Tumori Journal Abstract Book - October 2020 - 144

144	

Tumori Journal 106(2S)

Conclusions: In this real-world study, 64.4% of patients
initiated cabozantinib at the recommended dose;
AE-related dose modifications were similar for the Full
and Primary Safety populations. No new safety signals

 

were seen in this 3-month interim analysis. Dose modifications may be required to optimize cabozantinib use in
routine care.
Funded by Ipsen

Primary Safety Population (initiated at 60 mg)

Full Safety Population
(initiated at any dose)

2L (n = 106)

Dose modification due to AEs, n (%)
Any
68 (64.2)
Reduction
42 (39.6)
Interruption
46 (43.4)
Discontinuation
8 (7.5)
AE intensity, n (%)
Grade 3
37 (34.9)
Grade 4
7 (6.6)

⩾ 3L (n = 111)

Total (n = 217)

2L (n = 146)

⩾ 3L (n = 191)

Total (n = 337)

74 (66.7)
57 (51.4)
51 (45.9)
15 (13.5)

142 (65.4)
99 (45.6)
97 (44.7)
23 (10.6)

84 (57.5)
51 (34.9)
55 (37.7)
11 (7.5)

122 (63.9)
81 (42.4)
88 (46.1)
24 (12.6)

206 (61.1)
132 (39.2)
143 (42.4)
35 (10.4)

42 (37.8)
5 (4.5)

79 (36.4)
12 (5.5)

54 (37.0)
8 (5.5)

72 (37.7)
10 (5.2)

126 (37.4)
18 (5.3)

H14
A phase 2 open label study of
cabozantinib in patients with
advanced or unresectable renal
cell carcinoma pre-treated with
one immune-checkpoint inhibitor:
the BREAKPOINT trial (MeetUro
trial 03 - NCT03463681)
Pircher C.1, Claps M.1, Montone R.1, De Giorgi U.2, Guadalupi V.1,
Mennitto A.1, Sepe P.1, De Braud F.3, Verzoni E.4, Procopio G.4
1
Medical Oncology Unit, Fondazione IRCSS Istituto Nazionale dei Tumori
di Milano, Milan, Italy, Milano; 2Department of Medical Oncology, Istituto
Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST IRCCS,
Meldola, Italy, Meldola; 3Medical Oncology Unit, Fondazione IRCSS Istituto
Nazionale dei Tumori di Milano, Milan, Italy. Department of Medical
Oncology & Hematology, University of Milan, via Festa del Perdono 7, 20122
Milan, Italy, Milano; 4Medical Oncology Unit, Fondazione IRCSS Istituto
Nazionale dei Tumori di Milano, Milan, Italy., Milano

Background: Antiangiogenic therapy was the milestone of
metastatic renal cell carcinoma (mRCC) treatment for many
years. Recently, immunotherapy (IM) showed to improved
survival of mRCC patients (pts), thus bringing new light for
the frontline standard of care. Prospective data evaluating
the efficacy of vascular endothelial growth factor (VEGF)targeted therapy in pts progressed to immune-checkpoint
inhibitors (ICI) are lacking. Among VEGF pathway blockers, the multi-kinase inhibitor cabozantinib (cabo) significantly prolonged survival in pre-treated mRCC pts.
Material and methods: This is an ongoing open label, single arm, multicenter, phase II study to evaluate efficacy and
safety of cabo in pts with advanced or unresectable RCC
pre-treated in adjuvant or I line with a PD-1/PD-L1 inhibitor

in monotherapy or combined with an anti-VEGF or antiCTLA-4. Cabo 60 mg/daily was given until progressive disease (PD) or unacceptable toxicity. The primary endpoint
was progression free survival, secondary endpoints were
overall survival, objective response rate and safety.
Results: To date, 15/49 planned pts were enrolled. Pts
median age was 56 years (range: 29-74), men in 80% of
cases. The average duration of the first line was 5.7 months
(range: 1-23). Baseline Karnofsky PS was 100 in 53% of
pts, 80-90 in 33% and 70-80 in 13%. 20% of pts had a
good Heng score, 33% intermediate and 40% poor. Pts
received on average 4 cycles of cabo (range 1-17 months).
8 pts interrupted therapy for PD, 1 did not start cabo yet
and 6 are on treatment. Grade (G) 3 adverse events (AEs)
occurred in 40% of pts; the most common AEs were diarrhea (G1, 20%; G2, 40%), hypothyroidism (G2, 26%),
mucositis (G1, 40%; G2, 6%), and fatigue (G1, 13%; G2,
33%). AEs led to transitory withholding of drug administration in 66% of pts and dose reduction in 20%.
Conclusions: So far, the treatment with cabo after a I line
anti-PD-1 based immunotherapy resulted safe and feasible.
The Breakpoint is the first prospective trial to provide evidence of efficacy and safety of the ICI-cabo sequence.
Moreover, the study includes the analysis of tumor and blood
samples in order to recognise biological and immunological
signatures to correlate with outcome and tolerability.

H15
PTEN and ARV-7 status in
circulating tumor cells by flow
cytometry in men with metastatic
castration-resistant prostate
cancer receiving enzalutamide
Tumori Journal Abstract Book - October 2020

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