Table 4.
Cumulative toxicity
| Patients | Cycles | |||||||
|---|---|---|---|---|---|---|---|---|
| Number | 50 | 247 | ||||||
| NCI-CTC Grade | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 |
| Nausea (%) | 23 (46) | 15 (30) | 3 (6) | - | 81 (33) | 23 (9) | 4 (2) | - |
| Vomiting (%) | 10 (20) | 6 (12) | 2 (4) | - | 19 (8) | 9 (4) | 2 (1) | - |
| Diarrhea (%) | 20 (40) | 12(24) | 14 (28) | - | 76 (30) | 28 (11) | 15 (6) | - |
| Hypoalbuminemia (%) | 2 (4) | 1 (2) | - | - | 2 (1) | 1 (0.5) | - | - |
| Constipation (%) | 17 (34) | 1 (2) | - | - | 22 (9) | 1 (0.5) | - | - |
| Stomatitis/mucositis (%) | 16 (32) | 2 (4) | 3 (6) | - | 29 (12) | 3 (1) | 3 (1) | - |
| Erythema (%) | 1 (2) | - | 1 (2) | - | 3 (1) | - | 1 (0.5) | - |
| Asthenia (%) | 13 (26) | 20 (40) | 3 (6) | - | 48 (19) | 38 (15) | 3 (1) | - |
| Neurotoxicity (%) | 36(72) | 5 (10) | - | - | 126(51) | 6 (2) | - | - |
| Hypertension (%) | 15 (30) | 4 (8) | 1 (2) | - | 27 (11) | 4 (2) | 1 (0.5) | - |
| Hypotension (%) | 1 (2) | - | - | - | 1 (0.5) | - | - | - |
| Hematuria (%) | 2 (4) | 1 (2) | - | - | 3 (1) | 1 (0.5) | - | - |
| Gengival recession/gengivitis (%) | 7 (14) | - | - | - | 10 (4) | - | - | - |
| Rhinitis (%) | 38 (76) | - | - | - | 110(44.5) | - | - | - |
| Epistaxis (%) | 31 (62) | 2 (4) | - | - | 68 (27.5) | 2 (1) | - | - |
| HFS (%) | 2 (4) | - | - | - | 2 (1) | - | - | - |
| Headache (%) | 6 (12) | - | - | - | 9 (4) | - | - | - |
| Hypokalemia (%) | 3 (6) | - | 1 (2) | - | 3 (1) | - | 1 (0.5) | - |
| Hypertransaminasemy (%) | 3 (6) | 2 (4) | 1 (2) | 1 (2) | 9 (4) | 6 (2) | 1 (0.5) | 1 (0.5) |
| Hyperpigmentation (%) | 6 (12) | 2 (4) | - | - | 14 (6) | 5 (2) | - | - |
| Fever without infection (%) | 10 (20) | - | - | - | 10 (4) | - | - | - |
| Alopecia (%) | 5 (10) | 9 (18) | 3 (6) | - | 11 (4) | 17 (7) | 7 (3) | - |
| Anemia (%) | 7 (14) | 4 (8) | - | - | 16 (6) | 4 (2) | - | - |
| Leucopenia (%) | 13 (26) | 17 (34) | - | - | 49 (20) | 26 (10.5) | - | - |
| Neutropenia (%) | 9 (18) | 14 (28) | 5 (10) | - | 35 (14) | 32 (13) | 8 (3) | - |
| Thrombocytopenia (%) | 7 (14) | 1 (2) | - | - | 16 (6) | 1 (0.5) | - | - |
Abbreviation: NCI-CTC, National Cancer Institute Common Toxicity Criteria.