Selection with a molecUlar PanEl foR Panitumumab EfficAcy in K-ras and n-ras wild type metastatic colorectal cancer (SUPER- PEAK)

Background

Currently we are able to exclude from anti-epidermal growth factor receptor (EGFR) treatment patients with putative refractory colorectal tumours (i.e. those harboring a RAS mutant status). However on the other hand a nonnegligible proportion of patients don't fully benefit from the use of chemotherapy in combination with anti-EGFR treatment (cetuximab or panitumumab), although in the absence of a mutation of the RAS genes. Published research data suggested that EGFR gene copy number, PIK3CA mutations, PTEN mutations or copy number variations and BRAF mutations may all represent predictive determinants for anti-EGFR therapy. However these factors were not incorporated into clinical practice particularly because prospective validation is lacking.

Trial design

The SUPER-PEAK is an ongoing, multicentre, biologically enriched, double blinded, prospectively stratified observational study. Patients receiving oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX) plus panitunumab as per indication, are divided into 2 prognostic groups on the basis of their molecular profile: favourable and unfavourable (respectively high and low probability for improved RR). According to PIK3CA mutational status, BRAF mutational status and EGFR gene copy number (GCN), patients are prospectively allocated to either the favourable group (PIK3CA and BRAF wild type and EGFR GCN ≥ 2.6) or the unfavourable group (PIK3CA mutation or BRAF mutation or EGFR GCN 

Clinical trial identification

EudraCT 2015-001408-72

Legal entity responsible for the study

Prof Mario Scartozzi

Funding

N/A

Disclosure

All authors have declared no conflicts of interest.