Colorectal cancer (CRC) is one of the most frequent cancers in the Western countries. In Italy, the epidemiology of CRC is very heterogeneous across regions. In 2015, the standardized incidence was 52/100.000 inhabitants whereas the standardized prevalence was 355/100.000 among 0-99-year-old individuals. About 50% of patients with CRC develop liver metastases, but of these only 25% are resectable. Surgical resection is the treatment of choice for resectable colorectal metastases. For unresectable metastatic CRC (mCRC), systemic medical therapy (chemotherapy) is the first-choice treatment, but local therapy such as loco-regional radiotherapy and ablative procedures, may be associated in an attempt to prolong survival or to palliate symptoms (e.g. pain). Radioembolization, also known as Selective Internal Radiation Therapy (SIRT) is a form of intra-arterial brachytherapy used to treat primary liver cancer and liver metastases.
The aim of this report is to provide an overview of the clinical, economic, organizational and ethical impact of SIRT using SIR-Spheres® Y-90 resin microspheres in the treatment of liver metastases from colorectal cancer in patients with unresectable, liver-dominant metastatic colorectal cancer who are chemotherapy-refractory or chemotherapy-intolerant. This study poses a particular focus on the Italian setting.
A systematic literature review was performed by querying 5 search engines namely, PubMed, Scopus, EBSCO, CRD, GIN. After the identification of duplicates, two reviewers blindly screened the records retrieved against some pre-defined inclusion/exclusion criteria. The selected studies where summarized narratively, following a simplified version of the EuNetHTA Core Model ® 2.1. Also, in order to get a deeper understanding of the use of this technology in Italy and its impact on clinical and economic outcomes a multidisciplinary advisory board with experts was established. They were asked to provide their opinion on some issues, considered of paramount importance within the Italian jurisdiction.
The opinions provided where integrated in the current document. The list of issues discussed by the advisory board is reported in Appendix 3.
The experts Advisory Board also committed in reviewing the first draft of the current document.
The most recent ESMO guidelines (2016) recommend SIRT as a treatment option for patients with liver-limited disease failing the available chemotherapeutic options. However, further evidence is now being generated upon the use of this technology in earlier treatment lines.