Mori et al., 2006 [12] |
III |
S1 showed more therapeutic effect in prevention of gastric cancer. |
Boku et al., 2009 [17] |
I |
S-1 was non-inferior to the continuous infusion of 5-FU in terms of Overall Survival (OS). |
Shiozawa et al., 2009 [14] |
I |
Japanese randomized phase III trial (GC0301/TOP-002) conducted in 326 patients to compare S1 with S-1 plus irinotecan showed a significant response advantage for combination arm (41.5% vs. 26.9%, p=0.35). |
Zang et al., 2009 [15] |
I |
In multicenter phase II clinical trial, the efficacy of oral S1 with biweekly regimen paclitaxel showed that response rate was good (43.6%) with greater survival days with this treatment regimen. |
Baba et al., 2009 [16] |
I |
A phase I trial applying increasing doses of oral administration of S-1 (65-80 mg/mL) for 21 days and increasing doses of CDDP (60-80 mg/mL) on day 22, every 35 days, was conducted to determine MTD and the recommended dose (RD) for the phase II studies. Phase I study of the sequential administration of S-1 and cisplatin for metastatic gastric cancer showed that this sequential administration of S-1 and CDDP every 35 days was tolerable and warranted a phase II trial. |