A Randomized Clinical Trial Comparing Proton Beam Radiotherapy to Transarterial Chemoembolization for Hepatocellular Carcinoma - Results of an Interim Analysis
Mené sur 69 patients atteints d'un carcinome hépatocellulaire récemment diagnostiqué, cet essai compare, du point de vue de la survie sans progression et de la survie globale à 2 ans, l'efficacité d'une chimio-embolisation transartérielle et d'une protonthérapie
Objective : This prospective randomized clinical trial was developed to compare treatment outcomes among patients with newly diagnosed hepatocellular carcinoma (HCC). This report describes results of a planned interim analysis. Methods : Eligible subjects had either clinical or pathologic diagnosis of HCC and met either Milan or San Francisco transplant criteria. Patients were randomly assigned to transarterial chemoembolization (TACE) or to proton beam radiotherapy. Patients randomized to TACE received at least one TACE with additional TACE for persistent disease. Proton beam radiotherapy was delivered to all areas of gross disease to a total dose of 70.2 Gy in 15 daily fractions over 3 weeks. Primary endpoint was progression-free survival, with secondary endpoints of overall survival, local tumor control and treatment-related toxicities as represented by post-treatment days of hospitalization. Results : At the time of this analysis 69 subjects were available for analysis. 36 were randomized to TACE and 33 to proton. Total days of hospitalization within 30 days of TACE/proton was 166 and 24 days respectively (p<0.001). Ten TACE and 12 proton patients underwent liver transplantation following treatment. Viable tumor identified in the explanted livers following TACE/proton averaged 2.4 and 0.9 cm respectively. Pathologic complete response following TACE/ proton was 10%/25% (p=o.38). The 2-year overall survival for all patients was 59% with no difference between treatment groups. Median survival time was 30 months (95%CI - 20.7-39.3 months). There was a trend toward improved 2-year local tumor control (88% vs. 45%, p=0.06) and progression-free survival (48% vs. 31%, p=0.06) favoring the proton beam treatment group. Conclusion : This interim analysis indicates similar overall survival rates for proton beam radiotherapy and TACE. There is a trend toward improved local tumor control and progression-free survival with proton beam. There are significantly fewer hospitalization days following proton treatment that may indicate reduced toxicity with proton beam therapy.