Gefitinib (IRESSA) in patients of Asian origin with refractory advanced non-small cell lung cancer: subset analysis from the ISEL study.

2.50
Hdl Handle:
http://hdl.handle.net/10541/72622
Title:
Gefitinib (IRESSA) in patients of Asian origin with refractory advanced non-small cell lung cancer: subset analysis from the ISEL study.
Authors:
Chang, Alex; Parikh, Purvish; Thongprasert, Sumitra; Tan, Eng Huat; Perng, Reury-Perng; Ganzon, Domingo; Yang, Chih-Hsin; Tsao, Chao-Jung; Watkins, Claire; Botwood, Nicholas; Thatcher, Nick
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.
Affiliation:
Johns Hopkins Singapore International Medical Centre, Singapore. alexchang@imc.jhmi.edu
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
Journal:
Journal of Thoracic Oncology
Issue Date:
Oct-2006
URI:
http://hdl.handle.net/10541/72622
PubMed ID:
17409969
Type:
Article
Language:
en
ISSN:
1556-1380
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorChang, Alex-
dc.contributor.authorParikh, Purvish-
dc.contributor.authorThongprasert, Sumitra-
dc.contributor.authorTan, Eng Huat-
dc.contributor.authorPerng, Reury-Perng-
dc.contributor.authorGanzon, Domingo-
dc.contributor.authorYang, Chih-Hsin-
dc.contributor.authorTsao, Chao-Jung-
dc.contributor.authorWatkins, Claire-
dc.contributor.authorBotwood, Nicholas-
dc.contributor.authorThatcher, Nick-
dc.date.accessioned2009-07-06T15:36:45Z-
dc.date.available2009-07-06T15:36:45Z-
dc.date.issued2006-10-
dc.identifier.citationGefitinib (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 Oncolen
dc.identifier.issn1556-1380-
dc.identifier.pmid17409969-
dc.identifier.urihttp://hdl.handle.net/10541/72622-
dc.description.abstractINTRODUCTION: 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.en
dc.language.isoenen
dc.subjectLung Canceren
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAged, 80 and over-
dc.subject.meshAntineoplastic Agents-
dc.subject.meshAsian Continental Ancestry Group-
dc.subject.meshCarcinoma, Non-Small-Cell Lung-
dc.subject.meshDouble-Blind Method-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshLung Neoplasms-
dc.subject.meshMale-
dc.subject.meshMiddle Aged-
dc.subject.meshProtein Kinase Inhibitors-
dc.subject.meshQuinazolines-
dc.subject.meshReceptor, Epidermal Growth Factor-
dc.subject.meshSurvival Rate-
dc.titleGefitinib (IRESSA) in patients of Asian origin with refractory advanced non-small cell lung cancer: subset analysis from the ISEL study.en
dc.typeArticleen
dc.contributor.departmentJohns Hopkins Singapore International Medical Centre, Singapore. alexchang@imc.jhmi.eduen
dc.identifier.journalJournal of Thoracic Oncologyen

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