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J.Y. Lee



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    P3.11 - Poster Session 3 - NSCLC Novel Therapies (ID 211)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.11-035 - An Open Label Compassionate Use Programme of BIBW 2992/afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated with Erlotinib or Gefitinib in Korea (ID 3028)

      09:30 - 09:30  |  Author(s): J.Y. Lee

      • Abstract

      Background
      Afatinib is a potent and selective, irreversible ErbB family blocker. Previous phase 3 trial demonstrated that afatinib prolonged progression-free survival compared with placebo in patients with advanced lung adenocarcinoma who progressed after 12 weeks of treatment with reversible EGFR tyrosine-kinase inhibitors (TKIs). The purpose of this Open Label Compassionate Use Programme is to provide afatinib to patients with advanced NSCLC with previous treatment failure on erlotinib or gefinitib and for whom no other approved treatment is available.

      Methods
      who have failed at least one line of platinum-based cytotoxic chemotherapy and following at least 6 months on erlotinib or gefinitib were eligible. Thestarting dose of afatinib was 50mg daily.

      Results
      Between Aug 2011 and Dec 2012, 107 patients were treated with afatinib. Most patients were females (60.7%) and never-smokers (69.2%) with a median age of 57 years. Of the 95 patients who had prior EGFR mutation results, 82 (86.3%) were positive. With afatinib treatment 25 (23.4%) of 107 patients had a partial response. Median progression-free survival was 4.6 months (95% CI 4.1-5.1). The most common adverse events were diarrhea (97 [90.7%] patients; 22 [20.6%] were grade 3) and rash or acne (72 [67.3%] patients; 11 [10.3%] were grade 3). No drug-related death was found. Sixty-four (59.8%) patients needed a dose reduction because of an adverse event.

      Conclusion
      Our results suggested that afatinib could be a feasible option to patients with advanced lung adenocarcinoma who have progressed after clinical benefit on previous EGFR TKIs.