Advanced hepatocellular carcinoma (HCC) treated with sunitinib (Su) and transarterial chemoembolization (TACE): Phase II trial final report.

275 Background: TACE and anti-angiogenic agents have individually been effective in inoperable HCC. In this prospective phase 2 study, the effects and PFS of Su+TACE was evaluated. Methods: Eligibility: ECOG PS 0, 1, inoperable HCC, Child Pugh (CP) A/B, platelets >100K, bilirubin < 2 and no contraindications to TACE. Treatment: Cycle (C) 1 -Su 37.5mg po days (d)1-7; - TACE with doxorubicin in lipodiol on d8;- Su 37.5mg po qd d15-36; - 2 wks off C2 onwards - Su 4 wks on (dose escalation to 50mg in pts without grade 3 toxicities);- 2 wks off DCE-MRI, sVEGFr, monocytes, and Su PK were assessed at d0, 8, 10, and 36. Results: Characteristics of the 16 pts were: median age 74 yr (range 40-86), all with CP A cirrhosis (etiology: hepB: 2, hepC: 6, ETOH: 1, unknown: 7), and PS 0: 12, PS 1: 4. 10 pts had liver only and 6 pts had extrahepatic disease. Median PFS was 8 mo (95% CI 4.3-9.3) and OS was 14.9 mo (95% CI 6.3-27.1) with a median follow up of 12.8 mo (5 pts still alive) receiving a median of 3 cycles (range ...