Purpose: A meta-analysis was performed to assess the efficacy and safety of cetuximab-based therapy vs noncetuximab therapy in advanced or metastatic colorectal cancer.
Method: A total of 4617 patients from seven randomized controlled trials were available for analysis, with 2305 patients in the cetuximab group and 2312 patients in the noncetuximab group. The efficacy data included progression-free survival (PFS), overall survival (OS) and overall response rate (ORR). The safety data that contained overall grade 3 and 4 adverse events (AEs), specific grade 3 and 4 toxicity such as acneiform rash, cetuximab-related skin toxicity, diarrhoea, fatigue, neutropenia, hypertension, nausea and hand-foot skin reaction are evaluated.
Result: There was a significant PFS benefit in favour of cetuximab-based therapy (HR = 0.68, 95%CI: 0.63 to 0.73) and OS benefit (HR = 0.90, 95%CI: 0.81 to 1.00). The ORR was significantly higher in the cetuximab-based arm (OR = 2.19, 95% CI: 1.30 to 3.68). The incidence of overall grade 3-4 toxicity was significantly higher in the cetuximab arm compared with the noncetuximab arm (61.2%vs 43.0%, OR = 2.32, 95%CI: 1.59-3.39). This difference was mainly attributed to cetuximab-related skin toxicity (OR = 5.86, 95%CI: 1.38-24.88), especially acneiform rash (OR = 51.37, 95%CI: 22.75-116.02). In addition, cetuximab resulted in a significant increase in grade 3 and 4 diarrhoea, fatigue and neutropenia, except for hypertension, nausea and hand-foot skin reaction.
Conclusion: Cetuximab-based therapy improves PFS and OS resulting in better ORR vs noncetuximab therapy. Its most common and severe AE is skin toxicity that should be predictable and manageable.