Gefitinib (IRESSA) in patients of Asian origin with refractory advanced non-small cell lung cancer: Subset analysis from the ISEL study
Journal
Journal of Thoracic Oncology
Journal Volume
1
Journal Issue
8
Pages
847-855
Date Issued
2006
Author(s)
Chang A
Parikh P
Thongprasert S
Tan E.H
Perng R.-P
Ganzon D
Tsao C.-J
Watkins C
Botwood N
Thatcher N.
Abstract
INTRODUCTION: The IRESSA Survival Evaluation in Lung Cancer (ISEL) phase III study compared the efficacy of gefitinib (IRESSA) versus placebo in patients with refractory advanced non-small cell lung cancer (NSCLC). Although a statistically significant difference in survival was not seen between gefitinib and placebo in the overall ISEL population, preplanned subset analyses demonstrated a significant survival benefit in patients who had never smoked and in patients of Asian origin. METHODS: In ISEL, 1692 patients who were refractory to or intolerant of their latest chemotherapy were randomized to receive either gefitinib (250 mg/day) or placebo, plus best supportive care. Preplanned subgroup analyses included an assessment of patients who were of Asian origin (n = 342). RESULTS: Two hundred thirty-five patients of Asian origin received gefitinib, and 107 received placebo. In these patients, treatment with gefitinib significantly improved survival compared with placebo (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.48, 0.91; p = 0.010; median survival, 9.5 versus 5.5 months). Patients of Asian origin also experienced statistically significant improvements in time to treatment failure with gefitinib compared with placebo (HR, 0.69; 95% CI, 0.52, 0.91; p = 0.0084; 4.4 versus 2.2 months), and objective response rates were higher with gefitinib than with placebo (12 versus 2%). Gefitinib was generally well tolerated in patients of Asian origin, with rash and diarrhea being the most common adverse events. No unexpected adverse events were observed. CONCLUSIONS: Treatment with gefitinib was associated with a significant improvement in survival in a subgroup of patients of Asian origin with previously treated refractory advanced NSCLC. ? 2006International Association for the Study of Lung Cancer.
Subjects
Asian; EGFR-TKI; Gefitinib; IRESSA; NSCLC
SDGs
Other Subjects
gefitinib; placebo; antineoplastic agent; epidermal growth factor receptor; gefitinib; protein kinase inhibitor; quinazoline derivative; acne; adult; advanced cancer; aged; article; Asian; cancer patient; cancer resistance; cancer survival; clinical trial; confidence interval; controlled clinical trial; controlled study; diarrhea; double blind procedure; drug efficacy; drug eruption; drug fatality; drug hypersensitivity; drug withdrawal; exfoliative dermatitis; female; hazard assessment; human; interstitial lung disease; lung non small cell cancer; major clinical study; male; multicenter study; patient assessment; phase 3 clinical trial; priority journal; pustule; randomized controlled trial; statistical significance; survival rate; survival time; therapy effect; treatment outcome; treatment response; Asian; drug antagonism; ethnology; lung tumor; middle aged; mortality; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Asian Continental Ancestry Group; Carcinoma, Non-Small-Cell Lung; Double-Blind Method; Female; Humans; Lung Neoplasms; Male; Middle Aged; Protein Kinase Inhibitors; Quinazolines; Receptor, Epidermal Growth Factor; Survival Rate
Type
journal article