Table 2.
Treatment-related toxicities
| Adverse events, n (%) | SP (n=54) | VP (n=54) | ||
|---|---|---|---|---|
| All grades | Grade 3–5 | All grades | Grade 3–5 | |
| Haematologic toxicities | ||||
| Leukopenia | 52 (96.3) | 22 (40.7) | 54 (100.0) | 43 (79.6) |
| Neutropenia | 48 (88.9) | 18 (33.3) | 51 (94.4) | 41 (75.9) |
| Thrombocytopenia | 23 (42.6) | 5 (9.3) | 12 (22.2) | 2 (3.7) |
| Anaemia | 43 (79.6) | 14 (25.9) | 48 (88.9) | 15 (27.8) |
| Febrile neutropenia | 5 (9.3) | 5 (9.3) | 9 (16.7) | 9 (16.7) |
| Non-haematologic toxicities | ||||
| AST increase | 15 (27.8) | 0 (0.0) | 15 (27.8) | 2 (3.7) |
| ALT increase | 23 (42.6) | 0 (0.0) | 25 (46.3) | 4 (7.4) |
| Total bilirubin increase | 14 (25.9) | 0 (0.0) | 8 (14.8) | 0 (0.0) |
| Nausea | 42 (77.8) | 2 (3.7) | 41 (75.9) | 2 (3.7) |
| Vomiting | 10 (18.5) | 1 (1.9) | 13 (24.1) | 0 (0.0) |
| Anorexia | 46 (85.2) | 7 (13.0) | 48 (88.9) | 8 (14.8) |
| Fatigue | 37 (68.5) | 2 (3.7) | 39 (72.2) | 2 (3.7) |
| Oesophagitis | 36 (66.7) | 2 (3.7) | 40 (74.1) | 0 (0.0) |
| Mucositis | 10 (18.5) | 0 (0.0) | 9 (16.7) | 0 (0.0) |
| Diarrhoea | 19 (35.2) | 3 (5.6) | 9 (16.7) | 0 (0.0) |
| Creatinine increase | 15 (27.8) | 0 (0.0) | 28 (51.9) | 0 (0.0) |
| Hyponatremia | 39 (72.2) | 10 (18.5) | 35 (64.8) | 4 (7.4) |
| Pneumonitis | 13 (24.1) | 5 (9.3) | 11 (20.4) | 4 (7.4) |
| Bleeding | 1 (1.9) | 1 (1.9) | 2 (3.7) | 2 (3.7) |
| Injection site reaction | 1 (1.9) | 0 (0.0) | 13 (24.1) | 0 (0.0) |
AST aspartate aminotransferase, ALT alanine aminotransferase, SP cisplatin plus S-1, VP cisplatin plus vinorelbine