Reduction of chemotherapy-induced neutropenia by AHCC in breast cancer patients: A randomized, double-blind, placebo-controlled, parallel-group exploratory study

Vollständiger Abstract

Worum geht es in dieser Arbeit?

Background: Neoadjuvant chemotherapy is increasingly used to reduce the size of lesions with anticancer drugs. In patients with breast cancer, tumor shrinkage increases the feasibility of breast-conserving surgery, which may help reduce psychological stress. It is important to maintain the relative dose intensity above a certain level to maximize the efficacy of chemotherapy. Active Hexose Correlated Compound (AHCC), a standardized extract of cultured Lentinula edodes mycelia, has been reported to reduce chemotherapy-related adverse events in patients with various cancers receiving different chemotherapy regimens. However, the effects of AHCC in breast cancer patients receiving FEC75 (fluorouracil 500 mg/m2 + epirubicin 75 mg/m2 + cyclophosphamide 500 mg/m2) treatment as neoadjuvant chemotherapy have not been well established. Objective: The purpose of this study was to explore the effects of AHCC on chemotherapy-related adverse events, including bone marrow suppression, in breast cancer patients receiving FEC75 as a neoadjuvant chemotherapy. Methods: Sixty breast cancer patients who were scheduled to receive neoadjuvant chemotherapy with the "paclitaxel followed by FEC75" regimen participated in this study. They took either placebo or AHCC (2.0 g/day) for 13 weeks, including the FEC75 treatment period. Results: AHCC significantly reduced the incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3–4 neutropenia on Cycle 3 Day 1 of FEC75 treatment. In addition, the dyspnea score on the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire version 3.0 (EORTC QLQ-C30) was significantly lower in the AHCC group than in the placebo group after completion of FEC75 treatment. The diarrhea score also tended to be lower in the AHCC group than in the placebo group. Conclusion: These findings suggest that AHCC reduces the incidence of CTCAE grade 3–4 neutropenia on Cycle 3 Day 1 of FEC75 treatment in breast cancer patients. Novelty of the Study: This randomized, double-blind, placebo-controlled exploratory study provides new clinical evidence on the effects of AHCC supplementation (2.0 g/day) in breast cancer patients receiving FEC75 as part of neoadjuvant chemotherapy. The study specifically demonstrates a significant reduction in the incidence of CTCAE grade 3–4 neutropenia on Cycle 3 Day 1 in the AHCC group compared with placebo, while also identifying potential improvements in selected chemotherapy-related quality-of-life symptoms. These findings extend previous research on AHCC by evaluating its potential supportive role in a defined breast cancer population receiving a specific neoadjuvant chemotherapy regimen. Keywords: AHCC; neoadjuvant chemotherapy; breast cancer; adverse event; leukopenia; QOL