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A pilot study employing hepatic intra-arterial irinotecan injection of drug-eluting beads as salvage therapy in liver metastatic colorectal cancer patients without extrahepatic involvement: the first southern Italy experience

Authors Ranieri G, Niccoli Asabella A, Altini C, Fazio V, Caporusso L, Marech I, Vinciarelli G, Macina F, de Ceglia D, Fanelli M, Ammendola M, Rubini G, Gadaleta CD

Received 12 May 2016

Accepted for publication 14 September 2016

Published 12 December 2016 Volume 2016:9 Pages 7527—7535


Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Ram Prasad

Peer reviewer comments 4

Editor who approved publication: Dr William Cho

Girolamo Ranieri,1 Artor Niccoli Asabella,2 Corinna Altini,2 Vito Fazio,1 Luciana Caporusso,1 Ilaria Marech,1 Gianluca Vinciarelli,1 Francesco Macina,1 Dario de Ceglia,1 Margherita Fanelli,2 Michele Ammendola,3,4 Giuseppe Rubini,2 Cosmo Damiano Gadaleta1

1Diagnostic and Interventional Radiology Unit with Integrated Section of Translational Medical Oncology, National Cancer Research Centre, Istituto Tumori “Giovanni Paolo II”, 2Nuclear Medicine Unit, University of Bari “Aldo Moro”, Bari, 3Department of Medical and Surgery Science, Clinical Surgery Unit, “Magna Graecia” Medical School, Catanzaro, 4Surgery Unit, National Cancer Research Centre, Istituto Tumori “Giovanni Paolo II”, Bari, Italy

Background: The main aim of this prospective study was to evaluate the efficacy of drug-eluting beads with irinotecan (DEBIRI) for liver metastases from colorectal cancer. Secondary aims were to evaluate survival and toxicity.
Methods: Twenty-five patients with metastases in <50% of the liver and without extrahepatic involvement were enrolled. Treatment response assessment was performed by multidetector contrast enhancement computed tomography (MDCT) with evaluation of the enhancement pattern of the target lesion and tumor response rates according to modified Response Evaluation Criteria in Solid Tumors (mRECIST, Version 1.1). All adverse events were recorded by the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events, Version 3.0. Associations of tumor response and variables were calculated using the chi-squared test. Overall survival (OS) was calculated using the Kaplan–Meier method. Comparisons were made using the log-rank test.
Results: According to mRECIST, complete response (CR) was observed in 21.8% of patients, partial response (PR) in 13%, stable disease (SD) in 52.2% and progressive disease (PD) in 13% of patients. Response rate (RR = CR + PR) was 34.8%. No associations between treatment response and variables such as Dukes’ classification, grading and Kras status were found (P>0.05). The median OS was 37 months (95% CI: 13.881 to 60.119). Cox regression model showed that neither site, Dukes’ classification, grading, Kras status nor number of chemotherapy treatments pre-DEBIRI influenced the OS. The log-rank test showed no statistically significant difference in OS among patients who underwent 1, 2 or 3 DEBIRI treatments (χ2=2.831, P=0.09). In our study, the main toxicities included postembolization syndrome (PES), hypertransaminasemia and fever.
Conclusion: The favorable tumor response and the favorable toxicity profile make DEBIRI treatment a potential third-line therapy. Although further larger studies are needed to confirm these data, we can state that DEBIRI is an attractive emerging treatment in these patients.

Keywords: colorectal cancer, liver metastases, transarterial chemoembolization, DEBIRI

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