食管化放疗联合尼妥珠单抗:寡转移性疾病姑息治疗的试点结果。

IF 1.4 4区 医学 Q4 ONCOLOGY
Fiona Day, Swetha Sridharan, Catherine Johnson, Gaik T Quah, Girish Mallesara, Mahesh Kumar, Amber-Louise Poulter, Anthony Morrison, Andre van der Westhuizen, Allison Fraser, Christopher Oldmeadow, Jarad Martin
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引用次数: 0

摘要

目的:许多食管癌患者因原发肿瘤和新发转移性疾病而出现吞咽困难。本研究的目的是测试nivolumab与低分量化放疗同时用于寡转移和阻塞性食管肿瘤患者的安全性和有效性:患者被纳入一项计划中的单臂2期临床试验。符合条件的患者均为既往未接受过治疗的寡转移性食管癌或胃食管癌(原发肿瘤放疗野外的氟脱氧葡萄糖-18正电子发射断层扫描显示转移灶≤5个)、吞咽困难且东部合作肿瘤学组表现状态为0-1。治疗方法包括对原发肿瘤同时进行2周的低分次放疗(30 Gy/10#)、每周一次卡铂(AUC2)、每周一次紫杉醇(50 mg/m2),以及每周2次、每次240 mg的尼夫单抗,之后每周4次、每次480 mg的尼夫单抗,直至疾病进展或总共24个月。第7周对单个转移灶进行立体定向放射治疗(SBRT)(24 Gy/3#):由于后勤原因,在试验结束前招募了五名患者作为新的参与者。现有参与者继续按照方案进行治疗,作为一个中心的试点研究。所有五名患者都完成了化学免疫疗法和 SBRT。所有患者的吞咽困难都得到了改善。两名患者完成了 24 个月的 nivolumab 治疗,未出现疾病进展。3名患者出现了3级不良事件(AEs),但没有出现4级不良事件、SBRT导致的不良事件或方案规定的特殊不良事件:一个中心的五名患者的试验结果表明,治疗的耐受性良好,并能有效缓解吞咽困难。应在一项多中心研究中测试同时使用检查点抑制剂的低分次化放疗的疗效。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Esophageal chemoradiotherapy with concurrent nivolumab: Pilot results in the palliative treatment of oligometastatic disease

Esophageal chemoradiotherapy with concurrent nivolumab: Pilot results in the palliative treatment of oligometastatic disease

Esophageal chemoradiotherapy with concurrent nivolumab: Pilot results in the palliative treatment of oligometastatic disease

Aims

Many patients diagnosed with esophageal cancer have dysphagia from their primary tumor and de novo metastatic disease. The purpose of this study was to test the safety and efficacy of nivolumab given concurrently with hypofractionated chemoradiotherapy to patients with oligometastatic and obstructing esophageal tumors.

Methods

Patients were enrolled in a planned single-arm, phase 2 clinical trial. Eligible participants had previously untreated oligometastatic (≤5 metastases on fludeoxyglucose-18 positron emission tomography scan outside the primary tumor radiotherapy field) esophageal or gastroesophageal carcinoma, dysphagia, and Eastern Cooperative Oncology Group performance status 0–1. Treatment was with 2 weeks of concurrent hypofractionated radiotherapy (30 Gy/10#) to the primary tumor, weekly carboplatin AUC2, weekly paclitaxel 50 mg/m2, and q2weekly nivolumab 240 mg, followed by nivolumab 480 mg continuing q4weekly until disease progression or 24 months total. A single metastasis was treated with stereotactic radiotherapy (SBRT) (24 Gy/3#) in week 7.

Results

Five patients were recruited before trial closure to new participants for logistical reasons. Existing participants continued treatment per protocol as a pilot study at one center. All five patients completed chemoradioimmunotherapy and SBRT. All patients derived an improvement in their dysphagia. Two patients completed 24 months of nivolumab without disease progression. Grade 3 adverse events (AEs) occurred in 3 patients, however, there were no grade 4 AEs, AEs due to SBRT, or AEs of special interest as defined by the protocol.

Conclusion

Pilot results from five patients at one center found that treatment was well tolerated and effective for dysphagia relief. The efficacy of hypofractionated chemoradiotherapy with concurrent checkpoint inhibition should be tested in a multicentre study.

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来源期刊
CiteScore
3.40
自引率
0.00%
发文量
175
审稿时长
6-12 weeks
期刊介绍: Asia–Pacific Journal of Clinical Oncology is a multidisciplinary journal of oncology that aims to be a forum for facilitating collaboration and exchanging information on what is happening in different countries of the Asia–Pacific region in relation to cancer treatment and care. The Journal is ideally positioned to receive publications that deal with diversity in cancer behavior, management and outcome related to ethnic, cultural, economic and other differences between populations. In addition to original articles, the Journal publishes reviews, editorials, letters to the Editor and short communications. Case reports are generally not considered for publication, only exceptional papers in which Editors find extraordinary oncological value may be considered for review. The Journal encourages clinical studies, particularly prospectively designed clinical trials.
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