Table 3 Efficacy analysis in the modified intention-to-treat population
Variable | CA-SAP group (n = 51) | SAP group (n = 53) | P value | FDR-adjusted P value |
|---|---|---|---|---|
Pathological response | ||||
TRG 0 (Complete) | 8 (15.7) | 3 (5.7) | ||
TRG 1 (Subtotal) | 9 (17.6) | 6 (11.3) | ||
TRG 2 (Partial) | 10 (19.6) | 21 (39.6) | ||
TRG 3 (Minimal or none) | 22 (43.1) | 19 (35.8) | ||
No gastrectomy | 2 (3.9) | 4 (7.5) | ||
Major pathological response rate (%, 95% CI) | 33.3 (19.9–46.7) | 17.0 (6.5–27.4) | 0.044 | 0.080 |
Complete response rate (%, 95% CI) | 15.7 (5.4–26.0) | 5.7 (0–12.1) | 0.089 | 0.118 |
Radiologic response | ||||
CR | 3 (5.9) | 0 (0.0) | ||
PR | 30 (58.8) | 23 (43.4) | ||
SD | 16 (31.4) | 28 (52.8) | ||
PD | 1 (2.0) | 2 (3.7) | ||
Unidentified | 1 (2.0) | 0 (0.0) | ||
Objective response rate (%, 95% CI) | 66.0 (52.4–79.6) | 43.4 (29.2–57.6) | 0.017 | 0.080 |
Disease control rate (%, 95% CI) | 96.1 (90.6–100) | 96.2 (90.0–100) | 0.677 | 0.677 |
Tumor downstaging | ||||
cT stage | Pre-treatment | Post-treatment | Pre-treatment | Post-treatment |
T1 | 0 (0.0) | 1 (2.0) | 0 (0.0) | 0 (0.0) |
T2 | 0 (0.0) | 10 (19.6) | 0 (0.0) | 5 (9.4) |
T3 | 5 (9.8) | 17 (33.3) | 8 (15.1) | 19 (35.8) |
T4 | 46 (90.2) | 22 (43.1) | 45 (84.9) | 29 (54.7) |
Unidentified | 0 (0.0) | 1 (2.0) | 0 (0.0) | 0 (0.0) |
T downstaging (%) | 27 (52.9) | 17 (32.1) | 0.025 | 0.080 |
cN stage | Pre-treatment | Post-treatment | Pre-treatment | Post-treatment |
N0 | 0 (0.0) | 13 (25.5) | 0 (0.0) | 9 (17.0) |
N+ | 51 (100.0) | 36 (70.6) | 53 (100.0) | 44 (83.0) |
Unidentified | 0 (0.0) | 1 (2.0) | 0 (0.0) | 0 (0.0) |
N downstaging (%) | 13 (25.5) | 9 (17.0) | 0.206 | 0.229 |
Surgical Fingdings | ||||
R0 resection rate (%, 95% CI) | 94.1 (87.4–100) | 81.1 (70.2–92.0) | 0.042 | 0.080 |
