Effectiveness and safety of anti-PD-1 monotherapy or combination therapy in Chinese advanced gastric cancer: A real-world study

PurposeGastric cancer (GC) is one of the most frequently diagnosed cancers and one of the leading causes of cancer deaths worldwide, especially in eastern Asia and China. Anti-PD-1 immune checkpoint inhibitors, Pembrolizumab and Nivolumab, have been approved for the treatment of locally advanced or...

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Main Authors: Tao Li, Tingting Liu, Lei Zhao, Lu Liu, Xuan Zheng, Jinliang Wang, Fan Zhang, Yi Hu
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-01-01
Series:Frontiers in Oncology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fonc.2022.976078/full
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author Tao Li
Tao Li
Tao Li
Tingting Liu
Tingting Liu
Lei Zhao
Lu Liu
Lu Liu
Xuan Zheng
Xuan Zheng
Xuan Zheng
Jinliang Wang
Jinliang Wang
Fan Zhang
Fan Zhang
Fan Zhang
Yi Hu
Yi Hu
Yi Hu
author_facet Tao Li
Tao Li
Tao Li
Tingting Liu
Tingting Liu
Lei Zhao
Lu Liu
Lu Liu
Xuan Zheng
Xuan Zheng
Xuan Zheng
Jinliang Wang
Jinliang Wang
Fan Zhang
Fan Zhang
Fan Zhang
Yi Hu
Yi Hu
Yi Hu
author_sort Tao Li
collection DOAJ
description PurposeGastric cancer (GC) is one of the most frequently diagnosed cancers and one of the leading causes of cancer deaths worldwide, especially in eastern Asia and China. Anti-PD-1 immune checkpoint inhibitors, Pembrolizumab and Nivolumab, have been approved for the treatment of locally advanced or metastatic gastric or gastroesophageal junction cancer (GC/GEJC). Our study evaluated the effectiveness and safety of anti-PD-1-based treatment (monotherapy or combination therapy) in Chinese patients with advanced or metastatic GC/GEJCs in a real-world setting.MethodsA retrospective cohort study was conducted, and 54 patients from May 31, 2015, to May 31, 2021, were included in our analysis, including 19 patients treated with anti-PD-1 monotherapy and 35 patients treated with anti-PD-1 combination therapy. Demographic and clinical information were evaluated. Clinical response, survival outcomes, and safety profile were measured and analyzed.ResultsOverall, the median overall survival (mOS) was 11.10 months (95% CI, 7.05–15.15), and the median progression-free survival (mPFS) was 3.93 months (95% CI, 2.47–5.39). Of the patients, 16.7% achieved a clinical response, and 72.2% achieved disease control. Prolonged overall survival (OS) and progression-free survival (PFS) and increased clinical response were observed in the combination group compared with the monotherapy group, although statistical significance was not reached. In subgroups with live metastases or elevated baseline neutrophil-to-lymphocyte ratio (NLR) levels, combination therapy outperformed anti-PD-1 alone in survival outcomes. Patients treated with anti-PD-1 monotherapy (n = 5, 26.3%) had fewer treatment-related adverse events (TRAEs) than those in the combination group (n = 22, 62.9%). There were also fewer patients with TRAEs of grades 3–5 with monotherapy (n = 2, 10.5%) than with combination therapy (n = 7, 20.0%). Pneumonitis in three patients was the only potential immune-related adverse event reported.ConclusionsAnti-PD-1-based monotherapy and combination therapy showed favorable survival outcomes and manageable safety profiles in advanced or metastatic GC/GEJCs. In clinical treatment, immunotherapy should be an indispensable choice in the treatment strategy for GC/GEJC. Patients with a heavy tumor burden and more metastatic sites might benefit more from combination therapy. Elderly patients and patients with more treatment lines or high Eastern Cooperative Oncology Group (ECOG) performance scores might be more suitable for immune monotherapy, and some clinical benefits have been observed.
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spelling doaj.art-84d23392e3de4496927a96d6794175ea2023-01-05T17:39:38ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2023-01-011210.3389/fonc.2022.976078976078Effectiveness and safety of anti-PD-1 monotherapy or combination therapy in Chinese advanced gastric cancer: A real-world studyTao Li0Tao Li1Tao Li2Tingting Liu3Tingting Liu4Lei Zhao5Lu Liu6Lu Liu7Xuan Zheng8Xuan Zheng9Xuan Zheng10Jinliang Wang11Jinliang Wang12Fan Zhang13Fan Zhang14Fan Zhang15Yi Hu16Yi Hu17Yi Hu18Graduate School, Medical School of Chinese People's Liberation Army (PLA), Beijing, ChinaDepartment of Oncology, The First Medical Center, Chinese People's Liberation Army (PLA) General Hospital, Beijing, ChinaChinese People's Liberation Army (PLA) Key Laboratory of Oncology, Key Laboratory for Tumor Targeting Therapy and Antibody Drugs, Ministry of Education, Beijing, ChinaGraduate School, Medical School of Chinese People's Liberation Army (PLA), Beijing, ChinaDepartment of Pulmonary and Critical Care Medicine, the Second Medical Center, Chinese People's Liberation Army (PLA) General Hospital, Beijing, ChinaInstitute of Translational Medicine, Chinese People's Liberation Army (PLA) General Hospital, Beijing, ChinaGraduate School, Medical School of Chinese People's Liberation Army (PLA), Beijing, ChinaDepartment of Nutrition, The First Medical Center, Chinese People's Liberation Army (PLA) General Hospital, Beijing, ChinaGraduate School, Medical School of Chinese People's Liberation Army (PLA), Beijing, ChinaDepartment of Oncology, The First Medical