BACKGROUND: The aim of this study was to perform an accurate exploration on the efficacy of oxaliplatin/5-fluorouracil/capecitabine-cetuximab combination therapy and its effects on K-Ras mutations in advanced colorectal cancer.

MATERIAL AND METHODS: Among 96 patients who suffered metastatic colorectal cancer without mutated K-Ras, 41 patients who were receiving treatment with oxaliplatin/5-fluorouracil/capecitabine and administered cetuximab as the initial treatment comprised the observation group; the remaining 55 patients receiving cetuximab as an alternative treatment comprised the control group.

RESULTS: The observation group experienced significantly higher objective response rates (ORRs), and disease control rates (DCRs), than the control group (P<0.05 for both). The median progression-free survival (PFS) rates of the observation group and the control groups were 11.2 months (95% confidence interval [CI]: 10.1–12.3 months) and 7.4 months (95% CI: 6.6–8.2 months). The median overall survival (OS) rates were 16.8 months (95% CI: 15.2–18.4 months) and 12.4 months (95% CI: 11.6–13.2 months), respectively. The observation group had significantly longer PFS and OS in comparison to the control group (P<0.05). The patients who underwent cetuximab treatment for ≥10 months had a slightly higher rate of K-Ras mutations than those treated with cetuximab for <10 months (9.1% versus 7.3%).

CONCLUSIONS: Oxaliplatin/5-fluorouracil/capecitabine plus cetuximab exhibited better efficacy as initial treatment than the alternative treatment; it was also highly safe. Unfortunately, some patients might develop K-Ras mutations after long duration of cetuximab treatment, suggesting that K-Ras mutations are correlated with tumor progression and depend on the duration or dose of cetuximab treatment.

Keywords: Colorectal Neoplasms, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, capecitabine, Cetuximab, Dose-Response Relationship, Drug, Drug Administration Schedule, Fluorouracil, Mutation, oxaliplatin, Progression-Free Survival, Proto-Oncogene Proteins p21(ras), Time Factors, young adult