TABLE 1.
Baseline Characteristics
| Parameter | Patients (n = 33) |
|---|---|
| Age (y) | Median, 64.5; range, 49–80 |
| Sex (n) | |
| Male | 26, 79% |
| ECOG PS (n) | |
| 0 | 10, 30% |
| 1 | 23, 70% |
| Smoking (n) | |
| Current | 4, 12% |
| Never or former | 29, 88% |
| Alcohol (n) | |
| Current | 24, 73% |
| Never or former | 9, 27% |
| Primary tumor location (n) | |
| Hypopharynx | 4, 13% |
| Larynx | 7, 22% |
| Oral cavity | 10, 30% |
| Oropharynx | 8, 24% |
| Unknown | 3, 10% |
| Disease extent at baseline (n) | |
| Loco/regional recurrence | 12, 36% |
| Metastatic disease | 21, 64% |
| Location metastases | |
| Lung | 28, 45% |
| Lymph node | 24, 39% |
| Bone | 5, 8% |
| Other (liver, adrenal gland, muscle) | 4, 8% |
| Prior treatments with curative intent* (n) | |
| Surgery alone | 3, 9% |
| Surgery with adjuvant radiation | 8, 24% |
| Surgery with adjuvant chemoradiation | 9, 27% |
| Radiation alone | 5, 15% |
| Chemoradiation | 8, 24% |
| Time from last platinum therapy (n) | |
| ≤6 mo | 1, 6% |
| >6 mo | 16, 94% |
| Histologic/cytologic biopsy† | |
| Archival | 17, 52% |
| Fresh | 16, 48% |
| PD-L1 status‡ (n) | |
| PD-L1 CPS < 1 | 13, 40% |
| PD-L1 CPS 1–20 | 8, 24% |
| PD-L1 CPS ≥ 20 | 6, 18% |
| No assessment possible | 6, 18% |
*
Chemotherapy regimen included monotherapy cisplatin or carboplatin, or combination regimens, for example, docetaxel, cisplatin and 5-fluorouracil or carboplatin and 5-fluorouracil.
†A fresh biopsy was defined as histologic or cytologic tumor biopsy performed at study enrollment up to < 1 mo before study enrollment.
‡PD-L1 assessment was performed on biopsy tissue from R/M disease. PD-L1 staining was performed using VENTANA SP263.
ECOG PS = Eastern Cooperative Oncology Group performance status.
Data are median and range, or n and %.