• 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, and Christoph C Zielinski.
• Institute of Oncology, 1000 Ljubljana, Slovenia.
• World J. Gastroenterol. 2010 Jul 7; 16 (25): 3133-43.

AimTo investigate efficacy and safety of cetuximab combined with two chemotherapy regimens in patients with unresectable metastatic colorectal cancer (mCRC).MethodsRandomized 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).ResultsNo 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.ConclusionThis 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.

41 keywords...

hide…