Retrospective Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Oncol. Feb 24, 2025; 16(2): 98079
Published online Feb 24, 2025. doi: 10.5306/wjco.v16.i2.98079
Programmed cell death 1 inhibitor sintilimab plus S-1 and gemcitabine for liver metastatic pancreatic ductal adenocarcinoma
Shi-Qiong Zhou, Peng Wan, Seng Zhang, Yuan Ren, Hong-Tao Li, Qing-Hua Ke
Shi-Qiong Zhou, Peng Wan, Seng Zhang, Yuan Ren, Hong-Tao Li, Qing-Hua Ke, Department of Chemoradiotherapy, The First Affiliated Hospital of Yangtze University, Jingzhou 434000, Hubei Province, China
Co-first authors: Shi-Qiong Zhou and Peng Wan.
Author contributions: Ke QH designed the study; Zhou SQ and Wan P performed the research and wrote the paper, they contributed equally to the manuscript as co-first authors; Li HT and Ren Y contributed new reagents and analytical tools; Zhang S analyzed the data; and all authors approved the submitted manuscript.
Institutional review board statement: The study was approved by the Ethics Committee of the First Affiliated Hospital of Yangtze University (No. KY202428).
Informed consent statement: Exemption from informed consent form was approved by the Ethics Committee of the First Affiliated Hospital of Yangtze University (No. KY202428).
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: All datasets during and/or analyzed during the current study are available from the corresponding author upon reasonable request at 3803354759@qq.com.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Qing-Hua Ke, Chief Physician, PhD, Department of Chemoradiotherapy, The First Affiliated Hospital of Yangtze University, No. 40 Jinglong Road, Shashi District, Jingzhou 434000, Hubei Province, China. 3803354759@qq.com
Received: June 17, 2024
Revised: October 21, 2024
Accepted: November 25, 2024
Published online: February 24, 2025
Processing time: 176 Days and 21.8 Hours
Abstract
BACKGROUND

Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive cancer with poor prognosis. When it metastasizes to the liver, treatment options become particularly limited and challenging. Current treatment options for liver metastatic PDAC are limited, and chemotherapy alone often proves insufficient. Immunotherapy, particularly programmed cell death 1 (PD-1) inhibitors like sintilimab, shows potential efficacy for various cancers but has limited reports on PDAC. This study compares the efficacy and safety of sintilimab plus S-1 and gemcitabine vs S-1 and gemcitabine alone in liver metastatic PDAC.

AIM

To explore the feasibility and effectiveness of combined PD-1 inhibitor sintilimab and S-1 and gemcitabine (combination group) vs S-1 and gemcitabine used alone (chemotherapy group) for treating liver metastatic pancreatic adenocarcinoma.

METHODS

Eligible patients were those with only liver metastatic PDAC, an Eastern Cooperative Oncology Group performance status of 0-1, adequate organ and marrow functions, and no prior anticancer therapy. Participants in the combination group received intravenous sintilimab 200 mg every 3 weeks, oral S-1 40 mg/m² twice daily on days 1-14 of a 21-day cycle, and intravenous gemcitabine 1000 mg/m² on days 1 and 8 of the same cycle for up to eight cycles or until disease progression, death, or unacceptable toxicity. Participants in the chemotherapy group received oral S-1 40 mg/m² twice daily on days 1-14 of a 21-day cycle and intravenous gemcitabine 1000 mg/m² on days 1 and 8 of the same cycle for up to eight cycles. Between June 2020 and December 2021, 66 participants were enrolled, with 32 receiving the combination treatment and 34 receiving chemotherapy alone.

RESULTS

The group receiving the combined therapy exhibited a markedly prolonged median overall survival (18.8 months compared to 10.3 months, P < 0.05) and progression-free survival (9.6 months vs 5.4 months, P < 0.05). compared to the chemotherapy group. The incidence of severe adverse events did not differ significantly between the two groups (P > 0.05).

CONCLUSION

The combination of PD-1 inhibitor sintilimab with S-1 and gemcitabine demonstrated effectiveness and safety for treating liver metastatic PDAC, meriting further investigation.

Keywords: Immunotherapy; Programmed cell death 1 inhibitor; Sintilimab; Chemotherapy; Metastatic; Pancreatic ductal adenocarcinoma

Core Tip: This study aimed to explore the feasibility and effectiveness of combining the programmed cell death 1 inhibitor sintilimab with S-1 and gemcitabine (combination group) vs using S-1 and gemcitabine alone (chemotherapy group) for treating liver metastatic pancreatic adenocarcinoma. The combination of programmed cell death 1 inhibitor sintilimab with S-1 and gemcitabine demonstrated effectiveness and safety for treating liver metastatic pancreatic ductal adenocarcinoma, meriting further investigation.