| 培美曲塞联合顺铂对比吉西他滨联合顺铂一线治疗晚期非鳞非小细胞肺癌的随机、对照、多中心临床研究 |
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| 引用本文： | 黄岩,刘云鹏,周建英,徐农,李宝兰,伍钢,方健,李凯,刘晓睛,刘巍,卢铀,王孟昭,刘文超,梁后杰,张沂平,黄诚,王顺金,王雅杰,于世英,常建华,王哲海,胡志皇,张力.培美曲塞联合顺铂对比吉西他滨联合顺铂一线治疗晚期非鳞非小细胞肺癌的随机、对照、多中心临床研究[J].中国肺癌杂志,2012(10):576-582. |
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| 作者姓名： | 黄岩 刘云鹏 周建英 徐农 李宝兰 伍钢 方健 李凯 刘晓睛 刘巍 卢铀 王孟昭 刘文超 梁后杰 张沂平 黄诚 王顺金 王雅杰 于世英 常建华 王哲海 胡志皇 张力 |
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| 作者单位： | 中山大学肿瘤防治中心,华南肿瘤学国家重点实验室;中国医科大学附属第一医院;浙江大学医学院附属第一医院;北京市胸科医院;华中科技大学同济医学院附属协和医院;北京大学肿瘤医院;津市肿瘤医院;中国人民解放军307医院;河北医科大学第四医院;四川大学华西医院;中国医学科学院协和医院;第四军医大学西京医院;第三军医大学第一附属医院;浙江省肿瘤医院;福建省肿瘤医院;南昌大学附属第二医院;上海市长海医院;华中科技大学同济医学院附属同济医院;复旦大学附属肿瘤医院;山东省肿瘤医院 |
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| 基金项目： | 江苏豪森药业集团股份有限公司项目(ClinicalTrials.gov注册号:NCT01194453)资助~~ |
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| 摘 要： | 背景与目的目前晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的标准治疗仍是含铂两药方案,国内外多项临床研究显示培美曲塞联合顺铂在晚期非鳞NSCLC具有较好的疗效及安全性,本研究拟评估国产培美曲塞二钠联合顺铂一线治疗晚期NSCLC的疗效与安全性。方法本研究是一项多中心、随机、阳性药物平行对照的临床试验。入组患者按1:1随机分为两组,分别接受培美曲塞二钠联合顺铂(PC组)或吉西他滨联合顺铂(GC组)治疗,21天为一个周期。主要研究终点为无进展生存期,次要研究终点主要包括1年生存率、客观缓解率、无3度或4度毒性生存期及其安全性。结果全国20家研究中心共纳入288例患者(各组144例),基于全分析集进行分析,PC组与GC组患者的中位无进展生存期分别为168天(5.6个月)和140天(4.7个月)(P=0.16);1年生存率分别为50.0%和54.9%(P=0.47);客观缓解率分别为24.4%和14.2%(P=0.06);无3度/4度毒性生存期分别为11.3个月和8.1个月(P=0.23)。总体不良反应发生率PC组明显低于GC组(81.95%vs93.75%,P=0.003)。结论两种含铂方案治疗晚期非鳞NSCLC具有相似的疗效,但PC方案不良反应更轻,有望成为晚期非鳞NSCLC一线治疗的新选择。
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| 关 键 词： | 肺肿瘤 培美曲塞 吉西他滨 顺铂 化学疗法 |
A Randomized, Controlled, Multicenter Clinical Trial Comparing Pemetrexed/Cisplatin and Gemcitabine/Cisplatin as First-line Treatment for Advanced Nonsquamous Non-small Cell Lung Cancer |
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| Yan HUANG,Yunpeng LIU,Jianying ZHOU,Nong XU,Baolan LI,Gang WU,Jian FANG,Kai LI,Xiaoqing LIU,Wei LIU,You LU,Mengzhao WANG,Wenchao LIU,Houjie LIANG,Yiping ZHANG,Cheng HUANG,Shunjin WANG,Yajie WANG,Shiying YU,Jianhua CHANG,Zhehai WANG,Zhihuang HU,Li ZHANG.A Randomized, Controlled, Multicenter Clinical Trial Comparing Pemetrexed/Cisplatin and Gemcitabine/Cisplatin as First-line Treatment for Advanced Nonsquamous Non-small Cell Lung Cancer[J].Chinese Journal of Lung Cancer,2012(10):576-582. |
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| Authors: | Yan HUANG Yunpeng LIU Jianying ZHOU Nong XU Baolan LI Gang WU Jian FANG Kai LI Xiaoqing LIU Wei LIU You LU Mengzhao WANG Wenchao LIU Houjie LIANG Yiping ZHANG Cheng HUANG Shunjin WANG Yajie WANG Shiying YU Jianhua CHANG Zhehai WANG Zhihuang HU Li ZHANG |
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| Affiliation: | 1,2 1Department of Medical Oncology, Sun Yat-sen University Cancer Center, 510060 Guangzhou, China; 2State Key Laboratory of Oncology in South China, 510060 Guangzhou, China; 3Department of Medical Oncology, First Hospital of China Medical University, 110001 Shenyang, China; 4Department of Respiratory Diseases, First Affiliated Hospital of Medical School of Zhejiang University, 310003 Hangzhou, China; 5Department of Chemotherapy, the First Affiliated Hospital of Medical School of Zhejiang University, 310003 Hangzhou, China; 6Department of General Medicine, Beijing Chest Hospital, Capital Medical Hospital, 101149 Beijing, China; 7Tumor Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430022 Wuhan, China; 8Department of Thoracic Medical Oncology, Peking University School of Oncology, Beijing Cancer