KHEMOEMBOLISASI transarterial ON LIVER CANCER A Clinical Study of the efficiency Addition of Ganoderma Lucidum Polysaccharide Peptide Extract Beta-Glucan Oral
ABSTRACT: Background: Hepatocellular carcinoma (HCC) is a primary liver malignancy with high prevalence rate, associated primarily with HBV. The incidence of HCC in South East Asia is approximately 18.35 per 100.000 male population and 5.70 per 100.000 female population. Cancer incidence in Indonesia is estimated at 100 new cases per 100.000 inhabitants. With a population of around 237 million, the incidence of new cases is 237.000 annually. A total of 5.7% of deaths of all ages are caused by cancer, which is the 7 th leading cause of death. HCC survival rate is about 2-6 months without accurate treatment. Treatment is generally ineffective as patients are already at an advanced stage. Transarterial Chemoembolization (TACE) is a promising therapy where the drug is administered directly through the nearest arteries supplying the tumor. Beta-Glucan drug is able to activate the immune cells that function to kill cancer cells. TACE and Beta-Glucan combined therapy is expected to treat HCC more efficiently. Objective: To evaluate the treatment response of TACE in HCC combined with Beta-Glucan drug administered orally. Materials and Methods: The study was conducted at Dr. Sardjito Hospital in 63 HCC patients which are still limited in the liver. The study is a randomized clinical trials. Patients were divided into 2 groups. The first group of 32 patients with TACE plus Beta-Glucan drug orally. The second group of 31 patients with TACE plus placebo. The study has ethical clearance approved. Patients were given informed consent. Patients were followed and examined for blood results and abdominal CT. Treatment response was recorded, as complete response, partial response, no response, deteriorating imunologic response. X 2 , t-test, relative risk and survival statistical analysis test were performed. Significance level is 0.05, confidence level is 95%, and power is 80%.Results: In �²-Glucan grup, patients with complete response were 4 (12.50%), partial were 16 (50%), no response were 3 (9.38%) and deteriorated response were 9 (28.12%). In the placebo group, patients with complete response were 0 patients (0%), partial were 11 (35.48%), no response were 2 (6.45%) and deteriorated response were 18 (58.07%). Survival rate of Beta-Glucan group was longer (median 39 weeks) than in the placebo group (median 26 weeks), CER = 64.5%, EER = 37.5%, RR = 0.58, RRR = 42%, ARR = 27% and NNT = 4. There is an increase in CD4, CD8 and IL-2 post TACE significantly (p<0.05). The placebo group had hazard risk 4.143 times of the Beta-Glucan group, significantly (p<0.05). Conclusion: HCC therapy with a combination of TACE and Beta-Glucan is beneficial to increase the therapeutic response, immunity and survival rate significantly.
