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Title: Multicenter phase II study of sequential radioembolization-sorafenib therapy for inoperable hepatocellular carcinoma
Authors: Chow, P.K.H. 
Poon, D.Y.H.
Khin, M.-W.
Singh, H.
Han, H.-S.
Goh, A.S.W.
Choo, S.-P.
Lai, H.-K.
Lo, R.H.G.
Tay, K.-H.
Lim, T.-G.
Gandhi, M.
Tan, S.-B. 
Soo, K.-C. 
Issue Date: 10-Mar-2014
Citation: Chow, P.K.H., Poon, D.Y.H., Khin, M.-W., Singh, H., Han, H.-S., Goh, A.S.W., Choo, S.-P., Lai, H.-K., Lo, R.H.G., Tay, K.-H., Lim, T.-G., Gandhi, M., Tan, S.-B., Soo, K.-C. (2014-03-10). Multicenter phase II study of sequential radioembolization-sorafenib therapy for inoperable hepatocellular carcinoma. PLoS ONE 9 (3) : -. ScholarBank@NUS Repository.
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: NCT00712790. © 2014 Chow et al.
Source Title: PLoS ONE
ISSN: 19326203
DOI: 10.1371/journal.pone.0090909
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