Table 2.
Comparison of background clinical characteristics of responders and nonresponders classified by a growth inhibition rate of 60 % at a 5-fluorouracil concentration of 1.0 µg/ml
| Characteristic | Responders (n = 76) | Non responders (n = 120) | P |
|---|---|---|---|
| Gender | 0.09 | ||
| Male | 61 (80.3 %) | 83 (69.2 %) | |
| Female | 15 (19.7 %) | 37 (30.8 %) | |
| Age | 62.5 years (32–78 years) | 67.0 years (33–79 years) | 0.01 |
| Cancer stagea | 0.54 | ||
| II | 14 (18.4 %) | 23 (19.2 %) | |
| III | 56 (73.7 %) | 92 (76.7 %) | |
| IV | 6 (7.9 %) | 5 (4.2 %) | |
| Tumor stagea | 0.42 | ||
| T1 | 0 (0 %) | 2 (1.7 %) | |
| T2 | 22 (28.9 %) | 27 (22.5 %) | |
| T3 | 47 (61.8 %) | 83 (69.2 %) | |
| T4 | 7 (9.2 %) | 8 (6.7 %) | |
| N stagea | 0.95 | ||
| N0 | 4 (5.3 %) | 7 (5.8 %) | |
| N1 | 38 (50.0 %) | 64 (53.3 %) | |
| N2 | 31 (40.8 %) | 45 (37.5 %) | |
| N3 | 3 (3.9 %) | 4 (3.3 %) | |
| Type of lymph node dissectiona | 0.29 | ||
| D2 | 71 (93.4 %) | 116 (96.7 %) | |
| D3 | 5 (6.6 %) | 4 (3.3 %) | |
| ECOG PS | 0.18 | ||
| 0 | 51 (67.1 %) | 91 (75.8 %) | |
| 1 | 25 (32.9 %) | 29 (24.2 %) | |
| RDIb | 70.2 % | 64.3 % | 0.29 |
| (0.9–186 %) | (0.4–119 %) | ||
| Type of gastrectomy | 0.80 | ||
| Total | 47 (61.8 %) | 72 (60.0 %) | |
| Distal | 29 (38.2 %) | 48 (40.0 %) | |
| Tumor histology | 0.54 | ||
| Intestinal type | 27 (35.5 %) | 52 (43.3 %) | |
| Diffuse type | 48 (63.2 %) | 67 (55.8 %) | |
| Unknown | 1 (1.3 %) | 1 (0.8 %) | |
| Sites of relapsec | n = 12 | n = 43 | |
| Local | 0 (0 %) | 5 (11.6 %) | 0.22 |
| Peritoneum | 4 (33.3 %) | 19 (44.2 %) | 0.50 |
| Liver | 4 (33.3 %) | 11 (25.6 %) | 0.59 |
| Distant | 4 (33.3 %) | 7 (16.3 %) | 0.19 |
| Lymph node | 4 (33.3 %) | 6 (14.0 %) | 0.12 |
There were no significant differences in the background clinical characteristics, except for age, between the responder and nonresponder groups, even when classified by any other defined cutoff values (data not shown)
ECOG PS Eastern Cooperative Oncology Group performance status, RDI relative dose intensity
aJapanese Classification of Gastric Cancer 13th edition
bRDI = actual intake of doses/total protocol doses of S-1 for 1 year (%)
cSome patients had plural relapses