The sample was divided into 2 comparative groups: patients who did not receive mEHT (no- mEHT, 67/106, 63.2%) and patients who were treated with mEHT (39/106, 36.8%).
Modulated electro-hyperthermia was performed using the EHY-2000plus device (CE0123, Oncotherm), 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.The selected upper abdominal quadrant was treated for a median of 3 sessions per week, for a total of 8 weeks, increasing the power applied and length of each session.
The first mEHT treatment was always performed applying 60 W for 40 minutes, then the time was gradually raised to 90 minutes and the power to 150 W in 2 weeks. The treatment was prolonged if there was evidence of positive effects.Patients treated with chemotherapy were treated with mEHT the same day or within the following 48 hours. During this period of time, indeed, the blood concentration of chemotherapy drugs is still high enough to benefit from mEHT synergy.
The analysis of tumor response was performed 3 months after mEHT + chemotherapy (mEHT group) or chemotherapy alone (no-mEHT group). Data were available for 34 and 36 patients in the mEHT and non-mEHT groups, respectively. The mEHT group had 22/34 (64.7%) partial response (PR), 10/34 (29.4%) stable disease (SD), and 2/34 (5.9%) progressive disease.As concerning the no-mEHT group, PR was observed in 3/36 (8.3%) patients, SD in 10/36 (27.8%) patients, and progressive disease in 23/36 (63.9%) patients.
The median OS of the mEHT group was 18.0 months (range = 1.5-68 months) and was significantly (P < .00165) higher than the 10.9 months observed (range = 0.4-55.4 months) for the non-mEHT group.The OS analysis of metastatic patients showed a significantly higher OS in the mEHT group (P = .0008). The arm with mEHT had n = 25 metastatic patients with a median OS of 17.8 months, while the non-mEHT group had n = 37 metastatic patients with median OS of 8.4 months.The benefit of mEHT in terms of survival was observed also when mEHT was used as first-line therapy (no previous treatments before mEHT). The arm with mEHT had n = 16 patients who received mEHT as first-line therapy that showed a median OS of 19.6 months, significantly (P = .00047) higher than that of the patients of the non-mEHT group who received only first-line chemotherapy (n = 29) and had a median OS of 8.4 months.
Adverse effect and safety
Each patient received an average 12.8 (range = 2-23) sessions of mEHT. Out of a total of 499 mEHT delivered sessions, the safety assessment of mEHT showed a limited number of adverse events 20/499 (4%). mEHT toxicity consisted of skin pain in 12 (2%) sessions, grade 1 burns in 6 (1%) patients, and grade 2 burns in 2 patients. 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 mEHT with electrocardiogram and cardiac ultrasound. No one had cardiac toxicity, increased blood pressure, or rhythm changes during mEHT treatments.
These results may suggest a beneficial effect of mEHT when combined with chemotherapy and/or radiotherapy, increasing response and OS for patients with locally advanced or metastatic pancreatic cancer. The results of this study suggested also that mEHT could be safe for pancreatic cancer therapy, resulting in very limited side effects.
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Scientific article publishing date : 9/27/2017
Immucura identifier :BSC21_072EN