Table 3.
Results of Phase II trials of S-1-based chemotherapy
| Study (region) | Regiment | Number of patients | RR (%) | PFS (months) | MST (months) | P value |
|---|---|---|---|---|---|---|
| JCOG9912 (Japan) | 5-FU | 234 | 9 | 2.9 | 10.8 | |
| CDDP + | 236 | 38 | 4.8 | 12.3 | NS | |
| irinotecan + S-1 | 234 | 28 | 4.2 | 11.4 | Noninferiority | |
| SPIRITS (Japan) | S-1 | 150 | 3 | 4.0 | 11.3 | P < 0.05 |
| S-1 + CDDP | 148 | 54 | 6.0 | 13.0 | ||
| GC0301/TOP-002 (Japan) | S-1 | 160 | 26.9 | 3.6 | 10.5 | NS |
| S-1 + irinotecan | 155 | 41.5 | 4.5 | 12.8 | ||
| START (Japan and Korea) | S-1 | 313 | 18.4 | 4.0 | 11.7 | NS |
| S-1 + docetaxel | 310 | 30.3 | 4.7 | 13.0 | ||
| FLAGS (Western) | S-1 + CDDP | 521 | 29.1 | 4.8 | 8.6 | NS |
| 5-FU + CDDP | 508 | 31.9 | 5.5 | 7.9 |
Abbreviations: 5-FU, 5-fluorouracil; CDDP, cisplatin; FLAGS, First-line Advanced Gastric Cancer Study; JCOG, Japan Clinical Oncology Group; MST, median survival time; NS, not significant; PFS, progression-free survival; RR, response rate; SPIRITS, Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer; START, Randomized Phase III Study of S-1 Alone Versus S-1 Plus Docetaxel in the Treatment for Advanced Gastric Cancer.