Modulated electro-hyperthermia in stage III and IV pancreatic cancer: Results of an observational study on 158 patients

OS

Overall Survival

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Summary

The aim of this study is to compare the results of CHT alone against CHT in combination with mEHT for the treatment of stage III and IV pancreatic cancer. According to the findings, adding mEHT to systemic CHT enhanced overall and progression-free survival as well as local tumor control while posing comparable toxicity.

Patients characteristics

158 patients >18 years old with histologically confirmed stage III and IV pancreatic cancer, treatment with CHT alone or in combination with mEHT. Patients must not have a pacemaker, bilirubin, or transaminase level > 3 times the normal value upper range level or bleeding. All patients are divided into two cohorts, 58 patients received CHT + mEHT and 100 patients received CHT alone.

Methodology

Modulated electro-hyperthermia was performed using the EHY-2000plus device (CE0123), applying a radiofrequency current of 13.56 MHz as carrier frequency that was modulated by time-fractal fluctuation. The energy was transferred by capacitive coupling, with precise impedance matching.

Treatment

Chemotherapy
The majority (95%) of gemcitabine-based treatments were administered on the same day of electro- hyperthermia treatment. In a minority of patients (5%), it was administered the following day or within the following 72 hours because of precarious clinical conditions and geographic accessibility. Even if gemcitabine had a half-life of 42-94 min and was eliminated within 5-11 hours after infusion.

Results

Survival
Median overall survival (OS) was greater for CHT + mEHT group than CHT group (19.5 months vs 11.02 months); also progression-free survival (PFS) was improved (12 months vs 3 months) for the CHT + mEHT group.
Tumor response
The association of mEHT resulted also in an improvement of tumor response at the 3 months’ time point, with a disease control rate (DCR) 95% vs 58% in CHT + mEHT group and CHT group, respectively. CHT + mEHT group had a greater partial response (PR) (52% vs 14%) and lower progressed disease (PD) (5% vs 58%) than CHT group.
Adverse effects and safety
Each patient received an average of 13 (range = 4-28) sessions of mEHT. Out of a total of 754 mEHT delivered sessions, the safety assessment of mEHT showed a limited number of adverse events 23/754 (4%). mEHT toxicity consisted of skin pain in 15 (3%) patients and burns in 8 (1%).
All these side effects were G1-G2 intensity and resolved with local medications and discontinuation of treatment for 1 week. All patients were evaluated before and after mEHT with electrocardiogram and cardiac ultrasound. No one had cardiac toxicity.

Conclusion

The addition of mEHT to systemic CHT improved overall and progression-free survival and local tumor control with comparable toxicity.

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Scientific article publishing date 11/24/2021

Immucura identifier BSC21_274EN

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