Tumori Journal Abstract Book - October 2020 - 143

H - Genitourinary Tumours	
to bone remodeling without rise in ptDNA. In an exploratory analysis, we found that initial ptDNA change correlates
with the duration of response to prior androgen deprivation
therapy (p<0.0001) but not to prior docetaxel (p=0.32).
Conclusions: PtDNA assessment could be useful and feasible biomarker for therapy monitoring in mCRPC, providing relevant information to the clinical management.
Prospective evaluation of these findings is now merited.

143
Conclusions: We showed that CRPC patients changing
AR CN status from baseline to PD time point had intermediate OS and we suggested that AR CN evaluation at baseline could be the most informative for clinical outcome of
CRPC patients treated with abiraterone or enzalutamide.
Larger prospective studies are warranted.

H13
H12
Changes in plasma AR copy number
and outcome to abiraterone and
enzalutamide
Gurioli G.1, Casadei C.1, Virga A.1, Conteduca V.1, Schepisi G.1, Gargiulo
S.1, Altavilla A.1, Lolli C.1, Scarpi E.1, Filograna A.1, De Giorgi U.1
1

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
IRCCS, Meldola, Forlì-Cesena

Background: Liquid biopsy, such as cell free DNA
(cfDNA) has emerged as a minimally invasive and good
source of biomarkers deriving from multiple metastases.
Androgen receptor (AR) copy number (CN) is considered
one of the main mechanisms of hormone-sensitive to hormone-resistant transition. Baseline AR CN status, detected
in plasma cfDNA, identifies castration-resistant prostate
cancer (CRPC) patients with worse outcome on abiraterone/enzalutamide. However, the impact of AR CN changes
during these treatments on CRPC clinical outcome is
unknown.
Material and methods: Plasma samples from 73 patients
treated with abiraterone or enzalutamide in pre- or postchemotherapy settings were collected at baseline and at the
time of progression disease (PD). Droplet digital polymerase chain reaction was used to assess AR CN status.
Results: We showed that 11 patients (15.1%) changed AR
CN status from baseline to PD (9 patients from normal to
gain, 2 from gain to normal). Patients changing AR CN
status from normal at baseline to gain at PD had intermediate median overall survival (OS) of 20.5 months (95%CI
8.0-44.2) between those who remained AR CN normal
from baseline to PD (27.3 months [95%CI 21.9-34.4]) and
those who remained AR CN gain from baseline to PD (9.1
months [95%CI 3.8-14.5]) (p < 0.0001). Patients changing AR CN from normal at baseline to gain at PD had a
median progression-free survival (PFS) of 9.2 months
(95%CI 2.0-14.7), patients who remained AR CN normal
had a median PFS of 9.1 months (95%CI 7.2-10.1) and
patients who remained AR CN gain had a median PFS of
5.4 (95%CI 3.6-6.5) (p= 0.0005). Both OS and PFS were
not significantly different between patients with AR CN
that changes from normal to gain and patients with stable
AR CN normal, suggesting that the difference on clinical
outcome depends on AR CN status at baseline.

Interim analysis of CASSIOPE, a
European real-world study of
cabozantinib for the treatment
of advanced renal cell carcinoma
(aRCC) following VEGF-targeted
therapy
Masini C.1, Hamberg P.2, Bigot P.3, Suárez C.4, Barthelemy P.5, Eymard
J.6, Gajate P.7, Dutailly P.8, Perrot V.8, Staehler M.9, Procopio G.10
1
Oncology Unit, AUSL-IRCCS di Reggio Emilia, Reggio Emilia, Italy; 2Franciscus
Gasthuis & Vlietland, Rotterdam, Netherlands; 3Centre Hospitalier
Universitaire d'Angers, Angers, France; 4Vall d'Hebron University Hospital and
Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain;
5
Hôpitaux Universitaires de Strasbourg/ICANS, Strasbourg, France; 6Institut
Jean Godinot, Reims, France; 7Hospital Universitario Ramón y Cajal, Madrid,
Spain; 8Ipsen, Boulogne-Billancourt, France; 9Universität München, Klinikum
Grosshadern, Munich, Germany; 10Fondazione IRCCS Istituto Nazionale dei
Tumori, Milan, Italy

Background: Cabozantinib is approved in Europe for the
treatment of aRCC in treatment-naive patients with intermediate or poor risk, or following VEGF-targeted therapy.
We report interim safety data on real-world use of cabozantinib as second- or later-line aRCC therapy.
Materials (patients) and methods: CASSIOPE
(NCT03419572) is an ongoing, non-interventional study
in patients with aRCC initiating cabozantinib after prior
VEGF-targeted therapy. This pre-planned interim analysis was conducted when 50% of patients had completed
⩾ 3 months of follow-up. The primary objective was to
describe dose modifications due to adverse events (AEs)
during the first 3 months of treatment; secondary objectives include AE characterisation and best overall
response (BOR) by RECIST 1.1.
Results: The Full Safety Population comprised 337 patients
receiving cabozantinib (median age, 66 y; 73.0% male;
83.7% clear-cell histology; 96.4% metastatic disease, 85.7%
ECOG 0-1); 265 (78.6%) remained on treatment at 3
months. The Primary Safety Population comprised 217
(64.4%) patients initiating cabozantinib at the recommended
60 mg dose; 109 (32.3%) initiated at 40 mg, and 6 (1.8%) at
20 mg. In the Full Safety Population, 30 (8.9%) patients died
during the first 3 months of treatment (disease progression,
19; serious AE, 9; other, 2); of those in whom BOR was evaluable (n = 131), 31.2% had a partial response, 53.4% had
stable disease and 15.3% had progressive disease. AE-related
dose modifications and AE intensity are shown in the Table.



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
Tumori Journal Abstract Book - October 2020 - 1
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Tumori Journal Abstract Book - October 2020 - Cover3
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