Abstract Background: Skin rash during treatment with epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKI) has been reported to be predictive for response and survival in patients with advanced non-small cell lung cancer (NSCLC). The aim of this analysis was to evaluate whether skin rash during treatment (as a biomarker) in a preoperative setting was related to response and survival. Methods: This study was designed as an open-label phase II trial (also known as M06NEL). Patients received preoperative erlotinib (Tarceva) 150 mg once daily for 3 weeks. Skin toxicity during treatment was analysed in relation to metabolic and histopathological response, overall survival (OS) and progression-free survival (PFS). Results: In total 59 patients (25 male, 34 female) were eligible for analysis. In 39 patients (66%) skin toxicity occurred. According to National Cancer Institute Common Toxicity Criteria (NCICTC), Grade 1 toxicity was seen in 15 patients (25%), Grade 2 in 19 patients (32%) and Grade 3 in five patients (8%). None of the patients showed skin toxicity Grade 4 and 5. The median follow up was 74 months. Thirty-six patients (61%) were alive at time of analysis. Twenty-seven patients (46%) showed disease progression during follow up. Hazard ratios (HR) indicated lower risk of death (HR = 0.66, 95%CI: 0.29 - 1.50) and progression (HR = 0.64, 0.30 - 1.36), although in this small group results were not significant. Skin rash did not adequately predict response. Conclusions: In this neoadjuvant setting with limited treatment time in patients with early stage NSCLC, skin rash was not associated with response and survival and cannot be used as an early biomarker.
Keywords: skin rash; neoadjuvant erlotinib; resectable; non-small cell lung cancer; tumor response; survival