Sorafenib (SFB) low dose in octogenarians with advanced or inoperable (a/i) HCC: Toxicity and efficacy evaluation.

Background: HCC accounts for approximately 90% of all primary liver cancers, and is the fifth most common cancer in the world. So far prognosis of AHCC is very poor, particularly if consider very elderly pts. Treatment with SFB at standard dose may results in untolerable toxicity especially in very old people with HCC Cancer Aim of the study is to investigate if SFB at reduced dose is efficient and tolerable in octogenarian people with HCC. Methods: 30 patients,16 male and 14 female with AHCC histologically proven were enrolled; mean age was 79. Main Inclusion Criteria: Child-Pugh A or B; adequate liver, hematological, and renal function; informed writed consent acquired. Comprehensive Geriatric Assessment (CGA) according to Balducci’s classification and PFS (ECOG) not greater then 1 were considered as well. Serum CgA, VEGF and αFP were evaluated at baseline. Response evaluation were according to RECIST. Results: Pts received SFB 400 mg p.o., daily until intolerable ADRs or progression disease No discontinuation of treatment was needed for all pts; only 6 pts experienced severe ADRs not discontinued treatment withdrawal was needed. Pts with good OS (median value:11mths) showed also lower values of serum CgA and VEGF better than pts with poor prognosis. This outcome is under investigation. Conclusions: SFB could be administered with “not inferiority criteria vs SFP std treatment. Even if increased age is poor prognostic factor for tolerability, the reduction of dose don’t seem to reduce the efficacy of treatment in this group of patients. On the other hand the minimization of ADRs positively affects the quality of life. Further data were needed to assess how the lower values of serum CgA and VEGF levels, could play a role as new prognostic factors in HCC advanced or inoperable in octogenarian people.