Randomised phase 3 study of panitumumab with FOLFOX compared to FOLFOX alone as 1st line treatment (tx) for metastatic colorectal cancer (mCRC): the PRIME trial


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James Cassidy1, Jean-Yves Douillard2, Salvatore Siena3, Josep Tabernero4, Ronald Burkes5, Mario Barugel6, Yves Humblet7, David Cunningham8, Michael Wolf9, Jennifer Gansert9

1Beatson Cancer Centre, Glasgow, UK, 2Centre Ren Gauducheau, Nantes, France, 3Ospedale Niguarda Ca Granda, Milan, Italy, 4Vall d'Hebrn University Hospital, Barcelona, Spain, 5Mount Sinai Hospital, Toronto, Canada, 6Hospital de Gastroenterologa, Buenos Aires, Argentina, 7Centre du Cancer de l'Universit Catholique de Louvain, Brussels, Belgium, 8The Royal Marsden NHS Foundation Trust, London, UK, 9Amgen Inc, California, USA

Abstract

Background
Panitumumab (pmab) is a fully human anti-epidermal growth factor receptor monoclonal antibody approved as monotherapy for patients (pts) with mCRC. The PRIME trial was designed to evaluate the efficacy and safety of pmab with FOLFOX vs FOLFOX alone as 1st-line tx for mCRC according to tumour KRAS mutational status (clinicaltrials.gov identifier: NCT00364013; sponsor: Amgen Inc).

Method
This was a randomised, multicenter, phase 3 study. Pts were randomised 1:1 to receive pmab 6.0 mg/kg Q2W+FOLFOX (Arm 1) vs FOLFOX alone (Arm 2).