Table 3.
Treatment related adverse event and Child-Pugh score progression of SBRT-IO vs. matched TACE.
| SBRT-IO (N = 16) | Matched TACE (N = 48) | P-value | |||
|---|---|---|---|---|---|
| Any Grade | Grades 3–4 | Any Grade | Grades 3–4 | ||
| Number (%) | Number (%) | ||||
| Treatment-related AEs | 3 (18.8%) | 29 (60.4%) | 0.004 | ||
| AEs lead to discontinuation | 2 (12.5%) | 1 (6.3%) | 12 (25%) | 5 (10.4%) | 0.295 |
| Treatment-related death | 0 (0%) | 0 (0%) | 2 (4.2%) | 1 (2.1%) | 0.407 |
| Hemoglobin | 8 (50%) | 0 (0%) | 38 (79.2%) | 4 (8.3%) | 0.06 |
| Leukocytes | 2 (12.5%) | 0 (0%) | 24 (50%) | 0 (0%) | 0.025 |
| Platelet | 12 (75%) | 1 (6.3%) | 26 (54.2%) | 6 (12.5%) | 0.251 |
| Bilirubin | 5 (31.3%) | 1 (6.3%) | 20 (41.7%) | 5 (10.4%) | 0.617 |
| AST/ALT | 15 (93.7%) | 0 (0%) | 43 (89.6%) | 25 (52.1%) | <0.001 |
| Nausea and vomiting | 4 (25%) | 0 (0%) | 13 (27.1%) | 0 (0%) | 0.456 |
| Diarrhea | 3 (18.8%) | 0 (0%) | 1 (2%) | 0 (%) | 0.002 |
| Appetite lost | 1 (6.3%) | 0 (0%) | 9 (18.9%) | 0 (0%) | 0.477 |
| Fatigue | 10 (62.5%) | 0 (0%) | 9 (18.7%) | 2 (4.2%) | 0.003 |
| Fever | 3 (18.8%) | 0 (0%) | 23 (47.9%) | 0 (0%) | 0.04 |
| Weight loss | 1 (6.3%) | 0 (0%) | 8 (16.7%) | 0 (0%) | 0.562 |
| Pain | 3 (18.8%) | 0 (0%) | 24 (50%) | 0 (0%) | 0.028 |
| Rash | 5 (31.3%) | 0 (0%) | 4 (8.3%) | 0 (0%) | 0.002 |
| Pruritus | 2 (12.5%) | 1 (6.3%) | 4 (8.3%) | 0 (0%) | 0.213 |
| Adrenal insufficiency | 1 (6.3%) | 0 (0%) | 1 (2.1%) | 0 (0%) | 0.407 |
| Progression of CP score ≥2 | |||||
| 3 months | 1/15 (6.7%) | 9/43 (20.9%) | 0.008 | ||
| 6 months | 1/15 (6.7%) | 3/25 (12.0%) | 0.021 | ||
| 12 months | 0/8 (0%) | 3/14 (21.4%) | <0.001 | ||
TACE, transarterial chemoembolization; SBRT-IO, combined stereotactic body radiotherapy and immunotherapy; AEs, adverse events; AST, Aspartate transaminase; ALT, Alanine transaminase; CP, Child–Pugh.
The incidence of only toxicities ≥5% is shown.