Table 2.
Adverse events of neoadjuvant therapy with talimogene laherparepvec according to the Common Terminology Criteria of Adverse Events (v.5.0)
| AE term | Total (n; %) | T-VEC-related (n; %) | ||||||
|---|---|---|---|---|---|---|---|---|
| Any grade | Grade 1 | Grade 2 | Grade 3–4 | Any grade | Grade 1 | Grade 2 | Grade 3–4 | |
| Any AE | 41 (100) | 27 (65.9) | 14 (34.1) | 0 (0) | 21 (51.2) | 12 (29.3) | 9 (21.9) | 0 (0) |
| Injection site reaction | 11 (26.8) | 5 (12.2) | 6 (14.6) | - | 11 (26.8) | 5 (12.2) | 6 (14.6) | - |
| Headache | 4 (9.8) | 3 (7.3) | 1 (2.4) | - | 4 (9.8) | 3 (7.3) | 1 (2.4) | - |
| Chills | 2 (4.8) | 2 (4.8) | - | - | 4 (9.8) | 3 (7.3) | 1 (2.4) | - |
| Pyrexia | 2 (4.8) | 1 (2.4) | 1(2.4) | - | 4 (9.8) | 3 (7.3) | 1 (2.4) | - |
| Diarrhea | 1 (2.4) | - | 1 (2.4) | - | 1 (2.4) | - | 1 (2.4) | - |
| Nausea | 1 (2.4) | 1 (2.4) | - | - | 1 (2.4) | 1 (2.4) | - | - |
| Post-surgical wound infection | 1 (2.4) | 1 (2.4) | - | - | - | - | - | - |
| Post-surgical hematoma | 1 (2.4) | 1 (2.4) | - | - | - | - | - | - |
| Post-surgical pain | 1 (2.4) | 1 (2.4) | - | - | - | - | - | - |
| Skin erosion | 1 (2.4) | 1 (2.4) | - | - | - | - | - | - |
| Herpes zoster | 1 (2.4) | - | 1 (2.4) | - | - | - | - | - |
| BCC | 2 (4.8) | - | 2 (4.8) | - | - | - | - | - |
| Hypokalemia | 1 (2.4) | 1 (2.4) | - | - | - | - | - | - |
| Alopecia | 1 (2.4) | 1 (2.4) | - | - | - | - | - | - |
| Bowens disease | 1 (2.4) | 1 (2.4) | - | - | - | - | - | - |
| Seborrheic dermatitis | 1 (2.4) | 1 (2.4) | - | - | - | - | - | - |
| Lipase increased | 1 (2.4) | - | 1 (2.4) | - | - | - | - | - |
| Hyponatremia | 1 (2.4) | 1 (2.4) | - | - | - | - | - | - |
| Pruritus | 2 (4.8) | 2 (4.8) | - | - | - | - | - | - |
| Respiratory tract infection | 1 (2.4) | 1 (2.4) | - | - | - | - | - | - |
| Gastrointestinal infection | 1 (2.4) | - | 1 (2.4) | - | - | - | - | - |
| Musculoskeletal pain | 1 (2.4) | 1 (2.4) | - | - | - | - | - | - |
| Constipation | 1 (2.4) | 1 (2.4) | - | - | - | - | - | - |
| Sciatica | 1 (2.4) | 1 (2.4) | - | - | - | - | - | - |
Safety was assessed in all patients, who received at least one dose of neoadjuvant T-VEC treatment. Fourteen patients (83.3%) developed AEs. T-VEC-related AEs were only mild, grade 1 and 2. No SAEs occurred. No previously unreported T-VEC-related AEs were detected.