A randomised phase II study of chemoradiotherapy with or without nimotuzumab in locally advanced oesophageal cancer: NICE trial

尼妥珠单抗 医学 放化疗 内科学 临床研究阶段 不利影响 危险系数 临床终点 癌症 肿瘤科 人口 胃肠病学 外科 置信区间 临床试验 表皮生长因子受体 环境卫生
作者
Gilberto de Castro,J. G. M. Segalla,Sérgio Jobim Azevedo,Carlos José Coelho de Andrade,D. Grabarz,Bruno de Araújo Lima França,Auro del Giglio,Nicolas Lazaretti,Maria Nunes Álvares,José Luiz Pedrini,Celio Kussumoto,João Nunes de Matos Neto,Nora Manoukian Forones,Hezio Jadir Fernandes Júnior,Giuliano Santos Borges,Gustavo Girotto,Ismael Dale Cotrim Guerreiro da Silva,Fauze Maluf‐Filho,Nils Gunnar Skare
出处
期刊:European Journal of Cancer [Elsevier BV]
卷期号:88: 21-30 被引量:51
标识
DOI:10.1016/j.ejca.2017.10.005
摘要

Purpose Chemoradiotherapy is the standard treatment for patients with inoperable locally advanced oesophageal cancer. We sought to assess the safety and efficacy of chemoradiation combined with nimotuzumab, a humanised antibody directed against epidermal growth factor receptor (EGFR). Patients and methods Untreated patients with inoperable locally advanced oesophageal cancer and no distant metastases were randomised to chemoradiotherapy (cisplatin and fluorouracil combined with external beam radiation) alone or in combination with nimotuzumab. The primary end-point was the endoscopic complete response (eCR) rate, and secondary end-points comprised quality of life (QoL) and safety. The combined eCR and pathologic complete response (cEPCR) and overall survival (OS) were also evaluated. Results We enrolled 107 patients with a mean age of 59 years, and 93% had squamous cell carcinoma. Toxicity was manageable in both arms with no important differences in adverse events (AEs). We performed post-treatment endoscopies in 67 patients, including 60 who had a biopsy. In the intent-to-treat population, the eCR rates with and without nimotuzumab were 47.2% and 33.3% (P = 0.17), respectively, and the cEPCR rates were 62.3% and 37.0% (P = 0.02), respectively. With a median follow-up of 14.7 months, the hazard ratio (HR) for OS was 0.68 (95% confidence interval (CI): 0.44–1.07; P = 0.09) with a median OS of 15.9 months for the nimotuzumab arm and 11.5 months for the control arm. Regarding QoL, a significant difference was observed for the physical subscale score (P = 0.03) with lower values for the control arm. Conclusion Combined chemoradiotherapy plus nimotuzumab is safe for patients with locally advanced oesophageal cancer, it appears to increase the cEPCR rate, and without compromising QoL. Clinical trials Identification number: EF024-201; Trial registry: NCT01249352.
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
PDF的下载单位、IP信息已删除 (2025-6-4)

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
刚刚
量子星尘发布了新的文献求助10
2秒前
2秒前
传奇3应助姜雪采纳,获得30
3秒前
都是小儿卡通书完成签到,获得积分10
4秒前
5秒前
澡雪发布了新的文献求助10
5秒前
wanci应助123采纳,获得10
6秒前
JILIGULU完成签到,获得积分10
6秒前
jindui发布了新的文献求助10
9秒前
我爱学习发布了新的文献求助10
10秒前
12秒前
李三阳发布了新的文献求助10
12秒前
hj990806完成签到,获得积分10
14秒前
15秒前
123mmmm发布了新的文献求助10
17秒前
21秒前
Orange应助徐婷采纳,获得10
21秒前
冷静如柏完成签到,获得积分10
22秒前
24秒前
今后应助linli采纳,获得10
25秒前
26秒前
今后应助111采纳,获得10
26秒前
ding应助欣慰的乌冬面采纳,获得10
26秒前
ceci完成签到,获得积分10
28秒前
123完成签到,获得积分10
28秒前
今后应助我爱学习采纳,获得10
29秒前
lei029发布了新的文献求助10
29秒前
徐婷完成签到,获得积分10
29秒前
Versa完成签到,获得积分10
31秒前
jindui完成签到,获得积分10
31秒前
32秒前
33秒前
在水一方应助泡泡糖采纳,获得10
33秒前
annie完成签到,获得积分10
34秒前
今后应助科研通管家采纳,获得10
35秒前
yar应助科研通管家采纳,获得10
35秒前
yar应助科研通管家采纳,获得10
35秒前
共享精神应助科研通管家采纳,获得10
35秒前
yar应助科研通管家采纳,获得10
35秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 700
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
Nucleophilic substitution in azasydnone-modified dinitroanisoles 500
不知道标题是什么 500
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
热门求助领域 (近24小时)
化学 材料科学 医学 生物 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 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3975426
求助须知:如何正确求助?哪些是违规求助? 3519848
关于积分的说明 11199831
捐赠科研通 3256122
什么是DOI,文献DOI怎么找? 1798124
邀请新用户注册赠送积分活动 877386
科研通“疑难数据库(出版商)”最低求助积分说明 806305