Table 4. Tumour response of patients with KRAS WT (n=54) and KRAS MT (n=10) metastatic or locally advanced colorectal cancer treated with anti-EGFR therapy according to ROC curve based cut-off values of EGFR GCN and chromosome 7 number evaluated by SISH.
Treatment response
|
PFS
|
OS
|
|||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Total no. of patients | PR | SD | PD | P-value Fisher's exact test | PFS time median (days) | P-value log-rank test | P-value Cox testa | HR | 95% CI | OS time median (days) | P-value log-rank test | P-value Cox testa | HR | 95% CI | |
KRAS WT and MT patients | 54 | ||||||||||||||
KRAS status | |||||||||||||||
KRAS WT | 44 | 11 (25) | 15 (34.1) | 18 (40.9) | NS | 151 | 0.01 | 0.01 | 0.40 | 0.20–0.84 | 352 | 0.3 | 0.3 | 0.67 | 0.32–1.38 |
KRAS MT | 10 | 0 | 3 (30) | 7 (70) | 81 | 249 | |||||||||
EGFR GCN status | |||||||||||||||
EGFR GCN ⩾4.0 | 34 | 10 (29.4) | 15 (44.1) | 9 (26.5) | 0.0006 | 224 | <0.0001 | <0.0001 | 0.21 | 0.10–0.43 | 483 | 0.004 | 0.006 | 0.41 | 0.22–0.77 |
EGFR GCN <4.0 | 20 | 1 (5) | 3 (15) | 16 (80) | 84 | 134 | |||||||||
KRAS WT patients | |||||||||||||||
EGFR GCN | |||||||||||||||
⩾4.0 | 28 | 10 (35.7) | 13 (46.4) | 5 (17.9) | 0.0002 | 244 | <0.0001 | <0.0001 | 0.17 | 0.07–0.39 | 598 | 0.001 | 0.002 | 0.32 | 0.16–0.66 |
<4.0 | 16 | 1 (6.2) | 2 (12.5) | 13 (81.3) | 84 | 134 | |||||||||
Chromosome 7 number | |||||||||||||||
⩾4.5 | 24 | 9 (37.5) | 10 (41.7) | 5 (20.8) | 0.009 | 214 | 0.2 | 0.2 | 0.67 | 0.35–1.29 | 520 | 0.1 | 0.1 | 0.56 | 0.28–1.13 |
<4.5 | 20 | 2 (10) | 5 (25) | 13 (65) | 94 | 225 | |||||||||
KRAS MT patients | |||||||||||||||
EGFR GCN | |||||||||||||||
⩾4.0 | 6 | 0 | 2 (33.3) | 4 (66.7) | NS | 94 | NS | 369 | NS | ||||||
<4.0 | 4 | 0 | 1 (25) | 3 (75) | 77 | 134 | |||||||||
Chromosome 7 number | |||||||||||||||
⩾4.5 | 6 | 0 | 2 (33.3) | 4 (66.7) | NS | 94 | NS | 369 | NS | ||||||
<4.5 | 4 | 0 | 1 (25) | 3 (75) | 77 | 134 |
Abbreviations: CI=confidence interval; CR=complete response; EGFR=epidermal growth factor receptor; GCN=gene copy number; HR=hazards ratio; MT=mutated; NS=not significant; OS=overall survival; PD=progressive disease; PFS=progression-free survival; PR=partial response; ROC= receiver operating characteristic; SD=stable disease; SISH=silver in situ hybridisation; WT=wild type.
Cox proportional hazards regression model. Treatment response values are given n (%). Significant P-values are shown in bold type.