Clinical Study of Modulated Electro‐Hyperthermia for Advanced Metastatic Breast Cancer

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Summary

The present study aims to demonstrate the result of Modulated electro-hyperthermia (mEHT) in the treatment of advanced breast cancer. The results suggest that mEHT is feasible and is a possible therapy for advanced breast cancer cases when standard therapies fail. mEHT had no side effects and may be combined with other treatments.

Patients characteristics

Ten patients with advanced or recurrent breast cancer participated in this trial. All patients had undergone conventional therapies following standard protocols for breast cancer. Patients received hormonal therapy, external irradiation, surgery, various chemotherapies, targeted molecular treatment, and other available state of the art therapies.

Methodology

Procedure of modulated electro-hyperthermia (mEHT).
Modulated electro-hyperthermia (mEHT) was performed twice a week in 7 patients and thrice a week in the other 3. The session lasted for ~60 min, with at least 1 day in between. The treatment was performed using the EHY2000+ device. The electrode used was 30 cm in diameter. Patients were placed in the supine position on the water mattress of the treatment bed. A step-up heating protocol was used, starting with 60 W, which was then increased to 140 W. The average number of treatments performed per patient was 48.6 (range, 8-90). The average dose of 374.6 (range, 371-376) kJ was administered.

Results

Statistics of mEHT.
Out of the 10 cases registered, 5 were stage 3 or 4 preoperatively. The ER status was positive in all cases, and HER2 was positive in 1 case. In 9/10 cases, some treatments were performed before mEHT; however, due to the lack of a satisfactory antitumor effect, mEHT was performed or combined with other treatments. As a result, 8-90 mEHTs were performed. There were no apparent complications during mEHT.
Clinical estimation of the PD case.
Patients felt comfortable with warming around the targeted area during treatment. The elevated body temperature observed was mild, and some patients presented with sweating without discomfort. In addition, there were no adverse effects, such as skin blisters, erythema, or dermatitis.
Partial response (PR) was achieved in 3/10 (30%) patients, and so was stable disease (SD). A total of 4/10 patients (40%) showed PD. All 3 patients (cases 2, 4 and 6) that were treated with a combination of mEHT and mTOR achieved PD. They had multiple-organ metastases from thebreast cancer and had undergone multiple sessions of mEHT (46-90). Cases 4 and 6 refused chemotherapy and only approved the use of mTOR, which has relatively few side effects, such as hair loss and malaise.
However, 2/3 PR patients exhibited a re-increase in tumor size after the follow-up period. By contrast, another patient recovered and underwent curative surgery. At the time of writing, she was still alive with no signs of recurrence (9 months after initial mEHT therapy). A total of 4 patients judged as PD exhibited worsening of the local tumor and metastases. In addition, case 2 received two types of chemotherapy in combination with 90 sessions of mEHT for 30 weeks. The tumor did not grow until 24 weeks after the start of treatment, but thereafter, lung metastasis gradually worsened, with the eventual occurrence of pleural effusion. Due to dyspnea, the patient could not visit the hospital; therefore, mEHT was discontinued.Clinical estimation of the PR cases.Showing the details, 2 PR cases are described. The PR cases 1, 7 and 10 had progression-free survival rates of 2, 7 and 9 months, respectively.

Conclusion

In conclusion, it was reported in the present study that the use of mEHT is feasible for advanced or recurrent meta- static breast cancer where pretreatment is ineffective. The results suggested that mEHT has no side effects and could be combined with various treatments for a long time.

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Scientific article publishing date 5/3/2021

Immucura identifier BSC21_033EN

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