The efficacy and safety of first‑line anti‑PD‑1/PD‑L1 immunotherapy for gastric esophageal cancer: A systematic review and meta‑analysis of phase III randomized controlled trials

Duan,Xiaoyang; Duan,Xiaoyang; Du,Huazhen; Du,Huazhen; Qi,Ran; Qi,Ran; Yuan,Meng; Yuan,Meng; Shi,Jian; Shi,Jian

doi:10.3892/etm.2023.11915

The efficacy and safety of first‑line anti‑PD‑1/PD‑L1 immunotherapy for gastric esophageal cancer: A systematic review and meta‑analysis of phase III randomized controlled trials

Authors:
- Xiaoyang Duan
- Huazhen Du
- Ran Qi
- Meng Yuan
- Jian Shi
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Affiliations: Department of Medical Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei 050000, P.R. China, Department of Emergency, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei 050000, P.R. China, Department of Pharmacy, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei 050000, P.R. China, Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka 807‑8555, Japan
Published online on: March 28, 2023 https://doi.org/10.3892/etm.2023.11915
Article Number: 216
Copyright: © Duan et al. This is an open access article distributed under the terms of Creative Commons Attribution License.

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Abstract

Immunotherapy‑based regiments have potential as first‑line treatment for advanced gastric esophageal cancer. The present study aimed to conduct a meta‑analysis of the association between the efficacy and safety of first‑line immunotherapy combined with chemotherapy in patients with unresectable locally advanced or metastatic gastric esophageal cancer. Subgroup analysis of patients with programmed death ligand 1 (PD‑L1) combined positive score (CPS) was conducted to identify the characteristics of patients with immune benefit and to provide a decision‑making basis for clinical practice. PubMed, Embase, Cochrane Library and other databases were searched to collect randomized controlled trials of immunotreatment‑based regimens (experimental group) versus conventional first‑line chemotherapy regimens (control group) for unresectable locally advanced or metastatic gastric esophageal cancer. The main outcome measures included progression‑free survival (PFS), overall survival (OS), objective response rate, disease control rate and safety, and the secondary outcomes were the differences in OS and PFS between patients with PD‑L1 CPS ≥10 and those with PD‑L1 CPS <10. In addition, Asian and non‑Asian populations were analysed. Nine studies with a total of 6,820 patients were included. The OS of patients treated with immunotherapy‑based regimens was significantly longer than that of those treated with chemotherapy alone [HR=0.74; 95% CI (0.69, 0.80); P<0.00001]. The OS of patients with PD‑L1 CPS ≥10 and PD‑L1 CPS <10 in the experimental group was significantly longer than that of patients in the control group [HR=0.68; 95% CI (0.59, 0.77); P<0.00001 and HR=0.73; 95% CI (0.62, 0.87); P=0.0005]. The PFS of patients being treated with immunotherapy‑based regimens was significantly longer than that of those treated with chemotherapy alone [HR=0.71; 95% CI (0.59, 0.86); P=0.0003]. In addition, the PFS of patients with PD‑L1 CPS ≥10 and PD‑L1 CPS <10 in the experimental group was significantly longer than that of patients in the control group [HR=0.67; 95% CI (0.49, 0.92); P=0.01 and HR=0.63; 95% CI (0.48, 0.83); P=0.001]. There was no significant difference in the overall incidence of adverse events and the incidence of grade 3 or above adverse events between the experimental and control groups [RR=1; 95% CI (0.99, 1.02); P=0.65 and RR=0.97; 95% CI (0.84, 1.12); P=0.69, respectively]. In conclusion, treatment with immunotherapy‑based regimens may prolong the OS of patients with unresectable locally advanced or metastatic gastric esophageal cancer and this treatment regimen is safe compared with chemotherapy alone.

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