Table IV.
Summary of previous studies in combination therapy of gemcitabine and S-1.
| Treatment schedule | Grade 3/4 toxicity (%) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Subject | Gemcitabine | S-1 | Interval | n | ORR (%) | PFS/TTP (month) | OS (month) | Leukopenia | Neutropenia | Thrombocytopenia | Anemia | (Refs.) |
| 1st-line, elderly (≥70) | 1,000 mg/m2, days 8 and 15 | 30 mg/m2 b.i.d., days 1–14 | q4w | 37 | 27.0 (95% CI: 15–42) | 4.2 (95% CI: 3.2–5.7) | 12.9 (95%CI: 10.4–14.7) | 27.0 | 45.9 | 13.5 | 13.5 | (17) |
| 1st-line | 1,000 mg/m2, days 1 and 8 | 30 mg/m2 b.i.d., days 1–14 | q3w | 41 | 22.0 (95% CI: 10.6–37.6) | 4.1 (95% CI: 2.8–5.6) | 15.5 (95% CI: 8.0–23.6) | 26.8 | 61.0 | 4.9 | 2.4 | (18) |
| 1st-line | 1,000 mg/m2, days 8 and 15 | 30 mg/m2 b.i.d., days 1–14 | q3w | 38 | 28.9 (95% CI: 15.4–45.9) | 5.5 (95% CI: 3.8–6.3) | 18.8 (95% CI: 11.7–23.9) | 28.9 | 50.0 | 18.4 | 5.3 | |
| 2nd-/3rd-line | 1,000 mg/m2, days 8 and 15 | 30 mg/m2 b.i.d., days 1–14 | q3w | 34 | 23.5 (95% CI: 9.1–38.0) | 6.6 (95% CI: 4.2–7.8) | 19.9 (95% CI: 9.3–22.2) | 21.0 | 50.0 | 12.0 | 18.0 | (19) |
| 1st-line, elderly (≥70) | 1,000 mg/m2, days 1 and 15 | 40 mg/m2 b.i.d., days 1–14 | q4w | 20 | 40.0 (95% CI: 18.5–61.5) | 6.4 (95% CI: 4.0–17.0) | 17.8 (95% CI: 7.0–46.0) | 29.0 | 24.0 | 0.0 | 0.0 | The present study |
ORR, overall response rate; PFS, progression-free-survival; TTP, time to progression; OS, overall survival; b.i.d., bis in die; CI, confidence interval.