Table 5.
24 Week treatment failure-free survival (TFFS) – n (%).
| carboplatin + paclitaxel | cisplatin + capecitabine | Odds Ratio (95% CI) | p value | |||
|---|---|---|---|---|---|---|
| Squamous cell | ||||||
| Patients randomised | 25 | 27 | ||||
| Died/progressed prior to week 24 scana | 3 | 12.0 | 0 | 0.0 | ||
| Valid CT scan doneb | 22 | 88.0 | 27 | 100.0 | ||
| Progression outside RT volume | 4 | 16.0 | 2 | 7.4 | ||
| Valid endoscopy donec | 21 | 84.0 | 23 | 85.2 | ||
| Residual/persistent disease | 3 | 12.0 | 0 | 0.0 | ||
| Response assessable | 25 | 100.0 | 27 | 100.0 | ||
| Failure-free | 17 | 68.0 | 25 | 92.6 | 0.14 (0.02–0.81) | 0.028d |
| Failure | 8 | 32.0 | 2 | 7.4 | ||
| Adenocarcinoma and undifferentiated | ||||||
| Patients randomised | 6 | 5 | ||||
| Died/progressed prior to week 24 scana | 1 | 16.7 | 1 | 20.0 | ||
| Valid CT scan doneb | 5 | 83.3 | 4 | 80.0 | ||
| Progression outside RT volume | 0 | 0.0 | 0 | 0.0 | ||
| Valid endoscopy donec | 5 | 83.3 | 3 | 60.0 | ||
| Residual/persistent disease | 1 | 16.7 | 0 | 0.0 | ||
| Response assessable | 6 | 100.0 | 5 | 100.0 | ||
| Failure-free | 4 | 66.7 | 4 | 80.0 | 0.50 (0.03–9.46) | 0.621e |
| Failure | 2 | 33.3 | 1 | 20.0 | ||
| Subgroup analyses of failure-free rate | ||||||
| Age | ||||||
| <70 | 10 | 62.5 | 15 | 93.8 | ||
| ≥70 | 11 | 73.3 | 14 | 87.5 | ||
| Sex | ||||||
| Male | 9 | 64.3 | 18 | 94.7 | ||
| Female | 12 | 70.6 | 11 | 84.6 | ||
| WHO status | ||||||
| 0 | 8 | 66.7 | 17 | 89.5 | ||
| 1 | 13 | 68.4 | 12 | 92.3 | ||
| Stage | ||||||
| I or II | 8 | 72.7 | 14 | 100.0 | ||
| III | 13 | 65.0 | 15 | 83.3 | ||
| Total disease length | ||||||
| <5 cm | 8 | 80.0 | 13 | 92.9 | ||
| ≥5 cm | 13 | 61.9 | 16 | 88.9 | ||
Therefore no CT scan due at 24 weeks.
Done at 24 weeks ( ± 4 weeks) after start of treatment.
Done at 24 weeks (+12/-4 weeks) after start of treatment.
Mixed effects logistic regression.
Chi square.