Trans-Arterial Chemoembolization with Irinotecan-Loaded Drug-Eluting Beads (DEBIRI) and Capecitabine in Refractory Liver Prevalent Colorectal Metastases: A Phase II Single-Center Study

Purpose: The purpose of this study was to evaluate feasibility, safety, tolerance, and efficacy of drug-eluting beads loaded with irinotecan (DEBIRI) in combination with capecitabine in the treatment of mCRC refractory to chemotherapy in patients affected by liver predominant metastatic disease. Materials and Methods: Twenty patients affected by CRC hepatic metastasis with liver-dominant disease, who had progression after two or more lines of chemotherapy, were enrolled. TACE with 100 mg of Irinotecan loaded into 2-ml of 70–150 µm drug-eluting beads was administrated every 4 weeks in patients with unilobar disease (2 treatments) and every 2 weeks in patients with bilobar disease (4 treatments). All patients assumed capecitabine 1000 mg/m2 twice daily on days 1–14 every 3 weeks, until disease progression. Primary endpoints were safety, tolerance and overall disease control (ODC); secondary endpoints were progression free survival (PFS) and overall survival (OS). Results: A total of 54 treatments were performed (54/66, 82 %). No intra/peri-procedural death occurred. During the mean follow-up of 11 months, two partial responses (PR) were reported with ODC of 60 % (2 PR + 10 stable disease). PFS and OS were 4 and 7.3 months, respectively. Univariate analysis showed that patients presenting with KRAS wild-type, good ECOG performance status and unilobar disease had a better prognosis. Only performance status (ECOG) correlated with OS in multivariate analysis (p = 0.03). Conclusion: DEBIRI with capecitabine seem to be a safe, technically feasible and well-tolerated treatment in chemotherapy refractory liver prevalent colorectal metastases.