Table 3.
Treatment-related adverse events reported in at least 2 patients.
| Event | PS 2-4 (n = 20) | PS 0/1 (n = 43) | Any Grade | Grade ≥3 | ||
|---|---|---|---|---|---|---|
| Any Grade | Grade ≥ 3 | Any Grade | Grade ≥ 3 | p | p | |
| Any event | 15 (75) | 6 (30) | 27 (63) | 6 (14) | NS | NS |
| Pneumonitis | 7 (35) | 5 (25) | 4 (9) | 1 (2) | 0.028 | 0.010 |
| Fever | 7 (35) | 0 | 1 (2) | 0 | 0.001 | NS |
| AST/ALT elevation | 4 (20) | 2 (10) | 4 (9) | 0 | NS | 0.097 |
| Diarrhea | 2 (10) | 0 | 2 (5) | 0 | NS | NS |
| Anorexia | 2 (10) | 0 | 1 (2) | 0 | NS | NS |
| Mucositis oral | 1 (5) | 0 | 4 (9) | 1 (2) | NS | NS |
| Creatinine increased | 1 (5) | 1 (5) | 2 (5) | 0 | NS | NS |
| Rash | 0 | 0 | 8 (19) | 1 (2) | 0.047 | NS |
| Fatigue | 0 | 0 | 6 (14) | 0 | NS | NS |
| Pruritus | 0 | 0 | 6 (14) | 0 | NS | NS |
| Rash acneiform | 0 | 0 | 3 (7) | 0 | NS | NS |
| Lung infection | 0 | 0 | 2 (5) | 1 (2) | NS | NS |
| Hot flashes | 0 | 0 | 2 (5) | 0 | NS | NS |
| Peripheral motor neuropathy | 0 | 0 | 2 (5) | 0 | NS | NS |
| ALP elevation | 0 | 0 | 2 (5) | 0 | NS | NS |
Abbreviations: PS: performance status; NS: not significant; AST: aspartate aminotransferase; ALT: alanine aminotransferase; ALP: alkaline phosphatase.