Table 2.
Chemotherapy details
| Cisplatin and fluorouracil: two cycles (n=451) | Epirubicin, cisplatin, and capecitabine: four cycles (n=446) | |
|---|---|---|
| Cycles started | ||
| None* | 2 (<1%) | 2 (<1%) |
| One | 14 (3%) | 12 (3%) |
| Two (completed two-cycle regimen) | 435 (96%) | 32 (7%) |
| Three | NA | 37 (8%) |
| Four (completed four-cycle regimen) | NA | 363 (81%) |
| Total completed chemotherapy | 435 (96%) | 363 (81%) |
| Delays to cycles† | ||
| Yes | 113 (25%) | 148 (33%) |
| No | 336 (75%) | 296 (66%) |
| No chemotherapy received | 2 (<1%) | 2 (<1%) |
| Reduction in cisplatin dose‡ | ||
| No | 373 (83%) | 378 (85%) |
| Yes | 61 (14%) | 53 (12%) |
| No cisplatin given | 1 (<1%) | 1 (<1%) |
| Less than two cycles given | 16 (4%) | 14 (3%) |
| Reduction in any dose‡ | ||
| No | 347 (77%) | 245 (55%) |
| Yes | 88 (20%) | 187 (42%) |
| Less than two cycles given | 16 (4%) | 14 (3%) |
Data are n (%). NA=not applicable.
All four patients who received no on-trial chemotherapy withdrew consent soon after randomisation.
A delay is defined as a cycle starting at least 25 days after the previous cycle, or at least 11 days after randomisation.
A reduction is defined as the dose decreasing by more than 10% compared with cycle one. A cycle was said to have started if any drug was administered.