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Clinical Trial
. 2010 Jul 7;16(25):3133-43.
doi: 10.3748/wjg.v16.i25.3133.

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

Janja Ocvirk  1 , 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 Zielinski
Affiliations
Clinical Trial

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

Janja Ocvirk et al. World J Gastroenterol. .

Abstract

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.

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Figures

Figure 1
Figure 1
Disposition of patients as of clinical cut-off date January 2008. The intention to treat (ITT) population comprised 77 patients randomized to FOLFOX6 plus cetuximab and 74 randomized to FOLFIRI plus cetuximab. 1Values based on all treated patients (n = 151). FOLFOX: 5-fluorouracil (5-FU) folinic acid (FA) and oxaliplatin; FOLFIRI: 5-FU FA and irinotecan; PD: Progressive disease; AE: Adverse event.
Figure 2
Figure 2
Kaplan Meier estimates for progression-free survival. A: By treatment group in the ITT population, FOLFOX6 plus cetuximab (n = 77) vs FOLFIRI plus cetuximab (n = 74); B: By KRAS mutation status in the KRAS population, KRAS wild-type (n = 62) vs KRAS mutation (n = 55); C: By tumor KRAS mutation status in patients receiving FOLFOX6 plus cetuximab, KRAS wild-type (n = 34) vs KRAS mutation (n = 23); D: By tumor KRAS mutation status in patients receiving FOLFIRI plus cetuximab, KRAS wild-type (n = 28) vs KRAS mutation (n = 32).
Figure 3
Figure 3
Kaplan Meier estimates for survival. A: By treatment group in the ITT population, FOLFOX6 plus cetuximab (n = 77) vs FOLFIRI plus cetuximab (n = 74); B: By tumor KRAS mutation status, KRAS wild-type (n = 62) vs KRAS mutation (n = 55); C: By KRAS mutation status in patients receiving FOLFOX6 plus cetuximab, KRAS wild-type (n = 34) vs KRAS mutation (n = 23); D: By tumor KRAS mutation status in patients receiving FOLFIRI plus cetuximab, KRAS wild-type (n = 28) vs KRAS mutation (n = 32).
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