Table 1.
Characteristics of subjects and clinical outcomes
| S-1 therapy | Surgery alone | |
|---|---|---|
| Number of patients |
529 |
530 |
| Age (median) |
63 |
63 |
| Sex (male) |
367 |
369 |
| Cancer stage (TNM classification) |
|
|
| IB |
1 |
0 |
| II |
264 |
282 |
| IIIA |
170 |
157 |
| IIIB |
54 |
56 |
| IV |
40 |
35 |
| Type of lymph –node dissection |
|
|
| D1 |
0 |
1 |
| D2 |
501 |
497 |
| D3 |
28 |
32 |
| Type of gastrectomy |
|
|
| Total |
220 |
201 |
| Distal |
301 |
316 |
| Proximal |
4 |
11 |
| Other |
4 |
2 |
| Adverse events more than grade 3* |
155 |
80 |
| Total no. of relapses |
162 |
221 |
| |
% |
% |
| 5-year survival (95% CI) |
72 (68–76) |
61 (57–65) |
| 5-year relapse-free survival (95% CI) | 65 (61–70) | 53 (49–57) |
The results are presented according to ITT (intention to treat): * The results from the safety analysis.