KEYNOTE-975 study design: a Phase III study of definitive chemoradiotherapy plus pembrolizumab in patients with esophageal carcinoma.
KEYNOTE-975 study design: a Phase III study of definitive chemoradiotherapy plus pembrolizumab in patients with esophageal carcinoma.
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DOI：
10.2217/fon-2020-0969
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发表时间：
2021-04
期刊：
影响因子：
--
通讯作者：
Enzinger P
中科院分区：
文献类型：
--
作者：
Shah MA;Bennouna J;Doi T;Shen L;Kato K;Adenis A;Mamon HJ;Moehler M;Fu X;Cho BC;Bordia S;Bhagia P;Shih CS;Desai A;Enzinger P
尽管进行了治愈性治疗，大多数局部晚期食管癌患者仍会出现疾病复发或局部进展，这凸显了对新疗法的需求。目前的指南建议对不适合手术切除的患者进行明确的放化疗，但生存结果较差。派姆单抗具有良好的耐受性，对于既往接受过治疗的晚期、不可切除的食管/食管胃交界癌患者具有良好的抗肿瘤活性。派姆单抗与放化疗结合可能会进一步改善一线治疗的结果。在这里，我们描述了双盲、III 期、安慰剂对照、随机 KEYNOTE-975 试验的设计和基本原理，该试验研究派姆单抗联合根治性放化疗作为局部晚期、不可切除的食管/胃食管交界癌患者的一线治疗。总生存期和无事件生存期是双重主要终点。临床试验注册：NCT04210115 (ClinicalTrials.gov)
Despite curative-intent treatment, most patients with locally advanced esophageal cancer will experience disease recurrence or locoregional progression, highlighting the need for new therapies. Current guidelines recommend definitive chemoradiotherapy in patients ineligible for surgical resection, but survival outcomes are poor. Pembrolizumab is well tolerated and provides promising antitumor activity in patients with previously treated, advanced, unresectable esophageal/esophagogastric junction cancer. Combining pembrolizumab with chemoradiotherapy may further improve outcomes in the first-line setting. Here, we describe the design and rationale for the double-blind, Phase III, placebo-controlled, randomized KEYNOTE-975 trial investigating pembrolizumab in combination with definitive chemoradiotherapy as first-line treatment in patients with locally advanced, unresectable esophageal/gastroesophageal junction cancer. Overall survival and event-free survival are the dual primary end points. Clinical trial registration: NCT04210115 (ClinicalTrials.gov)
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作者：
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