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.

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: DEBIRI; colorectal cancer; liver metastases; transarterial chemoembolization.

Figure 1

MDCT baseline and post-DEBIRI treatment in a complete responder patient. Notes: A 74-year old patient with right colon cancer, mutated Kras status, who performed 2 lines of systemic chemotherapy. Baseline MDCT axial images (A–D) showed multiple hypodense liver metastases. MDCT performed 1 month after DEBIRI treatment (E–H) showed the same hypodense lesions without contrast enhancement. The patient was considered as a complete responder. OS was 24 months and the patient showed G1 fever and G1 hypertransaminasemia. Abbreviations: MDCT, multidetector contrast enhancement computed tomography; DEBIRI, drug-eluting beads with irinotecan; OS, overall survival.

Figure 2

Angiography pre- and post-DEBIRI treatment in a complete responder patient. Notes: A 60-year old patient with single metastasis from colorectal cancer in the III–IV segment of the left lobe of the liver. In the pretreatment angiography (A) the red arrows show the moderate and diffuse vascularization of the unencapsulated lesion with irregular margins. In the posttreatment angiography (B) the red arrows show the lack of the vascularization in the site of the lesion as a complete response to the treatment. In the upper part of the figure (A and B), the dual chamber cardiac catheter of the pacemaker is evident. Abbreviation: DEBIRI, drug-eluting beads with irinotecan.

Figure 3

OS curve for 25 patients who underwent DEBIRI treatment. Abbreviations: OS, overall survival; DEBIRI, drug-eluting beads with irinotecan; Cum, cumulative.