First-Line Gefitinib in Patients Aged 75 or Older With Advanced Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations NEJ 003 Study

作者：Maemondo Makoto; Minegishi Yuji^*; Inoue Akira; Kobayashi Kunihiko; Harada Masao; Okinaga Shoji; Morikawa Naoto; Oizumi Satoshi; Tanaka Tomoaki; Isobe Hiroshi; Kudoh Shoji; Hagiwara Koichi; Nukiwa Toshihiro; Gemma Akihiko

来源：Journal of Thoracic Oncology, 2012, 7(9): 1417-1422.

DOI：10.1097/JTO.0b013e318260de8b

• Non-small cell lung cancer
• Epidermal growth factor receptor mutation
• Gefitinib

Introduction: Recent studies have demonstrated that first-line treatment with gefitinib, an epidermal growth factor receptor (EFGR)-targeted tyrosine kinase inhibitor, is significantly superior to standard chemotherapy for advanced non-small-cell lung cancer (NSCLC) harboring EGFR sensitive mutations. Meanwhile, the efficacy of gefitinib therapy among elderly populations diagnosed with EGFR-mutated NSCLC has not yet been elucidated. The purpose of this study was to investigate the efficacy and feasibility of gefitinib for chemotherapy-naive patients aged 75 or older with NSCLC harboring EGFR mutations; generally, these patients have no indication for treatment with platinum doublets. %26lt;br%26gt;Methods: Chemotherapy-naive patients aged 75 years or older with performance status 0 to 1 and advanced NSCLC harboring EGFR mutations, as determined by the peptide nucleic acid-locked nucleic acid polymerase chain reaction clamp method, were enrolled. The enrolled patients received 250 mg/day of gefitinib orally. %26lt;br%26gt;Results: Between January 2008 and May 2009, 31 patients were enrolled, all of whom were eligible. The median age was 80 (range, 75-87) years. Twenty-five patients (81%) were women, and 30 patients (97%) had adenocarcinoma. The overall response rate was 74% (95% confidence interval, 58%-91%), and the disease control rate was 90%. The median progression-free survival was 12.3 months. The common adverse events were rash, diarrhea, and liver dysfunction. One treatment-related death because of interstitial lung disease occurred. %26lt;br%26gt;Conclusions: This is the first study that verified safety and efficacy of first-line treatment with gefitinib in elderly patients having advanced NSCLC with EGFR mutation. Considering its strong antitumor activity and mild toxicity, first-line gefitinib may be preferable to standard chemotherapy for this population.

• 出版日期2012-9