Hospital and Institute, 100142 Beijing, China; 9Department of Thoracic Medical Oncology, Tianjin Medical University Cancer Institute and Hospital, 300060 Tianjin, China; 10Department of Thoracic Medical Oncology, Affiliated Hospital of Academy of Military Medical Sciences, 100071 Beijing, China; 11Department of Medical Oncology, Hebei Medical University Fourth Hospital, 050011 Shijiazhuang, China; 12Department of Thoracic oncology, West China Hospital, West China School of Medicine Sichuan University, 610041 Chengdu, China; 13Department of Respiratory Diseases, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, 100730 Beijing, China; 14Department of Oncology, Xijing Hospital, Fourth Military Medical University, 710032 Xi’an, China; 15Department of Oncology, First Affiliated Hospital, Third Military Medical University, 400038 Chongqing, China; 16Department of Medical Oncology, Zhejiang Cancer Hospital, 310022 Hangzhou, China; 17Department of Thoracic Oncology, Fujian Provincial Cancer Hospital, 350014 Fuzhou, China; 18Department of Oncology, Second Affiliated Hospital of Nanchang University, 330006 Nanchang, China; 19Department of Oncology, Changhai Hospital of Shanghai, Second Military Medical University, 200433 Shanghai, China; 20Cancer Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430030 Wuhan, China; 21Department of Medical Oncology, Fudan University Shanghai Cancer Center, 200032 Shanghai, China; 22Department of Medical Oncology, Shandong Cancer Hospital, 250117 Jinan, China |
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| Abstract: | Background and objective Platinum-based doublet chemotherapy is still the standard first-line treatment for non-small cell lung cancer (NSCLC). Previous studies have demonstrated that pemetrexed combined with platinum had promising efficacy and safety profile in NSCLC, especially in patients with nonsquamous NSCLC. This trial was conducted to evaluate the efficacy and safety of pemetrexed made in China as first-line treatment. Methods The present study was a randomized, controlled, multicenter clinical trial. Patients were randomly assigned (1:1) to receive cisplatin plus pemetrexed chemotherapy (PC group) or gemcitabine plus cisplatin (GC group) every 3 weeks. The primary end point was progression free survival (PFS) and the secondary end points included 1 year survival rate, objective response rate (ORR), survival with-out grade 3/4 toxicity (SWT3/4) and safety profile. Results A total of 288 patients from 20 institutions across China were enrolled into the study. Based on the Full Analyses Set (FAS), the PFS was 168 days (5.6 months) vs 140 days (4.7 months) (P=0.16), one year survival rate was 50.0% vs 54.9% (P=0.47), ORR was 24.4% vs 14.2% (P=0.06) in the PC group and the GC group, respectively; Survival without grade 3/4 toxicity was 11.3 months in GC group vs 8.1 months in PC group (P=0.23). In terms of the safety, side effects were less observed on the PC group (81.95% vs 93.75%, P=0.003). The main side effects included leukopenia, neutropenia, emesis, anemia, thrombopenia. Conclusion The both regimens have similar efficacy as the treatment for advanced nonsquamous NSCLC, but pemetrexed plus cisplatin regimen has better safety profile and seems to have longer PFS, which makes it a new option as the first line setting. |
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| Keywords: | Lung neoplasm Pemetrexed Gemcitabine Cisplatin Chemotherapy |
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