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
Abstract
BACKGROUND

Locally advanced pancreatic cancer (LAPC) is a common malignant digestive system tumor that ranks as the fourth leading cause of cancer-related death in the world. The prognosis of LAPC is poor even after standard treatment. Irreversible electroporation (IRE) is a novel ablative strategy for LAPC. Several studies have confirmed the safety of IRE. To date, no prospective studies have been performed to investigate the therapeutic efficacy of conventional gemcitabine (GEM) plus concurrent IRE.

AIM

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

METHODS

From February 2016 to September 2017, a total of 68 LAPC patients were treated with GEM plus concurrent IRE n = 33) or GEM alone n = 35). 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.

RESULTS

There were no treatment-related deaths. The technical success rate of IRE ablation was 100%. The GEM + IRE group had a significantly longer OS from the time of diagnosis of LAPC (19.8 mo vs 9.3 mo, P < 0.0001) than the GEM alone group. The GEM + IRE group had a significantly longer PFS (8.3 mo vs 4.7 mo, P < 0.0001) than the GEM alone group. Tumor volume less than 37 cm3 and GEM plus concurrent IRE were identified as significant favorable factors for both the OS and PFS.

CONCLUSION

Gemcitabine plus concurrent IRE is an effective treatment for patients with LAPC.

Keywords: Irreversible electroporation, Gemcitabine, Locally advanced pancreatic cancer, Overall survival, Progression free survival, Prognostic factors

Core Tip: Locally advanced pancreatic cancer (LAPC) is a common malignant digestive system tumor with poor prognosis. Gemcitabine (GEM) is currently used as a first-line chemotherapy for treatment of LAPC; however, the overall outcome was poor. Irreversible electroporation (IRE) is a novel, non-thermal ablation technology that uses high voltage electrical pulses to induce pore formation, resulting in cell apoptosis. We found that GEM plus concurrent IRE resulted in significantly prolonging overall survival compared with chemotherapy alone. Therefore, GEM plus concurrent IRE has a synergistic effect on the clinical treatment of LAPC.