Observational Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Oncol. Nov 24, 2021; 12(11): 1064-1071
Published online Nov 24, 2021. doi: 10.5306/wjco.v12.i11.1064
Modulated electro-hyperthermia in stage III and IV pancreatic cancer: Results of an observational study on 158 patients
Giammaria Fiorentini, Donatella Sarti, Girolamo Ranieri, Cosmo Damiano Gadaleta, Caterina Fiorentini, Carlo Milandri, Andrea Mambrini, Stefano Guadagni
Giammaria Fiorentini, Department of Onco-Hematology, Azienda Ospedaliera “Ospedali Riuniti Marche Nord”, Pesaro 61122, Italy
Donatella Sarti, Oncology Department, Ospedale S. Maria Della Misericordia, ASUR1, Urbino 61029, Italy
Girolamo Ranieri, Cosmo Damiano Gadaleta, Interventional and Integrated Medical Oncology, National Cancer Research Centre, IRCCS Istituto Tumori "Giovanni Paolo II", Bari 70124, Italy
Caterina Fiorentini, Department of Medical Biothecnologies, Division of Cardiology, University Hospital of Siena, Siena 53100, Italy
Carlo Milandri, Medical Oncology Unit, San Donato Hospital, Arezzo 52100, Italy
Andrea Mambrini, Department of Oncology - ASL Toscana Nord Ovest, Massa Carrara Hospital, Massa 54100, Italy
Stefano Guadagni, Applied Clinical Sciences and Biotechnology, Section of General Surgery, University of L’Aquila, L’Aquila 67100, Italy
Author contributions: Fiorentini G, Sarti D and Guadagni S wrote the paper; Ranieri G and Gadaleta CD performed the data collection; Fiorentini C collected and evaluated the interactions between hyperthermia and heart; Milandri C and Mambrini A reviewed the manuscript.
Institutional review board statement: The study was reviewed and approved by the Istituto Tumori Giovanni Paolo II, Bari, Italy Institutional Review Board (Approval No. 948/CE).
Informed consent statement: All study participants provided informed written consent prior to study enrolment.
Conflict-of-interest statement: No conflict of interest.
Data sharing statement: No further technical appendix, statistical code, and dataset are available.
STROBE statement: The authors have read and revised the manuscript based on the STROBE guidelines.
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: Giammaria Fiorentini, MD, Adjunct Professor, Chief Doctor, Director, Department of Onco-Hematology, Azienda Ospedaliera “Ospedali Riuniti Marche Nord”, Via Lombroso, Pesaro 61122, Italy. g.fiorentini2020@gmail.com
Received: February 23, 2021
Peer-review started: February 23, 2021
First decision: May 7, 2021
Revised: May 18, 2021
Accepted: September 30, 2021
Article in press: September 30, 2021
Published online: November 24, 2021
Research background

Hyperthermia has been used as cancer therapy for decades, especially for its benefits in enhancing chemotherapy and radiotherapy efficacy. Modulated electro-hyperthermia (mEHT) is a relatively new method of hyperthermia that targets malignant cell membranes and the extracellular matrix, overcoming the issue of homogenous tissue heating.

Research motivation

The efficacy of mEHT is known for several types of tumors, including pancreatic cancer. Pancreatic cancer has a poor prognosis, and the combination of mEHT with chemo- and/or radiotherapy might be important to increase tumor response and improve survival.

Research objectives

The aim of this study was to compare outcomes of chemotherapy (CHT) alone or in association with mEHT for the treatment of locally advanced pancreatic cancer.

Research methods

Data were collected retrospectively from a cohort of 158 consecutive patients with stage III-IV pancreatic cancer that were treated with CHT alone (63%) or in combination with mEHT (37%) from 2003 to 2019. These data included patients’ characteristics, type of chemotherapy, previous surgery or radiotherapy, tumor response, survival, progression free survival, and adverse events.

Research results

The evaluation of survival showed that CHT + mEHT group had a longer overall (19.5 mo vs 11.02 mo, P < 0.001) and progression free (12 mo vs 3 mo, P < 0.001) survival. The association of mEHT improved also tumor response with disease control rate 95% vs 58% (P < 0.001). Toxicity was comparable in the two study groups and hyperthermia-related adverse events were mainly G1-2.

Research conclusions

The results obtained in this study provided new evidence that mEHT improved survival and tumor response, delaying the progression insurgence. The introduction of mEHT, moreover, did not influence chemotherapy tolerability, and hyperthermia-related adverse events were limited.

Research perspectives

This observational study provides further evidence that mEHT association to chemotherapy can enhance its benefit in pancreatic cancer patients. Further studies are required to confirm these results in a large cohort study and to evaluate treatment safety and efficacy.