P2.06-021 Efficacy and Safety of ASP8273 versus Erlotinib or Gefitinib as First-Line Treatment in Subjects with EGFRMut+ NSCLC

Abstract

Background: Genexol-PM is a novel Cremophor EL(CrEL)-free polymeric micelle formation of paclitaxel.This multicentre study was designed to compare Genexol-PM and CrEL-based paclitaxel in combination with cisplatin in terms of efficacy and safety as first-line therapy in advanced non-small cell lung cancer.Methods: Chemonaive patients aged from 18 to 70 years with histologically or cytologically confirmed, locally advanced, metastatic or recurrent advanced NSCLC and an ECOG performance status of 0e1 were randomised 2:1 to the treatment group (Genexol-PM+ cisplatin) and the controll group (paclitaxel+cisplatin). Patients were treated with Genexol-PM 230mg/m2 intravenously without premedication or paclitaxel 175mg/m2 intravenously with premedication plus cisplatin 70mg/m2 on day 1 of a 3-week cycle for up to six cycles. Intrapatient dose escalation of Genexol-PM to 300mg/m2 was carried out in treatment group from the second cycle if the prespecified toxic effects were not observed after the first cycle.Results: 170 patients were randomised into the study. PFS and OS data are not yet mature. Conclusion: This multicenter study is in progress.

First-Line Treatment in EGFR Mutant Non-Small Cell Lung Cancer: Is There a Best Option?

“…In ARCHER 1050, there was a significant increase in dermatitis acneiform (13.7%), diarrhea (8.4%), increased ALT (8.5%), paronychia (7.5%) and stomatitis (3.5%) in the dacomitinib arm ( 26 ). A different third-generation inhibitor, ASP8273, was compared to erlotinib/gefitinib in the first-line SOLAR study, and the trial was discontinued based on results from an interim data analysis in the investigational arm ( 27 ).…”