Prospective Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Sep 15, 2017; 9(9): 379-384
Published online Sep 15, 2017. doi: 10.4251/wjgo.v9.i9.379
Polyethylene glycol microspheres loaded with irinotecan for arterially directed embolic therapy of metastatic liver cancer
Giammaria Fiorentini, Riccardo Carandina, Donatella Sarti, Michele Nardella, Odysseas Zoras, Stefano Guadagni, Riccardo Inchingolo, Massimiliano Nestola, Alessandro Felicioli, Daniel Barnes Navarro, Fernando Munos Gomez, Camillo Aliberti
Giammaria Fiorentini, Donatella Sarti, Onco-Hematology Department, Azienda Ospedaliera “Ospedali Riuniti Marche Nord”, 61122 Pesaro, Italy
Riccardo Carandina, Camillo Aliberti, Oncology Radiodiagnostics Department, Oncology Institute of Veneto, Institute for the Research and Treatment of Cancer, 35128 Padova, Italy
Michele Nardella, Riccardo Inchingolo, Massimiliano Nestola, Diagnostic and Interventtional Radiology Department, Ospedale Madonna delle Grazie, 75100 Matera, Italy
Odysseas Zoras, Surgical Oncology University of Crete, ESSO Board of Directors Member, Rector of the University, Voutes Campus, Heraklion, 71003 Crete, Greece
Stefano Guadagni, Department of Applied Clinical Sciences and Biotechnology, Section of General Surgery, University of L’Aquila, 67100 L’Aquila, Italy
Alessandro Felicioli, Diagnostic and Interventtional Radiology Department, Azienda Ospedaliera “Ospedali Riuniti Marche Nord”, 61122 Pesaro, Italy
Daniel Barnes Navarro, Interventional Radiology Department, Hospital Clínic de Barcelona, 08036 Barcelona, Spain
Author contributions: Fiorentini G and Sarti D wrote the paper and made tables and figures; Carandina R, Nardella M, Inchingolo R, Nestola M, Felicioli A, Barnes Navarro D, Munos Gomez F and Aliberti C collected the data; Zoras O and Guadagni S supervised the study.
Institutional review board statement: The study was reviewed and approved by the Azienda Ospedaliera “Ospedali Riuniti Marche Nord” Institutional Review Board.
Clinical trial registration statement: This study is registered at https://clinicaltrials.gov. This was part of the study: ClinicalTrials.gov Identifier: NCT01891552.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Authors declare no conflict of interests for this article.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Dr. Giammaria Fiorentini, Onco-Hematology Department, Azienda Ospedaliera “Ospedali Riuniti Marche Nord”, Via Lombroso 1, 61122 Pesaro, Italy. g.fiorentini@alice.it
Telephone: +39-721-364005
Received: May 11, 2017
Peer-review started: May 11, 2017
First decision: May 23, 2017
Revised: May 24, 2017
Accepted: June 30, 2017
Article in press: July 3, 2017
Published online: September 15, 2017
Processing time: 123 Days and 0.5 Hours
Abstract
AIM

To study tumor response, and tolerability of arterially directed embolic therapy (ADET) with polyethylene glycol embolics loaded with irinotecan for the treatment of colorectal cancer liver metastases (CRC-LM). Secondary objectives were to monitor quality of life, time to progression and survival of patients.

METHODS

Patients were included in the study if they were affected by CRC-LM, refractory to systemic chemotherapy, treated with ADET using polyethylene glycol embolics, and had liver involvement < 50%. Tumor response, performance status (PS), tumor marker antigens, and quality of life (QoL) were monitored at 1, 3 and 6 mo after ADET. QoL was assessed with the Palliative Performance Scale (PPS).

RESULTS

We treated 50 consecutive CRC-LM patients with ADET using polyethylene glycol embolics. Their tumor response one month after ADET was: 28% of complete response (CR), 48% of partial response (PR), 8% stable disease (SD), and 16% of progression. Tumor response 3 mo after ADET was CR 24%, PR 38%, SD 19% and progression disease (PD) 19%. Tumor response 6 mo after ADET was CR 18%, PR 44%, SD 21% and PD 18%. QoL was 90% PPS at each time point. Median time to progression for patients who progressed was 2.5 mo (range 0.8-6). Median follow-up was 14 mo (0.8-25 range). ADETs were performed with no complications. Observed side effects (mild or moderate intensity) were: Pain in 32% of patients, increase of transaminase levels in 20% and fever in 14%, whereas 30% of patients did not complain any adverse event.

CONCLUSION

The treatment of unresectable CRC-LM with ADET using polyethylene glycol microspheres loaded with irinotecan was effective in tumor response and resulted in mild toxicity, and good QoL.

Keywords: Liver metastases, Arterially directed embolic therapy, Colorectal cancer, Polyethylene glycol embolics, Irinotecan

Core tip: Patients with liver metastases from colorectal cancer are in 80% of cases non-indicated for resection. The standard first line treatment of unresectable liver metastases is systemic chemotherapy, however this method results in progression for 70% of patients. The indicated therapy for refractory patients is the chemoembolization. In this study, we monitored tumor response, and adverse events after chemoembolization of colorectal cancer liver metastases with polyethylene glycol embolics loaded with irinotecan. Chemoembolization with these embolics is effective in terms of tumor response, time to progression, survival and quality of life and resulted in mild toxicity.