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Gastrointestinal Cancer Drug-eluting Beads in the Treatment of Hepatocellular Carcinoma and Colorectal Cancer Metastases to the Liver Jacques Blümmel, 1 Sven Reinhardt, 2 Markus Schäfer, 3 Carl Gilbert, 4 Lee Sun 5 and Jane Ren 6 1. Senior Scientist in R&D; 2. Chemist in R&D; 3. Biochemist in R&D; 4. Senior R&D Project Manager; 5. Director, Material Technology; 6. Senior Vice President and Chief Technology Officer, CeloNova BioSciences, Inc., San Antonio, Texas, US Abstract Drug-eluting beads (DEBs) may become a standard of care in the treatment of unresectable liver cancers. DEBs have a significant advantage by offering simultaneous embolisation, and sustained release of antineoplastic agents in a controlled manner, resulting in a localisation of the drug in the targeted tumour, while minimising its systemic exposure. This article reviews current treatment options for liver cancer and concentrates on the benefits of DEBs for patients with unresectable liver cancer. Preclinical and clinical studies suggest smaller microspheres and extended release characteristics as key properties that will enable DEB device technologies to become a standard of care for unresectable liver cancer. A new, tightly size-calibrated DEB ≤100 μm, Embozene TANDEM™, was designed to meet these requirements. Keywords Drug-eluting bead, microspheres, transarterial chemoembolisation, hepatocellular carcinoma, colorectal cancer metastases Disclosure: All authors are employees at CeloNova BioSciences, Inc. Received: 20 April 2012 Accepted: 30 April 2012 Citation: European Oncology & Haematology, 2012;8(3):162–6 Correspondence: Lee Sun, CeloNova BioSciences, Inc., 18615 Tuscany Stone, Suite 100, San Antonio, TX 78258, US. E: lsun@celanova.com Support: The publication of this article was funded by CeloNova BioSciences, Inc. Hepatocellular carcinoma (HCC) is the most common primary liver malignancy (70–85  %) 1 with an associated mortality of >600,000 per year. 2,3 Underlying cirrhosis is the major risk factor, 2 with an estimated annual risk of developing HCC of 4–8 %. 2,4 Hepatitis B is responsible for 53–80 % of all cases. 2 Hepatitis C is the major cause of HCC in Japan, the US, Latin America and Europe. 3 Untreated HCC patients have a median survival of 3–8 months. 5 Nearly one million patients are diagnosed with colorectal cancer (CRC) worldwide every year. 6 Thirty to fifty percent of them develop hepatic metastases (hmCRC); 6–8 hmCRC is responsible for two-thirds of CRC deaths. 8 One- and five-year survival rates for untreated hmCRC patients are <30 % and <5 %, respectively. 2 Untreated hmCRC has a median survival of 5–10 months. 2 Treatment Options The Barcelona Clinic Liver Cancer (BCLC) staging system is commonly used for HCC. 9 It takes into account underlying liver disease, tumour characteristics and general performance status. 4,10 About 30  % 4 of patients in Western countries identified as having BCLC stage 0 or A HCC are eligible for curative treatments, including liver transplantation (LT), liver resection (LR) and various ablation techniques (ATs). 11 LT provides excellent outcomes applying the Milan criteria, with five-year survival rate of 70 % and recurrence rates below 15 %. 12 LT is the only curative option for the underlying cirrhosis. 13,14 However, because of the shortage of potential liver donors and progression of the HCC, the risk of dropout from liver transplantation waiting lists is up to 4 % per month. 15 162 LR is the treatment of choice for HCC in non-cirrhotic patients (~5 % of cases in Western countries, ~40 % in Asia). 15 In the case of underlying cirrhosis, candidates need to be carefully selected to diminish the risk of post-operative liver failure with increased risk of death. 15,16 In HCC patients after LR, the risk of tumour recurrence exceeds 70 % at five years. 15 ATs include chemical (e.g., percutaneous ethanol injection [PEI]) and thermal (e.g., radiofrequency ablation [RFA]) ablation. PEI results in five-year survival rates of 47–53  % (Child–Pugh class A, early-stage tumours). 17 PEI has high local recurrence rates of 33–43 %. 17 For RFA, depending on Child–Pugh class and location of lesions in the liver in early-stage HCC patients, five-year survival rates of around 60 % have been reported. 17 In hmCRC, unlike HCC, LR is the only potential curative standard treatment. 18–20 In patients with hmCRC, LR provides five-year survival rates in the range of 25–58 %. 18 However, only 10–20 % of patients are suitable for LR. 2,21 Recurrence rates for hmCRC after LR range from 60–70 %. 22 Drug-eluting Beads Conventional chemotherapy should not be recommended for HCC treatment. 4,23 Most patients with HCC are not suitable for curative treatments. Patients with end-stage disease have a median survival of only three months and should receive symptomatic treatment. 24 Sorafenib has been found to improve the survival of patients with advanced-stage HCC (10.7 months versus 7.9 months for placebo). 25 Dual blood supply of the liver and almost exclusive arterial blood © TOUCH BRIEFINGS 2012