Multicenter randomized, open-label phase II trial of sequential erlotinib and gemcitabine compared with gemcitabine monotherapy as first-line therapy in elderly or ECOG PS two patients with advanced NSCLC
Michael Michael, Shane C White, Ehtesham Abdi, Louise Nott, Phillip Clingan, Allan Zimet, Peter Button, Daniel Gregory, Benjamin Solomon, Alexander Dobrovic, Hongdo Do, Stephen Clarke
Asia-Pacific Journal of Clinical Oncology | WILEY | Published : 2015
AIM: The potential beneficial interaction between erlotinib and chemotherapy may require sequencing or pharmacodynamic separation. The aim of this study was to evaluate the efficacy and tolerance of sequential erlotinib and gemcitabine versus gemcitabine monotherapy as first-line therapy in elderly or ECOG PS-2 patients with advanced non-small cell lung carcinoma. METHODS: The primary objective of this multicenter randomized Phase II study was progression-free survival (PFS). Secondary objectives were overall response rate (ORR), disease control rate, response duration, overall survival and safety. Patients were randomized to either gemcitabine (1250 mg/m2 Day 1, 8 q28 days) followed by erlo..View full abstract
The GATE study was sponsored by Roche Products, Pty Limited, Australia. The authors would like to thank all study investigators, coordinators and patients who participated in the study. We would also like to thank the Roche study team. Medical writing assistance was provided by Dr Joseline Ojaimi from Roche Products.