Table 2.
Treatment Related Toxicities
| Toxicity, no. of pts (%) | Arm A (n=28) | Arm B (n=27) | All (n=55) |
|---|---|---|---|
| Any grade 3+ toxicity | 5 (18) | 6 (22) | 11 (20) |
| Any grade 4/5 toxicity | 1 (4) | 0 | 1 (2) |
| Rash, maximum grade | |||
| Any grade | 19 (68) | 19 (70) | 38 (69) |
| Grade 1 | 12 (43) | 10 (37) | 22 (40) |
| Grade 2 | 7 (25) | 5 (19) | 12 (22) |
| Grade 3 | 0 | 4 (15) | 4 (7) |
| Dermatologic, other than rash* | |||
| Any, grade 1–3 | 7 (25) | 9 (33) | 16 (29) |
| Diarrhea | |||
| Any grade | 9 (32) | 7 (26) | 16 (29) |
| Grade 1 | 7 (25) | 7 (26) | 14 (25) |
| Grade 2 | 2 (7) | 0 | 2 (4) |
| Grade 3+ | 0 | 0 | 0 |
| Other gastrointestinal | |||
| Anorexia, grade 1–2 | 5 (18) | 9 (33) | 14 (25) |
| Anorexia, grade 3 | 2 (7) | 1 (4) | 3 (5) |
| AST elevation | 4 (14) | 0 | 4 (7) |
| Dehydration, grade 1–2 | 0 | 1 (4) | 1 (2) |
| Dehydration, grade 3 | 1 (4) | 1 (4) | 2 (4) |
| Hyperbilirubinemia | 0 | 1 (4) | 1 (2) |
| Nausea, grade 1–3** | 2 (7) | 6 (22) | 8 (15) |
| Xerostomia | 0 | 2 (7) | 2 (4) |
| Other | |||
| Pneumonitis, grade 3 | 1 (4) | 0 | 1 (2) |
*
erythema, hyperpigmentation, pruritus, xerodermia.
**
only one grade three nausea was recorded