Modulated Electro-Hyperthermia (mEHT) in cancer patients: experiences on 110 patients

Artícle written by Giammaria Fiorentini, Donatella Sarti, Virginia Casadei, Caterina Fiorentini

Onco-Ematology Department, Azienda Ospedaliera “Ospedati Riuniti Marche Nord”, 61122 Pesaro, italy

Department of Medical Biothecnologies, Division of Cardiology, University of Siena, 53100 Siena, Italy,

Presented at 36º ICHS, Budapest, 2018

Background and aims:

There has been a significant improvement in the development and application of hyperthermia treatment and there is a continuous interest and ongoing clinical research in the field of hyperthermia. This study aim to evaluate the efficacy in terms of tumor response, pain reduction and improvement of quality of life due to modulated electro- hyperthermia
(mEHT), for the treatment of cancer.

Methods

This was a retrospective observational clinical study. Patients were included in the study if they had >18 years, informed consent signed, indication for treatment with mEHT.

Hyperthermia was performed with short radiofrequency waves of 13.56 MHz using a capacitive coupling technique keeping the skin surface at 26 C°. The applied power ranged between 40-150 Watts and the calculated average equivalent temperature in the tumors was above 41,5 C° for more than 90% of the treatment duration (20-60 minutes gradually).

Results

Characteristics of patients

110 consecutive patients were enrolled in the study, tumor distribution was: 11 (10%) colon, 11 (10%), ovary, 10 (9%) central nervous system, 10 (9%) breast, 10 (9%) liver (cholangiocarcinoma and HCC), 10 (9%) lung, 9 (8%) pancreas, 8 (7%) prostate, 5 (5%) pseudo mixoma peritoneii, 5 (5%) stomach, 4 (5%) melanoma, 2(2%) mesothelioma, 3(3%) bladder, 3 (3%) liposarcome and 11 (10%) other type of tumor. Other chracteristics of the
sample were: 50% presence of metastasis, 70% received concomitant radio or chemotherapy and median number of mEHT cycles was 8 (range 1-37).

Tumor response analysis three months after mEHT showed 3% complete remission and 41% partial remission, 31 % of stable disease and 25% of progression. Median pain intensity and quality of life improved in 85% of the sample. mEHT toxicity was mostly mild (G1). The small total number of adverse events (5%) in this study supports the strong safety profile of mEHT. No complications were observed during the treatments. Cardiac evaluation was performed for all patients with EKG and echocardiography before and after the last cycle of mEHT. No significant variations were observed.

Figure 1. Tumor response (3 months)

Conclusion

mEHT appears to have promising efficacy in adults with several types of tumor and it can be considered as a highly indicated palliative therapy.

Figure 2. Patient with squamous cellular intraoral tumor
a) baseline, b) one and c) three months after mEHT.
The tumor arises from the gum and perforates the cheek.
Figure 3. Patient, 49yrs with breast cancer and bone metastases.
a) CT scans at baseline showed partial osteolytic metastases (arrow) in thoracic vertebrae.
b) Three months after mEHT, osseous lesions din not change in size, but showed osteoblastic reaction (arrows in B), representing good response, and disappearance of the back pain.

Text extracted from Oncothermia Journal, Volumen 24, October 2018.

www.oncothermia-journal.com/journal/2018/Efficacy_of_Modulated_electro_hyperthermia_(mEHT)_in_cancer_ patients.pdf

Effects of the addition of electro-hyperthermia (Oncothermia) to chemoradiotherapy in cancer of the cervix. Randomized clinical trial – Phase III.

Dr. Minara CA of the University of Witwatersrand, Johannesburg, South Africa has published in the journal Oncothermia journal 21:56 57, 2017 an update on the phase III randomized clinical trial investigating the effects of the addition of electrons hyperthermia to chemoradiotherapy for patients with cancer of the cervix in South Africa.

The electrohyperthermia (EHT) trial is an ongoing phase III randomized clinical trial that is conducted at the Charlotte Maxeke Johannesburg Academic Hospital. The overall objective is to determine the clinical effects of the addition of modulated electrohyperthermia (EHT) to standard treatment protocols for locally advanced cervical cancer patients in state health care in South Africa. The objectives are to evaluate the effects of the addition of EHT on local control of the disease, quality of life, acute and late toxicity and overall survival.

Methods:

The purpose of the study is to treat 236 women with a FIGO IIB to IIIB stage of cervical cancer. Participants are randomly assigned to a group of “Hyperthermia” (EHT plus chemoradiation) and a group of “Control” (chemoradiation alone), strata of randomization: HIV status; years; stage of the disease. All participants receive external radiation of 50 Gy, 3 doses of brachytherapy with a high dose rate of 8 Gy and cisplatin. The “Oncothermia” group receives two local EHT treatments of 55 minutes per week during radiation therapy. Local control of the disease is evaluated by positron emission tomography (PET) scans. Adverse events, quality of life and overall survival are recorded and the data analyzed.

Results:

The first 100 participants are evaluated until they reach 6 months after treatment.

There has been a positive trend in the survival and local control of the disease in the group receiving OT.

There are no significant differences in acute adverse events or quality of life between the two groups.

The preliminary results of the addition of EHT are positive without impact on adverse events, however, this should be confirmed with more patients at the end of the study.