Intraoperative electrochemotherapy of colorectal liver metastases: A prospective phase II study

Eur J Surg Oncol. 2020 Sep;46(9):1628-1633. doi: 10.1016/j.ejso.2020.04.037. Epub 2020 Apr 25.

Abstract

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.

Keywords: Bleomycin; Colorectal liver metastases; Electrochemotherapy; Electroporation; Local tumor control.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 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*
  • Liver Neoplasms / secondary
  • Male
  • Middle Aged
  • Progression-Free Survival
  • Response Evaluation Criteria in Solid Tumors
  • Tumor Burden

Substances

  • Antibiotics, Antineoplastic
  • Bleomycin