Table 2.
One-year and overall survival results from the REAL 2 trial (4 therapy arms in a 2×2 design).31
| 2×2 Comparisons Per Protocol | 1-year OS (95% CI) | Median OS | HR (95% CI) |
|---|---|---|---|
| 5-FU: ECF + EOF | 39.4% (35.0–43.7) | 9.6 months | 1 |
| Capecitabine: ECX + EOX | 44.6% (40.1–49.0) | 10.9 months | 0.86 (0.75–0.99)* |
| Cisplatin: ECF + ECX | 40.1% (35.7–44.4) | 10.1 months | 1 |
| Oxaliplatin: EOX + EOF | 43.9% (39.4–48.4) | 10.4 months | 0.92 (0.80–1.05)* |
| Regimens ITT | |||
| ECF (n = 263) | 37.7% (31.8–43.6) | 9.9 months | 1 |
| EOF (n = 245) | 40.4% (34.2–46.5) | 9.3 months | 0.95 (0.79–1.15) |
| ECX (n = 250) | 40.8% (34.7–46.9) | 9.9 months | 0.92 (0.76–1.11) |
| EOX (n = 244) | 46.8% (40.4–52.9) | 11.2 months | 0.80 (0.65–0.97)† |
There were no significant differences in response rates comparing ECF to EOF, ECX and EOX (41%, 42%, 46%, and 48%, respectively); grade 3/4 nonhematologic toxicity 36%, 42%, 33%, and 45%; and grade 3/4 neutropenia 42%, 30% (P = .008), 51% (P = .043), and 28% (P = .001), respectively.
The upper limit of the 95% CI < 1.23. We can therefore conclude noninferiority.
P = .025 comparison with ECF
Abbreviations: CI, confidence interval; ECF, epirubicin/cisplatin/5-FU; ECX, epirubicin/cisplatin/capecitabine; EOF, epirubicin/oxaliplatin/5-FU; EOX, epirubicin/oxaliplatin/capecitabine; HR, hazard ratio; ITT, intent to treat; OS, overall survival.
Reprinted with permission from the American Society of Clinical Oncology. Cunningham D, Rao S, Starling N, et al: Randomized multicenter phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced esophagogastric cancer. The REAL 2 trial. 2006 ASCO Annual Meeting Proceedings. J Clin Oncol 24:18S, 2006 (abstr LBA4017)