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

• DOI: 10.1371/journal.pone.0090909
• Publication Date: 2014-03-10T20:43:33Z
• Authors: 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
• Keywords: Tolerability; Interquartile range; Clinical endpoint; Liver Cancer

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 efficacy in patients with hepatocellular carcinoma (HCC) not amenable curative therapies.Sorafenib (400 mg twice-daily) initiated 14 days post-radioembolization yttrium-90 (90Y) resin microspheres given as a procedure. primary endpoints were best overall response rate (ORR) using RECIST v1.0.Secondary included: disease control (complete [CR] plus partial responses [PR] stable [SD]) survival (OS).Twenty-nine Barcelona Clinic Liver Cancer (BCLC) stage B (38%) or C (62%) HCC received median 3.0 GBq (interquartile range, 1.0) 90Y-microspheres followed by sorafenib (median dose/day, 600.0 mg; duration, 4.1 months). Twenty eight experienced ≥1 toxicity; 15 (52%) grade ≥3. Best ORR 25%, including 2 (7%) CR 5 (18%) PR, (54%) SD. Disease 100% 65% BCLC C, respectively. Two had sufficient enable radical therapy. Median survivals for 20.3 8.6 months, respectively.This shows potential manageable toxicity radioembolization-sorafenib.ClinicalTrials.gov NCT00712790.