First-line gefitinib in Caucasian EGFR mutation-positive NSCLC patients

A phase-IV, open-label, single-arm study

J. Y. Douillard, G. Ostoros, M. Cobo, T. Ciuleanu, R. McCormack, A. Webster, T. Milenkova

Research output: Contribution to journalArticle

197 Citations (Scopus)

Abstract

Background:Phase-IV, open-label, single-arm study (NCT01203917) to assess efficacy and safety/tolerability of first-line gefitinib in Caucasian patients with stage IIIA/B/IV, epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC).Methods:Treatment: gefitinib 250 mg day-1 until progression. Primary endpoint: objective response rate (ORR). Secondary endpoints: disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety/tolerability. Pre-planned exploratory objective: EGFR mutation analysis in matched tumour and plasma samples.Results:Of 1060 screened patients with NSCLC (859 known mutation status; 118 positive, mutation frequency 14%), 106 with EGFR sensitising mutations were enrolled (female 70.8%; adenocarcinoma 97.2%; never-smoker 64.2%). At data cutoff: ORR 69.8% (95% confidence interval (CI) 60.5-77.7), DCR 90.6% (95% CI 83.5-94.8), median PFS 9.7 months (95% CI 8.5-11.0), median OS 19.2 months (95% CI 17.0-NC; 27% maturity). Most common adverse events (AEs; any grade): rash (44.9%), diarrhoea (30.8%); CTC (Common Toxicity Criteria) grade 3/4 AEs: 15%; SAEs: 19%. Baseline plasma 1 samples were available in 803 patients (784 known mutation status; 82 positive; mutation frequency 10%). Plasma 1 EGFR mutation test sensitivity: 65.7% (95% CI 55.8-74.7).Conclusion:First-line gefitinib was effective and well tolerated in Caucasian patients with EGFR mutation-positive NSCLC. Plasma samples could be considered for mutation analysis if tumour tissue is unavailable.

Original languageEnglish
Pages (from-to)55-62
Number of pages8
JournalBritish Journal of Cancer
Volume110
Issue number1
DOIs
Publication statusPublished - 2014

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Epidermal Growth Factor Receptor
Non-Small Cell Lung Carcinoma
Mutation
Confidence Intervals
Mutation Rate
Disease-Free Survival
Safety
Survival
gefitinib
Exanthema
Diarrhea
Neoplasms
Adenocarcinoma

Keywords

  • Caucasian
  • EGFR mutation
  • gefitinib
  • NSCLC

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

First-line gefitinib in Caucasian EGFR mutation-positive NSCLC patients : A phase-IV, open-label, single-arm study. / Douillard, J. Y.; Ostoros, G.; Cobo, M.; Ciuleanu, T.; McCormack, R.; Webster, A.; Milenkova, T.

In: British Journal of Cancer, Vol. 110, No. 1, 2014, p. 55-62.

Research output: Contribution to journalArticle

Douillard, J. Y. ; Ostoros, G. ; Cobo, M. ; Ciuleanu, T. ; McCormack, R. ; Webster, A. ; Milenkova, T. / First-line gefitinib in Caucasian EGFR mutation-positive NSCLC patients : A phase-IV, open-label, single-arm study. In: British Journal of Cancer. 2014 ; Vol. 110, No. 1. pp. 55-62.
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abstract = "Background:Phase-IV, open-label, single-arm study (NCT01203917) to assess efficacy and safety/tolerability of first-line gefitinib in Caucasian patients with stage IIIA/B/IV, epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC).Methods:Treatment: gefitinib 250 mg day-1 until progression. Primary endpoint: objective response rate (ORR). Secondary endpoints: disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety/tolerability. Pre-planned exploratory objective: EGFR mutation analysis in matched tumour and plasma samples.Results:Of 1060 screened patients with NSCLC (859 known mutation status; 118 positive, mutation frequency 14{\%}), 106 with EGFR sensitising mutations were enrolled (female 70.8{\%}; adenocarcinoma 97.2{\%}; never-smoker 64.2{\%}). At data cutoff: ORR 69.8{\%} (95{\%} confidence interval (CI) 60.5-77.7), DCR 90.6{\%} (95{\%} CI 83.5-94.8), median PFS 9.7 months (95{\%} CI 8.5-11.0), median OS 19.2 months (95{\%} CI 17.0-NC; 27{\%} maturity). Most common adverse events (AEs; any grade): rash (44.9{\%}), diarrhoea (30.8{\%}); CTC (Common Toxicity Criteria) grade 3/4 AEs: 15{\%}; SAEs: 19{\%}. Baseline plasma 1 samples were available in 803 patients (784 known mutation status; 82 positive; mutation frequency 10{\%}). Plasma 1 EGFR mutation test sensitivity: 65.7{\%} (95{\%} CI 55.8-74.7).Conclusion:First-line gefitinib was effective and well tolerated in Caucasian patients with EGFR mutation-positive NSCLC. Plasma samples could be considered for mutation analysis if tumour tissue is unavailable.",
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T1 - First-line gefitinib in Caucasian EGFR mutation-positive NSCLC patients

