Electrochemotherapy for large cutaneous recurrence of breast cancer: A phase II clinical trial

Abstract

Background. Cutaneous recurrences of breast cancer may cause considerable discomfort due to ulceration, oozing, and pain and can also be difficult to treat. Electrochemotherapy is a localised anticancer treatment using electric pulses to make cell membranes permeable, augmenting uptake of chemotherapeutic drugs, and thus enabling highly efficient tumour cell kill. This is the first systematic investigation of electrochemotherapy for larger cutaneous recurrences of breast cancer. Patients and methods. We conducted a phase II trial for patients with cutaneous recurrences where no further treatment options were available. Primary endpoint was objective response evaluated by clinical examination. Secondary endpoints included response evaluated by PET/CT, change in lung diffusion capacity, patient reported symptoms, and distress related to bodily appearance. Treatment consisted of bleomycin injection followed by application of electric pulses. Results. Seventeen heavily pre-treated patients received electrochemotherapy. Twelve patients were evaluable (follow-up > 8 weeks). CT showed four (33%) patients achieving over 50% tumour volume reduction, clinical examination showed one CR and one PR (OR 17%). Symptomatic relief included decreasing exudates, odour, and bleeding. Treatment was well tolerated; the main side effect was post-treatment pain. Conclusion. This first phase II study indicates that electrochemotherapy is a promising treatment alternative for cutaneous recurrences of breast cancer.

Acknowledgements

We would like to thank all the patients that participated in this trial. We would like to thank the staff at the Breast Cancer team at Department of Oncology together with the staff of the PET division at Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital Herlev for assistance. The study was investigator funded and initiated. Electrodes for the study as well as database assistance were provided by IGEA (Carpi, Italy). This work was supported by The Danish Agency for Science Technology and Innovation number 271 -  07–0513, The Research Council of Herlev Hospital, The Danish Cancer Research Foundation, Breast Friends, Agnethe Løvgreens Grant. Julie Gehl is a research fellow of the Royal Swedish Academy, supported by the Acta Oncologica Foundation.

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.