416 476
Table 2 – Efficacy of immune checkpoint inhibitors in randomized clinical trials in urological cancer
Treatment
Patients
(
n
)
Median
follow-up (mo)
(CI)
Median
OS (mo)
(CI)
Median
PFS (mo)
(CI)
ORR
(CI)
CR
PR
SD PD NE Median duration
of response (mo)
(CI)
Other
Urothelial cell cancer
Bellmunt et al (2017)
[23]
Pembrolizumab 200 mg
270 14.1
(9.9–22.1)
a10.3
(8.0–11.8)
b2.1
(2.0–2.2)
b21.1%
(16.4–26.5)
b19
(7%)
38
(14.1%)
47
(17.4%)
131
(48.5%)
35
(13.0%)
NR
(1.6+ to 15.6+)
aChemotherapy
272 14.1
(9.9–22.1)
a7.4
(6.1–8.3)
b3.3
(2.3–3.5)
b11.4%
(7.9–15.8)
b9
(3.3%)
22
(8.1%)
91
(33.5%)
90
(33.1%)
60
(22.1%)
4.3
(1.4+ to 15.4+)
aRenal cell cancer
Motzer et al (2015)
[26]
Nivolumab 3 mg/kg
410 NA
25.0
(21.8–NR)
b4.6
(3.7–5.4)
b25%
4
(1%)
99
(24%)
141
(34%)
143
(35%)
23
(6%)
12.0
(0–27.6)
aEverolimus 10 mg
411 NA
19.6
(17.6–23.1)
b4.4
(3.7–5.5)
b5%
2
(1%)
20 (5%) 227
(55%)
114
(28%)
48
(12%)
12.0
(0–22.2)
aMotzer et al (2015)
[25]
Nivolumab 0.3 mg/kg
60 NA
18.2
(16.2–24.0)
c2.7
(1.9–3.0)
c20%
(13.4–28.2)
c1
(2%)
11
(18%)
22
(37%)
24
(40%)
2
(3%)
NR
(NR–NR)
cNivolumab 2 mg/kg
54 NA
25.5
(19.8–28.8)
c4.0
(2.8–4.2)
c22%
(15.0–31.1)
c1
(2%)
11
(20%)
23
(43%)
18
(33%)
1
(2%)
NR
(4.2–NR)
cNivolumab 10 mg/kg
54 NA
24.7
(15.3–26.0)
c4.2
(2.8–5.5)
c20%
(13.4–29.1)
c0
(0%)
11
(20%)
24
(44%)
17
(32%)
2
(4%)
22.3
(4.8–NR)
cChoueiri et al (2016)
[24]
All patients
91 NA
NA
NA
15%
(8.7–24.5)
b2
(2%)
12
(13%)
42
(46%)
27
(30%)
8
(9%)
NA
Previously treated group Nivolumab 0.3 mg/kg
22 NA
16.4
(10.1–NR)
bNA
9%
(1.1–29.2)
b0
(0%)
2
(9%)
8
(36%)
9
(41%)
3
(14%)
NA
Nivolumab 2 mg/kg
22 NA
NR
NA
18%
(5.2–40.3)
b0
(0%)
4
(18%)
10
(46%)
5
(23%)
3
(14%)
NA
Nivolumab 10 mg/kg
23 NA
25.2
(12.0–NR)
bNA
22%
(7.5–43.7)
b0
(0%)
5
(22%)
11 (48%) 6
(26%)
1
(4%)
NA
Treatment-naive group
Nivolumab 10 mg/kg
24 NA
NR
NA
13%
(2.7–32.4)
b2
(8%)
1
(4%)
13
(54%)
7
(29%)
1
(4%)
NA
PSARR (CI)
bProstate cancer
Beer et al (2017)
[27]
Ipilimumab
400
24–48
28.7
(24.5–32.5)
b5.6
(5.3–6.3)
bNA NA NA NA NA NA NA 23%
(19–27)
bPlacebo
202
24–48
29.7
(26.1–34.2)
b3.8
(2.8–4.1)
bNA NA NA NA NA NA NA 8%
(5–13)
bKwon et al (2014)
[28]
Radiotherapy with ipilimumab
399
9.9
(4.3–16.7)
d11.2
(9.5–12.7)
b4.0
(3.6–4.3)
bNA NA NA NA NA NA NA 13.1%
(9.5–17.5)
bRadiotherapy with placebo
400
9.3
(5.4–14.6)
d10.0
(8.3–11.0)
b3.1
(2.9–3.4)
bNA NA NA NA NA NA NA 5.2%
(3.0–8.4)
bCI = confidence interval; OS = overall survival; PFS = progression-free survival; ORR = objective response rate; CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease; NE = not
evaluable; PSARR = prostate-specific antigen response rate; NA = not available; NR = not reached.
a
Range.
b
CI 95%.
c
CI 80%.
d
Interquartile range.
E U R O P E A N U R O L O G Y 7 2 ( 2 0 1 7 ) 4 1 1 – 4 2 3
416