Introduction: Avelumab (Ave) is approved for metastatic urothelial carcinoma (mUC) maintenance therapy and prolongs overall survival (OS). We explored trends related to Ave treatment of mUC patients. Methods: A total of 72 patients with mUC treated with first-line chemotherapy, from January 2019 to November 2022, at our affiliated institutions, were analyzed. We compared clinical parameters and the prognosis of patients treated with Ave (n = 43) because of progression during first-line chemotherapy, with untreated patients (Ave-untreated; n = 29). Among the Ave-treated group, we classified patients showing a complete or partial response or stable disease in their best response to Ave maintenance therapy as Ave-suitable patients; these were retrospectively analyzed. Potential prognostic factors, including the Geriatric Nutritional Risk Index (GNRI) for determining patients suitable for Ave, were evaluated. Results: The basic clinical parameters of patients when first-line treatment was initiated were not statistically different between the two groups. The Ave-suitable group (median 26.6 months, 95% confidence interval [CI]: 19.4–not reached [NR]) showed significantly longer median OS after first-line treatment than the Ave-untreated group (median 12.0 months, 95% CI: 7.5–NR) with tolerable adverse events. The cut-off values of prognostic factors were set by the receiver operating characteristic curve. Low age and GNRI sustainability were revealed as significant prognostic factors for being Ave-suitable both in univariate and multivariate analysis. Conclusion: In mUC, Ave maintenance prolonged OS within tolerable safety profiles. GNRI sustainability may be used as a biomarker to predict being Ave-suitable.

1.
Krabbe
LM
,
Eminaga
O
,
Shariat
SF
,
Hutchinson
RC
,
Lotan
Y
,
Sagalowsky
AI
, et al
.
Postoperative nomogram for relapse-free survival in patients with high grade upper tract urothelial carcinoma
.
J Urol
.
2017
;
197
(
3 Pt 1
):
580
9
.
2.
National Cancer Institute
.
SEER cancer stat facts: bladder cancer
.
3.
European Society for Medical Oncology
.
Bladder cancer treatment recommendations
;
2020
.
4.
Grivas
P
,
Agarwal
N
,
Pal
S
,
Kalebasty
AR
,
Sridhar
SS
,
Smith
J
, et al
.
Avelumab first-line maintenance in locally advanced or metastatic urothelial carcinoma: applying clinical trial findings to clinical practice
.
Cancer Treat Rev
.
2021
;
97
:
102187
.
5.
Balar
AV
,
Galsky
MD
,
Ronsenberg
JE
,
Powles
T
,
Petrylak
DP
,
Bellmunt
J
, et al
.
Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial
.
Lancet
.
2017
;
389
(
10064
):
67
76
.
6.
Mori
K
,
Pradere
B
,
Moschini
M
,
Mostafaei
H
,
Laukhtina
E
,
Schuettfort
VM
, et al
.
First-line immune-checkpoint inhibitor combination therapy for chemotherapy-eligible patients with metastatic urothelial carcinoma: a systematic review and meta-analysis
.
Eur J Cancer
.
2021
;
151
:
35
48
.
7.
National Comprehensive Cancer Network
.
NCCN clinical practice guidelines in oncology
.
Bladder Cancer
.
2021
.
8.
Powles
T
,
Park
SH
,
Voog
E
,
Caserta
C
,
Valderrama
BP
,
Gurney
H
, et al
.
Avelumab maintenance therapy for advanced or metastatic urothelial carcinoma
.
N Engl J Med
.
2020
;
383
(
13
):
1218
30
.
9.
Grivas
P
,
Monk
BJ
,
Petrylak
D
,
Reck
M
,
Foley
G
,
Guenther
S
, et al
.
Immune checkpoint inhibitors as switch or continuation maintenance therapy in solid tumors: rationale and current state
.
Target Oncol
.
2019
;
14
(
5
):
505
25
.
10.
