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Safety and toxicity of radioembolization plus Sorafenib in advanced hepatocellular carcinoma: analysis of the European multicentre trial SORAMIC
Author(s) -
Ricke Jens,
Bulla Karsten,
Kolligs Frank,
PeckRadosavljevic Markus,
Reimer Peter,
Sangro Bruno,
Schott Eckart,
Schütte Kerstin,
Verslype Chris,
Walecki Jerzy,
Malfertheiner Peter
Publication year - 2015
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.12622
Subject(s) - medicine , sorafenib , hepatocellular carcinoma , liver function , adverse effect , toxicity , gastroenterology , selective internal radiation therapy , ascites , surgery , urology
Background & Aims The benefits of combined systemic and liver‐directed treatments in inoperable intermediate‐ or advanced‐stage hepatocellular carcinoma ( HCC ) have yet to be defined. This article presents the planned safety analyses for the first 40 patients randomized to radioembolization with yttrium‐90 ( 90 Y) resin microspheres followed by sorafenib ( n = 20) or sorafenib only ( n = 20) in the SORAMIC study. Methods Patients identified for palliative treatment who were poor candidates for transarterial (chemo)embolization (including those failing TACE ) with preserved liver function (Child–Pugh ≤B7) and ECOG performance status <2 were screened. Radioembolization was administered using a sequential lobar approach. On day 3 after the last radioembolization procedure, sorafenib 200 mg twice daily was initiated escalating to 400 mg twice daily 1 week later; a matching sorafenib dose schedule was initiated in the control arm. Results Patients were followed up for a median of 8.3 months. Median total implanted activity of 90 Y was 1.87 (range: 0.54–2.35) GB q. Patients received a similar intensity and duration of sorafenib in the combination‐treatment arm (median daily dose 614 mg over 8.5 months) and control arm (557 mg over 9.6 months). The incidence of total (196 vs. 222) and grade ≥3 (43 vs. 47) adverse events was similar in combination‐treatment arm and control arm respectively ( P > 0.05). No significant differences in the number of total or grade 3/4 toxicities were recorded for: total bilirubin, albumin, liver enzymes, ascites, Child–Pugh, fatigue, hand–foot skin reaction, blood pressure or diarrhoea. Conclusions Radioembolization followed by sorafenib appears to be as well tolerated as sorafenib alone.