Table 1.
Major phase 3 trials involving biologics in combination with chemotherapy in the advanced/metastatic gastric cancer setting
| Trial | No. of patients | Treatment arms |
HR for OS/Death (P value) |
Survival Comparison (in months) |
|---|---|---|---|---|
| First line | ||||
| Lordick et al 5 (EXPAND trial) | 904 | CX and cetuximab vs CX | 1.004 (0.9547) | OS: 9.4 vs 10.7 |
| Waddell et al 6 (REAL-3 trial) | 553 | EOC and panitumumab vs EOC | 1.37 (0.013) | OS: 8.8 vs 11.3 |
| Bang et al 18 (ToGA trial) | 584 | CX, CF and trastuzumab vs CX and CF* | 0.74 (0.0046) | OS: 13.8 vs 11.1 |
| Hecht et al 19 (TRIO-013/LOGIC trial) | 545 | CapeOx and lapatinib vs CapeOx and placebo | 0.91 (0.35) | OS: 12.2 vs 10.5 |
| Ohtsu et al 12 (AVAGAST trial) | 774 | Cisplatin, 5FU and bevacizumab vs cisplatin and 5FU | 0.87 (0.1002) | OS: 12.1 vs 10.1 PFS: 6.7 vs 5.3 |
| Second line | ||||
| Dutton et al 3 (UK COG trial) | 449 | Gefitinib vs placebo | 0.9 (0.29) | OS: 3.73 vs 3.63 |
| Fuchs et al 15 (REGARD trial) | 355 | BSC and ramucirumab vs BSC | 0.776 (0.047) | OS: 5.2 vs 3.8 |
| Wilke et al 16 (RAINBOW trial) | 665 | Paclitaxel and ramucirumab vs paclitaxel | 0.81 (0.017) | OS: 9.6 vs 7.4 |
| Satoh et al 20 (TyTAN trial) | 420 | Paclitaxel and lapatinib vs lapatinib | 0.84 (0.2088) | OS: 11.0 vs 8.9 |
| Third line | ||||
| Qin et al 17 | 271 | BSC and apatinib vs BSC | 0.71 (0.015) | OS: 6.5 vs 4.7 PFS: 2.6 vs 1.8 |
| Ohtsu et al 25 (GRANITE-1 trial) | 656 | BSC and everolimus vs BSC and placebo | 0.90 (0.1244) | OS: 5.4 vs 4.3 |
*
Hazard ratio reduced to 0.8 on follow-up analysis
HR: hazard ratio; OS: Overall survival; PFS: Progression free survival; CX: Cisplatin and Capecitabine; EOC: Epirubicin, Oxaliplatin and Capecitabine; BSC: Best supportive care; CF: Cisplatin and 5FU; Cape Ox: Capecitabine and Oxaliplatin.