BTG plc company has announced promising data for DC BeadM1™, supporting the efficacy and tolerability of doxorubicin-eluting DC BeadM1™ in the treatment of patients diagnosed with liver-confined HCC (hepatocellular carcinoma). The preliminary results of the study, in which patients achieved a median overall survival (OS) of 41 months, were presented during the 2015 CIRSE (Cardiovascular and Interventional Radiological Society of Europe) International Conference in Lisbon, Portugal.
While DC Bead® drug-eluting bead is backed by clinical safety and efficacy data in over 3,000 HCC patients, DC BeadM1TM is a more recent addition to the product range. Designed with a narrow size distribution, so that it can travel deeper into the vasculature of the tumour, while also allowing for a more concentrated drug delivery>sup>1, DC BeadM1™ offers a new standard-of-care and a much more targeted therapy than conventional chemoembolisation for the treatment of HCC.
"Unlike the majority of cancer-types, for which improvements in diagnosis and treatment are set to result in a significant 17% reduction in mortality by 2030, the burden of HCC is continuing to grow, with mortality predicted to increase by 39% over this same time period," commented Dr Camillo Aliberti from the Istituto Oncologico Veneto, Padua, Italy and lead author of 'A Single-Centre, Retrospective, Single-Arm, Open-Label Study of DC BeadM1™ in HCC: Preliminary results'. "We are always looking for refinements and improvements to the tools we have to optimise outcomes in this challenging patient population. DC BeadM1TM is a promising new addition to the proven DC Bead® product range and this study is significant in terms of the impressive safety and efficacy results it demonstrates."
The single-centre, retrospective, single-arm, open-label study, reviewed the treatment of 547 HCC patients treated with DC BeadM1™ loaded with doxorubicin, between 2013 and 2015. Response, measured using mRECIST (modified Response Evaluation Criteria in Solid Tumors [RECIST] guideline), showed a median overall survival (OS) of 41 months, and a median progression-free survival (PFS) of 15 months. Furthermore, there were no significant treatment-related adverse events (AEs).
Economic evaluation of glass yttrium-90 microspheres versus sorafenib
A second piece of analysis, also presented during CIRSE 2015, looked to evaluate the cost-effectiveness of 90Y microspheres (TheraSphere®), a novel radioembolisation therapy that consists of millions of small glass microspheres containing radioactive 90Y, versus sorafenib for the treatment of advanced HCC.
The analysis was conducted using the methodological criteria published by NICE2. Within the analysis 10-year (lifetime) outcomes were estimated with results showing improvements across all measures for TheraSphere® (Time-To-Progression (TTP) versus sorafenib [6.2 vs. 4.9 months], increased median Overall Survival (mOS) versus sorafenib [13.8 vs. 9.7 months], and increased quality-adjusted life years (QALYs) versus sorafenib [1.12 vs. 0.85 years]). As a result, the total lifetime cost of TheraSphere® treatment (in the UK) was calculated to be significantly lower compared to sorafenib (£21,441 vs. £34,050).
Jane Lapon, BTG VP, Global Market Access (OUS) commented, "This exciting data supports a rapidly developing clinical evidence base for the use of TheraSphere® as an alternative treatment modality in HCC. At a time of global austerity, the analysis also suggests there is potential for it to be a more cost-effective treatment than the current standard-of-care."
Peter Pattison, BTG General Manager Interventional Oncology, Commercial Operations, "One of the most significant challenges we currently face in healthcare, and no more so than in the area of oncology, is cost effectiveness and affordability for our healthcare systems. This data highlights the potential of alternatives to systemic chemotherapy, to drive improved value and efficiencies."