Intraoperative electrochemotherapy of colorectal liver metastases: A prospective phase II study.
Adult
Aged
Aged, 80 and over
Antibiotics, Antineoplastic
/ therapeutic use
Bleomycin
/ therapeutic use
Colorectal Neoplasms
/ pathology
Electrochemotherapy
/ methods
Female
Humans
Intraoperative Care
Liver Neoplasms
/ drug therapy
Male
Middle Aged
Progression-Free Survival
Response Evaluation Criteria in Solid Tumors
Tumor Burden
Bleomycin
Colorectal liver metastases
Electrochemotherapy
Electroporation
Local tumor control
Journal
European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology
ISSN: 1532-2157
Titre abrégé: Eur J Surg Oncol
Pays: England
ID NLM: 8504356
Informations de publication
Date de publication:
09 2020
09 2020
Historique:
received:
18
02
2020
revised:
20
03
2020
accepted:
20
04
2020
pubmed:
11
5
2020
medline:
9
2
2021
entrez:
11
5
2020
Statut:
ppublish
Résumé
A previous pilot study proved the feasibility, safety and efficacy of electrochemotherapy in the treatment of colorectal liver metastases. The aim of this study was to evaluate long-term effectiveness and safety of electrochemotherapy in the treatment of unresectable colorectal liver metastases. In this prospective phase II study, patients with metachronous colorectal liver metastases were included. In all patients, at least one metastasis was unresectable due to its central location or a too-small future remnant liver volume. Patients were treated by electrochemotherapy using intravenously administered bleomycin during open surgery. Treated were 84 metastases in 39 patients. Local tumor control, progression-free survival and overall survival were evaluated. The objective response was 75% (63% CR, 12% PR). The median duration of the response was 20.8 months for metastases in CR and 9.8 months for metastases in PR. The therapy was significantly more effective for metastases smaller than 3 cm in diameter than for larger ones. There was no difference in response according to the metastatic location, i.e., metastases in central vs. peripheral locations. Progression-free survival was better in patients who responded well to electrochemotherapy compared to those metastases that had a partial response or progressive disease. However, there was no difference in overall survival, with a median of 29.0 months. Electrochemotherapy has proven to be safe and effective in the treatment of colorectal liver metastases, with a durable response. It provides local tumor control that enables patients with unresectable metastases to receive further treatments.
Sections du résumé
BACKGROUND AND OBJECTIVES
A previous pilot study proved the feasibility, safety and efficacy of electrochemotherapy in the treatment of colorectal liver metastases. The aim of this study was to evaluate long-term effectiveness and safety of electrochemotherapy in the treatment of unresectable colorectal liver metastases.
PATIENTS AND METHODS
In this prospective phase II study, patients with metachronous colorectal liver metastases were included. In all patients, at least one metastasis was unresectable due to its central location or a too-small future remnant liver volume. Patients were treated by electrochemotherapy using intravenously administered bleomycin during open surgery. Treated were 84 metastases in 39 patients. Local tumor control, progression-free survival and overall survival were evaluated.
RESULTS
The objective response was 75% (63% CR, 12% PR). The median duration of the response was 20.8 months for metastases in CR and 9.8 months for metastases in PR. The therapy was significantly more effective for metastases smaller than 3 cm in diameter than for larger ones. There was no difference in response according to the metastatic location, i.e., metastases in central vs. peripheral locations. Progression-free survival was better in patients who responded well to electrochemotherapy compared to those metastases that had a partial response or progressive disease. However, there was no difference in overall survival, with a median of 29.0 months.
CONCLUSIONS
Electrochemotherapy has proven to be safe and effective in the treatment of colorectal liver metastases, with a durable response. It provides local tumor control that enables patients with unresectable metastases to receive further treatments.
Identifiants
pubmed: 32387070
pii: S0748-7983(20)30434-0
doi: 10.1016/j.ejso.2020.04.037
pii:
doi:
Substances chimiques
Antibiotics, Antineoplastic
0
Bleomycin
11056-06-7
Types de publication
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1628-1633Informations de copyright
Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest Damijan Miklavčič holds patents on electrochemotherapy that have been licensed to IGEA S. p.a (Carpi, Italy) and is also a consultant to various companies with an interest in electroporation-based technologies and treatments. The other authors have no competing interests.