Intra-arterial Hepatic Chemoembolization (TACE) of Liver Metastases from Ocular Melanoma with Slow-release Irinotecan-eluting Beads. Early Results of a Phase II Clinical Study

Background: Uveal melanoma (UM) is the most common primary intraocular malignancy in adults and the liver is the predominant site of metastases (LM). If metastases appear, none of the systemic treatments established for cutaneous melanoma so far have any significant impact. Several authors have adopted trans-arterial chemoembolization (TACE) as palliation. TACE combines hepatic artery embolization with infusion of concentrated doses of chemotherapeutic drugs. DC Beads are new embolic products that can be loaded with irinotecan (IRI). The beads consist of polyvinyl alcohol microspheres modified with sulfonic acid groups and are available at different size ranges from 100 to 900 microns in diameter. The use of IRI as drug-eluting beads seems to optimize TACE in UM. Objective: Our purpose was to assess the safety and efficacy of this new kind of TACE in a phase II clinical study. Patients and Methods: Ten patients with LM from UM were treated with TACE-containing beads preloaded with IN (100 mg). Results: All patients had an objective response, three presented a very good partial response and seven obtained a partial response. The median follow-up time from the beginning of therapy was 6.5 months (range 4-9 months). Eight patients are alive at the time of this analysis. The most important adverse event was abdominal pain during the procedure. Adequate supportive treatment with antibiotic and antiemetic prophylaxis, desametazone and intravenous hydration is strictly necessary until stabilization of serum levels of transaminases and to prevent infections. A major analgesic such as morphine must be used before and after the procedure. Conclusion: TACE containing beads preloaded with IRI is effective in the treatment of LM from UM. This approach seems to have better efficacy than previous TACE regimens adopted.