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

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. 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 A mu m 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/m(2) 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). 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). DEBIRI with capecitabine seem to be a safe, technically feasible and well-tolerated treatment in chemotherapy refractory liver prevalent colorectal metastases.