Multicenter Phase II Study of Sequential Radioembolization-Sorafenib Therapy for Inoperable Hepatocellular Carcinoma

Pierce K H Chow, Donald Y H Poon, Maung-Win Khin, Harjit Singh, Ho-Seong Han, Anthony S W Goh, Su-Pin Choo, Hee-Kit Lai, Richard H G Lo, Kiang-Hiong Tay, Teong-Guan Lim, Mihir Gandhi, Say-Beng Tan, Khee-Chee Soo and for the Asia-Pacific Hepatocellular Carcinoma Trials Group

PLOS ONE, 2014, vol. 9, issue 3, 1-12

Abstract: Background: The safety and tolerability of sequential radioembolization-sorafenib therapy is unknown. An open-label, single arm, investigator-initiated Phase II study (NCT0071279) was conducted at four Asia-Pacific centers to evaluate the safety and efficacy of sequential radioembolization-sorafenib in patients with hepatocellular carcinoma (HCC) not amenable to curative therapies. Methods: Sorafenib (400 mg twice-daily) was initiated 14 days post-radioembolization with yttrium-90 (90Y) resin microspheres given as a single procedure. The primary endpoints were safety and tolerability and best overall response rate (ORR) using RECIST v1.0.Secondary endpoints included: disease control rate (complete [CR] plus partial responses [PR] and stable disease [SD]) and overall survival (OS). Results: Twenty-nine patients with Barcelona Clinic Liver Cancer (BCLC) stage B (38%) or C (62%) HCC received a median of 3.0 GBq (interquartile range, 1.0) 90Y-microspheres followed by sorafenib (median dose/day, 600.0 mg; median duration, 4.1 months). Twenty eight patients experienced ≥1 toxicity; 15 (52%) grade ≥3. Best ORR was 25%, including 2 (7%) CR and 5 (18%) PR, and 15 (54%) SD. Disease control was 100% and 65% in BCLC stage B and C, respectively. Two patients (7%) had sufficient response to enable radical therapy. Median survivals for BCLC stage B and C were 20.3 and 8.6 months, respectively. Conclusions: This study shows the potential efficacy and manageable toxicity of sequential radioembolization-sorafenib. Trial Registration: ClinicalTrials.gov NCT00712790.

Date: 2014
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0090909

DOI: 10.1371/journal.pone.0090909

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