CC BY-NC-ND 4.0 · Endosc Int Open 2020; 08(02): E124-E132
DOI: 10.1055/a-1027-6735
Original article
Owner and Copyright © Georg Thieme Verlag KG 2020

Electrochemotherapy for colorectal cancer using endoscopic electroporation: a phase 1 clinical study

Hanne Falk Hansen
 1   Center for experimental drug and gene electrotransfer (C*EDGE), Department of Oncology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark
,
Michael Bourke
 2   Cork Cancer Research Centre, University College Cork, Ireland
,
Trine Stigaard
 3   Gastro Unit, Department of Surgical Gastroenterology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark
,
James Clover
 2   Cork Cancer Research Centre, University College Cork, Ireland
,
Martin Buckley
 4   Gastroenterology Department, Mercy University Hospital, Cork, Ireland
,
Micheal O’Riordain
 5   Department of Surgery, Mercy University Hospital, Cork, Ireland
,
Des C. Winter
 6   Centre for Colorectal Disease, St Vincent’s University Hospital, Dublin, Ireland 
,
Helle Hjorth Johannesen
 7   Department of Radiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark
,
Rasmus Hvass Hansen
 7   Department of Radiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark
,
Hanne Heebøll
 7   Department of Radiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark
,
Patrick Forde
 2   Cork Cancer Research Centre, University College Cork, Ireland
,
Henrik Loft Jakobsen
 3   Gastro Unit, Department of Surgical Gastroenterology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark
,
Ole Larsen
 8   Department of Oncology, Herlev and Gentofte Hospital, University of Copenhagen. Denmark
,
Jacob Rosenberg
 3   Gastro Unit, Department of Surgical Gastroenterology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark
10   Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
,
Declan Soden
 2   Cork Cancer Research Centre, University College Cork, Ireland
,
Julie Gehl
 1   Center for experimental drug and gene electrotransfer (C*EDGE), Department of Oncology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark
 9   Center for Experimental Drug and Gene Electrotransfer (C*EDGE), Department of Clinical Oncology and Palliative Care, Zealand University Hospital, Roskilde, Denmark
10   Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
› Institutsangaben
Weitere Informationen

Publikationsverlauf

submitted 12. April 2019

accepted after revision 16. Juli 2019

Publikationsdatum:
22. Januar 2020 (online)

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Abstract

Background and study aims Electrochemotherapy is an anticancer treatment that uses electric pulses to facilitate uptake of chemotherapeutic drugs in tumor cells and has proven to have a high local cytotoxic effect with minimal adverse events. Electrochemotherapy has mostly been used in treatment of cutaneous metastases but development of a new endoscopic electrode device has made treatment of colorectal tumors possible. This first-in-man multicenter phase I study investigated safety and efficacy of electrochemotherapy using endoscopic electroporation in patients with colorectal tumors.

Patients and methods Seven patients with colorectal tumors who were deemed ineligible for or had declined standard treatment were included. They were treated with bleomycin either intratumorally or intravenously and the electric pulses were delivered through the endoscopic electrode device. Safety and efficacy were assessed clinically and by scans immediately after treatment and adverse events were reported. Response was evaluated up to 6 months after treatment by scans (magnetic resonance imaging or computed tomography) and endoscopic examinations.

Results Seven patients aged 62 to 88 years with multiple comorbidities were included and had one or two treatments each. Post-treatment scans showed tumor responses in the treated areas and no damage to surrounding tissues. Only a few grade one adverse events were reported. Three patients had preoperative rectal bleeding, of which two reported cessation of bleeding and one reported decreased bleeding.

Conclusion This first-in-man study shows that electrochemotherapy for colorectal tumors using the endoscopic electrode device can induce local tumor response and is safe also for fragile elderly patients with comorbidities.