Table 3. Toxicities (JCOG Toxicity Criteria, Worst Grade of Any Course).
|
CE
|
SPE
|
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Grade
|
|||||||||||
| Toxicity | 1 | 2 | 3 | 4 | 3+4 (%) | 1 | 2 | 3 | 4 | 3+4 (%) | P-value |
| Haematologic | |||||||||||
| Leucopenia | 5 | 45 | 46 | 13 | (54) | 8 | 43 | 49 | 7 | (51) | 0.79 |
| Neutropenia | 0 | 5 | 46 | 58 | (95) | 4 | 7 | 41 | 57 | (90) | 0.22 |
| Anaemia | 9 | 58 | 32 | — | (29) | 20 | 45 | 27 | — | (25) | 0.54 |
| Thrombocytopenia | 20 | 18 | 29 | 32 | (56) | 16 | 15 | 12 | 5 | (16) | <.01 |
| Non-haematologic | |||||||||||
| Nausea/vomiting | 40 | 24 | 2 | — | (2) | 46 | 28 | 3 | — | (3) | 0.68 |
| Diarrhoea | 8 | 9 | 1 | 0 | (1) | 11 | 3 | 1 | 0 | (1) | 1.0 |
| Bilirubin | — | 31 | 0 | 0 | (0) | — | 16 | 1 | 0 | (1) | 0.50 |
| AST | 47 | 9 | 3 | 0 | (3) | 30 | 8 | 6 | 0 | (6) | 0.33 |
| ALT | 40 | 9 | 2 | 0 | (2) | 38 | 8 | 4 | 0 | (4) | 0.45 |
| Creatinine | 10 | 2 | 0 | 0 | (0) | 27 | 3 | 1 | 0 | (1) | 0.50 |
| Hyponatraemia | 38 | 11 | 7 | 11 | (16) | 46 | 20 | 6 | 9 | (14) | 0.58 |
| PaO2 | 39 | 21 | 7 | 1 | (10) | 44 | 23 | 2 | 1 | (4) | 0.22 |
| Fever | 15 | 15 | 0 | 0 | (0) | 21 | 16 | 0 | 0 | (0) | — |
| Infection | 12 | 15 | 5 | 3 | (7) | 16 | 7 | 5 | 1 | (6) | 0.78 |
| Bleeding | 8 | 1 | 0 | 0 | (0) | 4 | 0 | 0 | 0 | (0) | — |
| Neurologic-sensory | 2 | 1 | 0 | — | (0) | 3 | 2 | 0 | — | (0) | — |
| Alopaecia | 67 | 22 | — | — | 66 | 15 | — | — | |||
CE, carboplatin plus etoposide; JCOG, Japan Clinical Oncology Group; PaO2, partial pressure of oxygen; SPE, split doses of cisplatin plus etoposide.