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Randomized phase II study of gefitinib versus erlotinib in patients with advanced non-small cell lung cancer who failed previous chemotherapy

Authors
Kim, Seung TaeUhm, Ji EunLee, JeeyunSun, Jong-muSohn, InsukKim, Seon WooJung, Sin-HoPark, Yeon HeeAhn, Jin SeokPark, KeunchilAhn, Myung-Ju
Issue Date
1월-2012
Publisher
ELSEVIER IRELAND LTD
Keywords
Gefitinib; Erlotinib; Non-small cell lung cancer
Citation
LUNG CANCER, v.75, no.1, pp.82 - 88
Indexed
SCIE
SCOPUS
Journal Title
LUNG CANCER
Volume
75
Number
1
Start Page
82
End Page
88
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/109173
DOI
10.1016/j.lungcan.2011.05.022
ISSN
0169-5002
Abstract
Purpose: Gefitinib and erlotinib are potent EGFR TKIs, with antitumor activity. In this randomized, single-center, non-comparative phase II trial, the efficacy and safety of gefitinib and erlotinib was evaluated as the second-line therapy for advanced non-small cell lung cancer (NSCLC). Patients and methods: Patients with locally advanced, metastatic stage IIIB/IV NSCLC who failed first-line chemotherapy and had either EGFR mutation or at least two out of three clinical factors associated with higher incidence of EGFR mutations (female, adenocarcinoma histology, and never-smoker) were eligible. Results: A total of 96 (48 per arm) patients were randomly assigned to gefitinib- or erlotinib-arm, respectively. Baseline characteristics were well-balanced between the two arms. The response rates (RR) were 47.9% in the gefitinib arm and 39.6% in the erlotinib arm. Median PFS was 4.9 months (95% CI, 1.3-8.5) in the gefitinib arm and 3.1 months (95% Cl, 0.0-6.4) in the erlotinib arm. The most common grade 3/4 toxicity was skin rash. Exploratory analyses showed that there was no significant difference in RR and PFS in the gefitinib arm compared to the erlotinib arm (RR (%) 47.9 vs. 39.6, p = 0.269; median survival (months) 4.9 vs. 3.1, p = 0.336). There was no significant difference in QOL between the two arms. Conclusion: Both gefitinib and erlotinib showed effective activity and tolerable toxicity profiles as second-line treatment for the selected population of NSCLC. We may consider conducting a phase III trial to directly compare the efficacy and toxicity between gefitinib and erlotinib in an enriched patient population. (C) 2011 Elsevier Ireland Ltd. All rights reserved.
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