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

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.

OriginalspracheEnglisch
Aufsatznummer106925
ZeitschriftEuropean Journal of Surgical Oncology
Jahrgang49
Ausgabenummer9
Seiten (von - bis)106925
ISSN0748-7983
DOIs
PublikationsstatusVeröffentlicht - 09.2023

Strategische Forschungsbereiche und Zentren

  • Zentren: Universitäres Cancer Center Schleswig-Holstein (UCCSH)
  • Profilbereich: Lübeck Integrated Oncology Network (LION)

Fingerprint

Untersuchen Sie die Forschungsthemen von „Calcium electroporation in cutaneous metastases - A non-randomised phase II multicentre clinical trial“. Zusammen bilden sie einen einzigartigen Fingerprint.

Zitieren