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Dose-limiting toxicities (DLTs) according to dose level.
| Dose level (5-FU/day) | Pts/cycles | After first cycle | After all courses (pts/cycles) | ||||
| Neutropenia | FN1 | stomatitis | diarrhea | asthenia | |||
| Level 1 (250 mg) | 3/4 | None | 1/1 | 1/1 | |||
| Level 2 (500 mg) | 10/35 | Stomatitis (1) | 4/5 | 6/11 | 1/1 | 4/7 | |
| Level 3 (750 mg) | 3/4 | Stomatitis (1) FN (1) |
2/2 | 1/1 | 2/2 | 1/1 | 1/1 |
1 FN denotes febrile neutropenia.
