Abstract
Purpose: Active hexose-correlated compound (AHCC), a standardized extract of cultured Lentinula edodes mycelia,
exerts antitumor effects through anti-inflammatory and immune-modulatory functions. Adjuvant therapy for patients with
hepatocellular carcinoma (HCC) who have undergone curative hepatectomy has not been established. The purpose of this
study was to evaluate the efficacy and safety of AHCC as adjuvant therapy in patients with advanced HCC after curative
hepatectomy. Patients and methods: The study design was single-armed, non-randomized, open (no one was blinded),
and uncontrolled. Patients with HCC who underwent curative hepatectomy were treated with AHCC (1g) 3 times daily
orally for 2 years. The inclusion criteria were HCC diagnosed preoperatively as stages A and B of the Barcelona clinic liver
cancer (BCLC) classification and alpha-fetoprotein×protein induced by vitamin K absence or antagonist II (PIVKA-II)≥105
for stage A. Results: A total of 29 patients were treated with AHCC, of which 25 (4 patients discontinued) were followed
up. The 2-year recurrence-free survival rate after resection was 48% for those without discontinuations and 55.2% for
all patients with a history of treatment. Serum albumin levels decreased to a minimum in the first postoperative month
and gradually recovered to the preoperative level at 6months. Almost no change in lymphocyte percentage was observed
during follow-up. Inflammation-based prognostic scores were maintained at favorable levels after hepatectomy. Toxicity
and adverse events were not observed in any patient. Conclusion: AHCC may be safe and effective in preventing HCC
recurrence after curative hepatectomy, and further randomized trials of AHCC for its use in this setting are warranted.
This clinical trial was registered in UMIN Clinical Trials Registry (ID UMIN000024396).
Keywords
AHCC, hepatocellular carcinoma, hepatectomy, recurrence, adjuvant