PLoS ONE (Jan 2014)

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,
  • Asia-Pacific Hepatocellular Carcinoma Trials Group

DOI
https://doi.org/10.1371/journal.pone.0090909
Journal volume & issue
Vol. 9, no. 3
p. e90909

Abstract

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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.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).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.This study shows the potential efficacy and manageable toxicity of sequential radioembolization-sorafenib.ClinicalTrials.gov NCT00712790.