16 / 27
Eckstein, M et al. Eur J Cancer 2019
approved PD-L1 assays in
urothelial carcinoma
4. Discussion
In UC, most clinical trials observed higher ORR in
patients with high PD-L1 expression but diverging re-
interchangeable performance (pooled PPA 89.4%;
Table
1
). Interestingly, the performance was even better for
algorithms with high cut-off values such as the TC/IC
25% algorithm (PPA: 87.8% and durvalumab;
[6]
) and
Table 3
Kappa values of the two trained observers.
Assay
TC/IC
!
25%
[6]
IC
!
5%
[7]
CPS
!
10
[4]
TC
!
5%
[24]
Ventana SP263
0.90 [0.84
e
0.96]
0.76 [0.67
e
0.85]
0.87 [0.81
e
0.94]
0.84 [0.77
e
0.91]
Ventana SP142
0.85 [0.72
e
0.96]
0.76 [0.64
e
0.87]
0.86 [0.78
e
0.95]
0.83 [0.73
e
0.92]
Dako 22c3
0.88 [0.81
e
0.94]
0.73 [0.63
e
0.84]
0.85 [0.79
e
0.92]
0.83 [0.76
e
0.91]
Dako 28
e
8
0.89 [0.83
e
0.95]
0.75 [0.65
e
0.84]
0.84 [0.77
e
0.91]
0.81 [0.74
e
0.89]
TC, tumour cells; IC, immune cells; CPS, combined positive score.
95% confidence intervals are depicted in dashes.
M. Eckstein et al. / European Journal of Cancer 106 (2019) 234
e
243
241