TY - JOUR
T1 - Cetuximab plus FOLFOX6 or FOLFIRI in metastatic colorectal cancer
T2 - Cecog trial
AU - Ocvirk, Janja
AU - Brodowicz, Thomas
AU - Wrba, Fritz
AU - Ciuleanu, Tudor E.
AU - Kurteva, Galina
AU - Beslija, Semir
AU - Koza, Ivan
AU - Pápai, Zsuzsanna
AU - Messinger, Diethelm
AU - Yilmaz, Ugur
AU - Faluhelyi, Zsolt
AU - Yalcin, Suayib
AU - Papamichael, Demetris
AU - Wenczl, Miklós
AU - Mrsic-Krmpotic, Zrinka
AU - Shacham-Shmueli, Einat
AU - Vrbanec, Damir
AU - Esser, Regina
AU - Scheithauer, Werner
AU - Zielinski, Christoph C.
PY - 2010/7/7
Y1 - 2010/7/7
N2 - 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.
AB - 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.
KW - 5-fluorouracil folinic acid and irinotecan
KW - 5-fluorouracil folinic acid and oxaliplatin
KW - Cetuximab
KW - KRAS
KW - Metastatic colorectal cancer
UR - http://www.scopus.com/inward/record.url?scp=77954372574&partnerID=8YFLogxK
U2 - 10.3748/wjg.v16.i25.3133
DO - 10.3748/wjg.v16.i25.3133
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C2 - 20593498
AN - SCOPUS:77954372574
SN - 1007-9327
VL - 16
SP - 3133
EP - 3143
JO - World Journal of Gastroenterology
JF - World Journal of Gastroenterology
IS - 25
ER -
