TABLE 2.
Outcome characteristics stratified by management strategy (intention-to-treat analysis)
| Characteristics | Observation group (n = 104) | Resection group (n = 77) | p value |
|---|---|---|---|
| Final tumor sizea (cm) | 1.2 (0.8–1.9) | 1.4 (1.1–1.9) | 0.3 |
| Final Primary tumor (T)b | 0.3 | ||
| T0 | 3 (3 %) | 0 | |
| T1 | 84 (81 %) | 67 (87 %) | |
| T2 | 17 (16 %) | 10 (13 %) | |
| Final regional lymph nodes (N)b | 0.4 | ||
| N0 | 104 (100 %) | 76 (99 %) | |
| N1 | 0 | 1 (1 %) | |
| Final tumor stageb | 0.3 | ||
| 0 | 3 (3 %) | 0 | |
| Ia | 84 (81 %) | 66 (86 %) | |
| Ib | 17 (16 %) | 10 (13 %) | |
| IIb | 0 | 1 (1 %) | |
| Follow-up (months) | 44 (14–77) | 57 (35–87) | 0.06 |
| Oncological status at last follow-up | NA | ||
| No evidence of disease | 27 (26 %) | 66 (86 %) | |
| Alive with disease | 73 (70 %) | 4 (5 %) | |
| Dead of other causes | 2 (2 %) | 4 (5 %) | |
| Dead of unknown causes | 2 (2 %) | 3 (4 %) | |
| 5Y overall survival, % (95 % CI) | 99 (97–100) | 91 (84–97) | 0.05 |
| 5Y metastasis-free survival, % (95 % CI) | 99 (97–100) | 88 (79–96) | 0.01 |
| Recurrencec | 0 | 5 (6 %) | NA |
Continuous variables are expressed as median (interquartile range); categorical variables are expressed as n (%)
NA not analyzed
Final tumor size in the observation group was measured from the last imaging taken at the end of the observation period. Final tumor size in the resection group was measured from the pathological report
Defined as the pathological staging for patients who underwent resection. For patients who were observed without resection, staging was defined clinically at last imaging follow-up
One patient that developed recurrence in the portal lymph node underwent re-resection and was NED (no evidence of disease) on last follow-up. The other four patients developed recurrences in the following sites: mesenteric lymph nodes (two patients), liver (one patient), and pelvis (one patient)