Cargando…

The efficacy and safety of sintilimab combined with chemotherapy as the first-line treatment for metastatic esophageal squamous cell carcinoma

Immunotherapy is a new treatment option for patients with esophageal squamous cell carcinoma (ESCC). However, no study has investigated the efficacy and safety of sintilimab combined with nanoparticle albumin-bound paclitaxel (Nab-PTX) and platinum as first-line treatment for metastatic ESCC. In thi...

Descripción completa

Detalles Bibliográficos
Autores principales: Zhao, Zheng, Yin, Ming-Mei, Zhao, Wei-Feng, Wang, Chao-Jie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10443762/
https://www.ncbi.nlm.nih.gov/pubmed/37603519
http://dx.doi.org/10.1097/MD.0000000000034794
_version_ 1785093906892849152
author Zhao, Zheng
Yin, Ming-Mei
Zhao, Wei-Feng
Wang, Chao-Jie
author_facet Zhao, Zheng
Yin, Ming-Mei
Zhao, Wei-Feng
Wang, Chao-Jie
author_sort Zhao, Zheng
collection PubMed
description Immunotherapy is a new treatment option for patients with esophageal squamous cell carcinoma (ESCC). However, no study has investigated the efficacy and safety of sintilimab combined with nanoparticle albumin-bound paclitaxel (Nab-PTX) and platinum as first-line treatment for metastatic ESCC. In this retrospective study, eligible patients with metastatic ESCC were administered sintilimab plus Nab-PTX, cisplatin, or nedaplatin for up to 4 to 6 cycles. Subsequently, patients without progressive disease (PD) continued to receive sintilimab every 3 weeks as maintenance treatment until unacceptable toxicity, PD, withdrawal of consent, or for up to 2 years. The primary endpoint was the objective response rate (ORR) and the secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety. A total of 22 patients diagnosed with metastatic ESCC were enrolled, 1 patient reached a complete response (CR), 15 patients achieved a partial response (PR), 4 patients had stable disease, and 2 had PD. The ORR was 72.7% (16/22) and the DCR was 90.9% (20/22). The time to response was 1.9 months (95% confidence interval [CI]:1.7–2.2 months). The median PFS was 8.9 months (95% CI, 7.1–10.7 months), and the median OS was 19.0 months. Exploratory biomarker analysis revealed that lactic dehydrogenase (LDH) was a potential marker for OS, and patients with high LDH levels had shorter mOS (13.0 months, 95% CI:7.5–18.5 months). Treatment-related adverse events (AEs) occurred in 21 patients (95.5%), most of which were grade 1 or 2. No treatment-related deaths occurred in this study. The results of this study suggested that sintilimab combined with Nab-PTX and platinum in patients with metastatic ESCC had a significantly high ORR and encouraging mPFS and mOS. LDH was a potential marker for OS, and the safety profile was manageable.
format Online
Article
Text
id pubmed-10443762
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Lippincott Williams & Wilkins
record_format MEDLINE/PubMed
spelling pubmed-104437622023-08-23 The efficacy and safety of sintilimab combined with chemotherapy as the first-line treatment for metastatic esophageal squamous cell carcinoma Zhao, Zheng Yin, Ming-Mei Zhao, Wei-Feng Wang, Chao-Jie Medicine (Baltimore) 5700 Immunotherapy is a new treatment option for patients with esophageal squamous cell carcinoma (ESCC). However, no study has investigated the efficacy and safety of sintilimab combined with nanoparticle albumin-bound paclitaxel (Nab-PTX) and platinum as first-line treatment for metastatic ESCC. In this retrospective study, eligible patients with metastatic ESCC were administered sintilimab plus Nab-PTX, cisplatin, or nedaplatin for up to 4 to 6 cycles. Subsequently, patients without progressive disease (PD) continued to receive sintilimab every 3 weeks as maintenance treatment until unacceptable toxicity, PD, withdrawal of consent, or