Table 1. Baseline characteristics (ITT population).
| Arm A FOLFOX4 (N=53) | Arm B cisplatin/ fluorouracil (N=44) | |
|---|---|---|
| Gender (n (%)) | ||
| Male | 45 (84.9%) | 38 (86.4%) |
| Age (years) | ||
| Median | 59.0 | 58.0 |
| Range | 39–81 | 41–80 |
| ECOG PS at baseline (n (%)) | ||
| 0 | 36 (67.9%) | 24 (54.5%) |
| 1 | 17 (32.1%) | 18 (40.9%) |
| 2 | 0 | 2 (4.5%) |
| Histological type (n (%)) | ||
| Adenocarcinoma | 11 (20.8%) | 6 (13.6%) |
| Squamous cell carcinoma | 42 (79.2%) | 38 (86.4%) |
| TNM classification (n (%)) | ||
| Stage IIA | 13 (24.5%) | 15 (34.1%) |
| Stage IIB | 6 (11.3%) | 2 (4.5%) |
| Stage III | 30 (56.6%) | 24 (54.5%) |
| Stage IVA | 4 (7.5%) | 3 (6.8%) |
| Location of primary tumour (n (%)) | ||
| Cervical | 6 (11.3%) | 1 (2.3%) |
| Upper thoracic | 14 (26.4%) | 14 (31.8%) |
| Middle thoracic | 21 (39.6%) | 22 (50.0%) |
| Lower thoracic | 14 (26.4%) | 9 (20.5%) |
| Inoperability (n (%)) | ||
| Carcinologic reason | 31 (58.5%) | 25 (26.8%) |
| Therapeutic/patient choice | 18 (34.0%) | 12 (27.3%) |
| Weight loss | ||
| <10% | 32/52 (61.6%) | 26/43 (60.5%) |
| ⩾10% | 20/52 (37.4%) | 16/43 (37.2%) |
| Median tumour length (mm) (range) | 50 (15–200)a | 50 (23–130) |
Abbreviations: ECOG=Eastern Cooperative Oncology Group; FOLFOX=oxaliplatin, fluorouracil and leucovorin; ITT=intent to treat; PS=performance status.
a
Unavailable for one patient.