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.

Objective: This study aimed to reveal the prevalence and characteristics of anguish among delirious patients with advanced cancer receiving specialized palliative care services. Methods: We conducted a subanalysis of a multicenter, prospective, observational study at 14 inpatient palliative care units and 10 general wards that offered psycho-oncology consultation service in Japan. We consecutively enrolled the patients with advanced cancer who were diagnosed with delirium and prescribed antipsychotics. Palliative care specialists decided whether patients suffered from anguish or not. We assessed patients’ background and severity of delirium with the Delirium Rating Scale-Revised (DRS-R-98). Results: Of 818 enrolled patients, 99 (12.1%) suffered from anguish. We observed a significant difference in the mean age (68.9±12.6 vs. 72.1±11.2, p=0.009), prevalence of dementia (2% vs. 10.4%, p=0.005) between patients with anguish and those without anguish. Patients with anguish had lower DRS-R-98 total scores before medication than those without anguish (15.3±8.1 vs. 17.3±7.8, p=0.018), but higher severity score in lability of affect (1.2±0.8 vs 1.0±0.9, p=0.023). Conclusions: The results of this study suggested that patients with anguish tend to be younger, mostly do not have dementia, and have lower delirium severity score but higher score in lability of affect. Nevertheless, further research, investigating appropriate evaluations and medical interventions for patients with anguish is warranted.

SUMMARY OF EVENT: Bacterial, mycotic peritonitis and Candida fungemia developed in a patient with moderate ascites who had undergone endoscopic ultrasound-guided biliary drainage (EUS-BD). Antibiotics and antifungal agent were administered and ascites drainage was performed. Although the infection improved, the patient's general condition gradually deteriorated due to aggravation of the primary cancer and he died. TEACHING POINT: This is the first report to describe infectious peritonitis after EUS-BD. Ascites carries the potential risk of severe complications. As such, in patients with ascites, endoscopic retrograde cholangiopancreatography (ERCP) is typically preferred over EUS-BD or percutaneous drainage to prevent bile leakage. However, ERCP may not be possible in some patients with tumor invasion of the duodenum or with surgically altered anatomy. Thus, in patients with ascites who require EUS-BD, we recommend inserting the drainage tube percutaneously and draining the ascites before and after the intervention in order to prevent severe infection.
Anti-Bacterial Agents ; Ascites ; Bile ; Candida ; Cholangiopancreatography, Endoscopic Retrograde ; Drainage ; Duodenum ; Endosonography ; Fungemia ; Humans ; Peritonitis

We describe the use of a C1 laminar screw in combination with a C2 laminar screw as a salvage technique to treat two patients, one with persistent first intersegmental artery and the other with vertebral artery occlusion after cervical spine fracture. The combined use of C1 and C2 laminar screws allows for good fixation of the atlantoaxial joint with a lower risk of vertebral artery injury; therefore, it can be an alternative surgical procedure for patients with congenital or traumatic anomalous vertebral artery.
Arteries ; Atlanto-Axial Joint ; Humans ; Spine ; Vertebral Artery

Mandibular cortical erosion detected on dental panoramic radiographs is associated with increased risk of osteoporosis in older adults. Additionally, many reports have demonstrated an association between decreased number of teeth present and osteoporosis. However, whether mandibular cortical erosion is associated with a decreased number of teeth remains unclear. The purpose of this study, therefore, was to clarify the association between mandibular cortical erosion and number of teeth present in Japanese men and women aged 40 years and older. Among patients who visited our university hospital and underwent dental panoramic radiography for the diagnosis of dental diseases, 839 patients (293 men and 546 women) aged 40–89 years (mean [SD], 63.7 [10.6] years) participated in this study. Multiple regression analysis revealed that mildly to moderately eroded cortex (p = 0.007) and severe eroded cortex (p < 0.001) were significantly associated with a decreased number of teeth present. Analysis of covariance adjusted for covariates revealed a significant association between mandibular cortical erosion category and number of teeth present (p < 0.001). Subjects with a severely eroded cortex had significantly fewer teeth present than those with a normal cortex (mean [SE], 20.7 [0.5] vs. 23.4 [0.3], p < 0.001) or mildly to moderately eroded cortex (22.2 [0.4], p = 0.04). Subjects with a mildly to moderately eroded cortex had significantly fewer teeth present than those with a normal cortex (p = 0.033). Our results suggest the significant association between mandibular cortical erosion and number of teeth present in Japanese men and women aged 40 years and older.
Adult ; Asian Continental Ancestry Group* ; Cross-Sectional Studies* ; Cytochrome P-450 CYP1A1 ; Diagnosis ; Female ; Humans ; Male ; Mandible ; Osteoporosis ; Radiography, Panoramic ; Stomatognathic Diseases ; Tooth*

Background: We retrospectively compared endscopic gastroduodenal stenting with gastrojejunostomy as a means of palliating malignant gastric and duodenal obstruction. Methods: This retrospective study investigated patients treated for malignant gastric and duodenal obstruction from April 2011 to April 2015 at Shikoku Cancer Center. Results: Of the 40 patients in this study, 25 underwent gastroduodenal stenting and 15 had operative gastrojejunostomy. Comparing the stenting and operative patients, technical success rate was 100% in both group, clinical success rate was 84% in stenting patients and 93% in operative patients. The median time to fluid intake was significantly shorter in stenting patients than operative patients(0 day vs 2 days, p=0.0003), and the median time to intake of solids was also significantly shorter in stenting patients(1day vs 3 days, p<0.0001).The median hospital stay was significantly shorter in stenting patients(9 days vs 23 days, p=0.0116). Median cost of hospitalization is more expensive in operative patients than stenting patients(¥1,106,170 vs ¥752,290, p=0.0052). Conclusion: Our study suggested that gastoroduodenal stent was less length of time to fluid/solid intake, and less costly than gastrojejunostomy.

