Phase Ii Trial of Epidermal Growth Factor Ointment for Patients with Erlotinib-Related Skin Effects

Abstract

ABSTRACT Aim: The efficacy of the epidermal growth factor receptor (EGFR) tyrosin kinase inhibitor erlotinib has been demonstrated in patients with non-small cell lung cancer (NSCLC) and pancreatic cancer (PC). Dermatologic reactions can be a surrogate marker for the efficacy of erlotinib and they can result in dose modification. Such reaction can cause significant physical and psycho-social discomfort to patients. In the present study, we evaluate the effect of epidermal growth factor (EGF) onitment on erlotinib related skin effects (ERSEs) Methods: This was an open label, noncomparative, multicenter, phase II trial. The patients included those diagnosed with NSCLC or PC who treated with erlotinib. Only patients had over Grade 2 ERSEs according to the National Cacer Institue's Common Terminoloy Criteria for Adverse Events (NCI-CTCAEs) v. 3.0 were enrolled. The EGF ointment was evenly applied to the skin lesions twice a day. The effectiveness defined as follows: (1) Grade2, 3, or 4 ERSEs downgraded to = Results: Between October 2012 and November 2013, 52 patients were enrolled in seven institutions in Korea. All the patients provided informed consent. The final evaluation included 46 patients (30 males, 16 females). The median age of patients was 61 (range,40-83). Thirty-one (67%) patients had NSCLC, and 15 had PC. According to the definition of effectiveness, the EGFointment was effective in 36 (78.3%) patients. There are NCI-CTCAE grading of the rash/desquamation improved from 1.22 +/- 1.15 to 0.54 +/- 0.81. The grading of rash/acne and itching improved from 2.02 +/- 083 to 1.13 +/- 0.89 and 1.52 +/- 0.84 to 0.67 +/- 0.90, respectively. The most common reason for discontinuing the study was disease progression (37%). There were no statistically significant differeces in the effectiveness of the EGF ointment by gender, age, tumor type, erlotinib dosage, and number of prior chemoherapy sessions. Conclusions: This is the first large-scale prospective study of the treatment of ERSEs. Based on the results, the EGF ointment is effective for ERSEs, regardless of gender, age, type of tumor, and dosage of erlotinib, The EGF ointment evently improved all kinds of symptoms of ERSEs. (NCT01593995) Disclosure: All authors have declared no conflicts of interest.