Table 2:
DFS Events/N |
DFS KM 2 Year Estimate (95% CI) |
DFS a HR (95% CI) |
|
---|---|---|---|
Arm: OPEN | 56/222 | 83.2 (78.3, 88.3) | Ref |
LAP | 56/240 | 79.5 (74.4, 84.9) | 0.95 (0.65, 1.37) |
Composite Score: Successful | 86/389 | 82.9 (79.2, 86.8) | Ref |
Unsuccessful resection | 26/73 | 69.1 (59, 81.1) | 1.87 (1.21, 2.91) |
Distal Margin: Negative | 108/454 | 81.6 (78, 85.3) | Ref |
Positive | 4/8 | 46.9 (21.5, 100) | 2.53 (0.93, 6.86) |
Circumferential Margin: > 1mm | 93/416 | 83.2 (79.6, 87) | Ref |
≤ 1 mm | 19/46 | 61 (48.1, 77.5) | 2.31 (1.40, 3.79) |
Completeness of TME: Complete | 83/356 | 82.7 (78.8, 86.8) | Ref |
Nearly complete | 19/76 | 75.6 (66.4, 86.1) | 1.15 (0.70, 1.90) |
Incomplete | 10/30 | 73.9 (58.9, 92.7) | 1.65 (0.85, 3.18) |
Rectal Perforation: No | 93/404 | 82.7 (79.1, 86.6) | Ref |
Yes | 19/58 | 70.7 (59.6, 83.9) | 1.65 (1.00, 2.71) |
Surgical approach: LAR | 23/142 | 86.7 (81.2, 92.6) | Ref |
LAR + Coloanal Anastomosis | 52/206 | 81.7 (76.5, 87.2) | 1.52 (0.93, 2.48) |
Abdominal Perineal Resection | 33/105 | 72.4 (64, 81.9) | 2.21 (1.30, 3.77) |
Location of tumor in rectum: | |||
Other (Top, High) | 48/233 | 83 (78.2, 88.1) | Ref |
Low | 64/229 | 79.4 (74.2, 85) | 1.38 (0.95, 2.0) |
Tumor distance from anal verge (cm)b | ~ | ~ | 0.94 (0.89, 1.00) |
Tumor size, largest dimension (cm)c | ~ | ~ | 1.03 (0.95, 1.13) |
Abbreviations: DFS, Disease Free Survival; KM, Kaplan Meier; TME, Total Mesorectal Excision; LAR, Lower Anterior Resection
– CoxPH model adjusted by arm reflecting Hazard Ratio and 95% Confidence Interval.
– Missing tumor distance for 3 patients (2 LAP).
– Missing tumor size for 15 patients (9 LAP).