Deep regional hyperthermia in combination with whole brain radiotherapy (WBRT) in poor prognosis patients with Brain Metastases header
12 Aug 2017

Clinical trial: Deep local hyperthermia in combination with Whole Brain RadioTherapy (WBRT) in Brain Metastases

Deep local hyperthermia (mHT) combined with WBRT in patients with poor prognosis brain metastases.

 

Clinical Trial Abstract

Purpose: The aim of this clinical trial is to assess for the first time, the role of locoregional deep hyperthermia in combination with radiotherapy and systemic therapy in patients with poor prognosis brain metastases (GPI ≤ 2.5).

Methods: Patients with confirmed cerebral metastases and classified as GPI score ≤2.5 were included in this prospective study. Pretreatment stratification was defined as patients with 0-1 GPI score (A group) and patients with 1.5-2.5 GPI score (B group). HT was applied twice a week, sixty minutes per session, during RT by a regional capacitive oncological hyperthermia device (Andromedic HyDeep 600WM) at 13.56 MHz radiofrequency (modulated RF-hyperthermia).

Results: Between June 2015 and June 2017, 15 patients and a total of 49 brain metastases were included in the protocol. All cancer patients received all HT sessions as planned. RT and systemic therapy were also completed as prescribed.
Tolerance to hyperthermia treatment was excellent and no toxicity was registered. Patients with HT effective treatment time longer than the median (W90time > 88%) showed better actuarial PFS at 6 and 12 months (100% & 66.7% respectively) compared with those with less effective HT treatment time (50% & 0% respectively) (p < 0.031).

Median OS was 6 months (range 1-36 months). Stratification by GPI score showed a median OS of 3 months (CI 95% 2.49-3.51) in Group A and 8.0 months (CI 95% 5.15-10.41) in Group B (p = 0.035).

Conclusions: locoregional deep hyperthermia is a feasible and safe technique to be used in combination with RT in brain metastases patients, improving PFS and survival in poor prognosis brain metastases patients.

In our study, 49 brain metastases from 15 patients belonging to the most unfavorable GPA groups were included: 6 patients had a score index of 0-1 (Group A) and 9 patients had a score index of 1.5-2.5 (Group B). All patients were treated with a combination of radiotherapy and locoregional hyperthermia. The first conclusion of our study is that combined RT and regional HT is a well-tolerated treatment in brain metastases patients. All treatments were administered as prescribed.

No toxicity due to HT was registered. In contrast, Byun et al. [13] in their study with intraoperative HT, described seizures and wound infection as complications of the combined treatment in a relevant number of cases. Deep modulated hyperthermia seems to be easier and safer to administer than complicated intraoperative treatments.

Quality of HT treatment (W90time > 88%) resulted in the strongest predictive factor for survival. Patients who received >88% of the hyperthermia treatment time at 90% of the power prescribed (150W) had excellent PFS rates, acknowledging the role of mHT in sensitizing tumors to radiochemotherapy [4-7].

According to overall survival, median OS was 6 months in our series, improving the poor results of standard treatment in these cases [3].

The association of oncological hyperthermia to RT +/- systemic treatment achieved a 53.1% probability of remaining alive at 6 months and 30.6% at 12 months in our brain metastasis (BM) patients.

Frequently Asked Questions about Brain Metastases Hyperthermia

Q: How does deep hyperthermia influence survival in brain metastases patients?

A: The prospective study demonstrated that adding modulated RF-hyperthermia (mHT) to whole-brain radiotherapy (WBRT) significantly improves Progression-Free Survival (PFS). Patients receiving high-quality HT reached a PFS rate of 100% at 6 months and 66.7% at 12 months, which is a substantial improvement over standard treatment outcomes.

Q: What is W90time and why is it crucial for HyDeep 600WM hyperthermia device efficacy?

A: W90time refers to the duration of the treatment session where at least 90% of the prescribed power is maintained. The study concluded that a W90 > 88% is the strongest predictor for survival, confirming the clinical importance of the power stability and precision provided by the HyDeep 600WM modulated RF hyperthermia  13.56 MHz technology.

Q: Are there risks of seizures or toxicity when using deep hyperthermia for brain tumors?

A: No. Unlike invasive or intraoperative methods, deep regional hyperthermia with the HyDeep 600WM mHT device was proven to be very safe. Zero toxicity or neurological complications, such as seizures, were recorded during the study, demonstrating excellent tolerance for oncology patients.

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