Originally published as JCO Early Release 10.1200/JCO.2008.16.3758 on October 14 2008

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Cetuximab Plus Irinotecan in Heavily Pretreated Metastatic Colorectal Cancer Progressing on Irinotecan: MABEL Study

Hansjochen Wilke, Robert Glynne-Jones, Josef Thaler, Antoine Adenis, Peter Preusser, Enrique Aranda Aguilar, Matti S. Aapro, Regina Esser, Anja H. Loos, Salvatore Siena

From the Kliniken Essen-Mitte, Essen; Muenster University Clinic, Department of Clinical Oncology, Muenster; and Merck KGaA, Darmstadt, Germany; Cancer Centre, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Klinikum Kreuzschwestern Wels, Wels, Austria; Centre Oscar Lambret, Lille, France; Hospital Reina Sofía, Medical Oncology Service, Córdoba, Spain; Institut Multidisciplinaire d'Oncologie (IMO) Clinique de Genolier, Genolier, Switzerland; and Divisione Oncologia Medica Falck Ospedale Niguarda Ca’ Granda, Milano, Italy

Corresponding author: Hansjochen Wilke, MD, Kliniken Essen-Mitte,Henricistraße 92, Essen, Germany 45136; e-mail: h.wilke{at}kliniken-essen-mitte.de

Purpose This large, multinational study aimed to confirm in a community practice setting the efficacy and safety of cetuximab plus irinotecan in patients with epidermal growth factor–expressing metastatic colorectal cancer (mCRC) who had recently failed an irinotecan-containing regimen.

Patients and Methods The primary objective was to determine the progression-free survival (PFS) rate at 12 weeks. The initial cetuximab dose was 400 mg/m² and was followed weekly by 250 mg/m²; irinotecan (according to prestudy regimen) was given weekly (125 mg/m² weekly for 4 of 6 weeks), every 2 weeks (180 mg/m² each), or every 3 weeks (350 mg/m² each).

Results The intention-to-treat/safety population comprised 1,147 treated patients who received irinotecan weekly (n = 93); every 2 weeks (n = 670); every 3 weeks (n = 356); or another dose (n = 28). The PFS rate at 12 weeks was 61%, and the median survival was 9.2 months. Treatment was generally well tolerated. The most common treatment-related grades 3 to 4 adverse events were diarrhea (19%), neutropenia (10%), rash (7%), and asthenia (6%). The rate of grades 3 to 4 infusion-related reactions (IRRs; composite adverse event category) was 1% for patients who received both antihistamine and corticosteroid premedication.

Conclusion Tolerability (except IRR incidence), PFS rate, and overall survival rate were in line with previous results. At 1%, the rate of IRRs in patients who received prophylactic premedication with both antihistamine and corticosteroid is lower than previously reported. MABEL clearly confirms in a community practice setting the efficacy and safety of cetuximab plus irinotecan in the treatment of mCRC.

published online ahead of print at www.jco.org on October 13, 2008.

Presented at the 41st Annual Meeting of the American Society of Clinical Oncology, May 13-17, 2005, Orlando, FL; 42nd Annual Meeting of the American Society of Clinical Oncology, June 2-6, 2006, Atlanta, GA; American Society of Clinical Oncology Gastrointestinal Cancers Symposium, January 19-21, 2007, Orlando, FL; 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL; and 14th European Cancer Conference, September 23-27, 2007, Barcelona, Spain.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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