A Randomized Clinical Trial Comparing Proton Beam Radiotherapy to Transarterial Chemoembolization for Hepatocellular Carcinoma - Results of an Interim Analysis

Publication date: Available online 13 February 2016
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): David A. Bush, Jason C. Smith, Jerry D. Slater, Michael L. Volk, Mark E. Reeves, Jason Cheng, Roger Grove, Michael E. de Vera
ObjectiveThis 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.MethodsEligible 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.ResultsAt 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.ConclusionThis 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.

Teaser

Proton therapy and TACE were compared in a randomized clinical trial for patients with HCC. An interim analysis revealed a trend toward improved LC and PFS while significantly reducing number of days patients were hospitalized within 30 days of treatment. There was no difference in OS between groups with a median survival of 30 months. Proton therapy showed tumor down-staging at transplant. This early reports suggests that proton therapy may be effective therapy for HCC.


from Cancer via ola Kala on Inoreader http://ift.tt/1RyUyjK
via IFTTT