Tumori Journal Abstract Book - October 2020 - 155

M - Melanoma and Skin Cancers

155

patients had rapid disease progression after 3 cycles with
increased LDH and dimensional median disease increase
by 42% (range 15-69%). Median os was 6.4 months
(range2-15). Five patients had a PS deterioration (from 0
to 1). Median progression-free survival was 4.5 months
(range 2-14). We have not recorded grade 3-4 toxicities.
Conclusions: These data suggest that MUM rarely respond
to immunotherapy with pembrolizumab. Only a very small
group of patients could benefit with durable stability.
MUM and cutaneous melanoma are two different disease
with different response to immunotherapy. Given the high
cost, current guidelines should be amended to reflect this
poor response of immunotherapy.

M05
Cost-effectiveness and costutility analysis of cemiplimab
in patients with advanced
cutaneous squamous cell
carcinoma in Italy
1

Ghetti G. , D'Avella M.C. , Ascierto P. , Pradelli L.
1

AdRes, Torino; 2Sanofi, Milano; 3Istituto Nazionale Tumori IRCCS
"Fondazione G. Pascale", Napoli

Background: In Italy, cutaneous squamous cell carcinoma
(CSCC) represents about 20-25% of non-melanoma skin
cancers. About 3-5% of patients with localized CSCC develops advanced CSCC (aCSCC), which include metastatic
(mCSCC) and locally advanced (laCSCC) disease, and are
no longer responsive to surgery or radiation. aCSCC is associated with high morbidity and mortality, including severe
disfigurement which can significantly increase the burden to
the patient. Cemiplimab, a human monoclonal antibody, is
the first systemic therapy approved for aCSCC patients.
This study aims to assess the cost-effectiveness and costutility of cemiplimab vs chemotherapy from the Italian
National Health Service (SSN) perspective.
Material and methods: A three-state partitioned survival
model was developed to estimate, over a 30-year horizon,
costs and outcomes for patients with aCSCC. A one-month
model cycle was chosen and half-cycle correction was
applied. Clinical efficacy, safety and quality of life (QoL)
data for cemiplimab were collected from the EMPOWERCSCC 1 study, whereas data for chemotherapy were taken
from publications identified via a systematic literature
review. In the absence of head-to-head randomized clinical
trials, a simulated treatment comparison using a Cox model
was performed to predict cemiplimab progression-free survival and overall survival given target population as
observed in the Jarkowski et al. study. Costs of drug acquisition/administration and management of adverse events
were included. Annual discount rate was 3%. Incremental
cost-effectiveness ratio (ICER) and incremental cost-utility

ratio (ICUR) were calculated as cost/Life Years (LY) gained
and cost/Quality-Adjusted Life Years (QALY) gained.
Sensitivity and scenario analyses were performed to assess
the robustness of results.
Results: Treatment with cemiplimab led to an increase of
life expectancy of 4.89 LYs and 3.99 QALYs and an incremental cost of € 136,047, resulting in an estimated ICER
and ICUR of 27,821 €/LY gained and 34,110 €/QALY
gained, respectively. The probabilistic sensitivity analysis
showed that both the ICER and the ICUR are below the
Italian SSN willingness to pay thresholds (60,000 €/LY
gained and 25,000-40,000 €/QALY gained, respectively).
Conclusions: Compared with chemotherapy, cemiplimab
improved both survival, in pre- and post-progression
health states, and patients' QoL. Cemiplimab can also be
considered a cost-effective option for treatment of aCSCC
patients in Italy.

M06
Cellular Analysis of
Bronchoalveolar Lavage Fluid
to Narrow Differential Diagnosis
of Checkpoint Inhibitor-related
Pneumonitis in Metastatic
Melanoma
Strippoli S.1, Fucci L.2, Negri A.2, Putignano D.2, Cisternino M.L.2,
Napoli G.2, Filannino R.2, De Risi I.2, Sciacovelli A.M.2, Guida M.2
1
IRCCS Istituto Tumori Giovanni Paolo II Bari, Bari; 2IRCCS Istituto Tumori
Bari Giovanni Paolo II, Bari

Background: The diagnosis of check-point inhibitor-related
pneumonitis (CIP) relies on radiological and clinical patterns
which are not specific and can mimic other conditions (cancer progression, infectious diseases or interstitial pneumonitis). Cell pattern analysis of bronchoalveolar lavage (BAL) is
well-known to support the diagnosis of interstitial lung disease; nevertheless, this analysis is not suggested by immunetoxicity management guidelines for CIP.
Methods: We conducted a single-center study by recruiting patients with stage IV melanoma treated with anti
PD-1 alone or with anti-CTLA4 who underwent BAL after
developing respiratory symptoms associated with computed tomography (CT) scan imaging suspected for CIP.
We also correlated the BAL features with the CT scan patterns and with various peripheral blood parameters to better define the profile of this patient population.
Results: Among 112 patients treated with check-point inhibitors in 2018-2019 we identified 5 (4%) cases of CIP. There
were 3 men, median age 58 years (43-77), in four cases the
ongoing therapy was anti-PD1. Median time of onset was 44
weeks (6-88), according to CTCAE 5.0 we observed grade 3
toxicity in 4 cases and grade 2 in 1 case. One patient also had
grade 3 colitis and two patients developed vitiligo as skin

Tumori Journal Abstract Book - October 2020

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