Cetuximab Alone or With Irinotecan for Resistant KRAS-, NRAS-, BRAF- and PIK3CA-wild-type Metastatic Colorectal Cancer: The AGITG Randomized Phase II ICECREAM Study
Jeremy D Shapiro, Subotheni Thavaneswaran, Craig R Underhill, Kristy P Robledo, Christos S Karapetis, Fiona L Day, Louise M Nott, Michael Jefford, Lorraine A Chantrill, Nick Pavlakis, Niall C Tebbutt, Timothy J Price, Mustafa Khasraw, Guy A Van Hazel, Paul M Waring, Sabine Tejpar, John Simes, Val J Gebski, Jayesh Desai, Eva Segelov
CLINICAL COLORECTAL CANCER | CIG MEDIA GROUP, LP | Published : 2018
BACKGROUND: The Irinotecan Cetuximab Evaluation and Cetuximab Response Evaluation (ICECREAM) study assessed the efficacy of cetuximab monotherapy compared with cetuximab combined with chemotherapy for quadruple wild-type (KRAS, NRAS, BRAF, or P13KCA exon 20) metastatic colorectal cancer. PATIENTS AND METHODS: Patients were enrolled in an open-label, multicenter, phase II trial and randomly assigned to cetuximab 400 mg/m2, then 250 mg/m2 cetuximab weekly, with or without irinotecan 180 mg/m2 every 2 weeks. The primary endpoint was 6-month progression-free survival; secondary endpoints were response rate, overall survival, toxicity, and quality of life. RESULTS: From 2012 to 2016, 48 patients ..View full abstract
This work was supported by an unrestricted medical grant from Merck Serono Australia, an affiliate of Merck KGaA, Darmstadt, Germany, to the Australasian Gastro-Intestinal Trials Group (AGITG).