Copyright
©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
Hyperthermia combined with chemotherapy vs chemotherapy in patients with advanced pancreatic cancer: A multicenter retrospective observational comparative study
Giammaria Fiorentini, Donatella Sarti, Andrea Mambrini, Ivano Hammarberg Ferri, Massimo Bonucci, Paola Giordano Sciacca, Marco Ballerini, Salvatore Bonanno, Carlo Milandri, Roberto Nani, Stefano Guadagni, Patrizia Dentico, Caterina Fiorentini
Giammaria Fiorentini, Ivano Hammarberg Ferri, Integrative Oncology, Integrative Oncology Outpatient Clinic, Bologna 40121, Italy
Donatella Sarti, Department of Oncology, Santa Maria della Misericordia Hospital, Urbino 60129, Italy
Andrea Mambrini, Department of Oncology, Azienda Sanitaria Locale Toscana Nord Ovest, Massa Carrara Hospital, Massa 54100, Italy
Massimo Bonucci, Integrative Oncology, Association Research Center for Integrative Oncology Treatments, Roma 00166, Italy
Paola Giordano Sciacca, Complementary Medicine Service, District Hospital of Merano, Merano 39012, Italy
Marco Ballerini, Hyperthermia Unit, Bellessere Medical Center, Terni 05100, Italy
Salvatore Bonanno, Radiotherapy Unit, A. Rizza Hospital, Siracusa 96100, Italy
Carlo Milandri, Medical Oncology, San Donato Hospital, Arezzo 52100, Italy
Roberto Nani, Interventional Radiology Unit, Humanitas Gavazzeni, Bergamo 24121, Italy
Stefano Guadagni, Applied Clinical Sciences and Biotechnology, Section of General Surgery, University of L'Aquila, L'Aquila 67100, Italy
Patrizia Dentico, Hyperthermia Service, Medical Oncology Unit, San Giuseppe Hospital, Empoli 50053, Italy
Caterina Fiorentini, Prevention and Sports Medicine, University Hospital Klinikum rechts der Isar, Technical University of Munich, Munich 80331, Germany
Author contributions: Fiorentini G, Sarti D and Guadagni S wrote the paper; Fiorentini G and Sarti D performed the formal analysis; Fiorentini G, Sarti D, Bonucci M, Hammarberg Ferri I, Mambini A, Sciacca P, Ballerini M, Bonanno S, Milandri C, Nani R, Guadagni S, Dentico P and Fiorentini C collected the data; Fiorentini G, Sarti D and Bonucci M administered and supervised the project administration; Fiorentini G, Sarti D, Bonucci M, Ferri I, Mambini A, Sciacca P, Ballerini M, Bonanno S, Milandri C, Nani R, Guadagni S, Dentico P and Fiorentini C reviewed and edited the final manuscript.
Institutional review board statement: The study was approved by our Institutional Review Board.
Informed consent statement: Patients were not required to give informed consent to the study because the analysis used anonymous data that were collected retrospectively after each patient agreed and performed the treatment after signing the written consent for the treatment.
Conflict-of-interest statement: The authors declare that they have no conflict of interest.
Data sharing statement: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
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: Giammaria Fiorentini, MD, Adjunct Professor, Chief Doctor, Director, Integrative Oncology, Integrative Oncology Outpatient Clinic, Via dell'Indipendenza, 20, Bologna 40121, Italy.
g.fiorentini@alice.it
Received: April 27, 2023
Peer-review started: April 27, 2023
First decision: May 12, 2023
Revised: May 18, 2023
Accepted: June 6, 2023
Article in press: June 6, 2023
Published online: June 24, 2023
Processing time: 54 Days and 15 Hours
BACKGROUND
Several studies report the useful therapeutic results of regional hyperthermia in association with chemotherapy (CHT) and radiotherapy for the treatment of pancreatic cancer. Modulated electro-hyperthermia (mEHT) is a new hyperthermia technique that induces immunogenic death or apoptosis of pancreatic cancer cells in laboratory experiments and increases tumor response rate and survival in pancreatic cancer patients, offering beneficial therapeutic effects against this severe type of cancer.
AIM
To assess survival, tumor response and toxicity of mEHT alone or combined with CHT compared with CHT for the treatment of locally advanced or metastatic pancreatic cancer.
METHODS
This was a retrospective data collection on patients affected by locally advanced or metastatic pancreatic cancer (stage III and IV) performed in 9 Italian centers, members of International Clinical Hyperthermia Society-Italian Network. This study included 217 patients, 128 (59%) of them were treated with CHT (no-mEHT) and 89 (41%) patients received mEHT alone or in association with CHT. mEHT treatments were performed applying a power of 60-150 watts for 40-90 min, simultaneously or within 72 h of administration of CHT.
RESULTS
Median patients’ age was 67 years (range 31-92 years). mEHT group had a median overall survival greater than non-mEHT group (20 mo, range 1.6-24, vs 9 mo, range 0.4-56.25, P < 0.001). mEHT group showed a higher number of partial responses (45% vs 24%, P = 0.0018) and a lower number of progressions (4% vs 31%, P < 0.001) than the no-mEHT group, at the three months follow-up. Adverse events were observed as mild skin burns in 2.6% of mEHT sessions.
CONCLUSION
mEHT seems safe and has beneficial effects on survival and tumor response of stage III-IV pancreatic tumor treatment. Further randomized studies are warranted to confirm or not these results.
Core Tip: Pancreatic cancer has very poor prognosis with a 5-year overall survival of 5% and a median overall survival (OS) time of 8-12 mo. The concomitant use of modulated electro-hyperthermia (mEHT) in addition to chemotherapy has been introduced. mEHT has specific antitumor effects, increasing survival and tumor response. This was a retrospective data collection on 217 patients affected by locally advanced pancreatic cancer performed in 9 Italian centres, aiming to assess survival, tumour response and toxicity. The mEHT group had a greater OS (20 mo vs 9 mo, P < 0.001), higher number of partial responses (45% vs 24%, P = 0.0018) and a lower number of progressions (4% vs 31%, P < 0.001) than no-mEHT group. Adverse events were observed in 2.6% of mEHT sessions. mEHT have beneficial effects on survival and tumor response of stage III-IV pancreatic tumor patients, without adding toxicity.
