First-line gefitinib therapy for elderly patients with non-small cell lung cancer harboring EGFR mutation: Central Japan Lung Study Group 0901.

ABSTRACT

BACKGROUND: The population of elderly patients with lung cancer 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 regarding gefitinib and elderly patients. PATIENTS AND METHODS: Chemotherapy-naïve patients aged 70 years or older with stage IIIB or IV NSCLC harboring EGFR-activating mutation were enrolled and treated with 250 mg of gefitinib daily until disease progression. The primary end point was response rate, and secondary end points were survival, safety, and quality of life. RESULTS: Twenty patients were enrolled, and the median age was 79.5 years (range 72-90). Overall response rate was 70% (95% CI 45.7-88.1%), and the disease control rate was 90% (95% CI 68.3-98.7%). The median progression-free survival and overall survival time were 10.0 and 26.4 months, respectively. The Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS) scores improved significantly 4 weeks after the initiation of gefitinib (P = 0.037) and maintained favorably over a 12-week assessment period. Among the seven items of FACT-LCS, shortness of breath and cough improved significantly after 4 weeks of treatment (P = 0.046 and P = 0.008, respectively). The most common adverse events were rash and liver dysfunction. Although Grade 1 pneumonitis developed in one patient, no treatment-related death was observed. CONCLUSION: First-line gefitinib therapy is effective and feasible for elderly patients harboring EGFR mutation, and improves disease-related symptoms, especially pulmonary symptoms like shortness of breath and cough.