Tumori Journal Abstract Book - October 2020 - 138

138	

Tumori Journal 106(2S)

in SOR arm. At 24 mos, RFS probability was 57%
(95%CI 42-76%) in obs arm and 50% (95%CI 34-71%)
in SOR arm; at 48 mos, RFS probability was 44% (95%CI
30-65%) in obs arm and 32% (95%CI 18-57%) in SOR
arm (p=0.342; HR 1.35; 95%CI 0.72-2.54). In obs arm, 2
pts died at 4 and 14 mos. 17/36 pts (47%) and 12/32
(37.5%) are relapse-free in obs and SOR arm, respectively. Recurrence was observed mostly in lung,

lymphnodes, brain, bone, liver and pancreas, regardless
of the previous metastasectomy site.
Conclusions: Metastasectomy followed by SOR in
mRCC pts does not offer clinical benefit in terms of RFS.
Anyway, surgery of metastases may be an option in wellselected pts to potentially prolong survival. Actually, in
this trial most pts (47% in obs arm) are relapse-free at a
median follow-up of 42 mos.

Table 1.  Available evidence.
Comparison

RCTs Cognitive impairment
(Investigator-assessed)
N

Toxicity (any grade)

N

Main results

STAMPEDE: Cog imp. 6.4% vs 3.8%
PROSPER: Cog / memory imp. 5% vs 2%
ARCHES: Cog / memory imp. 4.5% vs 2.1%
ENZAMET: Cog dist. 2.8% vs 0.5%;
concentration imp. 5.3% vs 1.1%; memory
imp. 14.6% vs 3.6%.
SPARTAN: mental imp. 5.1% vs 3.0%
ARAMIS: Cog disorders 0.4% vs 0.2%;
memory imp. 0.5% vs 1.3%
NCT02125357: Montreal <26 at week 12:
47% vs 54%

0
1

0
0

ENZAMET: mean changes
worse for Enz (p<0.0001);
deterioration-free survival
better for Enz (3-yr 33% vs
21%, p=0.0003)
-

0
0

-

Abi vs Ctrl
Enz vs Ctrl

5
7

1
3

Apa vs Ctrl
Dar vs Ctrl

2
1

1
1

Cabazitaxel vs Abi / Enz
Abi vs Enz

1
1

0
1

TOTAL

17

Cognitive function
(PRO-based)

7 (41.2%)

H03
Evaluation of cognitive
function (CogF) in randomized
trials testing new-generation
hormonal treatments (NGHT) in
patients with prostate cancer
(PC): a systematic review
Vignani F.1, Marandino L.2, Buttigliero C.3, Gamba T.4, Necchi A.5,
Tucci M.6, Di Maio M.7
1
SCDU Oncologia Medica, AO Ordine Mauriziano, Torino; 2Dipartimento
di Oncologia, Università degli Studi di Torino / Fondazione IRCCS
Istituto Nazionale dei Tumori di Milano, Milano; 3Dipartimento di
Oncologia, Università degli Studi di Torino / AOU San Luigi Gonzaga,
Orbassano (TO); 4Dipartimento di Oncologia, Università degli Studi di
Torino / AO Ordine Mauriziano, Torino; 5Istituto Nazionale dei Tumori
di Milano - Fondazione IRCCS, Milano; 6Ospedale C. Massaia, Asti;
7
Dipartimento di Oncologia, Università degli Studi di Torino, AO
Ordine Mauriziano, Torino

Background: In recent years, NGHT initially approved
for metastatic castration resistant PC (mCRPC) have also
shown efficacy in non-metastatic CRPC (nmCRPC) and in
hormone sensitive PC (HSPC). An earlier use and a longer
duration of NGHT, added up to androgen deprivation therapy, requires evaluation of the impact on patient-reported
outcomes (PROs), and particularly on CogF. Aim of this
systematic review is to focus on the evidence about CogF

1 (5.9%)  

in all randomized trials (RCTs) testing NGHT in patients
(pts) with PC.
Methods: RCTs testing abiraterone acetate (Abi), enzalutamide (Enz), apalutamide (Apa), darolutamide (Dar) were
searched in Pubmed and major meetings. For each RCT,
we assessed (i) availability of investigator-assessed cognitive impairment and disorders; (ii) availability of PRObased evaluation of CogF.
Results: 17 RCTs (17300 pts, 9793 assigned to NGHT)
were included (Table 1). Investigator-based evaluation of
the incidence of CogF impairment was available in 7 RCTs
(41.2%): 1 mCRPC, 3 nmCRPC, 3 HSPC. 17 / 17 RCTs
(100%) included PROs collection, but PRO tools adopted
allowed evaluation of CogF in 2 RCTs (11.8%). Among
them, PRO-based CogF results were presented only in 1
RCT (5.9%): in ENZAMET, mean changes were worse
with Enz (p<0.0001), but deterioration-free survival
favored Enz vs placebo (p=0.0003).
Conclusions: Clinical development of NGHT has not
included a systematic evaluation of CogF. Assessment by
investigators is at risk of underreporting, but CogF deterioration could be relevant, at least in a proportion of pts.
Commonly used PROs do not allow or allow only partially
CogF analysis, and methodology of analysis can jeopardize interpretation of CogF results. Although direct comparisons are scanty, there could be differences between
different NGTH.
Tumori Journal Abstract Book - October 2020

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