Tumori Journal Abstract Book - October 2020 - 161

N - Head and Neck Tumours	
Material and Methods: We collected a series of ONB
treated with curative intent at the ENT of Spedali Civili,
Brescia and Ospedale di Circolo Varese, Italy. Clinical
data of the patients were retrieved, as well as histological
specimens, whose diagnosis was re-evaluated by two
expert pathologists. We performed gene expression profiling on FFPE samples using Affymetrix Clariom S microarray, and carried out functional enrichment analysis to
investigate key pathways associated with progression-free
survival (PFS).
Results: A series of 42 patients treated between 2001 and
2019 was considered. One patient was excluded due to
poor quality of FFPE sample. Main characteristics of the
patients: mainly male (52%); median age 53 year; stage
I-II 17%, III-IV 83%; Hyams grade I 7%, II 45%, III 48%.
Patients were treated by surgery and 79% received postoperative radiation, while only 1 patient received also neoadjuvant chemotherapy. After a median follow up of 51
months, we identified disease progression in 12 cases.
Median PFS was 38,8 months (5 - 99). Clinical characteristics (gender, global stage, Hyams grade, T stage and N
stage) were not associated with outcome. Patients experiencing recurrence had a disease characterized by enrichment mainly in pathways related to TGF-beta binding,
regulation of cytokine biosynthesis, toll-like receptor 4,
PIP3, p-53 mediated apoptosis signalling in response to
DNA damage, TNF and IFN alfa; on the contrary, patients
without any recurrence after surgery showed increased
expression of genes related to DNA methylation, ubiquitin
ligase complex and retinoid acid binding.
Conclusions: ONB is characterized by heterogeneous
gene expression pathways, related to patient's outcome.
Definition of characterizing transcriptomic pathways may
pave the way to tailored treatment approaches.

N09
Nivolumab for treatment of
Recurrent/Metastatic SquamousCell Carcinoma of the Head and
Neck (R/M HNSCC): real-world data
and possible prognostic factors
Trudu L.1, Shoval Y.2, Napolitano M.1, Schipilliti F.M.1, Depenni R.1,
Dominici M.1, Milella M.2, Bertolini F.1, Tondulli L.2
1
Azienda Ospedaliero - Universitaria di Modena, Modena; 2Azienda
Ospedaliera Universitaria Integrata di Verona, Verona

Background: Immune checkpoint inhibitors (ICIs) represent a new active class of agents recently approved for
platinum-refractory R/M HNSCC. Despite the increase of
overall survival (OS), no prognostic factors have been
established to predict outcome, yet.
Methods: We retrospectively reviewed 37 patients (pts)
with platinum-refractory R/M HNSCC who received at

161
least 2 doses of nivolumab 240 mg every 2 weeks from
2016 to 2020 at University Hospitals of Modena and
Verona. We investigated nivolumab efficacy in real-world
patients and prognostic factors associated with the response
to treatment.
Results: The overall cohort include 37 pts: 27(73%) males,
27(73%) smokers, median age 62 (43-77), median BMI
22.5 (17.22-34.6). Most of the pts had a primary cancer in
oral cavity (11, 30%) or oropharynx (11, 30%). 34 pts (92%)
received previous locoregional treatments (surgery + radio
+ chemotherapy), while nivolumab was administered as >
second line therapy in 33 pts (89%). Median follow-up was
7 (1-18) months (mos); median progression-free survival
(PFS) and OS were 5 (0.5-17) and 8 mos (2-17), respectively. Best overall response (BOR) was complete response
in 3 pts (8%), partial response in 5(14%), stable disease in
9(24%), progression disease (PD) in 20 pts (54%). We
divided patients in 2 prognostic groups: long survival (LS)
group, 23 pts (62%) with OS ⩾ 6 mos and early progressors
(EP), 14 pts (38%) with OS<6 mos. Among clinical variables, performance status (PS) confirmed its prognostic role:
in LS group 9 pts (39%) had PS 0 vs 1(7%) and 13(57%)
with PS 1 vs 12(86%) in EP group. Among bio-humoral
variables (haemoglobin, eosinophil count, neutrophil/lymphocyte ratio, LDH), only eosinophil count significantly
differed among LS vs EP (median value of 0.17 vs 0.06 x
103/mmc). Among molecular variables: PD-L1 TPS expression was evaluated in 20 pts: 7 pts had PD-L1 < 1%, 10
PD-L1 1-49%, 3 PD-L1 ⩾ 50%; no correlation with OS was
detected, but all responsive pts had detectable PD-L1.
Finally, immune-related adverse events (irAEs) were investigated: 15 pts (40%) experienced toxicity (10 pts G1-G2, 2
pts G3); among them 10 (67%) were in LS group.
Conclusions: Nivolumab is the standard of care in platinum refractory R/M HNSCC, not pre-treated with ICIs.
However, not all pts would benefit from this treatment. In
order to improve survival, biomarkers and prognostic factors for patient's selection are needed.

N10
Cancer of the oral cavity: a
single Institution experience
Gusmaroli E.1, Violati M.2, Careri C.2, Provenzano L.2, Luciani A.2,
Codecà C.2, Rabbiosi D.3, Franzese C.4, Moneghini L.5, Biglioli F.3,
Ferrari D.2
1
Università degli Studi di Milano, Milano; 2Medical Oncology Unit, ASST Santi
Paolo e Carlo, University of Milan, Italy., Milano; 3Maxillo-Facial Surgery Unit,
ASST Santi Paolo e Carlo, University of Milan, Italy., Milano; 4Department
of Radiotherapy and Radiosurgery Istituto Clinico Humanitas, Milano;
5
Pathology Unit, ASST Santi Paolo e Carlo, University of Milan, Italy, Milano

Background: About 6,000 oral cavity squamous cell carcinoma (OCSCC) are diagnosed in Italy each year, which
cause about 3,000 deaths. Oral cavity tumors can present as
Tumori Journal Abstract Book - October 2020

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