Retrospective observational Clinical Study on Relapsed Malignant Gliomas Treated with Electro-hyperthermia

Brain scans glioblastoma

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Summary

This study aims to evaluate the efficacy and tolerability of electro-hyperthermia (ET) for patients with malignant glioma. The observation was conducted with patients who had a failure of previous temozolamide-based chemotherapy and radiotherapy, indication for treatment with ET. The results concluded ET, to have promising efficacy in adults with reaped malignant glioma.

Introduction

24 patients with high grade gliomas (HGG) ages 22-81 years old with the median age of 60 years old, Eastern Cooperative Oncology Group (ECOG) performance status ≥2, normal hematological values and vital signs. Nineteen (79%) patients had glioblastoma multiforme (13 were of grade 1- 3 and 6 of grade 4), 5 (21%) astrocytoma.

Most patients 22 (92%) were pre-treated with surgery, and all patients were pre-treated with temozolomide associated to radiotherapy. All patients were pre-treated with surgery (22/24), temozolomide and radiotherapy.

Methodology

All patients received pre-procedural medications with a suspension of glycerol 18% and dexamethasone 12mg before each ET session. ET with short RF waves of 13.56 MHz was applied with capacitive coupling technique maintaining 26 C° at skin contact. ET was performed with an EHY 2000 device. Power from 40 up to 150 Watt, resulting in an average equivalent temperature of >40 C° in the tumors, for more than 90% of the treatment duration (from 20 up to 60 minutes). ET was performed in three sessions per week, increasing the power and time each session. First treatment was always at 40 Watt for 20 minutes. Time was gradually raised from 20 to 60 minutes and power from 40 up to 150 Watt in two weeks.

Treatment

The applied power ranged between 40-150 Watts and the calculated average equivalent temperature in the tumors was above 40.5°C for more than 90% of the treatment duration. Duration treatment increases from 20 to 60 min. One treatment is: 3 session/week for 4 weeks and recycle if evidence of clinical benefit or stable disease. Each patient received 24 sessions (range 12 – 64).

Results

Tumor response and survival
Tumor response analysis two months after ET showed 2 (8%) patients achieved complete remission (ages 22 and 26 with astrocytomas), 5 (21%) partial remission (2 astrocytomas, and 3 glioblastomas), with a response rate of 29%. The median duration of response was 6 months (4- 24) for gliomas, and 44 months for astrocytomas (14-156+). Stable disease was observed in 8 (33%) of patients (2 astrocytomas, and 6 glioblastomas) and progression in 9 (38%) glioblastoma patients.

The median survival of whole study population was 19.5 months (range 2-156), 55% survival rate at 1 year, and 15 % at two-year overall survival. 3 long survivor patients at 156 months, 60 and62 months in astrocytomas. Ten patients had an objective clinical benefit as resulting from an increase of their ECOG from 3 to 1 in 4 (16%) patients and to 0 in 2 (8%) patients.

Tolerability
ET toxicity was mostly mild (Grade 1). One (4%) patient had head pain, one (4%) scalp burn, five (21%) epilepsy that was resolved with a medication including diazepam 10 mg in 100 ml of saline and levetiracetam in tablets without any further attack.

Conclusion

ET hyperthermia therapy for recurrent HGG is feasible and may increase tumor response and survival. ET is a non-invasive method to treat HGG without severe toxicity.

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Scientific article publishing date : 22/02/2018

Immucura identifier : BSC21_052EN

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