Myxopapillary ependymoma in childhood typically occurs in the central nervous system. There are few surgical cases of myxopapillary ependymoma of the cauda equina in children. We report a case of myxopapillary ependymoma of the cauda equina in a 5-year-old boy, who presented with leg pain and abnormal gait. Subtotal resection surgery was performed. Following the subtotal tumor resection, follow-up magnetic resonance imaging evaluation showed a recurrent tumor. As a result, we performed a second subtotal tumor resection and followed with postoperative radiation therapy. No further evidence of the disease has been noted elsewhere in the patient in over ten years of follow-up. Myxopapillary ependymoma of the cauda equina in a young boy was improved by subtotal tumor resection and postoperative radiation therapy.
Cauda Equina* ; Central Nervous System ; Child ; Child, Preschool* ; Ependymoma* ; Follow-Up Studies ; Gait ; Humans ; Leg ; Magnetic Resonance Imaging ; Male

We investigated the possible association between genetic polymorphisms in the dopamine receptor and serotonin transporter genes and the responses of schizophrenic patients treated with either risperidone or perospirone. The subjects comprised 27 patients with schizophrenia who were clinically evaluated both before and after treatment. The genotyping of the polymorphisms of the dopamine D2 receptor gene (DRD2) (rs1801028 and rs6277), the dopamine D4 receptor gene (DRD4) (120-bp tandem repeats and rs1800955), and serotonin transporter gene (5HTT)(variable number of tandem repeats; VNTR) were performed using the real-time polymerase chain reaction and sequencing. In DRD2 and 5HTT-VNTR, there were no significant correlations between clinical response and polymorphism in the case of risperidone, and for perospirone treatment it was impossible to analyze the clinical evaluation due to the absence of genotype information. On the other hand, in DRD4 there were significant correlations in the two-factor interaction effect on the Positive and Negative Syndrome Scale (PANSS) between the two drugs [120-bp tandem repeat, p=0.003; rs1800955, p=0.043]. Although the small sample represents a serious limitation, these results suggest that variants in DRD4 are a predictor of whether treatment will be more effective with risperidone or with perospirone in individual patients.
Genotype ; Hand ; Humans ; Isoindoles ; Polymorphism, Genetic ; Real-Time Polymerase Chain Reaction ; Receptors, Dopamine ; Receptors, Dopamine D2 ; Receptors, Dopamine D4 ; Risperidone ; Schizophrenia ; Serotonin Plasma Membrane Transport Proteins ; Tandem Repeat Sequences ; Thiazoles

We examined the clinical effect of a functional food containing both soy isoflavone and black cohosh extract (test food) on Simplified Menopausal Index (SMI) in a double blind study. Twenty four peri-menopausal women were divided into two groups and four capsules of either the test food or placebo were ingested everyday for eight weeks. The daily intakes of soy isoflavone and black cohosh extract were 50.0 mg and 80.0 mg respectively. As compared with placebo group, the scores of menopausal symptoms such as “stiff neck” and “backache” significantly improved (p<0.05), and the score of “irritation” tended to improve in test food group but not significant statistically. When these results were stratified according to the severity of pretrial menopausal symptoms, the effects of test food were shown to be more effective in mild case group. These results suggest that the functional food containing soy isoflavone and black cohosh extract alleviate menopausal disturbances and improve the quality of life for peri-menopausal women.

Objectives: Human T cell leukemia virus type-I (HTLV-I) is a causative agent of human T-cell leukemia and HTLV-I associated myelopathy (HAM/TSP). HTLV-I carriers are often infected vertically, especially via mother's milk. Since 1985, clinical measures have been adopted at a hospital in Okinawa to prevent vertical infections.
Methods: We examined HTLV-I antibodies in all of the women (total 11, 506) who gave birth after 24 gestational weeks at a hospital on the Okinawa main island from January 1985 to December 1999.
Results: The positive rate among all pregnant women was always higher than that among primipara alone. Both figures decreased over the period studied, but the primiparity rate (36-39%) did not change significantly. The percentage of HTLV-I positive primipara pregnant women among the HTLV-I positive total was close to the primiparity rate from 1985 to 1988, but it was considerably lower than the overall primiparity rate thereafter (22-26%).
Conclusions: Preventive measures against HTLV-I infection did not contribute to the decrease in HTLV-I positive mothers before 1999 because these measures were adopted from 1985, and so there must be other reasons for the decrease in HTLV-I positive rate. Further studies on social factors and by year of birth are needed to identify factors influencing HTLV-carrier ratios among pregnant women.