Table 2.
Outcomes of studies of docetaxel and S-1 combinations
| Author | Regimen(s) | No. of patients | Study design, phase | Tumor type | Grade 3/4 neutropenia, % | Other grade 3/4 AEs, n (%), and safety conclusion | Median OS, months | ORR, % |
|---|---|---|---|---|---|---|---|---|
| Kunisaki et al50 | Docetaxel 20–45 mg/m2 days 1 and 15 + S-1 oral 80–120 mg/day, days 1–7 and days 15–21 | 21 | I | Advanced gastric adenocarcinoma | n/a (DLT = neutropenia) | n/a | n/a | 57.1 |
| Park et al51 | Docetaxel 35 mg/m2 days 1 and 8 + S-1 oral 40 mg/m2 bid days 1–14, q3w | 52 | II | Metastatic gastric adenocarcinoma | 29.4 | Febrile neutropenia (19.6) | 13.7 | 66.7 |
| Sato et al52 | Docetaxel 60 mg/m2 day 8 + S-1 oral 40 mg/m2 bid days 1–14, q3w | 31 | II | Advanced or unresectable gastric adenocarcinoma | 51.6 (grade 4: 32) | Anorexia (29), nausea (26.6) | n/a | 87.1 |
| Yamaguchi et al53 | Docetaxel 40 mg/m2 day 1 + S-1 oral 40 mg/m2 bid days 1–14, q4w | 46 | II | Advanced gastric adenocarcinoma | 67 | Leukopenia (41), anemia (22), anorexia (22), hyponatremia (17) | 14.0 | 46 |
| Yoshida et al54 | Docetaxel 40 mg/m2 day 1 + S-1 oral 40 mg/m2 bid days 1–14, q3w | 48 | II | Advanced or recurrent gastric adenocarcinoma | 58.3 | Febrile neutropenia (8.3), leukopenia (41.7), appetite loss (14.6) | 14.3 | 56.3 |
| Nakayama et al55 | Docetaxel 40 mg/m2 + cisplatin 60–80 mg/m2 day 1 + S-1 40 mg/m2 bid days 1–14, q4w | 14 | I | Advanced gastric adenocarcinoma | n/a | DLT: grade 3 diarrhea, febrile neutropenia, delayed resumption of treatment | n/a | n/a |
Abbreviations: AE = adverse event; bid = twice daily; DLT = dose-limiting toxicity; n/a = not available; ORR = overall response rate; OS = overall survival; q3w = once every 3 weeks; q4w = once every 4 weeks.