T2 - A phase-IV, open-label, single-arm study

AU - Douillard, J. Y.

AU - Ostoros, G.

AU - Cobo, M.

AU - Ciuleanu, T.

AU - McCormack, R.

AU - Webster, A.

AU - Milenkova, T.

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N2 - Background:Phase-IV, open-label, single-arm study (NCT01203917) to assess efficacy and safety/tolerability of first-line gefitinib in Caucasian patients with stage IIIA/B/IV, epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC).Methods:Treatment: gefitinib 250 mg day-1 until progression. Primary endpoint: objective response rate (ORR). Secondary endpoints: disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety/tolerability. Pre-planned exploratory objective: EGFR mutation analysis in matched tumour and plasma samples.Results:Of 1060 screened patients with NSCLC (859 known mutation status; 118 positive, mutation frequency 14%), 106 with EGFR sensitising mutations were enrolled (female 70.8%; adenocarcinoma 97.2%; never-smoker 64.2%). At data cutoff: ORR 69.8% (95% confidence interval (CI) 60.5-77.7), DCR 90.6% (95% CI 83.5-94.8), median PFS 9.7 months (95% CI 8.5-11.0), median OS 19.2 months (95% CI 17.0-NC; 27% maturity). Most common adverse events (AEs; any grade): rash (44.9%), diarrhoea (30.8%); CTC (Common Toxicity Criteria) grade 3/4 AEs: 15%; SAEs: 19%. Baseline plasma 1 samples were available in 803 patients (784 known mutation status; 82 positive; mutation frequency 10%). Plasma 1 EGFR mutation test sensitivity: 65.7% (95% CI 55.8-74.7).Conclusion:First-line gefitinib was effective and well tolerated in Caucasian patients with EGFR mutation-positive NSCLC. Plasma samples could be considered for mutation analysis if tumour tissue is unavailable.

AB - Background:Phase-IV, open-label, single-arm study (NCT01203917) to assess efficacy and safety/tolerability of first-line gefitinib in Caucasian patients with stage IIIA/B/IV, epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC).Methods:Treatment: gefitinib 250 mg day-1 until progression. Primary endpoint: objective response rate (ORR). Secondary endpoints: disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety/tolerability. Pre-planned exploratory objective: EGFR mutation analysis in matched tumour and plasma samples.Results:Of 1060 screened patients with NSCLC (859 known mutation status; 118 positive, mutation frequency 14%), 106 with EGFR sensitising mutations were enrolled (female 70.8%; adenocarcinoma 97.2%; never-smoker 64.2%). At data cutoff: ORR 69.8% (95% confidence interval (CI) 60.5-77.7), DCR 90.6% (95% CI 83.5-94.8), median PFS 9.7 months (95% CI 8.5-11.0), median OS 19.2 months (95% CI 17.0-NC; 27% maturity). Most common adverse events (AEs; any grade): rash (44.9%), diarrhoea (30.8%); CTC (Common Toxicity Criteria) grade 3/4 AEs: 15%; SAEs: 19%. Baseline plasma 1 samples were available in 803 patients (784 known mutation status; 82 positive; mutation frequency 10%). Plasma 1 EGFR mutation test sensitivity: 65.7% (95% CI 55.8-74.7).Conclusion:First-line gefitinib was effective and well tolerated in Caucasian patients with EGFR mutation-positive NSCLC. Plasma samples could be considered for mutation analysis if tumour tissue is unavailable.

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