title: 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.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Diagnostic and Interventional Radiology Unit with Integrated Section of Translational Medical Oncology, National Cancer Research Centre, Istituto Tumori "Giovanni Paolo II".
authors.forename: Girolamo
authors.initials: G
authors.lastname: Ranieri
authors.affiliation: Nuclear Medicine Unit, University of Bari "Aldo Moro", Bari.
authors.forename: Artor
authors.initials: A
authors.lastname: Niccoli Asabella
authors.affiliation: Nuclear Medicine Unit, University of Bari "Aldo Moro", Bari.
authors.forename: Corinna
authors.initials: C
authors.lastname: Altini
authors.affiliation: Diagnostic and Interventional Radiology Unit with Integrated Section of Translational Medical Oncology, National Cancer Research Centre, Istituto Tumori "Giovanni Paolo II".
authors.forename: Vito
authors.initials: V
authors.lastname: Fazio
authors.affiliation: Diagnostic and Interventional Radiology Unit with Integrated Section of Translational Medical Oncology, National Cancer Research Centre, Istituto Tumori "Giovanni Paolo II".
authors.forename: Luciana
authors.initials: L
authors.lastname: Caporusso
authors.affiliation: Diagnostic and Interventional Radiology Unit with Integrated Section of Translational Medical Oncology, National Cancer Research Centre, Istituto Tumori "Giovanni Paolo II".
authors.forename: Ilaria
authors.initials: I
authors.lastname: Marech
authors.affiliation: Diagnostic and Interventional Radiology Unit with Integrated Section of Translational Medical Oncology, National Cancer Research Centre, Istituto Tumori "Giovanni Paolo II".
authors.forename: Gianluca
authors.initials: G
authors.lastname: Vinciarelli
authors.affiliation: Diagnostic and Interventional Radiology Unit with Integrated Section of Translational Medical Oncology, National Cancer Research Centre, Istituto Tumori "Giovanni Paolo II".
authors.forename: Francesco
authors.initials: F
authors.lastname: Macina
authors.affiliation: Diagnostic and Interventional Radiology Unit with Integrated Section of Translational Medical Oncology, National Cancer Research Centre, Istituto Tumori "Giovanni Paolo II".
authors.forename: Dario
authors.initials: D
authors.lastname: de Ceglia
authors.affiliation: Nuclear Medicine Unit, University of Bari "Aldo Moro", Bari.
authors.forename: Margherita
authors.initials: M
authors.lastname: Fanelli
authors.affiliation: Department of Medical and Surgery Science, Clinical Surgery Unit, "Magna Graecia" Medical School, Catanzaro; Surgery Unit, National Cancer Research Centre, Istituto Tumori "Giovanni Paolo II", Bari, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Ammendola
authors.affiliation: Nuclear Medicine Unit, University of Bari "Aldo Moro", Bari.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Rubini
authors.affiliation: Diagnostic and Interventional Radiology Unit with Integrated Section of Translational Medical Oncology, National Cancer Research Centre, Istituto Tumori "Giovanni Paolo II".
authors.forename: Cosmo Damiano
authors.initials: CD
authors.lastname: Gadaleta
keywords: DEBIRI; colorectal cancer; liver metastases; transarterial chemoembolization