학술논문

Safety and efficacy of gefitinib monotherapy for patients (pts) ≥80 years (yrs) with advanced non-small cell lung cancer (NSCLC): A phase II subset analysis.
Document Type
Academic Journal
Source
Journal of Clinical Oncology (J CLIN ONCOL), 5/21/2009 Supplement Part 1 of 2; 27: e19059-e19059. (1p)
Subject
Language
English
ISSN
0732-183X
Abstract
e19059 Background: Lung cancer is a disease of the elderly with median age at diagnosis of 70 yrs. The very elderly pts (age ≥80 yrs) with advanced NSCLC have not been well studied, even though this proportion is increasing over coming years. There are no data to evaluate the safety and efficacy of gefitinib treatment for pts ≥80 yrs with advanced NSCLC.Methods: We reported the phase II trial of gefitinib monotherapy in chemotherapy-naïve pts of 75 yrs or older with advanced NSCLC (J Thorac Oncol. 2008;3: 1166-1171). We analyzed data for pts ≥80 yrs, comparing with those <80 yrs in our trial.Results: A total of 28 pts were 80 yrs old and over in our trial. Patient characteristics: male/female = 12/16, median age = 82 (range 80-90), ECOG PS 0/1/2=7/13/8, stage IB/IIIA/IV=1/3/24, and adenocarcinoma (Ad)/non-Ad= 22/6. Five pts achieved partial response. The response rate was 18% (CI 95%, 6-39). The disease control rate was 50%. Median survival time was 9 months and 1-year survival rate was 39%. The most frequent adverse events were skin disorders (86%). Nine pts (32%) experienced toxicities ≥grade 3. There were two pts with possible interstitial lung disease including one treatment-related death. Tumor samples from 10 pts were analyzed for EGFR mutation status. EGFR mutations were detected in tumor tissues from 5 pts, of which 3 had partial responses (60%). Table shows the difference between the pts ≥80 yrs and those <80 yrs.Conclusions: Gefitinib monotherapy is effective and relatively well tolerated for pts ≥80 yrs with advanced NSCLC. Gefitinib has potential as a first-line therapeutic option even if elderly pts are more than 80 yrs old. [Table: see text] No significant financial relationships to disclose.