Efficacy according to biomarker status of cetuximab plus FOLFOX-4 as first-line treatment for metastatic XXXX : the OPUS study.

@entity901 @entity1 @entity4181 @entity984 @entity5 @entity14 @entity817 @entity1487
BACKGROUND: The randomized phase II OPUS ( @entity901 and Cetuximab in First-Line Treatment of Metastatic @entity14 ) study showed that @entity5 @entity984 mutation status was predictive for outcome in @entity1 receiving cetuximab plus FOLFOX-4 ( @entity901 / @entity1487 / @entity4181 ) as first-line therapy for metastatic @entity14 (mCRC). @entity1 AND METHODS: The biomarker analysis was extended through the use of additional DNA samples extracted from stained tissue sections. @entity984 and @entity817 @entity5 mutation status was determined for new (and for @entity817 , existing) samples using a PCR technique. Clinical outcome was reassessed according to mutation status. Overall survival data are presented. RESULTS: Of 315 @entity984 evaluable @entity1 samples (93%), 179 @entity5 (57%) were @entity984 wild type. Eleven of 309 (4%) @entity984 / @entity817 evaluable @entity5 (all @entity984 wild type) carried @entity817 mutations. The addition of cetuximab to FOLFOX-4 significantly improved progression-free survival (hazard ratio 0.567, P = 0.0064) and response (odds ratio 2.551, P = 0.0027) in @entity1 with @entity984 wild-type @entity5 . A favorable effect on survival was also observed. CONCLUSIONS: These results confirm the efficacy of cetuximab plus FOLFOX-4 in the first-line treatment of @entity1 with @entity984 wild-type mCRC and confirm @entity984 mutation status as an effective predictive biomarker. The small number of @entity5 with @entity817 mutations precluded the drawing of definitive conclusions concerning the predictive or prognostic utility of this biomarker.
