Phase II Study of 4-fraction Carbon Ion Radiotherapy for Hepatocellular Carcinoma

Introduction: A phase II study of Carbon Ion Radiotherapy (CIRT) for HCC according to a 52.8 cobalt gray equivalent (GyE) /4-fraction/1-week regime was conducted from April 2001 to February 2003. Purpose: To evaluate the efficacy of 4-fraction CIRT for HCC. Methods: Eligibility criteria were as follows: biopsy-proven, recurrent or residual tumor after other treatments or no indication for any other treatment; no prior radiotherapy for target tumors; Child-Pugh grade A or B. Results: Forty-seven patients with chronic liver disease of Child-Pugh grade A in 37, B in 10 were enrolled. The median age at therapy was 69 years. The median tumor size was 3.7 (1.2-7.5)cm in diameter. During a median follow-up of 60 (48-70)months, no treatment-related hepatic failure and death occurred. Incidence of grade 3 early hepatic toxicity in the serum-GPT, ALB, T.BIL, PT and ALP according to NCI-CTC (ver.2) was 0, 11, 0, 2, and 13%, respectively. No other grade 3 or worse adverse effect occurred. In 92% of patients, the Child-Pugh score did not increase by more than 1 point within 1 year after the therapy. Local control rate was 96% at 1 to 5 years. Overall and cause-specific survival rates at 3 and 5 years were 57% and 67%, 34% and 42%, respectively. Those in the 27 patients initially treated with CIRT were 63% and 81%, 40% and 52%, respectively. Conclusion: Four-fraction CIRT for HCC seems to have a promising potential as a new, radical, and minimally invasive therapeutic option for HCC.ILCA\u27s First Annual Conferenc