National Cancer Institute, Bangkok, Thailand.
Hepatic cancer is responsible for morbidity and mortality throughout the world and a definite increase incidence has been reported recently. Even small primary tumor has high chance of invasion and intrabiliary extension but asymtomatic in early stages. Although resectable, recurence is common and short duration of survival. Today many biological response modifier (BRM) have been studies but not clearly elucidated. AHCC a new BRM boosts immune system may increase role in palliative or downstaging a patient with advanced hepatic cancer.
Objectives: The level of interleukin-12 (IL-12) and interferon ( (IFN-() was estimated in advanced hepatic cancer patients treated with AHCC or non-AHCC (Placebo). The overall change of quantity of life (QOL) was observed in both groups. Finally the overall survival rate was compared between the two groups.
Patients and methods: Total 51 patients with advanced biopsy-proven hepatic cancer were enrolled from Aug.6, 2002 to Jan. 31, 2004. They were not undergoing resection and unsuitable for chemoembolization and also had no brain metastases or no psychiatric illness. Signed informed consent. This study was a randomized and placebo-controlled trial, and the subjects were divided into 2 groups; the AHCC and non AHCC (placebo) group. The AHCC group and the non AHCC group orally received 6 gm AHCC (freeze dry 3.6 gms) and placebo daily for 6 months, respectively. Questionnaires for QOL were collected at 0.13 and 6 months. The level of IL-12 and IFN-( in 10 ml of citrated blood, and 10 ml clotted blood for blood chemistry at 0,1,2,3 and 6 months. Further more the quantitative determination of IL-12, IFN-( and blood chemistry was also performed in 34 age-matched normal Thais.
Results: A total of 51 patients were finally enrolled in this clinical study but 7 cases (2 AHCC-treated, 5 placebo-treated) were not available for evaluation. So the assessment of the study were performed in 34 (AHCC-treated) and 10 non-AHCC treated patients. AHCC-treated (M /F=28 /6), age 34-72 yrs. Non-AHCC treated (M /F=9/1) age 37-71 yrs. Preliminary analysis of 25 cases (15 AHCC, 10 non-AHCC) after 6 months all non-AHCC treated group died in 1.5 months but AHCC-treated 73% survived. So non-AHCC treated group has been stopped and AHCC treated group was further ongoing to Jan 31, 2004 for the last case. NO CR or PR was observed but there is one stable disease and are surviving. No any side effect was found in all patients treated with AHCC. Of the 44 patients, 33 received AHCC. There was significant longer survived time p=0.000 (95% CI). Significant different in lymphocyte (%) at 2 months p=0.011. No significant difference in AST, ALT, IL-12, IFN-( (small sample size as death during follow up). QOL was improved in AHCC treated patients. Tendency of maintaining level of clinical parameter in AHCC group during longer survival.
การประชุมวิชาการกระทรวงสาธารณสุขครั้งที่ 13 ประจำปี 2548
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