RT Journal Article
T1 First-line gefitinib in Caucasian EGFR mutation-positive NSCLC patients: a phase-IV, open-label, single-arm study.
A1 Douillard, J-Y
A1 Ostoros, G
A1 Cobo, M
A1 Ciuleanu, T
A1 McCormack, R
A1 Webster, A
A1 Milenkova, T
K1 Gefinitib
K1 NSCLC
K1 EGFR mutation
K1 Caucasian
K1 Neoplasias pulmonares
K1 Estudios prospectivos
K1 Inhibidores de proteína cinasas
K1 Receptor del factor de crecimiento epidérmico
K1 Antineoplásicos
K1 Grupo de ascendencia continental europea
K1 Progresión de la enfermedad
K1 Supervivencia sin Enfermedad
K1 Carcinoma de pulmón de células no pequeñas
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.
PB Nature Publishing Group
SN 0007-0920
YR 2014
FD 2014-01-07
LK http://hdl.handle.net/10668/1847
UL http://hdl.handle.net/10668/1847
LA en
NO Douillard JY, Ostoros G, Cobo M, Ciuleanu T, McCormack R, Webster A, et al. First-line gefitinib in Caucasian EGFR mutation-positive NSCLC patients: a phase-IV, open-label, single-arm study. Br. J. Cancer. 2014; 110(1):55-62
DS RISalud
RD Apr 12, 2025