Tumori Journal Abstract Book - October 2020 - 137

H - Genitourinary Tumours	
Melacrino-Morelli, Reggio Calabria; 6MD - ARNAS Garibaldi, Catania;
7
Medical Oncology Unit, Antonio Perrino Hospital, Brindisi; 8Departmental
Unit of Experimental Uro-Andrological Clinical Oncology, Istituto Nazionale
Tumori - IRCCS - Fondazione G. Pascale, Naples; 9Department of Clinical
Medicine and Surgery University of Naples, Naples; 10Oncology Unit 2 - Città
della Salute e della Scienza di Torino, Torino; 11Medical Oncology Unit 2,
Department of Translational Research and New Technologies in Medicine
and Surgery, University of Pisa, Pisa; 12Medical Oncology Unit, Department
of General & Specialistic Medicine, University Hospital of Parma, Parma;
13
Department of Urology, Ospedale F. Miulli, Acquaviva delle Fonti, Bari;
14
Oncology Unit, SS Antonio e Biagio e Cesare Arrigo Hospital, Alessandria;
15
Medical Oncology Unit, IRCCS Giovanni Paolo II, Bari; 16Medical Oncology
Division, ASST Vimercate, Vimercate; 17Department of Oncology, University
of Turin; Candiolo Cancer Institute - FPO- IRCCS, Candiolo, Candiolo (TO);
18
Department of Medical, Oral and Biotechnological Sciences, G. d'Annunzio
University of Chieti, Urology unit, "SS. Annunziata Hospital", Chieti;
19
Department of Urology, Sapienza Rome University Policlinico Umberto
I, Rome; 20Department of Radiation Oncology, Azienda OspedalieroUniversitaria Careggi, University of Florence, Florence; 21Department of
Medical Oncology, University Campus Biomedico, Rome

Background: In pivotal trials, abiraterone significantly
improved survival in both chemotherapy-naive and docetaxel pretreated patients with metastatic castration-resistant prostate cancer (mCRPC). Real-world data in the
chemotherapy-naïve setting are limited, largely deriving
from small retrospective studies.
Methods: ABitude is an observational, prospective study
aiming at describing outcomes of mCRPC patients treated
with abiraterone in clinical practice. Chemotherapy-naive
mCRPC patients were consecutively enrolled in 49 Italian
centers at abiraterone start (February 2016-June 2017)
and are being followed for 3 years, with evaluation every
~6 months. Several clinical and patients reported outcomes were examined. Kaplan-Meier curves and multivariable Cox regression models were used for the
analyses.
Results: This is the second interim analysis of the ABitude
study. Among 481 enrolled patients, 453 were evaluable
for analyses. At baseline, median age was 77 years and
~69% of patients had comorbidities (mainly cardiovascular diseases). Metastases were located mainly at bones
and lymph nodes (42% only bones, 22% only lymph
nodes, 23% both sites); 8.4% of patients had visceral
metastases. During a median follow-up of 18 months, 1and 2-years probability of radiographic progression free
survival (rPFS) were 73.9% and 56.2%, respectively; the
corresponding rates for overall survival (OS) were 87.3%
and 70.4%. In multivariable analyses, the number of bone
metastases significantly affected rPFS and OS. During
abiraterone treatment, 65% of patients had a ⩾50% prostate-specific antigen (PSA) decline, and quality of life
(QoL) remained appreciably high. Among symptomatic
patients according to the Brief Pain Inventory (BPI)
(32%), BPI scores significantly declined after 6 months of
treatment, and 1-year rPFS and OS were, respectively,
66.4% and 77.2%. Eight patients (1.7%) had serious
adverse reactions to abiraterone.

137
Conclusions: Abiraterone is effective and safe for
chemotherapy-naive mCRPC patients in clinical practice;
symptomatic patients improve pain and have similar clinical outcomes to the overall patients' population.

H02
Treatment with sorafenib (SOR)
vs observation (obs) following
radical metastasectomy in
patients (pts) with metastatic
renal cell carcinoma (mRCC):
updated data on the randomized
prospective RESORT trial
Mennitto A.1, Apollonio G.1, Verzoni E.1, Cognetti F.2, Miceli R.1,
Milella M.3, Mosca A.4, Chiuri V.E.5, Bearz A.6, Morelli F.7, Ortega
C.8, Atzori F.9, Donini M.10, Claps M.1, Sepe P.1, Guadalupi V.1, De
Braud F.1, Montone R.1, Procopio G.1
1
Fondazione IRCCS Istituto Nazionale Tumori, Milan; 2Regina Elena National
Cancer Institute, Rome; 3University of Verona - Faculty of Medicine, Verona;
4
Candiolo Cancer Institute, FPO-IRCC, Candiolo; 5Ospedale Vito Fazzi, Lecce;
6
Centro di Riferimento Oncologico - CRO, Aviano; 7IRCCS Fondazione Casa
Sollievo della Sofferenza, San Giovanni Rotondo; 8ASL CN 2, Alba e Bra;
9
Azienda Ospedaliero-Universitaria di Cagliari, Cagliari; 10Istituti Ospitalieri di
Cremona, Cremona

Background: In well-selected mRCC pts radical metastasectomy can prolong survival. Previously we reported that
SOR following surgery did not increase relapse free survival (RFS) over obs in a randomized prospective trial.
Now we present the updated follow up data of the RESORT
trial (NCT0144487).
Material and methods: The multicenter, randomized,
phase II RESORT trial enrolled pts with clear-cell mRCC
undergoing radical surgery of the primary tumor and
metastases (⩽3 lesions). Within 12 weeks from metastasectomy, pts were randomized (1:1) to obs or SOR 400
mg BID for 52 weeks. Stratification factors were time
from nephrectomy to metastases (⩽ or >12 months
[mos]), site (lung vs others) and number of metastases
(single vs multiple). Primary endpoint of the study was
RFS, defined as the time from randomization to disease
relapse or death. The secondary were overall survival
and toxicity. RFS curves were estimated with the KaplanMeier method and compared with the log-rank test. We
used the Cox model to estimate the hazard ratio (HR)
SOR vs obs.
Results: Between November 2012 and November 2017
we enrolled 76 pts, of whom 69 randomized. The analysis
was performed on 68 pts (32 in SOR and 36 in obs arm)
because one of them never started therapy. 81% in SOR
and 80% in obs arm had a single metastasis and lung was
the main involved site in 31% and 24%, respectively. At
a median follow up time of 42 mos (interquartile range
31-58) the median RFS was 35 mos in obs arm vs 21 mos



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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