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

  • 10818

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    P1.11-017 - First-line gefitinib therapy for elderly patients with non-small cell lung cancer harboring EGFR mutation: Central Japan Lung Study Group 0901 (ID 1413)

    09:30 - 09:30  |  Author(s): T. Yokoyama
    • Abstract

    Background
    Recently, the elderly population of lung cancer patients is increasing worldwide. Although first-line gefitinib is one of the standard treatments for advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation, few data have been reported on elderly patients. Thus, we conducted a phase II trial to evaluate the efficacy, safety, and quality of life of first-line gefitinib therapy for this specific population.

    Methods
    Chemotherapy-naïve patients aged 70 years or older with stage IIIB or IV non-small cell lung cancer harboring EGFR activating mutation were enrolled and treated with gefitinib 250 mg daily until disease progression or unacceptable toxicity occurred. Quality of life was assessed by the Lung Cancer Subscale of the Functional Assessment of Cancer Therapy-Lung (FACT-LCS) questionnaire, before and during treatment (at 4, 8, and 12 weeks). The primary endpoint was response rate.

    Results
    Twenty patients were enrolled between June 2009 and March 2011. The median age was 79.5 years (range: 72-90). All the patients had adenocarcinoma, 13 patients (65%) were female, 12 had exon 19 deletion, and 8 had L858R mutation. Overall response rate was 70% (95% CI, 46 - 88%), and the disease control rate was 90% (95% CI, 68 - 99%). The median progression-free survival was 10.0 months and the 2-year survival rate was 55%. The median follow-up time was 26.4 months and median overall survival time has not been reached yet. The most common adverse events were rash and liver dysfunction, and grade 1 interstitial lung disease developed in one patient. No treatment-related death was observed. The scores of FACT-LCS improved significantly four weeks after the initiation of gefitinib and maintained a favorable tendency during 12 weeks (p = 0.037). Among the seven items of FACT-LCS, especially shortness of breath and cough improved significantly after 4 weeks of treatment (p = 0.046, p = 0.008, respectively).

    Conclusion
    The present study reveals that first-line therapy with gefitinib is effective and feasible for elderly patients harboring EGFR mutation and improves disease-related symptoms, especially shortness of breath and cough.