ABSTRACT Introduction Dermatological toxicity in the form of acneiform rash is a common event in NSCLC patients being treated with anti-EGFR TKIs. An association between clinical benefit by EGFR-targeted therapy and development of this form of skin toxicity has been noted. The objective of this meta-analysis was to assess the predictive value of skin rash for outcome in patients with NSCLC treated with E or G. Materials and methods Prospective clinical trials or retrospective case series with reported survival (OS), progression (PFS/TTP) and response rate (RR) as a function of skin rash were serched in PubMed until January 2012. The selected studies have to include adult patients with histologically confirmed NSCLC treated with G or E, alone or in combination with other approved agents. Hazard ratios with 95% confidence intervals (HRs) for PFS/TTP and OS and risk ratios (RRs) for response rate in patients with rash were pooled in a meta-analysis. Results Twenty-four publications were included in this meta-analysis (17 prospective trials and 7 retrospective case series) for a total of 3032 patients. For the primary endpoint (OS) the occurrence of skin rash was significantly associated with reduced risk of death in patients treated with E or G (HR 0.30, p Conclusion A predictive factor as cutaneous rash that can be objectively evaluated during the course of the disease treatment could be useful in NSCLC to decide early the course of treatment and to shift to another line of treatment. The occurrence of skin rash during treatment with anti-EGFR TKIs for NSCLC represents a significant strong predictor of efficacy of these drugs. Disclosure All authors have declared no conflicts of interest.