Table 5.
Efficacies and adverse reactions of S-1 alone and of S-1 in combination with low- or high-dose CDDP
| A retrospective study (Ref. 52) |
SPIRITS trial (Phase III) (Refs 50,51) |
||
|---|---|---|---|
| S-1 and low-dose CDDP, n = 32 | S-1 and high-dose CDDP, n = 148 | S-1 alone, n = 150 | |
| Efficacy | |||
| Response rate | 78.1% (25/32) | 54.0% (47/87) | 31.1% (33/106) |
| Prior chemotherapy | |||
| Absent | 80.0% (16/20) | 54.0% (47/87) | 31.1% (32/106) |
| Present | 75.1% (9/12) | — | — |
| MST | 12 months | 13 months | 11 months |
| 1-year survival | 48.1% | 54.1% | 46.7% |
| 2-year survival | 23.0% | 23.6% | 15.3% |
| Adverse events | |||
| Total (≥G3, %) | 15.6 (5/32) | 66.9 (99/148) | 24.7 (37/150) |
| Hematologic | |||
| Leukocytopenia | 0 | 11.5 | 2.0 |
| Anemia | 0 | 25.7 | 4.0 |
| Thrombocytopenia | 12.5 | 5.4 | 0 |
| Non-hematologic | |||
| Nausea/vomiting | 0 | 15.6 | 3.3 |
| Anorexia | 0 | 30.4 | 6.0 |
| Fatigue | 0 | 4.1 | 1.3 |
| HFS | 0 | 0 | 0 |
| Renal dysfunction | 3.1 | 0 | 0 |
| Convenience and quality of life (QOL) | Hydration (−) Outpatient |
Hydration (+) Hospitalization (3–4 days/5 weeks) |
Hydration (−) Outpatient |
SPIRITS, S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer; CDDP, cisplatin; MST, median survival time; HFS, hand–foot syndrome.