Table 2. Patient characteristics.
| ITT population | 18 | (100.0%) |
| Sex | ||
| Male | 11 | (61%) |
| Female | 7 | (39%) |
| Median age (years) | 54.2 (Range 38.9–72.0) | |
| LDH | ||
| ⩽UNL | 5 | (28%) |
| >UNL | 13 | (72%) |
| Performance status (ECOG) | ||
| 0 | 6 | (33%) |
| 1 | 9 | (50%) |
| 2 | 3 | (17%) |
| Metastatic sitesa | ||
| Skin/lymph nodes | 18 | (100%) |
| Lung | 11 | (61%) |
| Liver | 5 | (28%) |
| Other visceral | 6 | (33%) |
| Bone | 1 | (6%) |
| M category (AJCC) | ||
| M1a | 1 | (6%) |
| M1b | 1 | (6%) |
| M1c | 16 | (88%) |
| Pretreatment (in stage IV)a | ||
| Chemotherapy | 18 | (100%) |
| Immunotherapy | 11 | (61%) |
| 1 therapy regimen | 8 | (44%) |
| 2 therapy regimens | 8 | (44%) |
| ⩾3 therapy regimens | 2 | (12%) |
| PP populationb | 16 | |
a
Multiple entries possible.
b
Reasons for exclusion from evaluation see study flow (Figure 1). ITT, intention to treat; LDH, lactate dehydrogenase; UNL, upper normal limit; ECOG, Eastern Cooperative Oncology Group; AJCC, American Joint Committee on Cancer; PP, per protocol.