We evaluated the anti-tumor activity of fermented grain extracts using a mouse tumor model. An experimental diet containing materials from fermented rice germ, wheat germ, hulled rice, soybean and seaweed (fermented materials, FM) was fed to 4-week-old female C57BL6 mice for 14 days prior to and 21 days following the subcutaneous implantation of B16 melanoma (5×10 ⁵ cells/mouse). FM retarded tumor growth and increased the duration of host survival. We further examined the anti-tumor activity of FM using the B16 metastasis model. An experimental diet containing FM was fed to C57BL6 mice for 14 days prior to and 21 days following B16 tail vein administration (5×10⁴ cells/mouse). The decrease in observed metastasis in the lungs of mice treated with FM was also significant. In order to identify this anti-tumor activity of FM, NK-activity in the FM fed mice was evaluated. However, the values were comparable to the control mice. These results suggest that the fermented grain extracts induce anti tumor activity in vivo, although the mechanism of this activity is not yet clear.

Objective: The primary objective of this study was to evaluate the safety of niraparib 300 mg/day in Japanese patients with platinum-sensitive, relapsed ovarian cancer in a maintenance setting. Methods: Phase 2, multicenter, open-label, single-arm study enrolled Japanese patients with platinum-sensitive, relapsed ovarian cancer who had received ≥2 platinum-based regimens.The primary endpoint (incidence of grade 3 or 4 thrombocytopenia-related events within 30 days after initial niraparib administration) was justified by the incidences of a global pivotal phase 3 study and its post-hoc safety analysis on thrombocytopenia, the major hematological adverse event of niraparib. The overall safety analysis examined other treatment-emergent adverse events (TEAEs). Results: Enrolled patients (n=19) had a median (min, max) body weight of 53.9 (40.8–79.1) kg; all but one patient weighed <77 kg. Most (94.7%) patients initially received niraparib 300 mg/day but this decreased in subsequent cycles (mean±standard deviation dose intensity, 191.6±65.7 mg/day). In total, 6/19 (31.6%) patients experienced grade 3 or 4 thrombocytopenia-related events within 30 days of initial niraparib administration.Other common TEAEs included nausea, and decreased platelet or neutrophil counts. No progression-free or overall survival events occurred; only 1 of 4 response-evaluable patients had a post-baseline tumor assessment (stable disease). Conclusion The incidence of grade 3 or 4 thrombocytopenia-related events in Japanese ovarian cancer patients was similar to that in the corresponding non-Japanese study. Overall, the safety profile was acceptable and consistent with the known safety profile and previous experience with niraparib.