PMID- 35595021 OWN - NLM STAT- MEDLINE DCOM- 20220622 LR - 20230710 IS - 1743-9159 (Electronic) IS - 1743-9159 (Linking) VI - 103 DP - 2022 Jul TI - Tislelizumab combined with chemotherapy as neoadjuvant therapy for surgically resectable esophageal cancer: A prospective, single-arm, phase II study (TD-NICE). PG - 106680 LID - S1743-9191(22)00457-5 [pii] LID - 10.1016/j.ijsu.2022.106680 [doi] AB - BACKGROUND: Clinical benefit of neoadjuvant immunotherapy in resectable esophageal squamous cell carcinoma (ESCC). remains unclear. This study evaluated the efficacy and safety of the programmed death 1 (PD-1) inhibitor tislelizumab combined with chemotherapy as neoadjuvant therapy in patients with resectable ESCC. METHODS: Treatment-naive patients were enrolled and eligible patients received 3 cycles of neoadjuvant therapy with tislelizumab, carboplatin, and nab-paclitaxel. The primary endpoint was surgery patients major pathological response (MPR). Subgroup analysis was stratified by tumor downstaging, circumferential resection margin (CRM), PD-ligand 1 (PD-L1) expression, and tumor mutation burden (TMB). Safety was assessed by adverse events (AEs) and postoperative complications. RESULTS: Between September 2020 and March 2021, 45 patients were enrolled. Thirty-six (80.0%) of 45 patients underwent surgery, and 29 (80.5%) underwent successful R0 resection. MPR and pathological complete response (pCR) for surgery patients were 72.0% and 50.0%, respectively. Intention to treatment (ITT) patients MPR and PCR were 57.5% and 40%. Downgrading occurred in 75% of 36 patients. MPR and pCR were identified to be associated with tumor downstaging and CRM but not PD-L1 expression or TMB. TPS levels in MPR and pCR group were significantly higher than that in Non-MPR and Non-pCR group, respectively. Treatment-related AEs of grade 3-4 and immune-related AEs occurred in 42.2% and 22.2% of 45 patients, respectively, and postoperative complications occurred in 77.8% of 36 patients. No treatment-related surgical delay or death occurred. No associations between gene mutation and pathological efficacy were observed. CONCLUSIONS: Tislelizumab plus chemotherapy as neoadjuvant therapy demonstrates promising antitumor activity for resectable ESCC with high rates of MPR, pCR, and R0 resection, as well as acceptable tolerability. CI - Copyright (c) 2022. Published by Elsevier Ltd. FAU - Yan, Xiaolong AU - Yan X AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: yanxiaolong@fmmu.edu.cn. FAU - Duan, Hongtao AU - Duan H AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: 646014852@qq.com. FAU - Ni, Yunfeng AU - Ni Y AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: 264246623@qq.com. FAU - Zhou, Yongan AU - Zhou Y AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: zhou.yongan@163.com. FAU - Wang, Xiaoping AU - Wang X AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: lebanxia@163.com. FAU - Qi, Haini AU - Qi H AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: 2259114900@qq.com. FAU - Gong, Li AU - Gong L AD - Department of Pathology, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: glzwd16@fmmu.edu.cn. FAU - Liu, Honggang AU - Liu H AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: drliuhg@163.com. FAU - Tian, Feng AU - Tian F AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: 50008245@qq.com. FAU - Lu, Qiang AU - Lu Q AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: luqianglu@126.com. FAU - Sun, Jianyong AU - Sun J AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: sunjianyong2@163.com. FAU - Yang, Ende AU - Yang E AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: 2256845168@qq.com. FAU - Zhong, Daixing AU - Zhong D AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: 48432999@qq.com. FAU - Wang, Tao AU - Wang T AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: tddocwangt@163.com. FAU - Huang, Lijun AU - Huang L AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: hljyxq@fmmu.edu.cn. FAU - Wang, Jian AU - Wang J AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: wjtm1976@163.com. FAU - Chaoyang Wang AU - Chaoyang Wang AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: wangcy123@163.com. FAU - Wang, Yuanyong AU - Wang Y AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: wangyuanyong@163.com. FAU - Wan, Zhiyi AU - Wan Z AD - Genecast Biotechnology Co., Ltd, 88 Danshan Road, Xidong Chuangrong Building, Suite C 1310-1318, Xishan District, Wuxi City, Jiangsu, 214104, China. Electronic address: gxmwzy@126.com. FAU - Lei, Jie AU - Lei J AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: leijiemd@163.com. FAU - Zhao, Jinbo AU - Zhao J AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: zhaojinbo@aliyun.com. FAU - Jiang, Tao AU - Jiang T AD - Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address: jiangtaochest@163.com. LA - eng PT - Clinical Trial, Phase II PT - Journal Article DEP - 20220518 PL - United States TA - Int J Surg JT - International journal of surgery (London, England) JID - 101228232 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0KVO411B3N (tislelizumab) SB - IM CIN - Int J Surg. 2023 Apr 01;109(4):1060-1061. PMID: 36917134 MH - Antibodies, Monoclonal, Humanized MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - *Esophageal Neoplasms/drug therapy/surgery MH - *Esophageal Squamous Cell Carcinoma/drug therapy/surgery MH - Humans MH - Neoadjuvant Therapy/adverse effects MH - Postoperative Complications/etiology MH - Prospective Studies OTO - NOTNLM OT - Chemotherapy OT - Esophageal cancer OT - Neoadjuvant therapy OT - Tislelizumab EDAT- 2022/05/21 06:00 MHDA- 2022/06/23 06:00 CRDT- 2022/05/20 19:25 PHST- 2022/01/25 00:00 [received] PHST- 2022/04/18 00:00 [revised] PHST- 2022/05/07 00:00 [accepted] PHST- 2022/05/21 06:00 [pubmed] PHST- 2022/06/23 06:00 [medline] PHST- 2022/05/20 19:25 [entrez] AID - S1743-9191(22)00457-5 [pii] AID - 10.1016/j.ijsu.2022.106680 [doi] PST - ppublish SO - Int J Surg. 2022 Jul;103:106680. doi: 10.1016/j.ijsu.2022.106680. Epub 2022 May 18.