PMID- 38077159 OWN - NLM STAT- MEDLINE DCOM- 20231216 LR - 20231216 IS - 2219-2840 (Electronic) IS - 1007-9327 (Print) IS - 1007-9327 (Linking) VI - 29 IP - 41 DP - 2023 Nov 7 TI - Long-term efficacy and predictors of pembrolizumab-based regimens in patients with advanced esophageal cancer in the real world. PG - 5641-5656 LID - 10.3748/wjg.v29.i41.5641 [doi] AB - BACKGROUND: Pembrolizumab combined with chemotherapy has been proven effective as first-line therapy in patients with advanced esophageal cancer. Few trials have assessed the safety and efficacy of this treatment in patients with locally advanced disease. AIM: To analyze long-term outcomes of pembrolizumab in locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) in the real world. METHODS: Patients with advanced ESCC admitted to our center from October 2019 to October 2021 were enrolled in this study. Clinical staging of the patients was based on the 8(th) edition of the American Joint Committee on Cancer TNM staging system. The patients received different treatments based on clinical stage. In brief, patients with locally advanced and resectable ESCC received neoadjuvant therapy combined with surgery. For those who were not candidates for resection, radical concurrent chemoradiotherapy plus pembrolizumab was more preferable. Patients with metastatic ESCC or who were unsuitable for radiotherapy underwent chemotherapy in combination with pembrolizumab. Long-term survival outcomes such as overall survival (OS), progression-free survival, disease-free survival, long-term adverse effects (AEs), immune maintenance therapy and predictors of immune checkpoint inhibitors (ICIs) efficacy were evaluated. RESULTS: A total of 55 patients with advanced ESCC were enrolled in this retrospective, observational study. The median age was 61 years (range 44-74), with 47.3% (26/55) of the patients in stage IV and 45.5% of the patients had the tumor (25/55) located in the middle third of the esophagus. The median OS in all patients was not reached. The 12-mo OS rate among all patients was 78.8% and the 18-mo OS rate was 72.7%. 9 patients died due to tumor progression and 7 patients died due to treatment-related complications. The therapeutic effect evaluated at the interim evaluation was significantly reflected in the long-term outcome. Patients with complete response or partial response in all patients (P = 0.005) and in the chemoradiotherapy plus pembrolizumab group (P = 0.007) obtained a better prognosis than non-responders. A total of 20 patients (20/55, 36%) received immune maintenance therapy. Baseline peripheral blood biomarkers of the neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and neutrophil-to-(leukocyte-neutrophil) ratio did not predict the efficacy of ICIs. CONCLUSION: Pembrolizumab combined with chemotherapy or radiotherapy resulted in favorable long-term survival in patients with locally advanced or metastatic ESCC, with safe and manageable long-term AEs. CI - (c)The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved. FAU - Wang, Hong-Chi AU - Wang HC AD - Department of Radiotherapy, The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China. FAU - Huang, Xiang AU - Huang X AD - Department of Radiotherapy, The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China. FAU - Chen, Jing AU - Chen J AD - Department of Radiotherapy, The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China. FAU - Li, Ye AU - Li Y AD - Department of Radiotherapy, The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China. FAU - Cong, Yang AU - Cong Y AD - Department of Radiotherapy, The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China. FAU - Qu, Bao-Lin AU - Qu BL AD - Department of Radiotherapy, The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China. FAU - Feng, Sheng-Qiang AU - Feng SQ AD - Health Service, The Guard Bureau of Joint Staff Department of Chinese PLA, Beijing 100017, China. FAU - Liu, Fang AU - Liu F AD - Department of Radiotherapy, The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China. liufangfsq@163.com. LA - eng PT - Journal Article PT - Observational Study PL - United States TA - World J Gastroenterol JT - World journal of gastroenterology JID - 100883448 RN - DPT0O3T46P (pembrolizumab) RN - 0 (Antibodies, Monoclonal, Humanized) SB - IM MH - Humans MH - Adult MH - Middle Aged MH - Aged MH - *Esophageal Neoplasms/drug therapy/pathology MH - *Esophageal Squamous Cell Carcinoma MH - Retrospective Studies MH - Antibodies, Monoclonal, Humanized/adverse effects MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects PMC - PMC10701330 OTO - NOTNLM OT - Chemotherapy OT - Esophageal cancer OT - Long-term survival OT - Pembrolizumab OT - Radiotherapy OT - Real-world COIS- Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article. EDAT- 2023/12/11 12:42 MHDA- 2023/12/17 09:42 PMCR- 2023/11/07 CRDT- 2023/12/11 06:25 PHST- 2023/07/27 00:00 [received] PHST- 2023/10/07 00:00 [revised] PHST- 2023/10/23 00:00 [accepted] PHST- 2023/12/17 09:42 [medline] PHST- 2023/12/11 12:42 [pubmed] PHST- 2023/12/11 06:25 [entrez] PHST- 2023/11/07 00:00 [pmc-release] AID - 10.3748/wjg.v29.i41.5641 [doi] PST - ppublish SO - World J Gastroenterol. 2023 Nov 7;29(41):5641-5656. doi: 10.3748/wjg.v29.i41.5641.