Phase I/II clinical trial of modulated electro-hyperthermia treatment in patients with relapsed, refractory or progressive heavily treated ovarian cancer

Yoo, Heon Jong; Lim, Myong Cheol; Seo, Sang Soo; Kang, Sokbom; Joo, Jungnam; Park, Soo‐Jin

doi:10.1093/jjco/hyz071

Cited by 12 publications

(16 citation statements)

References 30 publications

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“…This may have resulted in undertreatment. However, a recent study indicated that the optimal dose of mEHT in the treatment of recurrent ovarian cancer is 150 W for 1 h (7), and that dose is similar to the energy used in the present study (140 W). Nevertheless, a strength of the present study was that it was a multi-center study.…”

Section: Discussionsupporting

confidence: 58%

“…Modulated electro-hyperthermia (mEHT) is a type of RFH that uses impedance coupling with amplitude-modulated 13.56 MHz carrier radiofrequency (4). Similar to conventional RFH, mEHT is usually administered for 60 min, 1-3 times per week (3,(5)(6)(7). However, unlike conventional RFH, the energy of radiofrequency is selectively absorbed by the tumor cells in mEHT (8).…”

Section: Introductionmentioning

confidence: 99%

“…To the best of our knowledge, only 3 trials investigating the effects of mEHT therapy on cancer have been published to date. Although the trials were on different cancers, the results all suggested that the addition of mEHT was beneficial for achieving a higher response rate (5) and better local control (6) than conventional treatments and was highly feasible (7). However, evidence on the usefulness and safety of mEHT combined with chemotherapy in the treatment of ovarian cancer is currently lacking (10).…”

Section: Introductionmentioning

confidence: 99%

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Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial

Kim

et al. 2021

Exp Ther Med

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The present study (KGOG 3030) aimed to evaluate the safety of modulated electro-hyperthermia (mEHT) therapy with weekly administration of paclitaxel or cisplatin in female patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. A total of 12 patients were randomized into the paclitaxel or cisplatin arm at a 1:1 ratio. Patients received weekly administration of paclitaxel (70 mg/m 2 ) or cisplatin (40 mg/m 2 ) intravenously on days 1, 8 and 15, and underwent mEHT therapy for 1 h on days 1, 4, 8, 11, 15, 18, 21 and 24 for each 4-week cycle. The primary endpoint was the occurrence of dose-limiting toxicity (DLT). The secondary endpoints were treatment-emergent adverse events (TEAEs), objective response rate, carbohydrate antigen 125 (CA125) response rate, progression-free survival (PFS) and overall survival (OS). In total, 16 patients were recruited, but four patients dropped out. None of the 12 remaining patients (6 each in the two arms) experienced DLT. Overall, 0 and 4 grade 3 TEAEs (anemia, nausea, neutrophil count decreased and platelet count decreased) occurred in the paclitaxel and cisplatin arm, respectively. Furthermore, one confirmed partial response and two CA125 responses were observed in the cisplatin arm. The median PFS time in the paclitaxel and cisplatin arms was 3.0 months (range, 1.7-4.6 months) and 6.8 months (range, 3.9-11.8 months), respectively, while the median OS time was 11.5 months (range, 8.4-28.8+ months) and not reached (range, 3.9-38.5+ months), respectively. In conclusion, mEHT therapy with weekly paclitaxel or cisplatin appeared safe and warrants further investigation. The present trial was registered with www.clinicaltrials.gov on January 22, 2015 (trial registration no. NCT02344095).

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Section: Discussionsupporting

confidence: 58%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial

Kim

et al. 2021

Exp Ther Med

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“…The aim of the study was to confirm the maximum tolerated dose of mEHT. Nineteen participants were treated with mEHT twice a week for 3 weeks, starting at 110 W and increasing the power to 130 W. No dose-limiting toxicities were noted with mEHT administered to the peritoneal region (31). An Italian study has also demonstrated the safety and tolerability of mEHT applied to a variety of solid tumors (32).…”

Section: Resultsmentioning

confidence: 99%

Review of the Clinical Evidences of Modulated Electro-Hyperthermia (mEHT) Method: An Update for the Practicing Oncologist

et al. 2019

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Background: Modulated electro-hyperthermia (mEHT) is a variation of the conventional hyperthermia which selectively targets the malignant cell membranes in order to heat the malignant tissue and sensitize the tissue to oncology treatments. Although widely applied, the formulation of guidelines for the use thereof is still in progress for many tumors.Aim: In this paper we review the literature on the effects of mEHT in cancer patients on local disease control and survival.Methodology: Our review on data presents the collected experience with capacitive hyperthermia treatments with the EHY-2000+ device (OncoTherm Ltd., Germany). A literature search was conducted in Pubmed and articles were grouped and discussed according to: trial type, animal studies, in vitro studies, and reviews. Search results from Conference Abstracts; Trial Registries; Thesis and Dissertations and the Oncothermia Journal were included in the discussions.Results: Modulated electro-hyperthermia is a safe form of hyperthermia which has shown to effectively sensitizes deep tumors, regardless of the thickness of the adipose layers. The technology has demonstrated equal benefits compared to other forms of hyperthermia for a variety of tumors. Given the effective heating ability to moderate temperatures, the improved tumor perfusion, and ability to increase drug absorption, mEHT is a safe and effective heating technology which can be easily applied to sensitize tumors which have demonstrated benefits with the addition of hyperthermia. Modulated electro-hyperthermia also appears to improve local control and survival rates and appears to induce an abscopal (systemic) response to ionizing radiation.Conclusion: Based on clinical studies, the method mEHT is a feasible hyperthermia technology for oncological applications. Concomitant utilization of mEHT is supported by the preclinical and clinical data.

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“…The detailed analysis of nodal disease on PET/CT scans in patients with HIV-positive and negative locally advanced cervical cancer shows the improvement of the patient status metabolically too [83]. The treatment of ovarian cancer has also shown advantages with the complementary application of mEHT in a clinical trial, and the successful mEHT complementary treatment of advanced ovarian cancer with thermo-chemotherapy and adjuvant immune therapy presented a significant improvement [84,85]. Others independently showed the feasibility of complex multimodal immunotherapy for patients with ovarian cancer [86].…”

Section: Discussionmentioning

confidence: 99%

Towards the Immunogenic Hyperthermic Action: Modulated ElectroHyperthermia

Szász¹

2020

COR

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Hyperthermia treatment for solid tumors is a long-used, but poorly accepted method in clinical use. Modulated electro-hyperthermia (mEHT, trade name: oncothermia®) changes the paradigm, introduces a novel, cellularly selective and immunogenic cell-ruination. The mEHT method produces tumor-vaccination, presenting the unharmed genetic information of cancer cells to immune cells [1]. The mEHT method is approved in more than 30 countries. Its phase II/III clinical applications indicate a broad perspective.

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Phase I/II clinical trial of modulated electro-hyperthermia treatment in patients with relapsed, refractory or progressive heavily treated ovarian cancer

Abstract: The hyperthermia treatment was feasible in patients with recurrent or progressive ovarian cancer without any complication and optimal dose of hyperthermia treatment was up to 150 W for 1 hour/day

Cited by 12 publications

References 30 publications

Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial

Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial

Review of the Clinical Evidences of Modulated Electro-Hyperthermia (mEHT) Method: An Update for the Practicing Oncologist

Towards the Immunogenic Hyperthermic Action: Modulated ElectroHyperthermia

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