Surgical arm | Clinical arm | Significance | |
N | 130 | 125 | |
ITT: 121 | ITT: 119 | ||
Not eligible: 9 | Not eligible: 6 | ||
Evaluable patients | 121 | 119 | |
Age (years), mean | 47.2 | 49.6 | p=0.09 |
Range | 20–69 | 24–71 | |
BMI, mean | 26.2 | 26.2 | p=0.83 |
Range | 16.4–48.1 | 15.7–51.4 | |
Karnofsky index (%) | 90 (70–100) | 90 (70–100) | p=0.45 |
Co-morbidity | |||
Cardiovascular | 24 (19.8%) | 24 (20.2%) | p=0.95 |
Diabetes | 9 (7.4%) | 7 (5.9%) | p=0.63 |
Prior abdominal surgery | 56 (46.3%) | 46 (38.7%) | p=0.23 |
Stage at randomization* | |||
IIB | 85 (70.2%) | 80 (67.2%) | |
IIIA | 4 (3.3%) | 6 (5%) | |
IIIB | 29 (24%) | 24 (20.2%) | |
IVA | 3 (2.5%) | 9 (7.6%) | p=0.44 |
Tumor size* | |||
≤4 cm | 31 (25.6%) | 22 (18.5%) | |
>4 cm | 90 (74.4%) | 97 (81.5%) | p=0.18 |
Histology* | |||
Squamous | 103 (85.1%) | 108 (90.8%) | |
Adenocarcinoma | 15 (12.4%) | 8 (6.7%) | |
Adenosquamous | 3 (2.5%) | 3 (2.5%) | p=0.33 |
Grade* | |||
G1 | 5 (4.1%) | 1 (0.8%) | |
G2 | 85 (70.2%) | 76 (63.9%) | |
G3 | 31 (25.6%) | 42 (35.3%) | p=0.046 |
LVSI* | |||
Negative | 98 (81%) | 101 (85%) | |
Positive | 21 (17%) | 14 (12%) | |
Indeterminate | 2 (2%) | 4 (3%) | p=0.24 |
HVSI* | |||
Negative | 109 (90%) | 111 (94%) | |
Positive | 10 (8%) | 4 (3%) | |
Indeterminate | 2 (2%) | 4 (3%) | p=0.11 |
*Only evaluable patients included in these sections.
HVSI, hemovascular space invasion: tumor cell invasion in microscopic blood vessels; LVSI, lymphovascular space invasion: tumor cell invasion in lymphatic vessels.