A Phase II Trial of Gefitinib Monotherapy in Chemotherapy-Naive Patients of 75 Years or Older with Advanced Non-small Cell Lung Cancer

作者：Ebi Noriyuki^*; Semba Hiroshi; Tokunaga Sho J I; Takayama Koichi; Wataya Hiroshi; Kuraki Takashige; Yamamoto Hidehiko; Akamine Shin J I; Okamoto Isamu; Nakanishi Yoichi

来源：Journal of Thoracic Oncology, 2008, 3(10): 1166-1171.

DOI：10.1097/JTO.0b013e318186a88d

• Gefitinib
• Non-small cell lung cancer
• Elderly

Background: Gefitinib has shown modest activity in patients with recurrent non-small cell lung cancer (NSCLC) after platinum-based chemotherapy. However, the activity of gefitinib as first-line chemotherapy remains unclear, especially unknown in elderly patients. A multicenter phase II trial was conducted to evaluate the efficacy and tolerability of gefitinib for elderly patients with chemotherapy-naive NSCLC.
Methods: Elderly chernotherapy-naNe patients with advanced NSCLC, ECOG PS of 0-2, and adequate organ functions received 250 mg/day of gefitinib. The primary objective of this study was to determine the objective response rate (RR). Secondary endpoints were tolerability, disease-related symptom using lung cancer subscale (LCS) in FACT-L, progression free survival (PFS) and overall survival (OS). We investigated mutation status of the epidermal growth factor receptor (EGFR) gene in cases with available tumor samples.
Results: Fifty patients were enrolled, of whom 49 were eligible. Median age (range) was 80 (75-90) years. Thirty-two patients were female (65%) and 40 patients had adenocarcinoma (82%). The objective RR was 25% (Cl 95%, 13-39). Median survival time was 10 months (Cl 95%, 7-20) and 1-year survival rate was 50%. The most frequent adverse events were skin disorders (76%). Fifteen patients (30%) experienced toxicities >= grade 3. There were four patients with possible interstitial lung disease including two treatment-related deaths. Symptom improvement rate using LCS was 49% at 4 weeks of gefitinib therapy. Tumor samples from 17 patients were analyzed for EGFR mutation status. EGFR mutations were detected in tumor tissues from 7 patients, of which 5 had partial responses (71%).
Conclusions: Gefitinib monotherapy is effective and relatively well tolerated in chemotherapy-naive elderly patients with advanced NSCLC. Gefitinib has potential as a first-line therapeutic option in elderly patients with advanced NSCLC.

• 出版日期2008-10