Center, Chinese People's Liberation Army (PLA) General Hospital, Beijing, ChinaChinese People's Liberation Army (PLA) Key Laboratory of Oncology, Key Laboratory for Tumor Targeting Therapy and Antibody Drugs, Ministry of Education, Beijing, ChinaGraduate School, Medical School of Chinese People's Liberation Army (PLA), Beijing, ChinaDepartment of Oncology, The Fifth Medical Center, Chinese People's Liberation Army (PLA) General Hospital, Beijing, ChinaGraduate School, Medical School of Chinese People's Liberation Army (PLA), Beijing, ChinaDepartment of Oncology, The First Medical Center, Chinese People's Liberation Army (PLA) General Hospital, Beijing, ChinaChinese People's Liberation Army (PLA) Key Laboratory of Oncology, Key Laboratory for Tumor Targeting Therapy and Antibody Drugs, Ministry of Education, Beijing, ChinaGraduate School, Medical School of Chinese People's Liberation Army (PLA), Beijing, ChinaDepartment of Oncology, The First Medical Center, Chinese People's Liberation Army (PLA) General Hospital, Beijing, ChinaChinese People's Liberation Army (PLA) Key Laboratory of Oncology, Key Laboratory for Tumor Targeting Therapy and Antibody Drugs, Ministry of Education, Beijing, ChinaPurposeGastric cancer (GC) is one of the most frequently diagnosed cancers and one of the leading causes of cancer deaths worldwide, especially in eastern Asia and China. Anti-PD-1 immune checkpoint inhibitors, Pembrolizumab and Nivolumab, have been approved for the treatment of locally advanced or metastatic gastric or gastroesophageal junction cancer (GC/GEJC). Our study evaluated the effectiveness and safety of anti-PD-1-based treatment (monotherapy or combination therapy) in Chinese patients with advanced or metastatic GC/GEJCs in a real-world setting.MethodsA retrospective cohort study was conducted, and 54 patients from May 31, 2015, to May 31, 2021, were included in our analysis, including 19 patients treated with anti-PD-1 monotherapy and 35 patients treated with anti-PD-1 combination therapy. Demographic and clinical information were evaluated. Clinical response, survival outcomes, and safety profile were measured and analyzed.ResultsOverall, the median overall survival (mOS) was 11.10 months (95% CI, 7.05–15.15), and the median progression-free survival (mPFS) was 3.93 months (95% CI, 2.47–5.39). Of the patients, 16.7% achieved a clinical response, and 72.2% achieved disease control. Prolonged overall survival (OS) and progression-free survival (PFS) and increased clinical response were observed in the combination group compared with the monotherapy group, although statistical significance was not reached. In subgroups with live metastases or elevated baseline neutrophil-to-lymphocyte ratio (NLR) levels, combination therapy outperformed anti-PD-1 alone in survival outcomes. Patients treated with anti-PD-1 monotherapy (n = 5, 26.3%) had fewer treatment-related adverse events (TRAEs) than those in the combination group (n = 22, 62.9%). There were also fewer patients with TRAEs of grades 3–5 with monotherapy (n = 2, 10.5%) than with combination therapy (n = 7, 20.0%). Pneumonitis in three patients was the only potential immune-related adverse event reported.ConclusionsAnti-PD-1-based monotherapy and combination therapy showed favorable survival outcomes and manageable safety profiles in advanced or metastatic GC/GEJCs. In clinical treatment, immunotherapy should be an indispensable choice in the treatment strategy for GC/GEJC. Patients with a heavy tumor burden and more metastatic sites might benefit more from combination therapy. Elderly patients and patients with more treatment lines or high Eastern Cooperative Oncology Group (ECOG) performance scores might be more suitable for immune monotherapy, and some clinical benefits have been observed.https://www.frontiersin.org/articles/10.3389/fonc.2022.976078/fullanti-PD-1gastric cancerreal-word studyChineseefficacy and safety analyses
spellingShingle Tao Li
Tao Li
Tao Li
Tingting Liu
Tingting Liu
Lei Zhao
Lu Liu
Lu Liu
Xuan Zheng
Xuan Zheng
Xuan Zheng
Jinliang Wang
Jinliang Wang
Fan Zhang
Fan Zhang
Fan Zhang
Yi Hu
Yi Hu
Yi Hu
Effectiveness and safety of anti-PD-1 monotherapy or combination therapy in Chinese advanced gastric cancer: A real-world study
Frontiers in Oncology
anti-PD-1
gastric cancer
real-word study
Chinese
efficacy and safety analyses
title Effectiveness and safety of anti-PD-1 monotherapy or combination therapy in Chinese advanced gastric cancer: A real-world study
title_full Effectiveness and safety of anti-PD-1 monotherapy or combination therapy in Chinese advanced gastric cancer: A real-world study
title_fullStr Effectiveness and safety of anti-PD-1 monotherapy or combination therapy in Chinese advanced gastric cancer: A real-world study
title_full_unstemmed Effectiveness and safety of anti-PD-1 monotherapy or combination therapy in Chinese advanced gastric cancer: A real-world study
title_short Effectiveness and safety of anti-PD-1 monotherapy or combination therapy in Chinese advanced gastric cancer: A real-world study
title_sort effectiveness and safety of anti pd 1 monotherapy or combination therapy in chinese advanced gastric cancer a real world study
topic anti-PD-1
gastric cancer
real-word study
Chinese
efficacy and safety analyses
url https://www.frontiersin.org/articles/10.3389/fonc.2022.976078/full
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