Background: Lentinan (LNT) is an immune adjuvant medicine for advanced gastric cancer in Japan. Recently, an oral formulation of superfine dispersed lentinan (SDL) has become clinically available. To investigate the safety and effectiveness of SDL, a multi center clinical study in patients with advanced colorectal cancer was conducted.
Patients and methods: Adverse events were assessed and the patients' quality of life (QOL) and the binding ability of peripheral blood monocytes (PBM) to LNT were also evaluated.
Results: Four grade 2 adverse events associated with SDL treatment were observed among the 80 patients. Adverse events associated with chemotherapy were observed in 9 out of the 64 chemotherapy-treated patients. Among the 48 patients assessed for QOL, the patients with low QOL scores before SDL treatment (n=23) reported a significant improvement in their QOL scores after 12 weeks of SDL administration. The rates of LNT-binding PBM in the QOL-improved group were significantly higher than those in the QOL-not-improved group (p<0.05).
Conclusion: SDL was safe and effective for suppressing the adverse effects of chemotherapy as well as improving QOL. The binding ability of PBM to LNT appears to be a promising predictor of QOL improvement after SDL administration.