Apolo
AB
,
Ellerton
JA
,
Infante
JR
,
Agrawal
M
,
Gordon
MS
,
Aljumaily
R
, et al
.
Avelumab as second-line therapy for metastatic, platinum-treated urothelial carcinoma in the phase Ib JAVELIN solid tumor study: 2-year updated efficacy and safety analysis
.
J Immunother Cancer
.
2020
;
8
(
2
):
e001246
.
11.
Powles
T
,
Huddart
RA
,
Elliott
T
,
Sarker
SJ
,
Ackerman
C
,
Jones
R
, et al
.
Phase III, double-blind, randomized trial that compared maintenance lapatinib versus placebo after first-line chemotherapy in patients with human epidermal growth factor receptor 1/2-positive metastatic bladder cancer
.
J Clin Oncol
.
2017
;
35
(
1
):
48
55
.
12.
Grivas
PD
,
Daignault
S
,
Tagawa
ST
,
Nanus
DM
,
Stadler
WM
,
Dreicer
R
, et al
.
Double-blind, randomized, phase 2 trial of maintenance sunitinib versus placebo after response to chemotherapy in patients with advanced urothelial carcinoma
.
Cancer
.
2014
;
120
(
5
):
692
701
.
13.
Sugiyama
Y
,
Naiki
T
,
Tasaki
Y
,
Mimura
Y
,
Etani
T
,
Noda
Y
, et al
.
GNRI sustainability during one cycle of first-line chemotherapy as a prognostic indicator in patients with metastatic urothelial carcinoma
.
Oncology
.
2023
;
101
(
4
):
224
33
.
14.
Bakaloudi
DR
,
Talukder
R
,
Lin
GI
,
Makrakis
D
,
Diamantopoulos
LN
,
Tripathi
N
, et al
.
Response and outcomes of maintenance avelumab after platinum-based chemotherapy (PBC) in patients with advanced urothelial carcinoma (aUC): “real world” experience
.
Clin Genitourin Cancer
.
2023
;
21
(
5
):
584
93
.
15.
Bellmunt
J
,
Chang
J
,
Pavilack-Kirker
M
,
Cappelleri
JC
,
Costa
N
,
Esterberg
E
, et al
.
Evaluating real-world characteristics of patients with advanced urothelial carcinoma eligible for avelumab maintenance therapy: a multicountry retrospective medical chart review
.
Clin Genitourin Cancer
.
2023
;
21
(
4
):
459
66
.
16.
Miyake
M
,
Shimizu
T
,
Oda
Y
,
Tachibana
A
,
Ohmori
C
,
Itami
Y
, et al
.
Switch-maintenance avelumab immunotherapy following first-line chemotherapy for patients with advanced, unresectable or metastatic urothelial carcinoma: the first Japanese real-world evidence from a multicenter study
.
Jpn J Clin Oncol
.
2023
;
53
(
3
):
253
62
.
17.
Grivas
P
,
Grande
E
,
Davis
ID
,
Moon
HH
,
Grimm
MO
,
Gupta
S
, et al
.
Avelumab first-line maintenance treatment for advanced urothelial carcinoma: review of evidence to guide clinical practice
.
ESMO Open
.
2023
;
8
(
6
):
102050
.
18.
Nagai
T
,
Naiki
T
,
Sugiyama
Y
,
Etani
T
,
Aoki
M
,
Gonda
M
, et al
.
A narrative review of peripheral blood parameters for urothelial carcinoma treated with systemic antitumor drugs
.
Transl Androl Urol
.
2023
;
12
(
5
):
790
801
.
19.
Etani
T
,
Naiki
T
,
Sugiyama
Y
,
Nagai
T
,
Iida
K
,
Noda
Y
, et al
.
Low geriatric nutritional risk index as a poor prognostic marker for second-line pembrolizumab treatment in patients with metastatic urothelial carcinoma: a retrospective multicenter analysis
.
Oncology
.
2020
;
98
(
12
):
876
83
.
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