Table 1.
Patient demographics and baseline disease characteristics.
| 2 mg per injection | 8 mg one injection | Total | ||
|---|---|---|---|---|
| Patients' characteristics - n (%) unless noted | (N = 28) | (N = 23) | (N = 51) | |
| Age – Median (range) | 63 (38–93) | 65 (43–91) | 64.5 (38–93) | |
| Sex | Male | (67.9) | (91.3) | (78.4) |
| Female | (32.1) | (8.7) | (21.6) | |
| ECOG PS | 0 | (17.9) | (26.1) | (21.5) |
| 1 | (82.1) | (73.9) | (78.5) | |
| Primary tumor location | Hypopharyngeal | 2 (7.1) | — | 2 (3.9) |
| Nasopharyngeal | — | 3 (13.0) | 3 (5.9) | |
| Oral | 13 (46.4) | 13 (56.5) | 26 (51.0) | |
| Oropharyngeal | 9 (32.1) | 2 (8.7) | 11 (21.6) | |
| Laryngeal | 3 (10.7) | 4 (17.4) | 7 (13.7) | |
| Unknown | 0 | 1 (4.3) | 1 (2.0) | |
| Staging at enrollment | Local | 2 (7.1) | 2 (8.7) | 4 (7.8) |
| Metastatic | 16 (57.1) | 14 (60.9) | 30 (58.8) | |
| Local + Metastatic | 10 (35.7) | 7 (30.4) | 17 (33.3) | |
| Organ involvement | Liver | 2 (7.1) | 2 (8.7) | 4 (7.8) |
| Lung | 9 (32.1) | 6 (26.1) | 15 (29.4) | |
| Bone | 2 (7.4) | 2 (8.7) | 4 (7.8) | |
| Skin/subcutaneous | 3 (10.7) | 8 (34.8) | 11 (21.6) | |
| Tissue | 16 (57.1) | 11 (47.8) | 27 (52.9) | |
| Lymph nodes | 13 (46.4) | 16 (69.6) | 29 (56.9) | |
| Other organs | ||||
| Prior locoregional therapy | Prior radiotherapy | 21 (75.0) | 20 (87.0) | 41 (80.3) |
| Prior surgery | 24 (85.7) | 22 (95.7) | 46 (90.2) | |
| Prior lines of systemic therapy | 0 | 9 | 3 | 12 |
| 1 | 15 | 11 | 26 | |
| 2 | 3 | 6 | 9 | |
| ≥3 | 1 | 3 | 4 | |
| Number of target lesions | 1 | 11 (39.3) | 6 (26.1) | 17 (33.3) |
| 2 | 10 (35.7) | 5 (21.7) | 15 (29.4) | |
| 3 | 4 (14.3) | 8 (34.8) | 12 (23.5) | |
| 4 | 1 (3.6) | 2 (8.7) | 3 (5.9) | |
| 5 | 2 (7.1) | 2 (8.7) | 4 (7.8) | |
| PD-L1 status | <1 | — | — | — |
| ≥1 to <20 | 16 (59.3) | 19 (82.6) | 35 (70.0) | |
| ≥20 | 11 (40.7) | 4 (17.4) | 15 (30) | |
| HPV status | Negative | 11 (39.3) | 6 (26.1) | 17 (33.3) |
| Positive | 10 (35.7) | 6 (26.1) | 16 (31.4) | |
| Unknown | 7 (25.0) | 11 (47.8) | 18 (35.2) | |