Caren van Roekel

93 Quality of life in patients treated with 166 Ho-radioembolization MATERIALS AND METHODS Patients and study design QoL was evaluated in patients included in the HEPAR I and HEPAR II studies (clinicaltrials.gov identifier NCT01031784 and NCT01612325). The inclusion criteria for treatment were exactly the same and the patient population in both studies was comparable (Table S1). In these studies, patients with unresectable, chemorefractory liver metastases of any primary origin and cholangiocarcinoma were included. Patients were eligible if they were diagnosed with liver-dominant disease, had a life expectancy of >3 months, had measurable disease on CT, had adequate liver, renal and bone marrow function, and had a WHO performance score of ≤2. The institutional review board approved these studies and all patients provided written informed consent. The aim of the HEPAR I study was to assess the safety and the maximum tolerated radiation dose of 166 Ho-RE. The maximum tolerated dose was found to be 60 Gy and its safety and efficacy was established in the HEPAR II study. A more detailed description of the study designs and the main study results have been published elsewhere (29-31). Treatment Patients received a work-up angiography approximately 1 week before treatment in which extra-hepatic vessels were coil-embolized, if necessary. A scout dose of 99m Tc-MAA (150 MBq, Technescan LyoMAA ® ; Mallinckrodt Medical B.V., Petten, The Netherlands) was administered to assess the extrahepatic and intra-hepatic distribution. After a 1-2 week interval, patients were scheduled for a second and third angiography. The second angiography was planned in the morning, during which patients received a scout dose of 166 Ho-microspheres, directly followed by SPECT and MRI. The treatment dose of 166 Ho-microspheres was administered that same afternoon and was followed by SPECT and MR image acquisition 3-5 days later (30, 31). Quality of life assessment QoL in patients was assessed using the validated European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 version 3.0 and QLQ- LMC21 questionnaires (32) (33). The EORTC QLQ-C30 contains 30 questions and the EORTC QLQ-LMC21 contains 21 items. They are composed of both multi-item scales and single-itemmeasures: from the questionnaires, a Global Health Status/ 3