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Title: Cetuximab Alone or With Irinotecan for Resistant KRAS-, NRAS-, BRAF- and PIK3CA-wild-type Metastatic Colorectal Cancer: The AGITG Randomized Phase II ICECREAM Study.
Austin Authors: Shapiro, Jeremy D;Thavaneswaran, Subotheni;Underhill, Craig R;Robledo, Kristy P;Karapetis, Christos S;Day, Fiona L;Nott, Louise M;Jefford, Michael;Chantrill, Lorraine A;Pavlakis, Nick;Tebbutt, Niall C ;Price, Timothy J;Khasraw, Mustafa;Van Hazel, Guy A;Waring, Paul M;Tejpar, Sabine;Simes, John;Gebski, Val J;Desai, Jayesh;Segelov, Eva
Affiliation: Department of Medical Oncology, Geelong Hospital, Geelong, Victoria, Australia
Department of Oncology, Monash Health and Monash University, Clayton, Victoria, Australia
Cabrini Haematology and Oncology Centre, Cabrini Hospital and Monash University, Malvern, Victoria, Australia
Oncology Department, University Hospital Leuven, Leuven, Belgium
Department of Medical Oncology, Royal Melbourne Hospital and Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia
Albury-Wodonga Regional Cancer Centre and University of New South Wales, East Albury, New South Wales, Australia
Department of Medical Oncology, Flinders Medical Centre and Flinders Centre for Innovation in Cancer, Flinders University, Bedford Park, South Australia, Australia
Department of Medical Oncology, Calvary Mater Newcastle Hospital and University of Newcastle, Waratah, New South Wales, Australia
Department of Medical Oncology, Royal Hobart Hospital, Hobart, Tasmania, Australia
Department of Medical Oncology, Peter MacCallum Cancer Centre, Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia
Department of Medical Oncology, Kinghorn Cancer Centre, St Vincent's Hospital and University of New South Wales, Darlinghurst, New South Wales, Australia
Northern Cancer Institute, Royal North Shore Hospital, and University of Sydney, St Leonards, New South Wales, Australia
Department of Medical Oncology, Austin Health, Heidelberg, Victoria, Australia
Medical Oncology Unit, Queen Elizabeth Hospital and Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia
School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia, Australia
Department of Pathology, University of Melbourne, Melbourne, Victoria, Australia
Issue Date: Dec-2018 2018-06-08
Publication information: Clinical colorectal cancer 2018; 17(4): 313-319
Abstract: 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 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. From 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. In 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.
DOI: 10.1016/j.clcc.2018.06.002
PubMed URL: 30463680
Type: Journal Article
Subjects: Cetuximab
Chemotherapy colon cancer
Appears in Collections:Journal articles

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