Table 3.
Drug-related toxicities.
| T/R | R/T | T | R | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| N | % | N | % | p-Value | N | % | N | % | p-Value | |
| All events G3/G4 N = 582 | 155 | 26.6 | 132 | 22.6 | - | 160 | 27.4 | 135 | 23.1 | - |
|
All pts who experienced
G3/G4 toxicities N = 390 |
89/146 | 60.9 (22.8) | 79/116 | 68.1 (20.2) | 0.24 | 118/325 | 36.3 (30.2) | 104/279 | 37.2 (26.6) | 0.86 |
|
All Haematologic events
G3/G4 N = 289 |
87 | 56.1 (14.9) | 65 | 49.2 (11.1) | 0.28 | 126 | 78.7 (21.6) | 11 | 8.1 (1.8) | <0.00001 |
| All non Haematologic events G3/G4 N=293 | 68 | 43.8 (11.6) | 67 | 50.7 (11.5) | 34 | 21.2 (5.8) | 124 | 91.8 (21.3) | ||
|
Most common Haematologic
toxicities G3/G4 |
||||||||||
| Neutropenia | 68 | 78.2 | 43 | 66.2 | 0.13 | 82 | 65.1 | 3 | 27.3 | 0.02 |
| Leucopenia | 2 | 2.3 | 0 | 0 | 0.5 | 6 | 4.8 | 0 | 0 | 1 |
| Thrombocytopenia | 3 | 3.4 | 5 | 7.7 | 0.28 | 3 | 2.4 | 0 | 0 | 1 |
| Anemia | 14 | 16.1 | 17 | 26.2 | 0.15 | 35 | 27.8 | 8 | 72.7 | 0.0042 |
| Most common non Haematologic toxicities G3/G4 | ||||||||||
| Fatigue | 33 | 48.5 | 19 | 28.4 | 0.02 | 21 | 61.8 | 34 | 27.4 | 0.0004 |
| Hand-foot skin reaction | 5 | 7.4 | 25 | 37.3 | 0.01 | 0 | 0 | 42 | 33.9 | 0.01 |
| Liver dysfunctions | 2 | 2.9 | 2 | 3 | 1 | 2 | 5.9 | 1 | 0.8 | 0.11 |
| Diarrhea | 10 | 14.7 | 2 | 3 | 0.03 | 7 | 20.6 | 13 | 10.5 | 1.14 |
| Skin disorders | 2 | 2.9 | 3 | 4.5 | 1 | 0 | 0 | 11 | 8.9 | 0.12 |
| Others | 16 | 23.5 | 16 | 23.9 | 1 | 4 | 11.8 | 23 | 18.5 | 0.44 |
Abbreviations: T, trifluridine/tipiracil; R, regorafenib.