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Br J Cancer. 2014 Jan 7;110(1):55-62. doi: 10.1038/bjc.2013.721. Epub 2013 Nov 21.

First-line gefitinib in Caucasian EGFR mutation-positive NSCLC patients: a phase-IV, open-label, single-arm study.

Author information

1
Institut de Cancérologie de l'Ouest, Centre René Gauducheau, Bd J. Monod, 44805 St-Herblain, Nantes, France.
2
National Koranyi Institute of Pulmonology, Piheno ut 1, Budapest H-1121, Hungary.
3
Hospital Regional Universitario Carlos Haya, Málaga, Andalucia 29010, Spain.
4
Institutul Oncologic Ion Chiricuta and UMF Iuliu Hatieganu, Cluj-Napoca 400015, Romania.
5
AstraZeneca, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK.

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.

PMID:
24263064
PMCID:
PMC3887309
DOI:
10.1038/bjc.2013.721
[Indexed for MEDLINE]
Free PMC Article

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