First-line gefitinib therapy for elder advanced non-small cell lung cancer patients with epidermal growth factor receptor mutations: Multicenter phase II trial (NEJ 003 study).

Abstract

7561 Background: First line treatment by gefitinib for NSCLC patients with EGFR mutations has been validated by us (NEJ 002 Study) and WJTOG3405. In these studies, patients with ages less than 75 years were enrolled. Namely, there has been no data of the first-line gefitinib for elderly patients with EGFR mutations. The purpose of this study was to investigate the efficacy and the feasibility of gefitinib for chemotherapy-naïve patients of 75 years or older advanced non-small cell lung cancer (NSCLC) harboring the epidermal growth factor receptor (EGFR) mutations. Methods: Chemotherapy-naïve patients of 75 years of age or older with advanced NSCLC, Eastern Cooperative Oncology Group performance status 0-1, adequate organ function who had EGFR mutations examined by peptide nucleic acid-locked nucleic acid polymerase chain reaction clamp (PNA-LNA PCR Clamp) method were enrolled and receive 250 mg/day of gefitinib alone. Results: Between January 2008 and May 2009, 31 patients were enrolled, of whom all patients were eligible. Median age (range) was 80 (75-87) years. Twenty five patients were female (81%) and 30 patients had adenocarcinoma (97%). Overall response rate was 74% (95% CI, 58% to 91%), and the disease control rate was 90%. The median progression-free survival was 13.6 months. The most common adverse events were rash, liver dysfunction and diarrhea. One treatment related death by interstitial lung disease was observed. Conclusions: This is the first report indicating that gefitinib first-line therapy could achieve a high efficacy with acceptable toxicity in advanced NSCLC patients with EGFR mutations who are 75 years of age or older. Updated data including overall survival will be presented in the conference. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca AstraZeneca, Chugai Pharma, Lilly, Novartis Research fund for translational researcch