Author of

• 12592

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  P3.10 - Poster Session 3 - Chemotherapy (ID 210)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/30/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 12613

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    P3.10-021 - Phase II Multicenter Trial of Erlotinib for Advanced Non-Small-Cell Lung Cancer with Epidermal Growth Factor Receptor Mutations (ID 1417)

    09:30 - 09:30  |  Author(s): K. Kido
    • Abstract

    Background
    Erlotinib is effective for non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations and also recommended in NCCN guidelines. However, there has been a few study done on second-line therapy in NSCLC with EGFR mutations in Japan. The aim of this phase II study was to evaluate the efficacy and safety of erlotinib therapy as second-line treatment in EGFR-mutated NSCLC who was previously treated with platinum doublet.

    Methods
    NSCLC patients with EGFR mutations (exon19 or 21) who were treated with platinum doublet previously as first-line therapy were treated with daily erlotinib (150mg/ day). The primary endpoint in this phase II study was response rate (RR), and the secondary endpoints were progression-free survival time (PFS), overall survival time (OS), and safety.

    Results
    From August 2009 to February 2012, 31 NSCLC patients were eligible in this phase II study. The patient’s demographics were a median age of 65 years (range 50-75 years), 21 men and 10 women, 30 adenocarcinomas and 1 other type of cancer, 9 never-smokers and 22 former smokers, PS (ECOG) were 0 in 15, 1 in 14, 2 in 2 patients, exon19 mutation in 15 and exon21 mutation in 16, respectively. Total RR of erlotinib treatment was 61.3%. The disease control rate was 93.5%. Median PFS was 308 days and OS was not reached. Toxicities such as acne, rush and diarrhea were less than Grade 2. Treatment-related death caused by pneumonitis in one patient.

    Conclusion
    Erlotinib therapy as second-line treatment in EGFR-mutated NSCLC patients who were treated with platinum doublet previously was effective with an acceptable toxicity profile.