尼莫妥珠单抗和 S-1 化疗联合放疗治疗营养不良和老年局部晚期食管癌的有效性和安全性:前瞻性II期研究。

IF 7 2区 医学 Q1 ONCOLOGY
Guojie Feng, Jiao Li, Nuo Yu, Ziyu Zheng, Xiongtao Yang, Lei Deng, Tao Zhang, Wenqing Wang, Wenyang Liu, Jianyang Wang, Qinfu Feng, Jima Lyu, Zefen Xiao, Zongmei Zhou, Nan Bi, Jianjun Qin, Xin Wang
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引用次数: 0

摘要

目的:确定性化放疗(dCRT)是治疗无法切除的局部晚期食管癌的标准疗法。然而,这种治疗方法有很大的毒性,而且大多数营养不良或老年患者无法完成这种治疗。因此,需要一种更适合这一人群的放疗联合方案。本研究旨在评估尼莫妥珠单抗和S-1化疗与同期放疗联合疗法对营养风险筛查2002(NRS-2002)评分较高的脆弱局部晚期食管癌患者的疗效和安全性:入选患者均为 NRS-2002 评分为 2 分或以上的不可切除食管癌患者。他们在接受 S-1 和尼莫妥珠单抗治疗的同时接受放疗,然后进行手术或最终放疗。主要终点是局部控制率(LRC):共有55名符合研究标准的患者入组。治疗结束后,15 名患者接受了手术治疗,40 名患者继续接受放疗。中位随访时间为 33.3 [95% 置信区间(95% CI),31.4-35.1]个月。全部患者一年后的LRC率为77.2%(95% CI,66.6%-89.4%)。3年后的总生存率(OS)和无事件生存率(EFS)分别为57.5%和51.5%。手术与更好的LRC[危险比(HR)=0.16;95% CI,0.04-0.70;P=0.015]、OS(HR=0.19;95% CI,0.04-0.80;P=0.024)和EFS(HR=0.25;95% CI,0.08-0.75;P=0.013)相关。大多数不良反应为1级或2级,未发生严重不良反应:结论:对于营养不良或高龄的局部晚期食管癌患者,放疗联合尼莫妥珠单抗和S-1是有效的,并且具有良好的安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Effectiveness and safety of combined nimotuzumab and S-1 chemotherapy with concurrent radiotherapy for locally advanced esophageal cancer in malnourished and elderly patients: A prospective phase II study.

Objective: Definitive chemoradiotherapy (dCRT) is the standard treatment for unresectable locally advanced esophageal cancer. However, this treatment is associated with substantial toxicity, and most malnourished or elderly patients are unable to complete this therapy. Therefore, there is a need for a more suitable radiotherapy combination regimen for this population. This study was aimed to evaluate the efficacy and safety of a combination regimen comprising chemotherapy with nimotuzumab and S-1 and concurrent radiotherapy for patients with fragile locally advanced esophageal cancer with a high Nutritional Risk Screening 2002 (NRS-2002) score.

Methods: Eligible patients with unresectable esophageal carcinoma who had an NRS-2002 score of 2 or higher were enrolled. They were treated with S-1 and nimotuzumab with concurrent radiotherapy, followed by surgery or definitive radiotherapy. The primary endpoint was the locoregional control (LRC) rate.

Results: A total of 55 patients who met the study criteria were enrolled. After completion of treatment, surgery was performed in 15 patients and radiotherapy was continued in 40 patients. The median follow-up period was 33.3 [95% confidence interval (95% CI), 31.4-35.1)] months. The LRC rate was 77.2% (95% CI, 66.6%-89.4%) at 1 year in the entire population. The overall survival (OS) rate and event-free survival (EFS) rate were 57.5% and 51.5% at 3 years, respectively. Surgery was associated with better LRC [hazard ratio (HR)=0.16; 95% CI, 0.04-0.70; P=0.015], OS (HR=0.19; 95% CI, 0.04-0.80; P=0.024), and EFS (HR=0.25; 95% CI, 0.08-0.75; P=0.013). Most adverse events were of grade 1 or 2, and no severe adverse events occurred.

Conclusions: For malnourished or elderly patients with locally advanced esophageal cancer, radiotherapy combined with nimotuzumab and S-1 is effective and has a good safety profile.

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来源期刊
自引率
9.80%
发文量
1726
审稿时长
4.5 months
期刊介绍: Chinese Journal of Cancer Research (CJCR; Print ISSN: 1000-9604; Online ISSN:1993-0631) is published by AME Publishing Company in association with Chinese Anti-Cancer Association.It was launched in March 1995 as a quarterly publication and is now published bi-monthly since February 2013. CJCR is published bi-monthly in English, and is an international journal devoted to the life sciences and medical sciences. It publishes peer-reviewed original articles of basic investigations and clinical observations, reviews and brief communications providing a forum for the recent experimental and clinical advances in cancer research. This journal is indexed in Science Citation Index Expanded (SCIE), PubMed/PubMed Central (PMC), Scopus, SciSearch, Chemistry Abstracts (CA), the Excerpta Medica/EMBASE, Chinainfo, CNKI, CSCI, etc.
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