6077 A meta-analysis of the CRYSTAL and OPUS studies combining cetuximab with chemotherapy (CT) as 1st-line treatment for patients (pts) with metastatic colorectal cancer (mCRC): Results according to KRAS and BRAF mutation status

Abstract

Results The meta-analysis of 845 pts with KRAS wt tumors demonstrated that the addition of cetuximab to CT provided a signifi cant benefi t for the primary study endpoints PFS and OR and for OS compared with pts receiving CT alone. Overall, the addition of cetuximab to CT in pts with KRAS wt tumors signifi cantly reduced the risk of disease progression by 34% (HR 0.66; 95% CI: [0.55–0.80]; p 2-fold (odds ratio 2.16; 95% CI: [1.64–2.86]; p<0.0001) compared with those pts who received CT alone. Furthermore OS was signifi cantly longer in KRAS wt pts receiving cetuximab plus CT compared with those receiving CT alone (HR 0.81; 95% CI [0.69–0.94]; p=0.006). Tests on heterogeneity did not indicate a difference in the treatment effect across studies. An analysis of the impact of BRAF mutation status on cetuximab activity is ongoing and will be presented at a later date. Conclusions The meta-analysis results strengthen the fi ndings obtained from the CRYSTAL and OPUS pt populations with KRAS wt tumors. Adding cetuximab to CT signifi cantly reduces the risk of disease progression, increases the chance of response and improves OS in the 1 st -line treatment of mCRC.