Table 2. Randomised studies evaluating epidermal growth factor receptor inhibitors in advanced colorectal cancer.
| Study | Treatment arms | Number of patients | Response rates (%) | P-value | Median progression-free survival (months) | P-value | Median overall survival (months) | P-value |
|---|---|---|---|---|---|---|---|---|
| First line | ||||||||
| Van Cutsem et al (2009) | FOLFIRI | 599 | 38.7 | — | 8.0 | — | 18.6 | — |
| CRYSTAL | FOLFIRI + cetuximab | 599 | 46.9 | 0.004 | 8.9 | 0.048 | 19.9 | 0.31 |
| Bokemeyer et al (2009) a | FOLFOX | 168 | 36 | — | 7.2 | — | NR | NR |
| OPUS | FOLFOX + cetuximab | 169 | 46 | 0.064 | 7.2 | 0.62 | NR | |
| Borner et al (2008) a | CAPOX | 37 | 14 | — | 5.8 | — | 16.5 | — |
| SAKK | CAPOX + cetuximab | 37 | 41 | NR | 7.2 | NR | 20.5 | NR |
| Heinemann et al (2008) a | CAPIRI +cetuximab | 93 | 47 | — | 6.7 | — | NR | — |
| German AIO | CAPOX + cetuximab | 92 | 48 | NR | 7.9 | NR | NR | NR |
| Ciuleanu et al (2008) a | FOLFIRI +cetuximab | 78 | 45 | — | 8.3 | — | 18.9 | — |
| CECOG | FOLFOX +cetuximab | 77 | 43 | NR | 8.6 | NS | 17.4 | NR |
| Hecht et al (2009) | FOLFOX + BEV | 410 | 48 | — | 11.4 | HR: 1.27 | 24.5 | HR: 1.43 |
| PACCE | FOLFOX + BEV + PAN | 413 | 46 | NS | 10.0 | (95% CI: 1.06–1.52) | 19.4 | (95% CI: 1.11–1.83) |
| Hecht et al (2009) | FOLFIRI + BEV | 115 | 40 | — | 11.7 | HR: 1.19 | 20.5 | HR: 1.42 |
| PACCE | FOLFIRI + BEV + PAN | 115 | 43 | NS | 10.1 | (95% CI: 0.79–1.79) | 20.7 | (95% CI: 0.77–2.62) |
| Second line | ||||||||
| Sobrero et al (2008) | Irinotecan | 650 | 4.2 | <0.0001 | 2.6 | <0.0001 | 9.99 | 0.7115 |
| EPIC | Irinotecan + cetuximab | 648 | 16.4 | 4.0 | 10.71 | |||
| Third and subsequent line | ||||||||
| Jonker et al (2007) | BSC | 285 | 0 | <0.001 | 1.8 | <0.001 | 4.6 | 0.005 |
| NCIC CO17 | Cetuximab + BSC | 287 | 8 | 1.9 | 6.1 | |||
| Van Cutsem et al (2007) | BSC | 232 | 0 | <0.0001 | 1.8 | <0.0001 | NR | 0.81 |
| Panitumumab + BSC | 231 | 10 | 2 | NR | ||||
| Cunningham et al (2004) | Cetuximab | 111 | 10.8 | 0.0074 | 1.5 | <0.001 | 6.9 | 0.48 |
| BONDa | Irinotecan + cetuximab | 218 | 22.9 | 4.1 | 4.8 | |||
| Tejpar et al (2007) EVERESTa | Irinotecan + cetuximab (standard dose) | 45 | 16 | — | 3.9 | — | 10 | — |
| Irinotecan + cetuximab (escalating dose) | 44 | 30 | NR | 4.8 | NR | 8.6 | NR | |
| Wilke et al (2008) MABELb | Irinotecan + cetuximab | 1147 | 20.1 | — | 3.2 | — | 9.2 | — |
LV=leucovorin; FOLFOX=oxaliplatin/infused 5-FU/LV; BEV=bevacizumab; FOLFIRI=irinotecan /infused 5-FU/LV; CAPOX=capecitabine/oxaliplatin; BSC=best supportive care; PAN=panitumumab; NR=not reported; HR=hazard ratio; CI=confidence interval.
The first treatment arm of each study was the control study.
All P-values were compared with control arms.
a
Randomised phase II studies.
b
Observational registry studies.