WJOG5008L | SPECTRA | TORG1018 | |
---|---|---|---|
Regimen | TRT + S-1 + CDDP vs TRT + VNR + CDDP | TRT + D-1 + CDDP vs TRT + PEM + CDDP | TRT + S-1 + CDDP vs TRT + DTX + CDDP |
N | 108 (54 each) | 102 (52 vs. 50) | 106 (53 each) |
RT (Gy) | 60 | 60 | 60 |
primary endpoint | 2-year OS rate | 2-year PFS rate | 2-year OS rate |
randomization period | Sep/2009 to Sep/2012 | Jan/2013 to Oct/2016 | May/2011 to Aug/2014 |
follow-up period (months) | 44.6 | 37.3 | 41.7 |
Eligibility criteria | |||
Age (years) | 20–74 | 20–74 | 20–74 |
PS | 0 or 1 | 0 or 1 | 0 or 1 |
Stage | Unresectable stage III | Unresectable stage III | Unresectable stage III |
HR for OS (95% CI) | 0.85 (0.48–1.49) | 0.95 (0.53–1.74) | 0.87 (0.49–1.55) |
Median OS (95% CI) | 40.9 (61.7–85.0) vs 39.0 (54.3–79.1) | 48.3 (32.3-NR) vs 59.1 (24.1–65.6) | 55.2 (32.7-NR) vs 50.8 (30.1-NR) |
Median PFS (95% CI) | 14.8 (10.7–18.4) vs 12.3 (10.2–14.3) | 12.7 (9.46–17.55) vs 13.8 (7.85–16.39) | 11.8 (9.5–17.1) vs 19.9 (12.3–29.9) |