Table 4.
Induction and maintenance of treatment-related adverse events (AEs).
| 5-FU/LV+anti-EGFR (n = 118) | Anti-EGFR (n = 66) | 5-FU/LV (n = 11) | Non-maintenance (n = 160)a | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Any grade | G3–G4 | Any grade | G3–G4 | Any grade | G3–G4 | Any grade | G3–G4 | ||
| Induction AEs, n (%) | |||||||||
| Non-hematological b | 43 (36.4) | 2 (1.7) | 15 (22.7) | 0 (0.0) | 6 (54.5) | 0 (0.0) | 82 (51.2) | 11 (6.9) | |
| Diarrhea | 44 (37.3) | 2 (1.7) | 20 (30.3) | 2 (3.0) | 4 (36.4) | 1 (9.1) | 88 (55.0) | 8 (5.0) | |
| Peripheral neuropathy c | 60 (50.8) | 7 (5.9) | 16 (24.2) | 2 (3.0) | 7 (63.6) | 0 (0.0) | 59 (36.9) | 6 (3.8) | |
| Hematological d | 43 (36.4) | 2 (1.7) | 15 (22.7) | 0 (0.0) | 6 (54.5) | 0 (0.0) | 82 (51.2) | 11 (6.9) | |
| Neutropenia | 52 (44.1) | 16 (13.6) | 20 (30.3) | 6 (9.1) | 6 (54.5) | 3 (27.3) | 83 (51.9) | 22 (13.8) | |
| Skin rash | 103 (87.3) | 26 (22.0) | 46 (69.7) | 7 (10.6) | 8 (72.7) | 1 (9.1) | 134 (83.8) | 35 (21.9) | |
| Paronychia/nail disorders e | 60 (50.8) | 5 (4.2) | 16 (24.2) | 2 (3.0) | 6 (54.5) | 1 (9.1) | 74 (46.3) | 8 (5.0) | |
| Other anti-EGFR-related f | 21 (17.8) | 2 (1.7) | 10 (15.2) | 2 (3.0) | 1 (9.1) | 0 (0.0) | 41 (25.6) | 6 (3.8) | |
| Maintenance AEs, n (%) | |||||||||
| Non-hematological b | 29 (24.6) | 0 (0.0) | 6 (9.1) | 0 (0.0) | 3 (27.3) | 0 (0.0) | – | ||
| Diarrhea | 20 (16.9) | 2 (1.7) | 9 (13.6) | 0 (0.0) | 1 (9.1) | 1 (9.1) | – | ||
| Hematological d | 27 (22.9) | 2 (1.7) | 5 (7.6) | 0 (0.0) | 3 (27.3) | 0 (0.0) | – | ||
| Neutropenia | 24 (20.3) | 0 (0.0) | 5 (7.6) | 1 (1.5) | 1 (9.1) | 0 (0.0) | – | ||
| Skin rash | 77 (65.3) | 10 (8.5) | 45 (68.2) | 6 (9.1) | 1 (9.1) | 0 (0.0) | – | ||
| Paronychia/nail disorders | 39 (33.1) | 2 (1.7) | 13 (19.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | – | ||
| Other anti-EGFR-related e | 14 (11.9) | 1 (0.8) | 10 (15.2) | 1 (1.5) | 0 (0.0) | 0 (0.0) | – | ||
5-FU/LV, 5-fluorouracil/leucovorin; EGFR, epidermal growth factor receptor; AEs, adverse events.
a
In the non-maintenance cohort, AEs have been collected throughout the entire duration of treatment.
b
Diarrhea and peripheral neuropathy excluded.
c
Among patients treated with oxaliplatin.
d
Neutropenia excluded.
e
Periungueal pyogenic granuloma, fissures, onycholysis, and others.
f
Hypomagnesemia, dry skin, pruritus, conjunctivitis, mucositis, and others.