Abstract
8054 Background: A randomized global phase III trial (REVEL) demonstrated statistically significant improvement in OS and PFS for DR versus D in patients (pts) with advanced NSCLC; a limited number of East Asian pts were given docetaxel (DOC) at 75 mg/m2, higher than 60 mg/m2recommended in Japan. Methods: A similar phase II study was conducted in Japan to evaluate the efficacy of DR for stage IV NSCLC following disease progression during or after prior platinum-based chemotherapy. Pts with EGFR mutant NSCLC who received prior EGFR tyrosine kinase inhibitor (TKI) therapy were enrolled as exploratory. Eligibility criteria included ECOG PS 0-1, age ≥ 20 years, and adequate organ function. Pts were randomized 1:1 to receive DOC 60 mg/m2+ramucirumab 10 mg/kg IV or placebo on Day 1 of a 21-day cycle until disease progression. Stratification factors: PS, gender, prior maintenance therapy. The primary endpoint was PFS to be analyzed after observing 134 PFS events for pts without prior EGFR-TKI therapy (primary po...
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
