Table 2.
Key phase III trials in metastatic colorectal cancer
| Author/trial | n | Arms | RR (%) | TTP (mo) | OS (mo) |
| Van Cutsem[48] | 602 | Capecitabine | 18.90 | 5.2 | 13.2 |
| 5FU/LV Mayo | 15.00 | 4.7 | 12.1 | ||
| (P NA) | (P = 0.65 NS) | (P = 0.33 NS) | |||
| De Gramont[53] | 420 | FOLFOX4 | 50.70 | 9 | 16.2 |
| LV5FU2 | 22.30 | 6.2 | 14.7 | ||
| (P = 0.0001) | (P = 0.0003) | (P = 0.12 NS) | |||
| Hochster | 147 | FOLFOX | 41 | 8.7 | 19.2 |
| TREE-1[56] | bFOL | 20 | 6.9 | 17.9 | |
| CapeOx | 27 | 5.9 | 17.2 | ||
| (P NA) | (P NA) | (P NA) | |||
| Hochster | 213 | FOLFOX + bevacizumab | 52 | 9.9 | 26 |
| TREE-2[56] | bFOL + bevacizumab | 39 | 8.3 | 20.7 | |
| CapeOx + bevacizumab | 46 | 10.3 | 27 | ||
| (P NA) | (P NA) | (P NA) | |||
| Fuchs | 430 | FOLFIRI | 46.60 | 7.6 | 23.1 |
| BICC-Ca[66] | mIFL | 41.90 | 5.8 | 17.6 | |
| (P = 0.10) | |||||
| CAPIRI | 38 | 5.5 | 18.9 | ||
| (P NA) | (P NA) | (P = 0.19 NS) | |||
| Fuchs | 117 | FOLFIRI + bevacizumab | 54.40 | 9.9 | NR |
| BICC-C 2[66] | mIFL + bevacizumab | 53.30 | 8.3 | 18.7 | |
| (P NA) | (P NA) | ||||
| Saltz[62] | 683 | IFL | 39 | 7 | 14.8 |
| 5FU/LV (Mayo) | 21 | 4.3 | 12.6 | ||
| (P < 0.001) | (P = 0.004) | (P = 0.04) | |||
| Irinotecan | |||||
| Douillard[63] | 387 | FOLFIRI | 35 | 6.7 | 17.4 |
| LV5FU2 (AIO) | 22 | 4.4 | 14.1 | ||
| (P =0.005) | (P < 0.001) | (P = 0.031) | |||
| Tournigand[88] | 220 | FOLFIRI ≥ FOLFOX6 | 56 | 8.5 | 21.5 |
| GERCOR | FOLFOX6 ≥ FOLFIRI | 54 | 8 | 20.6 | |
| (P = NS) | (P = 0.26 NS) | (P = 0.99 NS) | |||
| Goldberg[89] | 795 | FOLFOX4 | 45 | 8.7 | 19.5 |
| N9741 | IFL | 31 | 6.9 | 15 | |
| (P = 0.002) | (P = 0.0014) | (P = 0.0001) | |||
| IROX | 35 | 6.5 | 17.4 | ||
| (P = 0.03) | (P = 0.001) | (P = 0.09 NS) | |||
| Colucci[90] | 360 | FOLFIRI | 31 | 7 | 14 |
| FOLFOX4 | 34 | 7 | 15 | ||
| (P = 0.60 NS) | (P = NS) | (P = 0.28 NS) | |||
| Ross[71] | 200 | Mitomycin C + infusional 5FU | 54 | 7.9 | 14 |
| Infusional 5FU | 38 | 5.4 | 15 | ||
| (P = 0.024) | (P = 0.033) | (P = NS) | |||
| Souglakos et al[91] | 283 | FOLFOXIRI | 43 | 8.4 | 21.5 |
| FOLFIRI | 33.6 | 6.9 | 19.5 | ||
| (P = 0.168 NS) | (P = 0.17 NS) | (P = 0.337 NS) | |||
| Falcone [92] | 244 | FOLFOXIRI | 66 | 9.8 | 22.6 |
| FOLFIRI | 41 | 6.9 | 16.7 | ||
| (P = 0.0002) | (P = 0.0006) | (P = 0.032) | |||
| Hurwitz[24] | 813 | IFL + bevacizumab | 44.8 | 10.6 | 20.3 |
| IFL | 34.8 | 6.2 | 15.6 | ||
| (P = 0.004) | (P < 0.001) | (P < 0.001) | |||
| Giantonio[78] | 822 | FOLFOX4 + bevacizumab | 22 | 7.2 | 12.9 |
| ECOGE 3200 | FOLFOX4 | 9 | 4.8 | 10.8 | |
| (P < 0.0001) | (P = 0.0018) | ||||
| Bevacizumab | Discontinued | ||||
| Cunningham[81] | 329 | Cetuximab + irinotecan | 22.9 | 4.1 | 8.6 |
| BOND-1 | Irinotecan | 10.8 | 1.5 | 6.9 | |
| (P = 0.007) | (P < 0.001) | (P = 0.48 NS) | |||
| BOND-2[102] | 74 | Cetuximab + irinotecan + bevacizumab | 38 | 8.5 | n/a |
| cetuximab + bevacizumab | |||||
| 23 | 6.9 | n/a | |||
| Peeters[87] | 463 | Panitumumab | Improved PFS | Approx 6.5 m both arms | |
| BSC | (HR 0.54 P < 0.0001) | (P = NS) |
NS: Not significant; BSC: Best supportive care; NA: Not available. aIn the BICC-C trial all arms were also randomized to +/- celecoxib, which neither improved efficacy nor toxicity of chemotherapy.