Retrospective Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Oncol. Jul 24, 2024; 15(7): 859-866
Published online Jul 24, 2024. doi: 10.5306/wjco.v15.i7.859
Programmed cell death 1 inhibitor sintilimab plus concurrent chemoradiotherapy for locally advanced pancreatic adenocarcinoma
Shi-Qiong Zhou, Peng Wan, Sen Zhang, Yuan Ren, Hong-Tao Li, Qing-Hua Ke
Shi-Qiong Zhou, Peng Wan, Sen 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, Wan P performed the research; Li HT and Ren Y contributed new reagents/analytical tools; Zhang S analyzed the data; Zhou SQ and Wan P wrote the paper; All authors have read and approved the submitted manuscript. Zhou SQ and Wan P contributed equally to this work and served as co-first authors.
Institutional review board statement: The present study was approved by the Ethics Committee of The First Affiliated Hospital of Yangtze University (No. KY202429) and was performed according to the Declaration of Helsinki.
Informed consent statement: Exemption from informed consent form was approved after review by the Ethics Committee of the First Affiliated Hospital of Yangtze University.
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, MM, PhD, Additional Professor, Chief Physician, 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: May 2, 2024
Revised: June 3, 2024
Accepted: June 26, 2024
Published online: July 24, 2024
Processing time: 74 Days and 23.6 Hours
Abstract
BACKGROUND

Pancreatic adenocarcinoma, a malignancy that arises in the cells of the pancreas, is a devastating disease with unclear etiology and often poor prognosis. Locally advanced pancreatic cancer, a stage where the tumor has grown significantly but has not yet spread to distant organs, presents unique challenges in treatment. This article aims to discuss the current strategies, challenges, and future directions in the management of locally advanced pancreatic adenocarcinoma (LAPC).

AIM

To investigate the feasibility and efficacy of programmed cell death 1 (PD-1) inhibitor sintilimab plus concurrent chemoradiotherapy for LAPC.

METHODS

Eligible patients had LAPC, an Eastern cooperative oncology group performance status of 0 or 1, adequate organ and marrow functions, and no prior anticancer therapy. In the observation group, participants received intravenous sintilimab 200 mg once every 3 wk, and received concurrent chemoradiotherapy (concurrent conventional fractionated radiotherapy with doses planning target volume 50.4 Gy and gross tumor volume 60 Gy in 28 fractions and oral S-1 40 mg/m2 twice daily on days 1-14 of a 21-d cycle and intravenous gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-d cycle for eight cycles until disease progression, death, or unacceptable toxicity). In the control group, participants only received concurrent chemoradiotherapy. From April 2020 to November 2021, 64 participants were finally enrolled with 34 in the observation group and 30 in the control group.

RESULTS

Thirty-four patients completed the scheduled course of chemoradiotherapy, while 32 (94.1%) received sintilimab plus concurrent chemoradiotherapy with 2 patients discontinuing sintilimab in the observation group. Thirty patients completed the scheduled course of chemoradiotherapy in the control group. Based on the Response Evaluation Criteria in Solid Tumors guidelines, the analysis of the observation group revealed that a partial response was observed in 11 patients (32.4%), stable disease was evident in 19 patients (55.9%), and 4 patients (11.8%) experienced progressive disease; a partial response was observed in 6 (20.0%) patients, stable disease in 18 (60%), and progressive disease in 6 (20%) in the control group. The major toxic effects were leukopenia and nausea. The incidence of severe adverse events (AEs) (grade 3 or 4) was 26.5% (9/34) in the observation group and 23.3% (7/30) in the control group. There were no treatment-related deaths. The observation group demonstrated a significantly longer median overall survival (22.1 mo compared to 15.8 mo) (P < 0.05) and progression-free survival (12.2 mo vs 10.1 mo) (P < 0.05) in comparison to the control group. The occurrence of severe AEs did not exhibit a statistically significant difference between the observation group and the control group (P > 0.05).

CONCLUSION

Sintilimab plus concurrent chemoradiotherapy was effective and safe for LAPC patients, and warrants further investigation.

Keywords: Immunotherapy; Concurrent chemoradiotherapy; Locally advanced pancreatic adenocarcinoma; Programmed cell death 1; Sintilimab

Core Tip: The article presents an insightful exploration of a study of the combination of sintilimab with S-1 and gemcitabine concurrent radiotherapy for locally advanced pancreatic cancer (LAPC). The observation group had significantly longer median progression-free survival and overall survival than the control group. The occurrence of severe adverse events did not exhibit a statistically significant difference between the observation group and the control group, with a P value greater than 0.05. It is considered a promising, effective, and well-tolerated treatment for LAPC.