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Use of cetuximab in a real-life setting in France with respect to KRAS status: Preliminary results of EREBUS cohort study.

e14094 Background: Cetuximab demonstrated survival outcome improvement in metastatic colorectal cancer (mCRC). Cetuximab was first launched as a second-line therapy in mCRC. In July 2008, this indication was extended to first-line therapy and restricted to mCRC patients with wild-type (wt) KRAS gene. We present here the preliminary results of the French EREBUS cohort study to describe cetuximab prescription patterns according to KRAS status in a real-life setting.


METHODS
EREBUS is a cohort study conducted in 93 French centres. Patients initiating cetuximab between Jan and Dec 2009 were identified from nominative hospital pharmacy dispensations. The cohort included mCRC patients treated in first-line were followed for 12 months to evaluate the rate of metastases resection, usage patterns, safety and effectiveness of cetuximab.


RESULTS
To date, 1044 patients treated by cetuximab for colorectal cancer have been identified. The investigation of KRAS status was performed in 94.3% patients, and of these 94.7% had wt KRAS gene. The investigation was performed on primary tumour (83.0%), on metastases (16.0%) or both (1.0%). The main reasons of absence of KRAS status investigation were: previous treatment by cetuximab (63.4%) and absence of available tumour material or technical issue with analysis (26.8%). Investigation of EGFR expression was performed for only 2.4% patients. Cetuximab was mainly prescribed in mCRC (97.9%): 34.5% as first-line therapy, 34.1% as second-line, 21.4% as third-line and 9.6% as fourth-line or more. Investigation of KRAS and wt status were similar whatever the type of treatment (investigation: between 93.2% and 100.0%; wt status: between 93.6% and 100.0%). Among the 74 mCRC patients treated in first-line: cetuximab was combined with irinotecan-based regimen (61.6%), oxaliplatin-based regimen (37.0%) or FOLFIRINOX (1.4%). Cetuximab was given weekly (31.1%) or every 2 weeks (68.9%).


CONCLUSIONS
EREBUS is the first post-marketing cohort study conducted in France to describe the usage patterns of cetuximab. Extensive investigation of KRAS status and the high proportion of patients with wt status indicates adherence to market authorisation, although EGFR expression remains rarely investigated.