Gefitinib (IRESSA) in patients of Asian origin with refractory advanced non-small cell lung cancer

Subset analysis from the ISEL study

Alex Y Chang, Purvish Parikh, Sumitra Thongprasert, Eng Huat Tan, Reury Perng Perng, Domingo Ganzon, Chih Hsin Yang, Chao Jung Tsao, Claire Watkins, Nick Botwood, Nick Thatcher

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)847-855
Number of pages9
JournalJournal of Thoracic Oncology
Volume1
Issue number8
DOIs
StatePublished - Oct 2006
Externally publishedYes

Fingerprint

Survival Analysis
Non-Small Cell Lung Carcinoma
Lung Neoplasms
Placebos
Survival
gefitinib
Confidence Intervals
Exanthema
Treatment Failure
Diarrhea
Drug Therapy
Therapeutics

Keywords

  • Asian
  • EGFR-TKI
  • Gefitinib
  • IRESSA
  • NSCLC

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Medicine(all)

Cite this

Gefitinib (IRESSA) in patients of Asian origin with refractory advanced non-small cell lung cancer : Subset analysis from the ISEL study. / Chang, Alex Y; Parikh, Purvish; Thongprasert, Sumitra; Tan, Eng Huat; Perng, Reury Perng; Ganzon, Domingo; Yang, Chih Hsin; Tsao, Chao Jung; Watkins, Claire; Botwood, Nick; Thatcher, Nick.

In: Journal of Thoracic Oncology, Vol. 1, No. 8, 10.2006, p. 847-855.

Research output: Contribution to journalArticle

Chang, AY, Parikh, P, Thongprasert, S, Tan, EH, Perng, RP, Ganzon, D, Yang, CH, Tsao, CJ, Watkins, C, Botwood, N & Thatcher, N 2006, 'Gefitinib (IRESSA) in patients of Asian origin with refractory advanced non-small cell lung cancer: Subset analysis from the ISEL study', Journal of Thoracic Oncology, vol. 1, no. 8, pp. 847-855. https://doi.org/10.1097/01243894-200610000-00014
Chang, Alex Y ; Parikh, Purvish ; Thongprasert, Sumitra ; Tan, Eng Huat ; Perng, Reury Perng ; Ganzon, Domingo ; Yang, Chih Hsin ; Tsao, Chao Jung ; Watkins, Claire ; Botwood, Nick ; Thatcher, Nick. / Gefitinib (IRESSA) in patients of Asian origin with refractory advanced non-small cell lung cancer : Subset analysis from the ISEL study. In: Journal of Thoracic Oncology. 2006 ; Vol. 1, No. 8. pp. 847-855.
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title = "Gefitinib (IRESSA) in patients of Asian origin with refractory advanced non-small cell lung cancer: Subset analysis from the ISEL study",
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.",
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T1 - Gefitinib (IRESSA) in patients of Asian origin with refractory advanced non-small cell lung cancer

T2 - Subset analysis from the ISEL study

AU - Chang, Alex Y

AU - Parikh, Purvish

AU - Thongprasert, Sumitra

AU - Tan, Eng Huat

AU - Perng, Reury Perng

AU - Ganzon, Domingo

AU - Yang, Chih Hsin

AU - Tsao, Chao Jung

AU - Watkins, Claire

AU - Botwood, Nick

AU - Thatcher, Nick

PY - 2006/10

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N2 - 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.

AB - 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.

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