Table 3.
Stage ΙΙ and low-risk stage ΙΙΙ |
High-risk stage ΙΙΙ |
|||||||
---|---|---|---|---|---|---|---|---|
Variable | Total number | n (%) | HR (95% CI) | P-value | Total number | n (%) | HR (95% CI) | P-value |
Age | 598 | 598 (100%) | 1.00 (0.98–1.03) | 0.80 | 394 | 394 (100%) | 1.00 (0.98–1.01) | 0.61 |
Gender | 598 | 0.49 | 394 | 0.88 | ||||
Male | 342 (57%) | Ref. | 234 (59%) | Ref. | ||||
Female | 256 (43%) | 0.86 (0.55–1.32) | 160 (41%) | 1.02 (0.75–1.40) | ||||
Randomized adjuvant treatment | 598 | 0.016 | 394 | 0.17 | ||||
CAP | 295 (49%) | Ref. | 197 (50%) | Ref. | ||||
CAP+BEV | 303 (51%) | 1.71 (1.10–2.65) | 197 (50%) | 1.24 (0.91–1.69) | ||||
Sidedness | 578 | 0.11 | 387 | 0.081 | ||||
Right | 321 (56%) | Ref. | 226 (58%) | Ref. | ||||
Left | 257 (44%) | 0.69 (0.44–1.09) | 161 (42%) | 1.32 (0.97–1.81) | ||||
Number of lymph nodes removed | 583 | <0.001 | 393 | 0.39 | ||||
>=12 | 453 (78%) | Ref. | 307 (78%) | Ref. | ||||
<12 | 130 (22%) | 2.28 (1.45–3.60) | 86 (22%) | 1.17 (0.82–1.66) | ||||
Histological grade | 572 | 0.84 | 383 | 0.43 | ||||
Well | 25 (4%) | Ref. | 13 (3%) | Ref. | ||||
Moderate | 461 (81%) | 0.85 (0.31–2.33) | 302 (79%) | 2.08 (0.66–6.52) | ||||
Poor | 86 (15%) | 0.72 (0.23–2.31) | 68 (18%) | 2.16 (0.66–7.10) | ||||
KRAS | 555 | 0.18 | 358 | 0.63 | ||||
Wild type | 374 (67%) | Ref. | 240 (67%) | Ref. | ||||
Mutated | 181 (33%) | 1.36 (0.86–2.13) | 118 (33%) | 1.09 (0.77–1.54 | ||||
BRAF | 544 | 0.27 | 371 | 0.089 | ||||
Wild type | 478 (88%) | Ref. | 315 (85%) | Ref. | ||||
Mutated | 66 (12%) | 0.63 (0.27–1.45) | 56 (15%) | 1.43 (0.94–2.17) | ||||
Microsatellite instability | 569 | 0.047 | 381 | 0.25 | ||||
MSI-H | 77 (14%) | Ref. | 42 (11%) | Ref. | ||||
MSS | 492 (86%) | 2.43 (0.98–6.01) | 339 (89%) | 1.39 (0.79–2.46) | ||||
CD8+ T-lymphocyte and stroma fraction | 598 | 0.076 | 394 | <0.001 | ||||
High CD8+ fraction and low stroma fraction | 282 (47%) | Ref. | 138 (35%) | Ref. | ||||
Low CD8+ fraction or high stroma fraction | 278 (46%) | 1.41 (0.90–2.23) | 222 (56%) | 1.36 (0.96–1.94) | ||||
Low CD8+ fraction and high stroma fraction | 38 (6%) | 2.20 (1.05–4.61) | 34 (9%) | 2.86 (1.75–4.69) | ||||
CD8+ T-lymphocyte fraction | 598 | 0.25 | 394 | 0.028 | ||||
High (>2.7%) | 331 (55%) | Ref. | 174 (44%) | Ref. | ||||
Low (<=2.7%) | 267 (45%) | 1.28 (0.84–1.96) | 220 (56%) | 1.43 (1.04–1.96) | ||||
Stroma fraction | 598 | 0.029 | 394 | 0.002 | ||||
Low (<56%) | 511 (85%) | Ref. | 324 (82%) | Ref. | ||||
High (>=56%) | 87 (15%) | 1.75 (1.05–2.92) | 70 (18%) | 1.74 (1.21–2.50) |
Definition: low-risk stage ΙΙΙ, pathological tumor stage (pT) 3 pathological lymph node stage (pN) 1 with neither lymphatic nor vascular invasion; high-risk stage ΙΙΙ, stage ΙΙΙ pT3 N1 with lymphatic and/or vascular invasion, pT4, or pN2. Abbreviation: HR, hazard risk; CI, confidence interval; Ref, reference; CAP, capecitabine; BEV, bevacizumab; MSI-H, microsatellite instability-high; MSS, microsatellite stable.