2013
DOI: 10.1038/bjc.2013.721
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First-line gefitinib in Caucasian EGFR mutation-positive NSCLC patients: a phase-IV, open-label, single-arm study

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-plan… Show more

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Cited by 365 publications
(279 citation statements)
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“…The approval was based on a phase IV study of gefitinib for first-line treatment of Caucasian patients with exon 19 or L858R EGFR mutations. In the 106 patients in this study, the overall response rate was 69.8 % with a median PFS of 9.7 months and median OS of 19.2 months [5].…”
Section: Clinical Efficacymentioning
confidence: 79%
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“…The approval was based on a phase IV study of gefitinib for first-line treatment of Caucasian patients with exon 19 or L858R EGFR mutations. In the 106 patients in this study, the overall response rate was 69.8 % with a median PFS of 9.7 months and median OS of 19.2 months [5].…”
Section: Clinical Efficacymentioning
confidence: 79%
“…Grade 3 or 4 transaminitis occurs in up to 11 % of patients. Rare fatal hepatotoxicity and interstitial pneumonitis have occurred with gefitinib [59,60,63,64]. [56].…”
Section: Clinical Safetymentioning
confidence: 99%
See 1 more Smart Citation
“…The patients randomly assigned to receive gefitinib had better progression-free survival than patients receiving standard chemotherapy (such as four to six cycles of carboplatin/paclitaxel). 6 Thus, the current approval is for a patient population, notably EGFR mutation-positive patients who were previously untreated, which is different than that of the 2003 approval.…”
Section: Discussionmentioning
confidence: 99%
“…Gefitinib, an orally active, selective and reversible EGFR-TKI, had been largely studied and developed for treatment in first-line setting of patients with advanced EGFR mutation-positive NSCLC compared with chemotherapy (3,4) both in Caucasian and non-Caucasian patients (5)(6)(7).…”
mentioning
confidence: 99%