Efficacy and safety of cetuximab plus FOLFOX in second-line and third-line therapy in metastatic colorectal cancer

Purpose: To evaluate the efficacy and adverse events with cetuximab plus FOLFOX administered as second- and third-line therapy in metastatic colorectal cancer (mCRC) patients. Methods: IPatients were administered cetuximab plus FOLFOX as second- and third-line therapy from January 2010 through October 2015. mCRC patients with wild type KRAS were also given irinotecan and/or oxaliplatin combined with fluoropyrimidine +/- bevacizumab. Tumor response and survival were evaluated using RECIST and Kaplan-Meier method respectively. Results: Sixty patients were included this study. Cetuximab plus FOLFOX was administered to 40 (66.7%) patients as second-line and to 20 (33.3%) as third-line therapy. Themajority of the patients had a good ECOG performance status (PS) (0 or 1). Clinical benefit was partial plus stable disease and it was 75.0% for both of these two lines. The median progression free survival (PFS) was 7.1 months (95% CI=3.2-10.9) and 6.0 months (95% CI=2.4-9.6), in the second- and third-line (p=0.484). The median overall survival (OS) was 14.3 and 9.2 months in second- and third-line therapy respectively (p=0.071). The common toxicities were haematologic and gastrointestinal, mostly grade 1 and 2. Conclusion: The addition of cetuximab to FOLFOX was well-tolerated and had antitumor activity both in second and third-line therapy in patients with mCRC.