A phase II, open label study to evaluate the relationship between skin rash and survival in patients with unresectable and/or metastatic pancreatic cancer treated with erlotinib combined with gemcitabine.

4094 Background: Skin rash is a common adverse event associated with HER1/EGFR-targeted agents. Clinical trials suggest a relationship between the development of rash and response and/or survival. The aim of this study is to evaluate the relationship between grade ≥ 2 skin rash and overall survival (OS). Methods: An open-label, single arm, non randomized, phase II study. Patients received gemcitabine 1,000 mg/m2 iv over 30 minutes on days 1, 8, and 15 in 4-week cycles combined with erlotinib 100 mg po per day until disease progression or unacceptable toxicity. OS was compared by Log-Rank test. Cox regression analysis evaluated the effect of independent variables (gender, age, Karnofsky PS (KPS), rash and cumulative dose of erlotinib) on survival. This study is ongoing. Results: Of 156 patients included from 2007 to 2009, 154 were evaluated. 36 patients had grade ≥ 2 rash and 118 grade 80...