Clinical Trials Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Nov 26, 2020; 8(22): 5564-5575
Published online Nov 26, 2020. doi: 10.12998/wjcc.v8.i22.5564
Gemcitabine plus concurrent irreversible electroporation vs gemcitabine alone for locally advanced pancreatic cancer
Yang-Yang Ma, Yin Leng, Yan-Li Xing, Hong-Mei Li, Ji-Bing Chen, Li-Zhi Niu
Yang-Yang Ma, Ji-Bing Chen, Central Laboratory, Affiliated Fuda Cancer Hospital, Jinan University, Guangzhou 510665, Guangdong Province, China
Yin Leng, Yan-Li Xing, Hong-Mei Li, Department of Oncology, Affiliated Fuda Cancer Hospital, Jinan University, Guangzhou 510665, Guangdong Province, China
Li-Zhi Niu, Department of Interventional Radiology, Affiliated Fuda Cancer Hospital, Jinan University, Guangzhou 510665, Guangdong Province, China
Author contributions: Ma YY wrote the paper; Leng Y, Xing YL, and Li HM performed the study selection; Chen JB analyzed the data; Niu LZ designed the project and edited the manuscript; all authors reviewed the final manuscript.
Supported by International Science Foundation of Affiliated Fuda Cancer Hospital, Jinan University, No. Y2018-ZD-01.
Institutional review board statement: The study was reviewed and approved by the Affiliated Fuda Cancer Hospital, Jinan University Institutional Review Board.
Clinical trial registration statement: The study was registered at ClinicalTrials.gov. The registration identification number is NCT02981719.
Informed consent statement: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors have no conflicts of interest to disclose.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
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: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Li-Zhi Niu, MD, PhD, Chief Physician, Department of Interventional Radiology, Affiliated Fuda Cancer Hospital, Jinan University, No. 2 Tangde West Road, Tianhe District, Guangzhou 510665, Guangdong Province, China. niuboshi@fudahospital.com
Received: August 12, 2020
Peer-review started: August 12, 2020
First decision: August 22, 2020
Revised: August 25, 2020
Accepted: September 26, 2020
Article in press: September 26, 2020
Published online: November 26, 2020
Processing time: 105 Days and 5.6 Hours
ARTICLE HIGHLIGHTS
Research background

Locally advanced pancreatic cancer (LAPC) is a common malignant digestive system tumor. Surgery and chemotherapy remain the primary treatments for patients with LAPC, however, the outcome is not always satisfactory. Irreversible electroporation (IRE) is an emerging physical ablation technology that uses high voltage short pulses to destroy the integrity of the cell membrane, resulting in cell apoptosis. To date, however, there has been a lack of prospective data to verify the therapeutic outcome of gemcitabine (GEM) plus concurrent IRE.

Research motivation

We hope to explore whether GEM plus concurrent IRE has a synergistic effect on the clinical treatment of LAPC.

Research objectives

To compare the therapeutic efficacy between conventional GEM plus concurrent IRE and GEM alone for LAPC.

Research methods

This prospective study (NCT02981719) was approved by the Institutional Ethics Committee of Affiliated Fuda Cancer Hospital, Jinan University. From February 2016 to September 2017, the included patients were treated with GEM plus concurrent IRE (n = 33, median age = 63) or GEM alone (n = 35, median age = 65). The largest median tumor diameter was 4.1 cm and 3.9 in the GEM + IRE and GEM alone group, respectively. Overall survival (OS), progression free survival (PFS), and procedure-related complications were compared between the two groups. Multivariate analyses were performed to identify any prognostic factors.

Research results

There were no treatment-related deaths. The technical success rate of IRE ablation was 100%. The median OS was 19.8 and 9.3 mo from the time of diagnosis in the GEM + IRE group and GEM alone group, respectively. The median PFS was 8.3 and 4.7 mo for the GEM + IRE group and GEM alone group, respectively. Tumor volume less than 37 cm3 and GEM plus concurrent IRE were identified as significant favorable factors for both the OS and PFS. Although certain major complications have been identified in our patients, we believe that the use of appropriate measures can help prevent these complications.

Research conclusions

GEM plus concurrent IRE can improve therapeutic efficacy with fewer complications, which provides a safe and effective method for the clinical treatment of LAPC.

Research perspectives

We focused on whether GEM plus concurrent IRE treatment has a synergistic effect. Our data demonstrate that GEM plus concurrent IRE is a safe and effective method for the clinical treatment of LAPC.