Gefitinib (IRESSA) in patients of Asian origin with refractory advanced non-small cell lung cancer: subset analysis from the ISEL study.
dc.contributor.author | Chang, Alex | |
dc.contributor.author | Parikh, Purvish | |
dc.contributor.author | Thongprasert, Sumitra | |
dc.contributor.author | Tan, Eng Huat | |
dc.contributor.author | Perng, Reury-Perng | |
dc.contributor.author | Ganzon, Domingo | |
dc.contributor.author | Yang, Chih-Hsin | |
dc.contributor.author | Tsao, Chao-Jung | |
dc.contributor.author | Watkins, Claire | |
dc.contributor.author | Botwood, Nicholas | |
dc.contributor.author | Thatcher, Nick | |
dc.date.accessioned | 2009-07-06T15:36:45Z | |
dc.date.available | 2009-07-06T15:36:45Z | |
dc.date.issued | 2006-10 | |
dc.identifier.citation | Gefitinib (IRESSA) in patients of Asian origin with refractory advanced non-small cell lung cancer: subset analysis from the ISEL study. 2006, 1 (8):847-55 J Thorac Oncol | en |
dc.identifier.issn | 1556-1380 | |
dc.identifier.pmid | 17409969 | |
dc.identifier.uri | http://hdl.handle.net/10541/72622 | |
dc.description.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. | |
dc.language.iso | en | en |
dc.subject | Lung Cancer | en |
dc.subject.mesh | Adult | |
dc.subject.mesh | Aged | |
dc.subject.mesh | Aged, 80 and over | |
dc.subject.mesh | Antineoplastic Agents | |
dc.subject.mesh | Asian Continental Ancestry Group | |
dc.subject.mesh | Carcinoma, Non-Small-Cell Lung | |
dc.subject.mesh | Double-Blind Method | |
dc.subject.mesh | Female | |
dc.subject.mesh | Humans | |
dc.subject.mesh | Lung Neoplasms | |
dc.subject.mesh | Male | |
dc.subject.mesh | Middle Aged | |
dc.subject.mesh | Protein Kinase Inhibitors | |
dc.subject.mesh | Quinazolines | |
dc.subject.mesh | Receptor, Epidermal Growth Factor | |
dc.subject.mesh | Survival Rate | |
dc.title | Gefitinib (IRESSA) in patients of Asian origin with refractory advanced non-small cell lung cancer: subset analysis from the ISEL study. | en |
dc.type | Article | en |
dc.contributor.department | Johns Hopkins Singapore International Medical Centre, Singapore. alexchang@imc.jhmi.edu | en |
dc.identifier.journal | Journal of Thoracic Oncology | en |
html.description.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. |