This is the report of a phase 2 study assessing efficacy and safety of first-line chemotherapy with cisplatin and gemcitabine plus selective internal radiotherapy (SIRT) administered during cycle 1 (1 hemiliver disease) or cycles 1 and 3 (disease involving both hemilivers) using yttrium-90 glass microspheres. 41 patients were included. Response rate at 3 months by RECIST was 39% (90%CI 26%-53%) according to local review, and 41% by central review; disease control rate was 98%. Median progression-free survival (PFS) was 14 months (95%CI 8-17 months), PFS rates were 55% at 12 months, and 30% at 24 months. Median overall survival (OS) was 22 months (95%CI 14-52 months), OS rates were 75% at 12 months, and 45% at 24 months. 29 patients (71%) had grade 3-4 adverse events; 9 patients (22%) could be downstaged to surgical intervention, 8 (20%) had R0 resection. A phase 3 trial comparing concomitant treatment versus chemotherapy alone is ongoing.
 
(Edeline J et al. – JAMA Oncology, 31 October 2019)

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