The Hepato-Oncology Group Gastroenterology, Surgery and Liver Transplantation, Fondazione Istituto Nazionale Tumori IRCCS - National Cancer Institute - Via Venezian 1, Milan 20133, Italy. email@example.com.
BACKGROUND AND RATIONALE:
yttrium-90 microspheres radioembolization (Y90RE) is a novel approach to radiation therapy for hepatocellular carcinoma (HCC), never tested in phase II studies. Fifty-two patients with intermediate (n.17) - advanced (n.35) HCC were prospectively recruited to assess, as primary endpoint, efficacy of Y90RE on time-to-progression (TTP). Secondary endpoints were tumor response, safety and overall survival (OS). All patients were ECOG 0-1, Child-Pugh A-B7. Y90RE treatments aimed at lobar delivery of 120 Gy. Retrospective dosimetric correlations were conducted and related to response.
Fifty-eight treatments were performed on 52 patients. Median follow-up was 36 months. Median TTP was 11 months with no significant difference between portal vein thrombosis (PVT) vs. no-PVT (7 vs. 13 mo). Median OS was 15 mo (95%CI: 12-18) with a non-significant trend in favor of non-PVT vs. PVT patients (18 vs. 13 mo). Five complete responses occurred (9.6%) and the 2yr-progression rate was 62%. Objective response was 40.4% whilst disease control rate (DCR: 78.8%) significantly affected survival (responders vs. non-responders: 18.4% vs. 9.1%; P = 0.009). Tumor response significantly correlated with absorbed dose in target lesions (r=0.60, 95%CI: 0.41-0.74, P <0.001) and a threshold of 500 Gy predicted response (AUC= 0.78). Mortality at 30-90 days was 0%-3.8%. Various grades of reduction in liver function occurred within 6 mo in 36.5% of patients with no differences among stages. At the multivariate analysis tumor response was the sole variable affecting TTP (P <0.001) and the second, after Child-Pugh stage, affecting survival.
Y90RE is an effective treatment in intermediate-advanced HCC, particularly in case of PVT. Further prospective evaluations comparing Y90RE with conventional treatments are warranted. (ClinicalTrials.gov NCT00910572)