Table 1.
Patient demographics, histological subtypes, and percentage necrosis in different phases of the trial
| Covariate | Level | Phase | Total N=30 | |
| I N=6 | II N=24 | |||
| Sex | F | 1 (16.7) | 8 (33.3) | 9 (30.0) |
| M | 5 (83.3) | 16 (66.7) | 21 (70.0) | |
| Age (median) | 60 (36–79) | 66 (28–80) | 65 (28–80) | |
| Pathology | Dedifferentiated liposarcoma | 0 (0) | 2 (8.3) | 2 (6.7) |
| Epithelioid sarcoma | 0 (0) | 1 (4.2) | 1 (3.3) | |
| Myxofibrosarcoma | 1 (16.7) | 1 (4.2) | 2 (6.7) | |
| Myxoid liposarcoma | 0 (0) | 5 (20.8) | 5 (16.7) | |
| Pleomorphic liposarcoma | 0 (0) | 1 (4.2) | 1 (3.3) | |
| Spindle cell rhabdomyosarcoma | 1 (16.7) | 0 (0) | 1 (3.3) | |
| Synovial sarcoma | 0 (0) | 2 (8.3) | 2 (6.7) | |
| Undifferentiated pleomorphic sarcoma | 4 (66.7) | 9 (37.5) | 13 (43.3) | |
| Undifferentiated sarcoma with myxoid stroma | 0 (0) | 1 (4.2) | 1 (3.3) | |
| Undifferentiated spindle cell sarcoma | 0 (0) | 2 (8.3) | 2 (6.7) | |
| Grade* | 1 | 0 (0) | 5 (20.8) | 5 (16.7) |
| 2 | 4 (66.7) | 10 (41.7) | 14 (46.7) | |
| 3 | 2 (33.3) | 9 (37.5) | 11 (36.7) | |
| HSV serology—pretreatment | Negative | 1 (16) | 8 (33) | 9 (30) |
| Positive | 5 (83) | 16(66) | 21(70) | |
| Overall best response | PR | 0 (0) | 1 (4.2) | 1 (3.3) |
| SD | 4 (66.7) | 16 (66.7) | 20 (66.7) | |
| PD | 2 (33.3) | 7 (29.2) | 9 (30.0) | |
| ≥95% necrosis | No | 4 (66.7) | 18 (78.3) | 22 (75.9) |
| Yes | 2 (33.3) | 5 (21.7) | 7 (24.1) | |
| Progression | No | 4 (66.7) | 13 (54.2) | 17 (56.7) |
| Yes | 2 (33.3) | 11 (50.0) | 13 (43.3) | |
| Deceased | No | 4 (66.7) | 14 (58.3) | 18 (60.0) |
| Yes | 2 (33.3) | 10 (41.7) | 12 (40.0) | |
| # TVEC injections† (median) | 11 (9–11) | 10 (5–11) | 10 (5–11) | |
| Necrosis (median)† | 75% (11%–99%) | 78% (8%–100%) | 78% (8%–100%) | |
| Median follow-up (months)† | 48.9 (2.9–57.7) | 22.2 (1.5–50.7) | 23.7 (1.5–57.7) | |
*Grading of sarcomas according to the French Federation of Cancer Centers Sarcoma Group.
†Numbers within parentheses indicate the range.
HSV, herpes simplex virus; PD, progressive disease; PR, partial response; SD, stable disease; TVEC, talimogene laherparepvec.