br Commissioning through Evaluation CtE is
Commissioning through Evaluation (CtE) is a national programme led by National Health Service (NHS) England that enables highly specialist treatments to be commis-sioned in selected provider centres with a planned evalua-tion phase . The evaluation is commissioned by the National Institute for Health and Care Excellence (NICE) and carried out by an independent research group, which as-sesses the clinical and cost-effectiveness of the intervention in a specific population. The aim of the programme was to evaluate the impact of SIRT on overall survival, progression-free survival (PFS) and liver-specific PFS (LPFS), and to assess safety.
Materials and Methods
This prospective, single-arm, observational, service-evaluation study was carried out between December 2013 and February 2017 in 10 NHS hospitals in England (Cam-bridge University Hospitals NHS Foundation Trust, Kings College Hospital NHS Foundation Trust, Leeds Teaching Hospitals NHS Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Nottingham University Hospitals NHS Trust, Oxford University Hospitals NHS Foundation Trust, The Christie NHS Foundation Trust, The Royal Free London NHS Foun-dation Trust, University Hospital Southampton NHS Foun-dation Trust, University Hospitals Birmingham NHS Foundation Trust). SIRT was provided as routine care at these centres and therefore this MHY1485 study was designated as a service-evaluation project within the NHS; patient consent for all procedures therefore used the sites’ routine NHS clinical governance processes. The SIRT registry is an online registry hosted by the British Society of Interventional Radiology incorporating national data on radio-embolisation of primary and secondary liver tumours. It holds de-identified data, and only those data relevant to this CtE study were extracted for analysis and transferred to an independent research group, Cedar (Cardiff and Vale Uni-versity Health Board), for analysis.
Adults with unresectable, chemotherapy-refractory, CRC liver metastases were eligible for treatment. Inclusion criteria included: histologically confirmed carcinoma with liver-specific or liver-dominant metastases not amenable to curative liver surgical resection; unequivocal and measur-able computed tomography evidence of liver metastases not treatable by surgical resection or local ablation with curative intent; World Health Organization performance status 0e2; life expectancy >3 months; evidence of clinical progression during or after both oxaliplatin-based and irinotecan-based chemotherapy, unless the patient had a specific contraindication to chemotherapy or did not tolerate either regimen; adequate haematological and he-patic function as follows: serum bilirubin ¼ 1.5 upper limit of normal; absolute neutrophil count >1.5 109/l, platelets >100 109/l; albumin ¼ 30 g/l; no central nervous system metastases or bone metastases, but patients were permitted to have limited extrahepatic disease (e.g. lung metastases, multiple lymph nodes or low-volume perito-neal disease, but the multidisciplinary team must have agreed that the extrahepatic disease was probably not life-threatening or a cause for significant morbidity if the liver metastases can be controlled with locally directed therapy); no evidence of ascites or cirrhosis.
Each site followed their local process for undertaking SIRT procedures. All patients received a hepatic arteriogram and a liver-to-lung breakthrough nuclear medicine scan to ensure suitability and to plan the delivery of the Y-90 microspheres. Selective coil embolisation of arteries to the stomach, duo-denum or other visceral structures was carried our as required to prevent non-target Y-90 delivery. SIRT was car-ried out using an established method. One of two brands of Conformite Europeene-marked active implantable medical devices was used to carry out the SIRT procedure: (i) SIR-Spheres (Sirtex Medical Ltd, Australia) resin microspheres;