for up to 2 years. The primary endpoint was the objective response rate (ORR) and the secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety. A total of 22 patients diagnosed with metastatic ESCC were enrolled, 1 patient reached a complete response (CR), 15 patients achieved a partial response (PR), 4 patients had stable disease, and 2 had PD. The ORR was 72.7% (16/22) and the DCR was 90.9% (20/22). The time to response was 1.9 months (95% confidence interval [CI]:1.7–2.2 months). The median PFS was 8.9 months (95% CI, 7.1–10.7 months), and the median OS was 19.0 months. Exploratory biomarker analysis revealed that lactic dehydrogenase (LDH) was a potential marker for OS, and patients with high LDH levels had shorter mOS (13.0 months, 95% CI:7.5–18.5 months). Treatment-related adverse events (AEs) occurred in 21 patients (95.5%), most of which were grade 1 or 2. No treatment-related deaths occurred in this study. The results of this study suggested that sintilimab combined with Nab-PTX and platinum in patients with metastatic ESCC had a significantly high ORR and encouraging mPFS and mOS. LDH was a potential marker for OS, and the safety profile was manageable. Lippincott Williams & Wilkins 2023-08-18 /pmc/articles/PMC10443762/ /pubmed/37603519 http://dx.doi.org/10.1097/MD.0000000000034794 Text en Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY) (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle 5700
Zhao, Zheng
Yin, Ming-Mei
Zhao, Wei-Feng
Wang, Chao-Jie
The efficacy and safety of sintilimab combined with chemotherapy as the first-line treatment for metastatic esophageal squamous cell carcinoma
title The efficacy and safety of sintilimab combined with chemotherapy as the first-line treatment for metastatic esophageal squamous cell carcinoma
title_full The efficacy and safety of sintilimab combined with chemotherapy as the first-line treatment for metastatic esophageal squamous cell carcinoma
title_fullStr The efficacy and safety of sintilimab combined with chemotherapy as the first-line treatment for metastatic esophageal squamous cell carcinoma
title_full_unstemmed The efficacy and safety of sintilimab combined with chemotherapy as the first-line treatment for metastatic esophageal squamous cell carcinoma
title_short The efficacy and safety of sintilimab combined with chemotherapy as the first-line treatment for metastatic esophageal squamous cell carcinoma
title_sort efficacy and safety of sintilimab combined with chemotherapy as the first-line treatment for metastatic esophageal squamous cell carcinoma
topic 5700
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10443762/
https://www.ncbi.nlm.nih.gov/pubmed/37603519
http://dx.doi.org/10.1097/MD.0000000000034794
work_keys_str_mv AT zhaozheng theefficacyandsafetyofsintilimabcombinedwithchemotherapyasthefirstlinetreatmentformetastaticesophagealsquamouscellcarcinoma
AT yinmingmei theefficacyandsafetyofsintilimabcombinedwithchemotherapyasthefirstlinetreatmentformetastaticesophagealsquamouscellcarcinoma
AT zhaoweifeng theefficacyandsafetyofsintilimabcombinedwithchemotherapyasthefirstlinetreatmentformetastaticesophagealsquamouscellcarcinoma
AT wangchaojie theefficacyandsafetyofsintilimabcombinedwithchemotherapyasthefirstlinetreatmentformetastaticesophagealsquamouscellcarcinoma
AT zhaozheng efficacyandsafetyofsintilimabcombinedwithchemotherapyasthefirstlinetreatmentformetastaticesophagealsquamouscellcarcinoma
AT yinmingmei efficacyandsafetyofsintilimabcombinedwithchemotherapyasthefirstlinetreatmentformetastaticesophagealsquamouscellcarcinoma
AT zhaoweifeng efficacyandsafetyofsintilimabcombinedwithchemotherapyasthefirstlinetreatmentformetastaticesophagealsquamouscellcarcinoma
AT wangchaojie efficacyandsafetyofsintilimabcombinedwithchemotherapyasthefirstlinetreatmentformetastaticesophagealsquamouscellcarcinoma