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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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成果类型:
期刊论文
作者:
Zhou, Caicun*;Wu, Yi-Long;Chen, Gongyan;Feng, Jifeng;Liu, Xiao-Qing;Wang, Changli;Zhang, Shucai;Wang, Jie;Zhou, Songwen;Ren, Shengxiang;Lu, Shun;Zhang, Li;Hu, Chengping;Hu, Chunhong;Luo, Yi;Chen, Lei;Ye, Ming;Huang, Jianan;Zhi, Xiuyi;Zhang, Yiping;Xiu, Qingyu;Ma, Jun;You, Changxuan
通讯作者:
Zhou, Caicun
作者机构:
[Wu, Yi-Long] Guangdong Acad Med Sci, Guangdong Gen Hosp, Guangdong Lung Canc Inst, Guangzhou, Guangdong, Peoples R China.
[Zhang, Shucai] Capital Med Univ, Beijing Chest Hosp, Beijing, Peoples R China.
[Zhang, Li] Sun Yat Sen Univ, Ctr Canc, Guangzhou 510275, Guangdong, Peoples R China.
[Zhang, Li] Beijing Union Med Coll Hosp, Beijing, Peoples R China.
[Chen, Lei] Shantou Univ, Coll Med, Canc Hosp, Shantou, Peoples R China.
通讯机构:
[Zhou, Caicun] Tongji Univ, Sch Med, Shanghai Pulm Hosp, Dept Oncol, Shanghai 200092, Peoples R China.
语种:
英文
期刊:
The Lancet. Oncology
ISSN:
1470-2045
年:
2011
卷:
12
期:
8
页码:
735-742
文献类别:
WOS:Article
所属学科:
ESI学科类别:临床医学;WOS学科类别:Oncology
入藏号:
WOS:000293272100024;PMID:21783417
基金类别:
F Hoffmann-La Roche (China); Science and Technology Commission of Shanghai Municipality [06DZ19502]
机构署名:
本校为其他机构
院系归属:
湘雅医院(第一临床学院)
湘雅二医院(第二临床学院)
摘要:
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<0.0001). Chemotherapy was associated with more grade 3 or 4 toxic effects than was erlotinib (including neutropenia in 30 [42%] of 72 patients and thrombocytopenia in 29 [40%] patients on chemotherapy vs no patients with either event on erlotinib); the most common grade 3 or 4 toxic effects with erlotinib were increased alanine aminotransferase concentrations (three [4%] of 83 patients) and skin rash (two [2%] patients). Chemotherapy was also associated with increased treatment-related serious adverse events (ten [14%] of 72 patients [decreased platelet count, n=8; decreased neutrophil count, n=1; hepatic dysfunction, n=1] vs two [2%] of 83 patients [both hepatic dysfunction]). INTERPRETATION: Compared with standard chemotherapy, erlotinib conferred a significant progression-free survival benefit in patients with advanced EGFR mutation-positive NSCLC and was associated with more favourable tolerability. These findings suggest that erlotinib is important for first-line treatment of patients with advanced EGFR mutation-positive NSCLC. FUNDING: F Hoffmann-La Roche Ltd (China); Science and Technology Commission of Shanghai Municipality.
参考文献:
Cappuzzo F, 2010, LANCET ONCOL, V11, P521, DOI 10.1016/S1470-2045(10)70112-1
Ferlay J, 2010, INT J CANCER, V127, P2893, DOI 10.1002/ijc.25516
Shigematsu H, 2005, J NATL CANCER I, V97, P339, DOI 10.1093/jnci/dji055
Jemal A, 2010, CA-CANCER J CLIN, V60, P277, DOI [10.3322/caac.20073, 10.1002/caac.20073]
Rosell R, 2009, NEW ENGL J MED, V361, P958, DOI 10.1056/NEJMoa0904554

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