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Cetuximab plus FOLFOX6 or FOLFIRI in metastatic colorectal cancer: CECOG trial

World Journal of Gastroenterology 2010年第25期16卷 3133-3143页

作者： Janja Ocvirk Thomas Brodowicz Fritz Wrba Tudor E Ciuleanu Galina Kurteva semir beslija Ivan Koza Zsuzsanna Pápai Diethelm Messinger Ugur Yilmaz Zsolt Faluhelyi Suayib Yalcin Demetris Papamichael Miklós Wenczl Zrinka Mrsic-Krmpotic Einat Shacham-Shmueli Damir Vrbanec Regina Esser Werner Scheithauer Christoph C Zie-linski Institute of Oncology 1000 Ljubljana Slovenia Clinical Division of Oncology Department of Medicine I Medical University of Vienna 1090 Vienna Austria Clinical Institute of Pathology Medical University of Vienna 1090 Vienna Austria Institutul Oncologic Cluj 400015 Cluj-Nap-oca Romania Department of Oncology National Specialized Hospital of Active Treatment in Oncology 1754 Sofi a Bulgaria Institute of Oncology Clinical Center of Sara-jevo University 71000 Sarajevo Bosnia-Herzegovina Department of Oncology National Cancer Institute 83310 Bratislava Slovak Republic AEK Onkologiai Osztaly 1122 Budapest Hungary Biometrics IST GmbH 68219 Mannheim Germany Department of Gastroenterology 9 Eylül Univer-sity Medical Faculty 35340 Izmir Turkey Oncology Department Veszprém County Hos-pital 8200 Veszprém Hungary Institute of Oncology Ankara Hacettepe Univer-sity 06100 Ankara Turkey Department of Medical Oncology Bank of Cyprus Oncology Center 2006 Nicosia Cyprus Department of Oncoradiology Markusovszky Teaching Hospital 9700 Szombathely Hungary Department of Medical Oncology Uni-versity Hospital for Tumors 10000 Zagreb Croatia Oncology Division Tel-Aviv Souraski Medical Center Tel Aviv 64239 Israel KBC Rebro Oncology Department 10000 Zagreb Croatia Merck KGaA D64293 Darmstadt Germany

AIM: To investigate efficacy and safety of cetuximab combined with two chemotherapy regimens in patients with unresectable metastatic colorectal cancer (mCRC). METHODS: Randomized patients received cetuximab with 5-fluorouracil (5-FU), folinic acid (FA) and oxaliplatin (FOLFOX) 6 (arm A, n = 74) or 5-FU, FA and irinotecan (FOLFIRI) (arm B, n = 77). KRAS mutation status was determined retrospectively in a subset of tumors (n = 117). RESULTS: No significant difference was found between treatment arms A and B in the progression-free survival (PFS) rate at 9 mo, 45% vs 34%; median PFS, 8.6 mo vs 8.3 mo [hazard ratio (HR) = 1.06]; overall response rate (ORR) 43% vs 45% [odds ratio (OR) = 0.93] and median overall survival (OS), 17.4 mo vs 18.9 mo (HR = 0.98). Patients with KRAS wild-type tumors demonstrated improved PFS (HR = 0.55, P = 0.0051), OS, (HR = 0.62, P = 0.0296) and ORR (53% vs 36%) and in arm A, improved PFS (HR = 0.49, P = 0.0196), OS (HR = 0.48, P = 0.0201) and ORR (56%vs 30%), compared with patients with KRAS mutated tumors. In arm B no significant differences were found in efficacy by KRAS mutation status. Treatment in arms A and B was generally well tolerated. CONCLUSION: This study confirms that combinations of cetuximab with FOLFOX6 or FOLFIRI are effective and significantly improve clinical outcome in KRAS wild-type compared with KRAS mutated mCRC.

关键词： Cetuximab 5-fluorouracil folinic acid and oxaliplatin 5-fluorouracil folinic acid and irinotecan KRAS Metastatic colorectal cancer

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