Tumori Journal Abstract Book - October 2020 - 32

32	
tumors showed a pathogenic POLE mutation (p.S459F and
p.P286R). The other TML-high, MSS, and POLE wt tumor
was dMMR at IHC (loss of MSH6 expression) and showed
a pathogenic MSH6 mutation (p.F1040fs). As compared
with low and intermediate TML, high TML was associated
with longer PFS (median PFS: 17.3 vs 10.6; HR: 0.54
[95% CI: 0.35- 1.09], P = .098) and OS (median OS: not
reached vs 23.7; HR :0.45 [95% CI: 0-28-1.13], P = .106).
At least one BRCAness alteration was reported in 40
(14%) of 296 patients. In all, 56 different BRCAness alterations were found, with ATM (21/56, 38%) and BRCA1/2
(13/56, 23%) being the most frequently mutated genes.
Longer PFS (13.4 vs 10.6 months; HR: 0.67 [95% CI:
0.48-0.93], P = .032) and OS (30.1 vs 23.9, HR: 0.66
[95% CI: 0.43-1.02], P = .062) were observed in the
BRCAness group.
Conclusions: TML-high tumors are not limited to MSIhigh, but may also present POLE or MSH6 somatic mutation and show improved outcomes. BRCAness alterations
are associated with better prognosis. Molecular alterations
predictive of benefit from targeted strategies are detectable
in a small percentage of mCRCs.

B07
Italian results of the phase
3b PRECONNECT study: safety,
tolerability and efficacy of
trifluridine/tipiracil in previously
treated metastatic colorectal
cancer
Zaniboni A.1, Barone C.A.2, Banzi M.C.3, Bergamo F.4, Blasi L.5,
Bordonaro R.6, Di Bartolomeo M.7, Di Costanzo F.8, Frassineti G.L.9,
Garufi C.10, Giuliani F.11, Latiano T.P.12, Martinelli E.13, Personeni
N.14, Racca P.15, Tamburini E.16, Tonini G.17, Besse M.18, Spione
M.18, Falcone A.19
1
Fondazione Poliambulanza, Istituto Ospedaliero, Brescia; 2Fondazione
Policlinico Universitario Agostino Gemelli IRCCS, Roma; 3IRCCS - Azienda
Ospedaliera Arcispedale S. Maria Nuova, Reggio Emilia; 4Istituto Oncologico
Veneto - IRCCS, Padova; 5Azienda Ospedaliera "Civico-Di Cristina-Benfratelli",
Palermo; 6Azienda Ospedaliera Garibaldi - Nesima, Catania; 7Fondazione
IRCCS - Istituto Nazionale dei Tumori, Milano; 8Azienda OspedalieroUniversitaria Careggi, Firenze; 9Istituto Scientifico Romagnolo per lo Studio
e la Cura dei Tumori (I.R.S.T.), Meldola (FC); 10Azienda Ospedaliera
San Camillo Forlanini, Roma; 11IRCCS Ospedale Oncologico di Bari, Bari;
12
Ospedale IRCSS Casa Sollievo della Sofferenza, San Giovanni Rotondo
(FG); 13 Università degli Studi della Campania "Luigi Vanvitelli", Napoli;
14
Humanitas Clinical and Research Center - IRCCS, Milano; 15A.O.U. Città
della Salute e della Scienza di Torino, Torino; 16Ospedale Infermi, Rimini;
17
Policlinico Universitario Campus Biomedico, Roma; 18Medical Affairs, Servier
Italia, Roma; 19Azienda Ospedaliero Universitaria Pisana, Pisa

Background: The international PRECONNECT early
access study demonstrated safety and efficacy of trifluridine/tipiracil (FTD/TPI) in the management of patients
with metastatic colorectal cancer (mCRC) who had progressed on standard therapies. Post-hoc analyses in a

Tumori Journal 106(2S)
national context are important due to the differences in the
disease management across countries.
Patients and methods: PRECONNECT is an international phase 3b, open-label, prospective, single-arm study
(NCT03306394). The Italian patient subset was extracted.
Safety and efficacy analyses were conducted in all patients
who received at least one dose of the study drugs. Patients'
quality of life (QoL) was assessed from baseline to end of
treatment (EOT).
Results: The Italian study cohort consisted of 161 patients
enrolled in 18 clinical centers. The median age at treatment
was 64 years (range 30-82). Ninety-eight patients (60.9%)
were males and 112 (69.5%) had an ECOG performance status (PS) score of 0. The median number of previous lines of
therapy was 3 and 59 (36.6%) of the patients received at least
4 previous lines. Median treatment duration was 3.2 months
(range 0.4-14.7), with 108 (67.1%) patients having 3 or more
cycles. The most common hematological adverse events
(AE) were neutropenia (41.0% > grade 3) and anemia
(13.7% > grade 3). Febrile neutropenia was reported in 3
patients (1.9%). The frequency of non-hematological grade 3
AEs was less than 5% for each of them, except for asthenia/
fatigue (6.8%). Eleven (6.8%) and 14 (8.7%) patients discontinued the drug and reduced the dose due to AEs, respectively.
The median progression free survival (PFS) was reached at
3.0 months (95% confidence interval [CI] 2.7-3.4), with a disease control rate of 28.6% (95% CI 21.7-36.2).
The median PFS was higher in patients who received at
least 3 cycles of FTD/TPI than in those who did not (4.0
versus 1.8 months, respectively). The median time to
ECOG PS = 2 was not reached, with only 15 patients
(10.1%) showing an ECOG PS > 2 at FTD/TPI treatment
discontinuation. Overall, there were no clinically relevant
changes in QoL, although the QLQ-C30 score improved in
25.4% of patients from baseline to EOT.
Conclusions: These are the first prospective data on the
clinical use of FTD/TPI in Italy. These results, in line with
those reported in the RECOURSE trial, confirm FTD/TPI
as a feasible and favorable treatment option for pretreated
mCRC patients.

B08
TP53 mutational status impacts
on survival outcomes of
patients (pts) with metastatic
colorectal cancer (mCRC) treated
with chemotherapy (CT) plus
Bevacizumab (Bev). An analysis
in the prospective, randomized,
phase III TRIBE-2 trial
Graziano F.1, Cremolini C.2, Lonardi S.3, Aprile G.4, Santini D.5,
Conca V.2, Tamburini E.6, Latiano T.P.7, Pietrantonio F.8, Passardi A.9,
Germani M.M.10, Zaniboni A.11, Antoniotti C.10, Rossini D.10, Falcone
A.10, Ruzzo A.12



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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