Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study
Journal Title: | The lancet oncology 2011, Vol.12 (8), p.735-742 |
Main Author: | Zhou, Caicun, Prof |
Other Authors: | Wu, Yi-Long, Prof , Chen, Gongyan, Prof , Feng, Jifeng, Prof , Liu, Xiao-Qing, Prof , Wang, Changli, Prof , Zhang, Shucai, Prof , Wang, Jie, Prof , Zhou, Songwen, MD , Ren, Shengxiang, MD , Lu, Shun, Prof , Zhang, Li, Prof , Hu, Chengping, Prof , Hu, Chunhong, Prof , Luo, Yi, Prof , Chen, Lei, Prof , Ye, Ming, Prof , Huang, Jianan, Prof , Zhi, Xiuyi, Prof , Zhang, Yiping, Prof , Xiu, Qingyu, Prof , Ma, Jun, Prof , You, Changxuan, Prof |
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Quelle: | Alma/SFX Local Collection |
Publisher: | England: Elsevier Ltd |
ID: | ISSN: 1470-2045 |
Link: | https://www.ncbi.nlm.nih.gov/pubmed/21783417 |
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title: | Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study |
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ispartof: | The lancet oncology, 2011, Vol.12 (8), p.735-742 |
description: | Summary Background Activating mutations in EGFR are important markers of response to tyrosine kinase inhibitor (TKI) therapy in non-small-cell lung cancer (NSCLC). The OPTIMAL study compared efficacy and tolerability of the TKI erlotinib versus standard chemotherapy in the first-line treatment of patients with advanced EGFR mutation-positive NSCLC. Methods We undertook an open-label, randomised, phase 3 trial at 22 centres in China. Patients older than 18 years with histologically confirmed stage IIIB or IV NSCLC and a confirmed activating mutation of EGFR (exon 19 deletion or exon 21 L858R point mutation) received either oral erlotinib (150 mg/day) until disease progression or unacceptable toxic effects, or up to four cycles of gemcitabine plus carboplatin. Patients were randomly assigned (1:1) with a minimisation procedure and were stratified according to EGFR mutation type, histological subtype (adenocarcinoma vs non-adenocarcinoma), and smoking status. The primary outcome was progression-free survival, analysed in patients with confirmed disease who received at least one dose of study treatment. The trial is registered at ClinicalTrials.gov , number NCT00874419 , and has completed enrolment; patients are still in follow-up. Findings 83 patients were randomly assigned to receive erlotinib and 82 to receive gemcitabine plus carboplatin; 82 in the erlotinib group and 72 in the chemotherapy group were included in analysis of the primary endpoint. Median progression-free survival was significantly longer in erlotinib-treated patients than in those on chemotherapy (13.1 [95% CI 10.58–16.53] vs 4.6 [4.21–5.42] months; hazard ratio 0.16, 95% CI 0.10–0.26; p |
language: | eng |
source: | Alma/SFX Local Collection |
identifier: | ISSN: 1470-2045 |
fulltext: | fulltext |
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