Author of

• 10801

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  P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10835

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    P1.11-035 - Outcomes of Afatinib-Based Regimens for Salvage Treatment of Advanced Stage Non-Small Cell Lung Cancer (NSCLC) Patients Who Had Been Heavily Pretreated (ID 2505)

    09:30 - 09:30  |  Author(s): C. Chi-Lu
    • Abstract

    Background
    The therapeutic development for advanced stage NSCLC has improved in the past decade, but the poor treatment outcome still poses a major challenge. Investigators have combined conventional platinum-based chemotherapy with epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), in the hope of achieving greater therapeutic efficacy. However, current data show that the combination strategy has repeatedly failed to provide a better survival benefit, irrespective of the mutation status of the tumors. However, it might not be true for combination of EGFR-TKI with individual agents which exhibit a variety of anti-cancer actions. Afatinib, a novel irreversible ErbB-family blocker, has shown to provide efficacious effects for advanced stage NSCLC patients. From the Phase I data, afatinib in combination with chemotherapy or anti-EGFR therapy exhibited tumor inhibition response. We present retrospective clinical evidences of patients from Compassionate Usage Program. These patients are treated with continuation of afatinib in combination, alternately, with various chemotherapies or anti-EGFR therapy.

    Methods
    Between August 2012 to February 2013, 37 patients were enrolled for the program, 11 of these patients died of disease progression either received afatinib for less than 2 weeks or never started afatinib treatment, the remaining 26 patients were included in this analysis. Patient characteristics are median age was 67 (range 46-84), gender (male/female = 8/18), ECOG status (PS 1/2/3: 16/2/4), EGFR mutation status (exon 19 deletion = 10; L858R mutation = 6; exon 18 mutation = 1; wild type = 5; unknown = 5). All of these patients had been previously treated with either gefitinib or erlotinib with no disease progression for more than 6 months. The median TKI-free interval was 125 days (range 0-1,450 days); 8 patients had no TKI-free interval. All patients but 1 started the treatment of afatinib monotherapy (30 mg or 40 mg daily), and subsequently, either paclitaxel (60 mg/m2, day 1, 8, and 15, 4-week cycle), docetaxel (30 mg, day 1, and 8, 3-week cycle), or cetuximab (250mg/m2, every 2 weeks) was added. The combination was alternated or discontinued when patient had disease progression according to RECIST criteria version 1.1, intolerability or severe toxicity.

    Results
    Of the whole group of patients, 25 received afatinib monotherapy, 11 with 1 afatinib doublet (afatinib/cetuximab = 3; afatinib/paclitaxel = 6; afatinib/docetaxel = 2); 2 with 2 afatinib doublets (afatinib/cetuximab and afatinib/docetaxel = 1; afatinib/cetuximab and afatinib/docetaxel = 1) and 1 with 3 afatinib doublets (afatinib/cetuximab, afatinib/paclitaxel and afatinib/docetaxel). The median duration from administration of frontline systemic treatment to initiation of afatinib was 3 years (range 1 - 10 years). These patients had received 2 to 7 (median 5) lines of treatment before receiving afatinib-based treatment. The median time to treatment failure was 223 days (95% CI: 217, 249) and median overall survival was 288 days (6 events). The toxicities were mild and manageable. There was no correlation between the values of TKI-free interval and duration of afatinib monotherapy.

    Conclusion
    Integration of afatinib with various treatment agents based on different treatment rationales, the afatinib-based treatment may potentially extend treatment duration and patient survival.