Table 1.
Efficacy in the RAS wild-type per-protocol population (N = 352)
| FOLFIRI plus cetuximab (N = 169) | FOLFIRI plus bevacizumab (N = 183) | OR/HR (95% CI) | P value | |
|---|---|---|---|---|
| All patients | ||||
| ORR, n (%) [95% CI] | 130 (77) [70–83] | 118 (65) [57–71] | 1.84b (1.15–2.93) | 0.014 |
| Early tumour shrinkage, n (%) (n = 320) | 105/150a (70) | 85/170a (50) | 2.33b (1.47–3.70) | 0.0004 |
| Median depth of response, % (n = 320)a | 50 | 33 | NA | <0.0001 |
| Median PFS, months (95% CI) | 10 (10–12) | 11 (10–12) | 0.99c (0.81–1.24) | 1.00 |
| Median OS, months (95% CI) | 33 (26–38) | 26 (24–29) | 0.75c (0.59–0.94) | 0.011 |
| Left-sided primary tumours | (N = 137) | (N = 136) | ||
| ORR, n (%) [95% CI] | 108 (79) (71–85) | 92 (68) (59–75) | 1.78b (1.03–3.07) | 0.041 |
| Median PFS, months (95% CI) | 11 (10–12) | 11 (10–13) | 0.97c (0.76–1.24) | 0.79 |
| Median OS, months (95% CI) | 38 (31–43) | 28 (25–32) | 0.71c (0.55–0.92) | 0.01 |
| Right-sided primary tumours | (N = 30) | (N = 45) | ||
| ORR, n (%) [95% CI] | 20 (67) (47–83) | 25 (56) (40–70) | 1.60b (0.61–4.18) | 0.47 |
| Median PFS, months (95% CI) | 7 (6–9) | 9 (7–12) | 1.56c (0.97–2.52) | 0.06 |
| Median OS, months (95% CI) | 19 (12–25) | 23 (19–24) | 1.14c (0.71–1.84) | 0.60 |
CI confidence interval, FOLFIRI fluorouracil, folinic acid and irinotecan, HR hazard ratio, NA not applicable, OR odds ratio, ORR objective response rate, OS overall survival, PFS progression-free survival.
aEarly tumour shrinkage and depth of response were centrally reviewed for all patients with available data.
bOdds ratio.
cHazard ratio.