Table 3 Description of events by treatment arm
Type of event | 5FU n =308 | 5FU-LEV n =357 | 5FU-FA n =312 | 5FU-FA-LEV n =350 | Total n =1327 |
|---|---|---|---|---|---|
First event, n (%) | |||||
Locoregional relapse | |||||
Anastomosis or perianastomosis | 5 (1.6) | 2 (0.6) | 2 (0.6) | 5 (1.4) | 14 (1.1) |
Abdominal or pelvic lymphnodes | 4 (1.2) | 3 (0.8) | 2 (0.6) | 6 (1.7) | 15 (1.1) |
Abdominal or pelvic masses | 17 (5.5) | 22 (6.1) | 15 (4.8) | 17 (4.9) | 71 (5.3) |
Peritoneal carcinosis | 7 (2.3) | 4 (1.1) | 2 (0.6) | 4 (1.1) | 17 (1.3) |
Distant metastases | |||||
Liver | 28 (9.1) | 32 (9.0) | 27 (8.6) | 31 (8.9) | 118 (8.9) |
Lung | 7 (2.3) | 8 (2.2) | 9 (2.9) | 4 (1.1) | 28 (2.1) |
Bone | 2 (0.6) | 2 (0.6) | 1 (0.3) | 2 (0.6) | 7 (0.5) |
Soft tissues | 1 (0.3) | 1 (0.3) | — | 1 (0.3) | 3 (0.2) |
Combination of distant sites | 8 (2.6) | 2 (0.6) | 5 (1.6) | 5 (1.4) | 20 (1.5) |
Locoregional+distant | 11 (3.6) | 10 (2.8) | 7 (2.2) | 10 (2.9) | 38 (2.9) |
Other or unknown site | 3 (1.0) | 8 (2.2) | 6 (1.9) | 6 (1.7) | 23 (1.7) |
Death without relapse | 10 (3.2) | 13 (3.6) | 12 (3.8) | 8 (2.3) | 43 (3.2) |
Death, n (%) | 67 (21.7) | 65 (18.2) | 67 (21.5) | 65 (18.6) | 264 (19.9) |
Second primary, n (%) | |||||
Colorectal | 3 (1.0) | 2 (0.6) | 2 (0.6) | 5 (1.4) | 12 (0.9) |
Leukemia | — | 1 (0.3) | — | — | 1 (0.07) |
Breast | 1 (0.3) | 1 (0.3) | 1 (0.3) | 1 (0.3) | 4 (0.3) |
Lung | — | 1 (0.3) | 1 (0.3) | 1 (0.3) | 3 (0.2) |
Thymoma | 1 (0.3) | — | — | — | 1 (0.07) |
Bladder | — | 1 (0.3) | — | — | 1 (0.07) |
Prostate | — | — | 1 (0.3) | 1 (0.3) | 2 (0.1) |
Thyroid | — | — | 2 (0.6) | — | 2 (0.1) |
