Calcium electroporation in cutaneous metastases - A non-randomised phase II multicentre clinical trial.

Mille Vissing, Mascha Pervan, John Pløen, Mazen Schnefeldt, Søren Rafael Rafaelsen, Lars Henrik Jensen, Achim Rody, Julie Gehl

Journal: European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology 2023;49(9):106925

PMID: 37268521

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Abstract

BACKGROUND

Cutaneous metastases can cause distressing symptoms and be challenging to treat. Local therapies are essential in management. Calcium electroporation uses calcium and electrical pulses to selectively kill cancer cells. This multicentre study aimed to define response in cutaneous metastases across different cancer types.

METHODS

Patients with tumours ≤3 cm of any histology were included (stable or progressing on current therapy ≥2 months), at three centres. Tumours were treated with 220 mM calcium chloride injection and manual application of eight 0.1 ms pulses with 1 kV/cm and 1Hz with a handheld electrode, in local or general anaesthesia. Clinical response was evaluated after 1, 2, 3, 4, 5, 6, and 12 months. Primary endpoint was response at two months. The overall response rate (ORR) was partial- and complete responses of treated tumours. MR-imaging and qualitative interviews were performed in respective subsets.

RESULTS

Nineteen patients with disseminated cancer (breast n = 4, lung n = 5, pancreatic n = 1, colorectal n = 2, gastric n = 1, and endometrial cancer n = 1) were enrolled, and 58 metastases were treated (50 once, 8 retreated). The ORR was 36% (95% CI 22-53) after two months. Best ORR was 51% (CR 42%; PR 9%). Previous irradiation improved outcomes (p = 0.0004). Adverse events were minimal. Median pain score was reduced after two months (p = 0.017). Treatment may relieve symptoms according to qualitative interviews. MRI showed restriction in treated tissue.

CONCLUSION

The majority of tumours were treated only once with calcium electroporation, achieving an ORR of 36% after two months and best ORR of 51%. Efficacy, symptom-relief and safety support calcium electroporation as a palliative treatment option for cutaneous metastases.

Address: Center for Experimental Drug and Gene Electrotransfer (C∗EDGE), Department of Clinical Oncology and Palliative Care, Zealand University Hospital, Roskilde and Næstved, Ringstedgade 61, 4700, Næstved, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200, Copenhagen, Denmark.; Department of Gynaecology and Obstetrics, University Hospital Schleswig-Holstein, Campus Lübeck, Germany Ratzeburger Allee 160, 23562, Lübeck, Germany.; Department of Oncology, University Hospital of Southern Denmark, Beriderbakken 4, 7100, Vejle, Denmark.; Department of Radiology, University Hospital of Southern Denmark, Beriderbakken 4, 7100, Vejle, Denmark.; Center for Experimental Drug and Gene Electrotransfer (C∗EDGE), Department of Clinical Oncology and Palliative Care, Zealand University Hospital, Roskilde and Næstved, Ringstedgade 61, 4700, Næstved, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200, Copenhagen, Denmark. Electronic address: [email protected].

DOI: 10.1016/j.ejso.2023.04.024