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A Randomized Phase 3 Trial Comparing Pemetrexed/Carboplatin and Docetaxel/Carboplatin as First-Line Treatment for Advanced, Nonsquamous Non-small Cell Lung Cancer
Rodrigues-Pereira, Jose2; Kim, Joo-Hang3; Magallanes, Manuel4; Lee, Dae Ho5; Wang, Jie6,7; Ganju, Vinod8; Martinez-Barrera, Luis9; Barraclough, Helen10; van Kooten, Maximiliano10; Orlando, Mauro1
关键词Carboplatin Docetaxel First-line Therapy Non-small Cell Lung Carcinoma Nonsquamous Pemetrexed
刊名JOURNAL OF THORACIC ONCOLOGY
2011-11-01
DOI10.1097/JTO.0b013e318226b5fa
6期:11页:1907-1914
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Oncology ; Respiratory System
研究领域[WOS]Oncology ; Respiratory System
关键词[WOS]CLINICAL-PRACTICE GUIDELINES ; CISPLATIN PLUS GEMCITABINE ; RISK-BENEFIT ANALYSIS ; 2ND EDITION ; FOLLOW-UP ; STAGE-IV ; CARBOPLATIN ; DOCETAXEL ; CHEMOTHERAPY ; TOXICITY
英文摘要

Introduction: This study compared survival without toxicity in patients with advanced, nonsquamous non-small cell lung cancer who were treated with first-line pemetrexed/carboplatin or docetaxel/carboplatin.

Methods: This multicenter, open-label, parallel-group, phase 3 trial comprised patients randomized (1:1) to pemetrexed/carboplatin (n = 128) or docetaxel/carboplatin (n = 132). Patients received treatment on day 1 of each 21-day cycle (maximum of six cycles). Treatment included carboplatin (area under the curve = 5 mg/ml x min) and pemetrexed (500 mg/m(2)) or docetaxel (75 mg/m(2)). The primary outcome measure, survival without treatment-emergent grade 3/4 toxicity, was defined as the time from randomization to the first treatment-emergent grade 3/4 adverse event or death and was analyzed using a log-rank test. The analysis population included 106 patients in the pemetrexed/carboplatin (Pem/Carb) group and 105 patients in the docetaxel/carboplatin (Doc/Carb) group.

Results: Survival without treatment-emergent grade 3/4 toxicity was significantly longer in the Pem/Carb versus the Doc/Carb group (log-rank p < 0.001; median survival without treatment-emergent grade 3/4 toxicity: 3.2 versus 0.7 months; adjusted hazard ratio = 0.45 [95% confidence interval: 0.34-0.61]). Overall survival was similar in the Pem/Carb versus the Doc/Carb group (log-rank p = 0.934; median survival: 14.9 versus 14.7 months; adjusted hazard ratio = 0.93 [95% confidence interval: 0.66-1.32]). Compared with the Doc/Carb group, fewer patients in the Pem/Carb group experienced grade 3/4 drug-related, treatment-emergent neutropenia, leukopenia, or febrile neutropenia, and more patients experienced anemia and thrombocytopenia. There were three study drug-related deaths during treatment in each group.

Conclusions: The favorable benefit-to-risk profile of pemetrexed/ carboplatin suggests that pemetrexed/carboplatin is an appropriate first-line treatment option for chemona ve patients with advanced, nonsquamous non-small cell lung cancer.

语种英语
WOS记录号WOS:000296700400018
资助机构Eli Lilly ; Eli Lilly Australia ; Eli Lilly and Company
引用统计
被引频次:50[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/51291
专题北京大学临床肿瘤学院_胸部肿瘤内科
作者单位1.Mil Hosp Mexico, Dept Med Oncol, Mexico City, DF, Mexico
2.Beijing Canc Hosp & Inst, Beijing, Peoples R China
3.INER, Dept Med Oncol, Mexico City, DF, Mexico
4.Eli Lilly Australia Pty Ltd, Sydney, NSW, Australia
5.Eli Lilly Interamer Inc, Buenos Aires, DF, Argentina
6.Inst Canc Arnaldo Vieira de Carvalho, Sao Paulo, Brazil
7.Yonsei Univ Hlth Syst, Yonsei Canc Ctr, Seoul, South Korea
8.Univ Ulsan, Coll Med, Asan Med Ctr, Dept Oncol, Seoul, South Korea
9.Peking Univ, Sch Oncol, Dept Thorac Med Oncol, Beijing 100871, Peoples R China
10.Frankston Private, Peninsula Oncol Ctr, Dept Oncol, Frankston, Vic, Australia
推荐引用方式
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Rodrigues-Pereira, Jose,Kim, Joo-Hang,Magallanes, Manuel,et al. A Randomized Phase 3 Trial Comparing Pemetrexed/Carboplatin and Docetaxel/Carboplatin as First-Line Treatment for Advanced, Nonsquamous Non-small Cell Lung Cancer[J]. JOURNAL OF THORACIC ONCOLOGY,2011,6(11):1907-1914.
APA Rodrigues-Pereira, Jose.,Kim, Joo-Hang.,Magallanes, Manuel.,Lee, Dae Ho.,Wang, Jie.,...&Orlando, Mauro.(2011).A Randomized Phase 3 Trial Comparing Pemetrexed/Carboplatin and Docetaxel/Carboplatin as First-Line Treatment for Advanced, Nonsquamous Non-small Cell Lung Cancer.JOURNAL OF THORACIC ONCOLOGY,6(11),1907-1914.
MLA Rodrigues-Pereira, Jose,et al."A Randomized Phase 3 Trial Comparing Pemetrexed/Carboplatin and Docetaxel/Carboplatin as First-Line Treatment for Advanced, Nonsquamous Non-small Cell Lung Cancer".JOURNAL OF THORACIC ONCOLOGY 6.11(2011):1907-1914.
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