Table 5.
Patients | PFS | OS | ||
---|---|---|---|---|
Median (M) [95%CI] | Log rank p-value | Median (M) [95%CI] | Log rank p-value | |
Age | ||||
<65 | 4.4 [2.6-6.2] | 0.49 | 14.3 [9.4-19.2] | 0.21 |
≧65 | 5.2 [3.3-7.0] | 21.4 [11.8-31.0] | ||
ECOG performance status score | ||||
0, 1 | 5.3 [3.1-7.4] | 0.58 | 18.6 [12.5-24.7] | 0.0198 |
2 | 4.3 [0.0-6.6] | 9.0 [4.9-13.1] | ||
Smoking status | ||||
Current or former | 4.6 [3.3-5.9] | 0.25 | 18.6 [12.3-24.9] | 0.65 |
Never | 6.4 [1.6-11.3] | 14.3 [13.4-15.1] | ||
PD-L1 status (CPS) | ||||
1-19 | 4.4 [1.3-7.5] | 0.94 | 17.1 [NA] | 0.73 |
20- | 5.3 [1.1-9.4] | NA [NA-NA] | ||
unknown | 4.6 [2.0-7.2] | 18.6 [11.8-25.5] | ||
Prior immunotherapy regimens | ||||
Pembrolizumab | 5.2 [3.3-7.0] | 0.79 | 17.1 [NA] | 0.43 |
Nivolumab | 4.6 [2.0-7.2] | 18.6 [11.8-25.5] | ||
Efficacy by ICI | ||||
CR or PR or SD | 6.4 [3.8-9.1] | 0.51 | 18.7 [12.5-25.0] | 0.21 |
PD | 4.4 [3.4-5.4] | 14.3 [8.8-19.7] | ||
Number of previous lines of systemic therapy before ICI for R/M SCCHN | ||||
= 1st line | 5.3 [3.6-6.9] | 0.029 | 18.6 [13.0-24.2] | 0.18 |
2nd line or more | 4.3 [2.9-3.6] | 12.5 [8.4-16.5] | ||
Regimen of PE-based chemo | ||||
PCE | 4.4 [2.8-6.0] | 0.15 | 17.1 [10.5-23.7] | 0.31 |
PTX+Cmab | 5.7 [2.1-9.4] | 18.6 [12.5-24.7] |
ECOG, Eastern Cooperative Oncology Group; CI, confidence interval; CPS, combined positive score; PFS, progression-free survival; ICI, immune check point inhibitor; CR, complete response; PR, partial response; SD, stable disease; PD, progression disease; PTX+Cmab, paclitaxel +cetuximab; PCE, paclitaxel+carboplatin+cetuximab.