Tumori Journal Abstract Book - October 2020 - 45

C - Gastrointestinal (non-Colorectal) Cancers	

C - Gastrointestinal (non-Colorectal)
Cancers
C01*
Updated results from the
randomized phase 2 trial
of avelumab alone or with
cetuximab for unresectable,
locally advanced or metastatic
squamous cell anal carcinoma
progressed to at least one line of
treatment: the CARACAS study
Prete A.A.1, Pietrantonio F.2, Messina M.3, Formica V.4, Corsi D.C.5,
Cortesi E.6, Frassineti G.L.7, Zampino M.G.8, Ronzoni M.9, Scartozzi
M.10, Casagrande M.11, Conca V.12, Bergamo F.1, Prisciandaro M.2,
Daniel F.1, Pagani F.2, Magni G.1, Vettore V.1, Zagonel V.1, Lonardi S.1
1

Veneto Institute of Oncology IOV - IRCCS, Padua; 2Fondazione IRCCS
Istituto Nazionale dei Tumori, Milan; 3Fondazione Istituto G. Giglio, Cefalù;
4
Tor Vergata University Hospital of Rome, Rome; 5San Giovanni Calibita
Fatebenefratelli, Rome; 6Sapienza University of Rome, Rome; 7Istituto
Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS,
Meldola; 8European Institute of Oncology IRCCS, Milan; 9Ospedale San
Raffaele, Milan; 10University Hospital, University of Cagliari, Cagliari;
11
Azienda Sanitaria Universitaria Integrata di Udine, Udine; 12Azienda
Ospedaliera Universitaria Pisana, Pisa

Background: Advanced squamous cell anal carcinoma
(advSCAC) is a rare disease and no standard therapies
beyond first line are currently available.
Data from retrospective case series and phase I and II prospective studies respectively suggest activity of the antiEGFR cetuximab (CET) and of immunotherapy in
advSCAC after the first line.
In this study, we evaluated activity and safety of avelumab
(AVE) alone or in combination with CET in pretreated
advSCAC.
Material (patients) and methods: In this open-label,
"pick the winner", prospective, multicenter randomized
phase 2 trial (NCT03944252), patients (pts) with mSCAC
with documented progressive disease after at least 1 line of
treatment were randomized 1:1 to receive either AVE (arm
A) or AVE plus CET (arm B). Primary endpoint was overall response rate (ORR). According to the Simon's twostage Mini-Max design used, the null hypothesis that the
true response rate was 5% (p = 0,05) was tested against
the alternative of a true response rate of 20% (p1= 0,20) in
each arm. Type I error rate was set at 0,05.
No formal comparison was allowed between the two arms.
Secondary endpoints were PFS, OS and safety
Results: 30 pts were enrolled in each arm, for a total of 60.
Median age was 63 years; M/F was 19/41. All baseline
characteristics were well balanced between the arms.
At a median follow up of 11 months, ORR was 10% (95%
CI 2.5 - 27) in arm A and 17% (95% CI 6.3 - 34,1) in arm
B: with 5 patients achieving PR in arm B, the primary endpoint was reached in this arm. Disease control rate (DCR)

45
was 50% (95% CI 35.3 - 71.3) in arm A and 57 (95% CI
42.4 - 77.6) in arm B.
Median PFS was 2.05 months (95% CI 1.84 - 5.52) in Arm
A and 3.88 months (95% CI 2.07 - 6.14) in Arm B. Median
OS data are not yet mature.
The most common treatment related adverse event (TRAE)
was fatigue in Arm A (17% of patients) and skin toxicity in
arm B (87% of patients); no permanent interruptions due
to TRAE were observed in arm A while 2 patients (7%) in
arm B permanently interrupted the treatment due to TRAE
Conclusions: The CARACAS study met its primary endpoint in the arm B, documenting promising activity of
EGFR and PD-L1 blockade in advSCAC; this strategy
deserves further investigation. Favorable safety profile
was observed in both the arm.

C02*
Real-life Italian experience with
perioperative FLOT for resectable
gastric cancer: results of
prospective observational
RealFLOT Study
Giommoni E.1, Lavacchi D.1, Tirino G.2, Fornaro L.3, Iachetta F.4,
Pozzo C.5, Satolli M.A.6, Spallanzani A.7, Puzzoni M.8, Stragliotto S.9,
Sisani M.10, Formica V.11, Giovanardi F.12, Strippoli A.5, Prisciandaro
M.13, Di Donato S.14, Pecora I.3, Romagnani A.4, Pillozzi S.1, De Vita
F.2, Antonuzzo L.1
1

Clinical Oncology Unit, AOU Careggi, Firenze; 2Division of Medical Oncology,
Department of Precision Medicine, University of Study of Campania "L.
Vanvitelli", Napoli; 3Medical Oncology, Azienda Ospedaliero-Universitaria
Pisana, Pisa; 4Medical Oncology Unit, Clinical Cancer Center, AUSL-IRCCS,
Reggio Emilia; 5Medical Oncology, Fondazione Policlinico Universitario "A.
Gemelli", IRCCS, Roma; 6Department of Medical Oncology, University of
Turin, Torino; 7University Hospital of Modena, Modena; 8Medical Oncology
Department, University Hospital, University of Cagliari, Cagliari; 9Oncology Unit
- Dipartimento di Oncologia Clinica e Sperimentale Istituto Oncologico Veneto
IOV-IRCCS, Padova; 10Medical Oncology, Usl Toscana Sudest, Arezzo; 11Internal
Medicine Department, Roma; 12Medical Oncology, Azienda Unità Sanitaria
Locale-IRCCS di Reggio Emilia, Reggio Emilia; 13Medical Oncology Department,
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; 14Medical Oncology,
Department Nuovo Ospedale-Santo Stefano Istituto Toscano Tumori, Prato

Background: Perioperative chemotherapy significantly
improved survival in patients with resectable gastric cancer (GC), increasing 5-year overall survival (OS) from
23% with surgery alone to 45% with FLOT (5-fluorouracil, oxaliplatin, docetaxel) regimen.
Methods: RealFLOT is an Italian, multicentric observational study, designed to describe the feasibility and activity, in terms of pathological responses and survival, of
perioperative FLOT in a real-world patient population
with resectable gastric or gastro-oesophageal junction
(GEJ) adenocarcinoma treated as clinical practice, and
according to inclusion criteria of FLOT4-AIO trial. We
also evaluated the prognostic role of microsatellite instability (MSI) status in a soubgroup of patients.



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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Tumori Journal Abstract Book - October 2020 - Cover3
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