Gemcitabine and oxaliplatin with or without erlotinib in advanced biliary-tract cancer: a multicentre, open-label, randomised, phase 3 study

医学 埃罗替尼 吉西他滨 奥沙利铂 内科学 化疗 肿瘤科 盐酸厄洛替尼 胰腺癌 癌症 胆道 胃肠病学 结直肠癌 表皮生长因子受体
作者
Yong‐Seok Jee,Se Hoon Park,Heung Moon Chang,Jun Suk Kim,Hye Jin Choi,Myung Ah Lee,Joung Soon Jang,Joung Soon Chang,Hei Cheul Jeung,Jung Hun Kang,Hyun Woo Lee,Dong Bok Shin,Hye Jin Kang,Jong‐Mu Sun,Joon Oh Park,Young Suk Park,Won Ki Kang,Ho Yeong Lim
出处
期刊:Lancet Oncology [Elsevier]
卷期号:13 (2): 181-188 被引量:427
标识
DOI:10.1016/s1470-2045(11)70301-1
摘要

Combination chemotherapy with gemcitabine and a platinum-based agent is regarded as a standard treatment for patients with advanced biliary-tract cancer. Results of phase 2 trials of single-agent erlotinib in biliary-tract cancer and of gemcitabine plus erlotinib in pancreatic cancer have shown modest benefits. Therefore, we aimed to investigate the efficacy of gemcitabine and oxaliplatin plus erlotinib versus chemotherapy alone for advanced biliary-tract cancer.In this open label, randomised, phase 3 trial, we randomly assigned patients (in a 1:1 ratio) with metastatic biliary-tract cancer (cholangiocarcinoma, gallbladder cancer, or ampulla of Vater cancer) to receive either first-line treatment with chemotherapy alone (gemcitabine 1000 mg/m(2) on day 1 and oxaliplatin 100 mg/m(2) on day 2) or chemotherapy plus erlotinib (100 mg daily). Treatment was repeated every 2 weeks until disease progression or unacceptable toxic effects. Randomisation was done centrally (stratified by participating centre and presence of measurable lesion). The primary endpoint was progression-free survival. Analyses were by intention-to-treat. This study is registered with ClinicalTrials.gov, number NCT01149122.133 patients were randomly assigned to the chemotherapy alone group and 135 to the chemotherapy plus erlotinib group. The groups were balanced except for a higher proportion of patients with cholangiocarcinoma in the group given erlotinib than in the chemotherapy alone group (96 [71%] patients vs 84 [63%]). Median progression-free survival was 4·2 months (95% CI 2·7-5·7) in the chemotherapy alone group and 5·8 months (95% CI 4·6-7·0) in the chemotherapy plus erlotinib group (hazard ratio [HR] 0·80, 95% CI 0·61-1·03; p=0·087). Significantly more patients had an objective response in the chemotherapy plus erlotinib group than in the chemotherapy alone group (40 patients vs 21 patients; p=0·005), but median overall survival was the same in both groups (9·5 months [95% CI 7·5-11·5] in the chemotherapy alone group and 9·5 months [7·6-11·4] in the chemotherapy plus erlotinib group; HR 0·93, 0·69-1·25; p=0·611). All-cause deaths within 30 days of random assignment occurred in one (1%) of the patients in the chemotherapy alone group and in four (3%) of those in the chemotherapy plus erlotinib group. The most common grade 3-4 adverse event was febrile neutropenia (eight [6%] patients in the chemotherapy alone group and six [4%] in the chemotherapy plus erlotinib group). No patient died of treatment-related causes during the study. Subgroup analyses by primary site of disease showed that for patients with cholangiocarcinoma, the addition of erlotinib to chemotherapy significantly prolonged median progression-free survival (5·9 months [95% CI 4·7-7·1] for chemotherapy plus erlotinib vs 3·0 months [1·1-4·9] for chemotherapy alone; HR 0·73, 95% CI 0·53-1·00; p=0·049).Although no significant difference in progression-free survival was noted between groups, the addition of erlotinib to gemcitabine and oxaliplatin showed antitumour activity and might be a treatment option for patients with cholangiocarcinoma.None.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
大幅提高文件上传限制,最高150M (2024-4-1)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
堀江真夏完成签到 ,获得积分10
刚刚
现代元灵完成签到 ,获得积分10
2秒前
4秒前
wenqing完成签到 ,获得积分10
5秒前
6秒前
fiu~完成签到 ,获得积分10
11秒前
Alex-Song完成签到 ,获得积分0
12秒前
肉肉完成签到 ,获得积分10
12秒前
欧欧欧导完成签到,获得积分10
12秒前
xiaowang完成签到 ,获得积分10
17秒前
旧雨新知完成签到 ,获得积分10
17秒前
daqing完成签到,获得积分10
18秒前
steven完成签到 ,获得积分10
20秒前
阜睿完成签到 ,获得积分10
31秒前
夜话风陵杜完成签到 ,获得积分0
31秒前
搞怪的笑南完成签到,获得积分10
34秒前
Casey完成签到,获得积分10
38秒前
dlut0407完成签到,获得积分10
41秒前
淡然易绿完成签到 ,获得积分10
41秒前
坦率绮山完成签到 ,获得积分10
41秒前
i好运发布了新的文献求助10
42秒前
KeLiang完成签到,获得积分10
43秒前
背后书雪完成签到 ,获得积分10
43秒前
甜甜玫瑰应助搞怪的笑南采纳,获得10
46秒前
lzq完成签到 ,获得积分10
47秒前
sjyu1985完成签到 ,获得积分10
49秒前
federish完成签到 ,获得积分10
51秒前
灼灼朗朗完成签到,获得积分10
52秒前
54秒前
畅快的谷秋完成签到 ,获得积分10
54秒前
科研通AI2S应助时间流浪者采纳,获得10
54秒前
杪夏二八完成签到 ,获得积分10
54秒前
兴奋冷松完成签到,获得积分10
57秒前
58秒前
傲娇曼凝完成签到,获得积分10
1分钟前
潇潇完成签到 ,获得积分10
1分钟前
满鑫发布了新的文献求助10
1分钟前
酷炫书芹完成签到,获得积分10
1分钟前
1分钟前
肉片牛帅帅完成签到,获得积分10
1分钟前
高分求助中
좌파는 어떻게 좌파가 됐나:한국 급진노동운동의 형성과 궤적 2500
Sustainability in Tides Chemistry 1500
TM 5-855-1(Fundamentals of protective design for conventional weapons) 1000
Cognitive linguistics critical concepts in linguistics 800
Threaded Harmony: A Sustainable Approach to Fashion 799
Livre et militantisme : La Cité éditeur 1958-1967 500
氟盐冷却高温堆非能动余热排出性能及安全分析研究 500
热门求助领域 (近24小时)
化学 医学 生物 材料科学 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 基因 遗传学 催化作用 物理化学 免疫学 量子力学 细胞生物学
热门帖子
关注 科研通微信公众号,转发送积分 3052675
求助须知:如何正确求助?哪些是违规求助? 2709898
关于积分的说明 7418335
捐赠科研通 2354494
什么是DOI,文献DOI怎么找? 1246139
科研通“疑难数据库(出版商)”最低求助积分说明 605951
版权声明 595921