Table 3.
Safety profiles and treatment discontinuations
| AE | Total (211) |
Child-Pugh grade A (166) |
Child-Pugh grade B (45) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LEN + DEB-TACE (142) |
LEN (69) |
LEN + DEB-TACE (115) |
LEN (51) |
LEN + DEB-TACE (27) |
LEN (18) |
|||||||
| any grade | grade ≥3 | any grade | grade ≥3 | any grade | grade ≥3 | any grade | grade ≥3 | any grade | grade ≥3 | any grade | grade ≥3 | |
| Hypertension, n (%) | 48 (33.8) | 12 (8.5) | 21 (30.4) | 7 (10.1) | 35 (30.4) | 9 (7.83) | 15 (29.4) | 5 (9.8) | 13 (48.1) | 3 (11.1) | 6 (33.3) | 2 (11.1) |
| Proteinuria, n (%) | 44 (30.9) | 15 (10.6) | 16 (23.2) | 6 (8.6) | 33 (28.7) | 11 (9.6) | 13 (25.5) | 5 (9.80) | 11 (40.7) | 4 (14.8) | 3 (16.7) | 1 (5.60) |
| Hand-foot syndrome, n (%) | 12 (8.40) | 0 | 6 (8.70) | 1 (1.4) | 10 (8.7) | 0 | 4 (7.8) | 1 (1.90) | 2 (7.4) | 0 | 2 (11.1) | 0 |
| Diarrhea, n (%) | 52 (36.6) | 12 (8.4) | 21 (30.4) | 8 (11.6) | 41 (35.7) | 10 (8.7) | 15 (29.4) | 6 (11.7) | 11 (40.7) | 2 (7.40) | 6 (33.3) | 2 (11.1) |
| Anorexia, n (%) | 68 (47.8) | 12 (8.5) | 31 (44.9) | 5 (7.2) | 54 (47.0) | 8 (7.0) | 21 (41.2) | 2 (3.90) | 14 (51.9) | 4 (14.8) | 10 (55.6) | 3 (16.7) |
| Nausea, n (%) | 54 (38.0) | 10 (7.0) | 28 (40.7) | 9 (13.4) | 42 (36.5) | 7 (6.1) | 23 (45.1) | 6 (11.7) | 12 (44.4) | 3 (11.1) | 5 (27.8) | 3 (16.7) |
| Fatigue, n (%) | 57 (40.1) | 1 (0.70) | 32 (46.4) | 2 (2.90) | 38 (33.0) | 0 | 23 (45.1) | 0 | 19 (70) | 1 (3.70) | 9 (50) | 2 (11.1) |
| AST elevation, n (%) | 78 (54.9) | 8 (5.60) | 17 (24.6) | 1 (1.4) | 66 (57.4) | 2 (1.7) | 14 (27.5) | 0 | 12 (44.4) | 6 (22.2) | 3 (16.7) | 1 (5.60) |
| ALT elevation, n (%) | 48 (33.8) | 3 (2.10) | 13 (18.8) | 2 (2.90) | 32 (27.8) | 2 (1.7) | 10 (19.6) | 0 | 16 (59.3) | 1 (3.70) | 3 (16.7) | 1 (5.60) |
| Bilirubin elevation, n (%) | 27 (19.0) | 3 (2.10) | 10 (14.5) | 1 (1.4) | 20 (17.4) | 2 (1.7) | 7 (13.7) | 0 | 7 (25.9) | 1 (3.70) | 3 (16.7) | 1 (5.60) |
| Thrombocytopenia, n (%) | 33 (23.2) | 12 (8.5) | 8 (11.6) | 2 (2.9) | 28 (24.3) | 9 (7.80) | 6 (11.8) | 2 (3.90) | 5 (18.5) | 3 (11.1) | 1 (5.60) | 0 |
| Hepatic encephalopathy, n (%) | 2 (1.40) | 1 (0.7) | 1 (1.40) | 1 (1.40) | 1 (0.90) | 0 | 0 | 0 | 1 (3.70) | 1 (3.70) | 1 (5.60) | 1 (5.60) |
| Interruption and/or dose reduction, n (%) | 35 (24.6) | 16 (23.1) | 27 (23.4) | 10 (19.6) | 8 (29.6) | 6 (33.3) | ||||||
AST, aspartate aminotransferase; ALT, alanine aminotransferase; DEB-TACE, drug-eluting bead transarterial chemoembolization; LEN, lenvatinib.