Table 4.
Univariate analysis of clinical factors associated with the 1-year PFS rate among patients with SCCHN.
| Variable | PFS Rate (1 Year) | (95% CI) | p | ||
|---|---|---|---|---|---|
| Age (years) | 0.406 | ||||
| 75 or higher (n = 11) | 39.8% | (11.0–68.0) | |||
| <75 (n = 67) | 27.1% | (15.9–39.4) | |||
| Sex | 0.618 | ||||
| Male (n = 65) | 29.5% | (17.0–43.2) | |||
| Female (n = 13) | 23.1% | (5.6–47.5) | |||
| Smoking statuse | 0.574 | ||||
| Smoker (n = 49) | 33.1% | (19.2–47.7) | |||
| Never-smoker (n = 29) | 25.5% | (11.1–42.6) | |||
| ECOG PS | 0.257 | ||||
| 0 or 1 (n = 71) | 31.4% | (19.8–43.8) | |||
| 2 or 3 or 4 (n = 7) | Not reached | ||||
| PD-L1 expression | 0.82 | ||||
| <1% (n = 5) | 26.7% | (1.0–68.6) | |||
| ≥1% (n = 16) | 24.6% | (4.6–52.8) | |||
| Radiotherapy to the primary tumor | < 0.001 * | ||||
| Radiotherapy (+) (n = 37) | 46.3% | (28.5–62.4) | |||
| Radiotherapy (−) (n = 41) | 9.2% | (1.0–28.9) | |||
| Site of recurrernt or metastatic tumors | |||||
| Local primary site | 0.654 | ||||
| Yes (n = 33) | 27.1% | (10.9–46.4) | |||
| No (n = 45) | 30.2% | (17.1–44.5) | |||
| Lymph nodes | 0.262 | ||||
| Yes (n = 44) | 25.5% | (12.8–40.3) | |||
| No (n = 34) | 33.2% | (15.9–51.6) | |||
| Lung | 0.061 | ||||
| Yes (n = 27) | 19.3% | (6.7–36.6) | |||
| No (n = 51) | 33.6% | (18.9–48.9) | |||
| Treatment of recurrent or metastatic tumors prior to nivolumab therapy | |||||
| Chemotherapy | 0.899 | ||||
| Yes (n = 55) | 32.0% | (19.7–44.9) | |||
| No (n = 23) | 14.8% | (1.3–43.4) | |||
| Platinum-containing chemotherapy | 0.598 | ||||
| Yes (n = 48) | 30.0% | (17.2–44.0) | |||
| No (n = 30) | 25.8% | (8.9–46.9) | |||
| Chemotherapy plus cetuximab | 0.071 | ||||
| Yes (n = 27) | 23.3% | (9.1–41.2) | |||
| No (n = 51) | 32.6% | (18.8–47.1) | |||
| Surgery | 0.419 | ||||
| Yes (n = 22) | 24.5% | (8.7–44.6) | |||
| No (n = 56) | 30.4% | (17.1–44.8) | |||
| Radiotherapy | 0.154 | ||||
| Yes (n = 22) | 25.5% | (9.3–45.4) | |||
| No (n = 56) | 30.3% | (17.2–44.3) | |||
| Platinum-refractory carcinoma a | 0.006 * | ||||
| Platinum-refractory (n = 44) | 18.4% | (7.6–32.0) | |||
| Not platinum-refractory (n = 34) | 43.6% | (24.6–61.1) | |||
| Occurrence of TRAEs | 0.002 * | ||||
| TRAEs (+) (n = 22) | 53.9% | (29.5–73.1) | |||
| TRAEs (−) (n = 56) | 19.0% | (8.8–32.3) | |||
a A carcinoma that progressed within six months after the last platinum-containing regimen or a residual carcinoma after the last platinum-containing regimen. CI, confidence interval; ECOG, Eastern cooperative oncology group; PFS, progression-free survival rate; SCCHN, squamous cell carcinoma of the head and neck; TRAEs, treatment-related adverse events. * Statistically significant.