1.Effect of long-term intake of termal water on gastric mucosal blood flow.
Juntaro TANAKA ; Shuuji MATSUMOTO ; Toshinobu SENOU ; Tadaaki ISHIBASHI ; Kouji OCHI ; Hideo HARADA
The Journal of The Japanese Society of Balneology, Climatology and Physical Medicine 1989;52(3):127-130
Effect of long-term intake of spa water on gastric mucosal blood flow was evaluated using an endoscopic organ reflex spectrophotometry together with an Olympus XQ-10 forward-viewing gastrofiberscope. Three healthy volunteers and nine patients with gastric diseases in remission (six with healed gastric ulcer and three with chronic gastritis) underwent two-week treatment consisting of daily intake of Misasa spa water (weakly radon containing bicarbonate salt spring, 38 to 42°C, 200ml, two times a day between meals), and gastric mucosal blood flow was measured at three spots of the stomach (lesser curvature of the pylorus, antrm, and angle) before and after the treatment period. Life style and medication were kept unchanged during the period. The following results were obtained:
1) Gastric mucosal blood flows (IHb) measured before and after the treatment were respectively 95.0±18.0 and 98.2±15.4 at the pylorus, 104.8±16.9 and 110.8±12.8 at the antrum, 116.1±20.4 and 118.7±18.5 at the angle.
2) Values measured after the treatment were higher than those measured before the treatment at pylorus in 75% of the patients and at the antrum and angle in 67% of the pa-tients.
3) However, assessment of the mean values before and after the treatment using the student's paired t-test revealed a significant increase in blood flow (P<0.05) only at the antrum.
Further studies are in progress to determine (1) the clinical significance of the improvement in gastric mucosal blood flow, such as the maintenance of remission, and (2) the characteristics of gastric diseases which are likely to respond favorably to the treament of taking spa water.
2.Phase 2 single-arm study on the safety of maintenance niraparib in Japanese patients with platinum-sensitive relapsed ovarian cancer
Kazuhiro TAKEHARA ; Takashi MATSUMOTO ; Junzo HAMANISHI ; Kosei HASEGAWA ; Motoki MATSUURA ; Kiyonori MIURA ; Shoji NAGAO ; Hidekatsu NAKAI ; Naotake TANAKA ; Hideki TOKUNAGA ; Kimio USHIJIMA ; Hidemichi WATARI ; Yoshihito YOKOYAMA ; Yoichi KASE ; Shuuji SUMINO ; Ajit SURI ; Hiroaki ITAMOCHI ; Nobuhiro TAKESHIMA
Journal of Gynecologic Oncology 2021;32(2):e21-
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.