 both in SorTKI (p=0.015) and Sor-CT (p<0.001), where it also acted
as an independent negative prognostic factor for OS
(p=0.002). Similarly, the extrahepatic spread of disease was
related to worse PFS1+2 (p=0.03) and OS (p=0.01) both in
Sor-CT (PFS1+2: p=0,04) and in Sor-IO (OS: p=0.03).
HCV etiology correlated with better PFS1+2 in all
sequences but IO-Sor, as did a lower BCLC stage with
respect to Sor-CT both in terms of PFS1+2 and OS (both
Cox's p=0.01).
Conclusions: In our series, Sor-TKI performed as the best
strategy, especially in low AFP and in HCV pts. A disease
extent beyond the liver played a poor prognostic role in
Sor-CT and Sor-IO. No predictive factors (not even HCV
etiology, unlike all other sequences) were found for IO-Sor,
likely due to its limited numerosity. Additional data are
still warranted.

C26
Tumor Burden Score: a useful
tool to predict immunerelated hepatotoxicity during
immunotherapy for HCC
D'Alessio A.1, Personeni N.2, Cammarota A.2, Prete M.G.2, Ferrillo
G.3, Pedicini V.3, Pressiani T.2, Smiroldo V.2, Bozzarelli S.2, Giordano
L.4, Santoro A.2, Rimassa L.2
1
Humanitas Clinical and Research Center - IRCCS, Rozzano; 2Medical
Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas
Clinical and Research Center - IRCCS, Rozzano; 3Department of Radiology,
Humanitas Clinical and Research Center - IRCCS, Rozzano; 4Biostatistics
Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center IRCCS, Rozzano

Background: Treatment with immune checkpoint inhibitors (ICI) is complicated by the development of hepatic
immune-related adverse events (HIRAEs) in around
9-20% of cases. While the risk factors for such adverse
events are largely unknown, we assessed the role of tumor
burden as a determinant for development of HIRAEs.

59
Material and methods: Our analysis included 36 patients
with HCC treated with a monoclonal antibody (mAb) targeting the programmed cell death receptor-1 or its ligand (PD-1/
PD-L1) as single agent (16 patients, 44%) or in combination
with a mAb against the cytotoxic T-lymphocyte-associated
protein 4 (CTLA-4) (20 patients, 56%). The pretreatment
Tumor Burden Score (TBS) was calculated considering both
the total number of liver nodules (a) and the maximum diameter (b) according to the following formula: TBS2 = a2 + b2.
Furthermore, we used a ROC curve to set a TBS threshold
which could be used to predict the onset of HIRAEs. HIRAEs
were categorized according to the Common Terminology
Criteria for Adverse Events (v. 5.0).
Results: 18 patients (50%) developed any grade HIRAEs,
of whom 5 (18%) developed G3-G4 HIRAEs. No G5 toxicity was registered. No patient permanently discontinued
treatment because of HIRAEs. Patients who developed
any grade HIRAEs had significantly higher mean values of
TBS compared to patients with no HIRAEs (13.4 [95% CI
8.3 - 18.5] vs 7.3 [95% CI 3.7 - 11.1], p = 0.048). We did
not find a significant correlation between the mean baseline TBS value and the development of G3-G4 HIRAEs
(12.0 vs 10.1, p = 0.70, in patients who developed G3-G4
HIRAEs vs those with a lower grade hepatotoxicity,
respectively). From the analysis of the ROC curve, we
chose a TBS threshold of 10, with an area under the curve
of 0.70 (95% CI 0.52-0.87, p = 0.046).
Patients with a TBS of 10 or more had a significantly
higher risk of developing any grade HIRAEs compared to
patients with TBS < 10 (Odds ratio = 5 [95% CI 1.117.8], p = 0.041). Median overall survival did not significantly differ between patients with TBS<10 and patients
with TBSā©¾10 (7.9 months vs 6.3 months, p = 0.60).
Conclusions: In HCC patients treated with ICI, hepatic
tumor burden could be a risk factor for the development of
any grade HIRAEs. TBS is a useful tool to measure hepatic
tumor burden and it could be used to predict the risk of
HIRAEs. The role of TBS in predicting HIRAEs needs to be
confirmed and validated in larger cohorts of HCC patients.

C27
TARGETING of Mitochondria as a
novel therapeutic strategy in
biliary tract cancer
Salati M.1, Barbato A.2, Indrieri A.2, Volpe M.2, Quadrano P.2,
Brillante S.2, Mirante L.2, Riccardo S.2, Cacchiarelli D.2, Iuliano
A.2, Franco B.3, Dominici M.4, Reggiani Bonetti L.5, Salatiello M.6,
Troncone G.6, Pietro C.2
1

Division of Oncology, Department of Oncology and Hematology, University
Hospital of Modena, Modena; 2Tigem - Telethon Institute of Genetics and
Medicine, Pozzuoli; 3Tigem - Telethon Institute of Genetics and Medicine,
Modena; 4Division of Oncology, Department of Oncology and Hematology,
University Hospital of Modena, Modena; 5Section of Pathology, Azienda



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
Tumori Journal Abstract Book - October 2020 - 1
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Tumori Journal Abstract Book - October 2020 - Cover3
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