To assess the efficacy and safety of cetuximab-based therapy versus non-cetuximab therapy for advanced cancer.

A total of 7,954 patients from 17 randomized controlled trials are identified, with 3,965 patients in the cetuximab group and 3,989 patients in the non-cetuximab group. The outcome was progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and grade 3/4 advent events.

There was a significant improvement of PFS (HR 0.83, 95%CI 0.78–0.88), OS (HR 0.89, 0.84–0.95), and ORR in the cetuximab group (OR 1.39, 1.22–1.58). In subgroup analysis, in colorectal cancer, there was a significant improvement of PFS (0.72, 0.66–0.78), OS (0.90, 0.81–1.00), and ORR in the cetuximab group (1.36, 1.15–1.60). In head and neck carcinoma, there was a significant improvement of PFS (0.63, 0.54–0.73), OS (0.78, 0.67–0.91), and ORR in the cetuximab group (1.57, 1.15–2.16). In non-small-cell lung cancer, there was a significant improvement of OS (0.86, 0.76–0.96) in the cetuximab group, and no difference on PFS (0.82, 0.64–1.07) and ORR (1.56, 0.85–2.88). In pancreatic cancer, there was no difference on PFS (1.11, 0.97–1.28), OS (1.07, 0.93–1.25), and ORR (0.94, 0.66–1.33). There were higher incidences of grade 3–4 toxicity (OR 1.84), skin-related toxicity (OR 31.80), acneiform rash (OR 30.14), and hypomagnesemia (OR 6.72) in the cetuximab group.

Cetuximab-based therapy improved PFS and OS, and better ORR versus non-cetuximab therapy. The severe adverse events should be predictable and manageable.