Table 2.
Efficacy outcomes according to RAS status and predictive model in training cohort.
| RAS assessable (n=106) |
RAS wild-type (n=93) |
RAS wild-type/ Model-defined responsive group (n=66) |
RAS wild-type/ Model-defined refractory group (n=27) |
|||||
|---|---|---|---|---|---|---|---|---|
| Cetuximab plus chemotherapy (n=50) |
Chemotherapy alone (n=56) |
Cetuximab plus chemotherapy (n=45) |
Chemotherapy alone (n=48) |
Cetuximab plus chemotherapy (n=29) |
Chemotherapy alone (n=37) |
Cetuximab plus chemotherapy (n=16) |
Chemotherapy alone (n=11) |
|
| Overall response | ||||||||
| CR | 1 (2.0%) | 0 (0%) | 1 (2.2%) | 0 (0%) | 1 (3.4%) | 0 (0%) | 0 (0%) | 0 (0%) |
| PR | 28 (56.0%) | 17 (30.4%) | 27 (60.0%) | 14 (29.2%) | 23 (79.3%) | 11 (29.7%) | 4 (25.0%) | 3 (27.3%) |
| SD | 14 (28.0%) | 21 (37.5%) | 12 (26.7%) | 19 (39.6%) | 3 (10.3%) | 14 (37.8%) | 9 (56.3%) | 5 (45.5%) |
| PD | 7 (14.0%) | 15 (26.8%) | 5 (11.1%) | 13 (27.1%) | 2 (6.9%) | 10 (27.0%) | 3 (18.8%) | 3 (27.3%) |
| Not assessable∗ | 0 (0%) | 3 (5.4%) | 0 (0%) | 2 (4.2%) | 0 (0%) | 2 (5.4%) | 0 (0%) | 0 (0%) |
|
| ||||||||
| ORR, % | 58.0 | 30.4 | 62.2 | 29.2 | 82.8 | 29.7 | 25.0 | 27.3 |
| OR | 3.17 | 4.00 | 11.35 | 0.889 | ||||
| 95% CI | 1.42-7.05 | 1.68-9.51 | 3.44-37.44 | 0.155-5.084 | ||||
| p (Chi-square or Fisher's) | 0.004 | 0.001 | <0.001 | 1.000 | ||||
| p for interaction test | 0.006 | |||||||
|
| ||||||||
| Radical resection rate of LM, % | 28.0 | 8.9 | 28.8 | 8.3 | 37.9 | 8.1 | 12.5 | 9.1 |
| OR | 3.97 | 4.47 | 6.93 | 1.43 | ||||
| 95% CI | 1.31-12.0 | 1.33-14.98 | 1.71-28.05 | 0.11-18.04 | ||||
| p (Chi-square or Fisher's) | 0.011 | 0.010 | 0.003 | 1.000 | ||||
|
| ||||||||
| PFS, months | ||||||||
| Median | 9.5 | 5.6 | 9.8 | 5.3 | 11.8 | 4.8 | 7.8 | 8.2 |
| 95%CI | 8.7-11.3 | 3.8-6.2 | 9.1-10.8 | 3.9-6.1 | 8.1-13.9 | 3.9-6.1 | 5.2-8.8 | 3.8-8.3 |
| HR | 0.60 | 0.52 | 0.25 | 1.25 | ||||
| 95%CI | 0.39-0.91 | 0.33-0.81 | 0.13-0.48 | 0.52-2.99 | ||||
| p (log-rank) | 0.010 | 0.002 | <0.001 | 0.588 | ||||
| p for interaction test | 0.001 | |||||||
|
| ||||||||
| OS, months | ||||||||
| Median | 30.0 | 22.1 | 35.1 | 21.7 | 39.6 | 20.0 | 25.6 | 33.8 |
| 95%CI | 15.3-42.6 | 17.0-25.0 | 21.4-44.6 | 17.5-24.5 | 25.6-48.4 | 12.9-27.1 | 18.1-29.9 | 11.2-48.8 |
| HR | 0.54 | 0.44 | 0.19 | 2.30 | ||||
| 95%CI | 0.30-0.97 | 0.23-0.83 | 0.08-0.47 | 0.61-8.77 | ||||
| p (log-rank) | 0.034 | 0.009 | <0.001 | 0.200 | ||||
| p for interaction test | 0.002 | |||||||
∗ 2 early deaths (less than 3 months) and 1 lost to follow-up before the first time evaluation by MDT.
CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; ORR, objective response rate; LM, liver metastases; PFS, progression free survival; OS, overall survival; HR, hazard ratio; OR, odds ratio; 95% CI, 95% confidence interval. MDT, multidisciplinary team; NE, not evaluable.