Tumori Journal Abstract Book - October 2020 - 176

176	

T - Miscellanea
T01
Preliminary results from the
RATIONAL study, the Italian
Registry of Actionable Mutations
Esposito Abate R.1, De Luca A.1, Novello S.2, Curigliano G.3,
Marchetti P.4, Fasola G.5, Conte P.6, Milella M.7, Pruneri G.8,
Frassineti G.L.9, Cremolini C.10, Gridelli C.11, Feroce F.1, Morabito A.1,
Pinto C.12, Normanno N.1
1

Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale, Napoli;
Università degli Studi di Torino, Torino; 3Istituto Europeo di Oncologia,
Milano; 4Ospedale Sant'Andrea, Roma; 5Ospedale Universitario di
Udine, Udine; 6Istituto Oncologico Veneto, Padova; 7Azienda Ospedaliera
Universitaria Integrata di Verona, Verona; 8Istituto Nazionale dei Tumori di
Milano, Milano; 9Istituto Scientifico Romagnolo per lo Studio e la Cura dei
Tumori (IRST) IRCCS, Meldola; 10Azienda Ospedaliero-Universitaria Pisana,
Pisa; 11Ospedale S.G. Moscati, Avellino; 12Azienda Unità Sanitaria Locale -
IRCCS, Reggio Emilia
2

Background: Registers of next-generation sequencing
(NGS)-based tumor profiling data might facilitate the
identification of subgroups of patients carrying actionable
genomic alterations who may benefit of molecularly targeted treatments. This approach might be particularly relevant in specific subgroups such as patients with cancers
of unknown primary (CUP).
Material (patients) and Methods: The RATIONAL study
is a multicenter, observational and prospective clinical
trial that involves 41 centers in Italy. The primary objective is the description of the frequency of actionable mutations in patients with advanced disease. The study enrolls
either patients who already received a NGS-based profiling of the tumor (Pathway A) or patients without NGSbased tumor profiling (Pathway B). In the latter case,
tissue testing is performed with the FoundationOne CDx
assay that identifies genetic alterations in 324 genes, as
well as the tumor mutational burden (TMB).
Results: To date, thirty-two centers are active and 337
patients have been enrolled. Sequencing data are available
for 240 patients. The most frequent tumor type is lung cancer (n. 130; 54% of cases), followed by tumors of the biliary tract (n.49; 20%), CUP (n.26; 11%), colorectal cancer
(n.24; 10%), and other tumor types (5%, n. 2 pancreatic
cancers, n.2 thyroid cancers, n. 2 sarcomas, n.1 breast cancer n.1 bladder cancer, n.1 adrenal gland cancer, n.1 ovary
cancer and n.1 melanoma). In 228 successfully sequenced
patients, 867 genetic alterations in 194 genes were identified. The most frequently altered gene was TP53 (47% of
cases), followed by KRAS (31%), EGFR (16%), PIK3CA
(10%), STK11 (9%) and APC (8%). In 22 patients with
CUP, 84 genetic alterations in 56 genes were observed.
The most frequent actionable mutations that might influence treatment decisions, including potential enrollment
into clinical trials, were observed in STK11, KRAS,
PI3KCA, ERBB2, PTEN, ATM, and BRAF genes. For

Tumori Journal 106(2S)
18/22 patients with CUP, TMB analysis was available,
with values ranging from 0 to 24 mut/Mb (mean of 6.27
mut/Mb; median 5.0 mut/Mb).
Conclusions: The creation of a national registry of genomic
data of cancer patients will help the clustering of patients
based on their molecular profile, regardless of the relatively
low frequency of many genetic alterations, and will favor
the progress of tumor-agnostic therapeutic approaches.

T02
Lifestyle changes in breast and
colorectal cancer survivors:
results from FUCSAM project
Mistrangelo M.1, Bertetto O.1, Barè C.1, Barone C.1, Beano A.1,
Bonomi A.1, Camussi E.2, Ciccone G.2, Gambaro G.1, Miraglia S.1,
Pacquola M.G.1, Piccinelli C.2, Romaniello I.1, Sarli F.1, Senore C.2,
Zunino S.1, Giordano L.2
1

Dipartimento Rete Oncologica Piemonte e Valle d'Aosta - AOU Città della
Salute e della Scienza, Torino; 2AOU Città della Salute e della Scienza CRPT Piemonte, Torino

Background: Lifestyles can improve quality of life and
survival in cancer survivors. FUCSAM project assess the
impact of preventive interventions (diet, physical activity
or both) after treatment for colorectal (CRC) or breast cancer (BC).
Methods: Patients with diagnosis of BC or CRC, at first
follow-up after surgery and medical therapy, free of disease,
were enrolled. Information leaflets and advices of lifestyle
programs were delivered. Each follow-up (for 3 years) the
following data were collected: co-morbidities, weight, waist
circumference, biological parameters,adherence toprograms, and lifestyles. A lifestyle score was built, assigning 1
point for improvement, -1 for worsening and 0 for stability.
Pre-/post- analyses were conducted with McNemar test and,
for continuous variables, with a Wilcoxon test. Crude and
adjusted ORs were computed, accounting for age, sex and
cancer diagnosis.
Results: Participants were 1,847 (311 CRC, 1536 BC),
90.7% female, mean age: 60.2±11.2, and 39% were
screen-detected cancers. Most cancers were in stage 1
(49.9%) or 2 (34.1%) at diagnosis, with a majority of early
lesions for screen-detected cancers (p<0.001). 99.2% of
participants received informative materials and 79.0%
suggestions of lifestyle interventions. At 6 months, overweight-obese participants decreased (52.8% to 50%;
p<0.001). This outcome was maintained at second FU (1
year) (p<0.001). At 6-month, an improvement was seen in
waist circumference (overweight from 74.8% to 72.2;
p<0.006), and metabolic syndrome (from 45.8% to 41.1%;
p<0.001). Favorable anthropometric outcomes were especially evident in women and participants adherent to the
program. An improvement was seen at 6 months for



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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