• Clin Colorectal Cancer · Dec 2018

    Randomized Controlled Trial Multicenter Study Comparative Study

    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, and Eva Segelov.
    • Cabrini Haematology and Oncology Centre, Cabrini Hospital and Monash University, Malvern, Victoria, Australia. Electronic address: jeremy.shapiro@monash.edu.
    • Clin Colorectal Cancer. 2018 Dec 1; 17 (4): 313-319.

    BackgroundThe 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 MethodsPatients 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.ResultsFrom 2012 to 2016, 48 patients were recruited. Two were ineligible, and 2 were not evaluable for response. Characteristics were balanced, except gender (male, 62% vs. 72%) and primary sidedness (left, 95% vs. 68%). For cetuximab compared with cetuximab-irinotecan, progression-free survival was 14% versus 41% (hazard ratio, 0.39; 95% confidence interval, 0.20-0.78; P = .008); response rate was 10% (2 partial responses) versus 38% (1 complete, 8 partial); P = .04. Grade 3 to 4 toxicities were less with cetuximab monotherapy (23% vs. 50%); global and specific quality of life scores did not differ.ConclusionIn comparison with cetuximab alone, cetuximab plus irinotecan increases the response rate and delays progression in irinotecan-resistant RAS wild-type colorectal cancer. This echoes data from molecularly unselected patients.Crown Copyright © 2018. Published by Elsevier Inc. All rights reserved.

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