Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: Results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer)

Nick Thatcher, Alex Y Chang, Purvish Parikh, José Rodrigues Pereira, Tudor Ciuleanu, Joachim Von Pawel, Sumitra Thongprasert, Eng Huat Tan, Kristine Pemberton, Venice Archer, Kevin Carroll

Research output: Contribution to journalArticle

Abstract

Background: This placebo-controlled phase III study investigated the effect on survival of gefitinib as second-line or third-line treatment for patients with locally advanced or metastatic non-small-cell lung cancer. Methods: 1692 patients who were refractory to or intolerant of their latest chemotherapy regimen were randomly assigned in a ratio of two to one either gefitinib (250 mg/day) or placebo, plus best supportive care. The primary endpoint was survival in the overall population of patients and those with adenocarcinoma. The primary analysis of the population for survival was by intention to treat. This study has been submitted for registration with ClinicalTrials.gov, number 1839IL/709. Findings: 1129 patients were assigned gefitinib and 563 placebo. At median follow-up of 7·2 months, median survival did not differ significantly between the groups in the overall population (5·6 months for gefitinib and 5·1 months for placebo; hazard ratio 0·89 [95% CI 0·77-1·02], p=0·087) or among the 812 patients with adenocarcinoma (6·3 months vs 5·4 months; 0·84 [0·68-1·03], p=0·089). Preplanned subgroup analyses showed significantly longer survival in the gefitinib group than the placebo group for never-smokers (n=375; 0·67 [0·49-0·92], p=0·012; median survival 8·9 vs 6·1 months) and patients of Asian origin (n=342; 0·66 [0·48-0·91], p=0·01; median survival 9·5 vs 5·5 months). Gefitinib was well tolerated, as in previous studies. Interpretation: Treatment with gefitinib was not associated with significant improvement in survival in either coprimary population. There was pronounced heterogeneity in survival outcomes between groups of patients, with some evidence of benefit among never-smokers and patients of Asian origin.

Original languageEnglish (US)
Pages (from-to)1527-1537
Number of pages11
JournalThe Lancet
Volume366
Issue number9496
DOIs
StatePublished - Oct 29 2005
Externally publishedYes

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Non-Small Cell Lung Carcinoma
Multicenter Studies
Lung Neoplasms
Placebos
Survival
Population
Adenocarcinoma
gefitinib
Survival Analysis
Drug Therapy
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

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Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer : Results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). / Thatcher, Nick; Chang, Alex Y; Parikh, Purvish; Pereira, José Rodrigues; Ciuleanu, Tudor; Von Pawel, Joachim; Thongprasert, Sumitra; Tan, Eng Huat; Pemberton, Kristine; Archer, Venice; Carroll, Kevin.

In: The Lancet, Vol. 366, No. 9496, 29.10.2005, p. 1527-1537.

Research output: Contribution to journalArticle

Thatcher, Nick ; Chang, Alex Y ; Parikh, Purvish ; Pereira, José Rodrigues ; Ciuleanu, Tudor ; Von Pawel, Joachim ; Thongprasert, Sumitra ; Tan, Eng Huat ; Pemberton, Kristine ; Archer, Venice ; Carroll, Kevin. / Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer : Results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). In: The Lancet. 2005 ; Vol. 366, No. 9496. pp. 1527-1537.
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abstract = "Background: This placebo-controlled phase III study investigated the effect on survival of gefitinib as second-line or third-line treatment for patients with locally advanced or metastatic non-small-cell lung cancer. Methods: 1692 patients who were refractory to or intolerant of their latest chemotherapy regimen were randomly assigned in a ratio of two to one either gefitinib (250 mg/day) or placebo, plus best supportive care. The primary endpoint was survival in the overall population of patients and those with adenocarcinoma. The primary analysis of the population for survival was by intention to treat. This study has been submitted for registration with ClinicalTrials.gov, number 1839IL/709. Findings: 1129 patients were assigned gefitinib and 563 placebo. At median follow-up of 7·2 months, median survival did not differ significantly between the groups in the overall population (5·6 months for gefitinib and 5·1 months for placebo; hazard ratio 0·89 [95{\%} CI 0·77-1·02], p=0·087) or among the 812 patients with adenocarcinoma (6·3 months vs 5·4 months; 0·84 [0·68-1·03], p=0·089). Preplanned subgroup analyses showed significantly longer survival in the gefitinib group than the placebo group for never-smokers (n=375; 0·67 [0·49-0·92], p=0·012; median survival 8·9 vs 6·1 months) and patients of Asian origin (n=342; 0·66 [0·48-0·91], p=0·01; median survival 9·5 vs 5·5 months). Gefitinib was well tolerated, as in previous studies. Interpretation: Treatment with gefitinib was not associated with significant improvement in survival in either coprimary population. There was pronounced heterogeneity in survival outcomes between groups of patients, with some evidence of benefit among never-smokers and patients of Asian origin.",
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T2 - Results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer)

AU - Thatcher, Nick

AU - Chang, Alex Y

AU - Parikh, Purvish

AU - Pereira, José Rodrigues

AU - Ciuleanu, Tudor

AU - Von Pawel, Joachim

AU - Thongprasert, Sumitra

AU - Tan, Eng Huat

AU - Pemberton, Kristine

AU - Archer, Venice

AU - Carroll, Kevin

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N2 - Background: This placebo-controlled phase III study investigated the effect on survival of gefitinib as second-line or third-line treatment for patients with locally advanced or metastatic non-small-cell lung cancer. Methods: 1692 patients who were refractory to or intolerant of their latest chemotherapy regimen were randomly assigned in a ratio of two to one either gefitinib (250 mg/day) or placebo, plus best supportive care. The primary endpoint was survival in the overall population of patients and those with adenocarcinoma. The primary analysis of the population for survival was by intention to treat. This study has been submitted for registration with ClinicalTrials.gov, number 1839IL/709. Findings: 1129 patients were assigned gefitinib and 563 placebo. At median follow-up of 7·2 months, median survival did not differ significantly between the groups in the overall population (5·6 months for gefitinib and 5·1 months for placebo; hazard ratio 0·89 [95% CI 0·77-1·02], p=0·087) or among the 812 patients with adenocarcinoma (6·3 months vs 5·4 months; 0·84 [0·68-1·03], p=0·089). Preplanned subgroup analyses showed significantly longer survival in the gefitinib group than the placebo group for never-smokers (n=375; 0·67 [0·49-0·92], p=0·012; median survival 8·9 vs 6·1 months) and patients of Asian origin (n=342; 0·66 [0·48-0·91], p=0·01; median survival 9·5 vs 5·5 months). Gefitinib was well tolerated, as in previous studies. Interpretation: Treatment with gefitinib was not associated with significant improvement in survival in either coprimary population. There was pronounced heterogeneity in survival outcomes between groups of patients, with some evidence of benefit among never-smokers and patients of Asian origin.

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