• Fischer von Weikersthal Ludwig L Klinikum Sankt Marien, Amberg, Germany., Andreas Schalhorn, Martina Stauch, Detlef Quietzsch, Peter A Maubach, Helmut Lambertz, Daniel Oruzio, Rudolf Schlag, Karin Weigang-Köhler, Ute Vehling-Kaiser, Manfred Schulze, Juergen Truckenbrodt, Mariele Goebeler, Johann Mittermüller, Daniel Bosse, Borika Szukics, Marc Grundeis, Thomas Zwingers, Clemens Giessen, and Volker Heinemann.
• Klinikum Sankt Marien, Amberg, Germany.
• Eur. J. Cancer. 2011 Jan 1; 47 (2): 206-14.

PurposeTo determine whether irinotecan plus oxaliplatin (mIROX) is superior to irinotecan plus infusional 5-fluorouracil, leucovorin (FUFIRI) as first-line therapy of patients with metastatic colorectal cancer (mCRC).Patients And MethodsA phase III, randomised, open-label multicentre study compared standard treatment with FUFIRI (irinotecan 80 mg/m(2), 5-fluorouracil 2000 mg/m(2), folinic acid 500 mg/m(2) weekly times 6) to mIROX using an identical schedule of irinotecan plus oxaliplatin 85 mg/m(2) applied on days 1, 15 and 29 of a 7-week cycle. The primary end-point was progression-free survival (PFS).ResultsA total of 479 eligible patients were randomly assigned. Progression-free survival was 7.2 months in the mIROX arm and 8.2 months in the FUFIRI arm [hazard ratio=1.14; 95% confidence interval (CI) 0.94-1.37; P=0.178]. Comparable results were also obtained for overall survival time with 19 months in the mIROX-arm and 22 months in the FUFIRI-arm (hazard ratio=1.08, P=0.276). Both regimens induced an identical objective response rate (ORR) of 41%, but disease control rate (ORR plus stable disease) was significantly greater in the FUFIRI group (81% versus 68%, P=0.001). Most frequent grades 1-4 side-effects of mIROX and FUFIRI treatment were nausea (80% versus 73%) and delayed diarrhoea (79% versus 68%). Grades 3-4 toxicities were generally below 10%, except for diarrhoea which was more frequent in the mIROX-arm compared to the FUFIRI-arm (19% versus 30%, P=0.006)ConclusionmIROX failed to show superior activity compared to high-dose 5-FU/folinic acid plus irinotecan. Due to better tolerability the combination of high-dose 5-FU/folinic acid and irinotecan remains a standard of care in first-line treatment of metastatic colorectal cancer.Copyright © 2010 Elsevier Ltd. All rights reserved.

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