Skin rash is a major side effect of
erlotinib, an inhibitor of the
epidermal growth factor receptor widely used in
cancer treatment and clinical trials.This study aims to evaluate the risk of skin toxicity with
erlotinib through a systematic review and meta-analysis of randomized controlled clinical trials (RCTs). Eligible studies included prospective RCTs in which
erlotinib was compared with controls at the starting dose of 150 mg daily. Incidence, relative risk (RR), and 95% confidence intervals (CIs) were calculated using a random-effects or fixed-effects model based on the heterogeneity of included studies. A total of 2,911 patients with a variety of solid
tumors from 9 RCTs were included for analysis. The overall incidence of all-grade
skin rash associated with
erlotinib was 70.4% (95% CI: 67.2%-73.4%), with 9.4% (95% CI: 8.0%-11.0%) being high grade (grade 3 or above). There was a significantly increased risk of all-grade
rash with
erlotinib in comparison with controls (RR, 3.43; 95% CI: 2.13-5.52; P < 0.001). The incidence of all-grade
rash was significantly lower in patients treated with the combination of
erlotinib and
chemotherapy than with
erlotinib alone (risk ratio, 0.84; 95% CI, 0.77-0.93; P = 0.001). In addition, RR of all-grade
rash was 4.72 (95% CI: 3.56-6.20) for
erlotinib alone and 2.34 (95% CI: 1.64-3.34) for the
erlotinib combination. In conclusion,
erlotinib is associated with substantial skin toxicity that may be modified by
chemotherapy.