Author of

• 17842

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  P2.06 - Poster Session with Presenters Present (ID 467)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 17862

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    P2.06-020 - A Open-Label Randomised Controlled Trial of First-Line Genexol-PM/ CrEL-Based Paclitaxel plus Cisplatin in Advanced NSCLC Patients (ID 4569)

    14:30 - 14:30  |  Author(s): M. Shi
    • 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 0–1 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 multicentre study is in progress.