Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Vertebral artery stump syndrome (VASS) is a rare condition that can cause posterior circulation ischemic stroke due to occlusion of the ipsilateral vertebral artery (VA) orifice, resulting in blood flow stagnation and embolus formation. Although there is no established treatment for this condition, we observed 3 cases of VASS out of 326 acute ischemic stroke cases at a single institution from April 2021 to October 2022. Despite the best possible antithrombotic treatment, all 3 patients had recurrent ischemic strokes. One patient underwent drug-eluting stenting of the VA orifice to relieve occlusive flow. The other 2 patients received coil embolization, which resulted in the disappearance of their culprit collateral flow. None of the patients had recurrent ischemic strokes after endovascular intervention. Based on our observations, stenting and coil embolization are effective methods for preventing future recurrences of VASS.

BACKGROUND: Before the COVID-19 vaccine became available, many Japanese people were undecided about whether or not to receive them. Their decisions were keys to achieving herd immunity. The impact of the type of information source on the COVID-19 vaccine uptake decision-making process remains unclear. We aimed to investigate the association between information source usage on COVID-19 and subsequent vaccine uptake status among those who have yet to decide whether to receive vaccines from non-prioritized people for vaccination. METHODS: Prospective cohort online self-administered surveys were conducted in February 2021 (T1), before the start of the mass vaccination program, and September-October 2021 (T2), when the vaccines were available to all citizens. The survey's target population was registered monitors of an Internet research company. Participants who answered "I want to get vaccinated after waiting to see how it goes." at T1 were eligible for analysis. The outcome variable was the COVID-19 vaccine uptake status in T2, and the predictors were 20 types of information sources, categorized based on people (family members, etc.), institutions (governments, etc.), or media (TV news, etc.). Adjusted odds ratio and 95% confidence intervals were estimated using logistic regression adjusted for possible confounders. RESULTS: The 5,139 respondents, mean age and standard deviation was 42.8 ± 12.5, 55.7% female, were eligible for analysis. 85.7% completed vaccination (including reserved/intended people) in T2. In the multivariate logistic analysis, odds ratios (95% confidence interval) for vaccine uptake were 1.49 (1.18-1.89) for workplaces/schools, 1.81 (1.33-2.47) for LINE, 0.69 (0.55-0.86) for Internet news and 0.62 (0.48-0.82) for video sharing sites. CONCLUSIONS The type of information source usage played an important role in the decision to vaccinate against COVID-19. Although caution is needed in interpreting the results, obtaining information from workplaces/schools and LINE was influential in promoting immunization.
Humans ; Female ; Male ; Information Sources ; COVID-19 Vaccines ; Prospective Studies ; Intention ; Japan ; COVID-19/prevention & control* ; Vaccination

Nephroblastomatosis (NBM) is a precursor of Wilms tumor. We herein report a case in which Wilms tumor was initially suspected and the affected kidney was removed.The tumor was subsequently diagnosed as intralobar NBM and a favorable outcome was achieved with postoperative chemotherapy. A 2-year-old boy who presented with gross hematuria was found to have an enlarged left kidney with hydronephrosis.Needle biopsy of the left kidney suggested Wilms tumor and left nephrectomy was performed. The tumor was histopathologically diagnosed as intralobar NBM.Although NBM is regarded as a precancerous lesion, a definite treatment plan has not yet been established. In the present case, we used a similar chemotherapy regimen to that for Wilms tumor. Eight years after the completion of chemotherapy, Wilms tumor has not developed or recurred. Appropriate management plans need to be developed by accumulating similar cases.

BACKGROUND: Ibaraki's Amabie-chan is a COVID-19 infection control system unique to Ibaraki prefecture, Japan. It requires residents to register each time they visit events, commercial facilities, and restaurants. The number of registrations has been limited, and its function alerting about people positive for COVID-19 infection seems not to be working. Nevertheless, registration with the system might have some impact on the user's behavior. In the current preliminary survey, the possible impact of Ibaraki's Amabie-chan on infection prevention behavior and fear of COVID-19 was investigated. METHODS: A cross-sectional, web-based, anonymous, and self-administered survey was conducted at two workplaces in Tsukuba Science City, Ibaraki, Japan. The first survey was conducted at one of the workplaces in November 2020, and the second survey, at the other workplace in February 2021. Variables of interest were sex, age group, marital status, employment status, Ibaraki's Amabie-chan use, COVID-19 Contact-Confirming Application use, ten items of infection prevention behaviors, and fear of COVID-19. Hierarchical linear regression analysis was performed. RESULTS: In both surveys, use of Ibaraki's Amabie-chan was significantly associated with COCOA use and with "physical condition management such as body temperature measurement." No association was found with other infection prevention behaviors or with fear of COVID-19. CONCLUSIONS Our findings did not provide sufficient evidence for the effectiveness of Ibaraki's Amabie-chan in regard to users' infection control behavior. Further detailed study is needed to investigate the effectiveness in terms of infection prevention and the cost-effectiveness of Ibaraki's Amabie-chan.
COVID-19/prevention & control* ; Cohort Studies ; Cross-Sectional Studies ; Fear ; Humans ; SARS-CoV-2

Background: Febrile neutropenia (FN) remains an important complication in pediatric cancer patients. The present study compared the efficacy of meropenem (MEPM) and piperacillin/tazobactam (PIPC/TAZ) with or without intravenous immunoglobulin (IVIG) as second-line therapy for FN in pediatric patients. Methods: As first-line treatment for FN, 394 episodes in 99 patients were randomly assigned to receive PIPC/TAZ (360 mg/kg/day, maximum 18 g/day) or MEPM (120 mg/ kg/day, maximum 3 g/day). Eighty-four episodes in 42 patients were judged as failures, and, thus, were enrolled for second-line treatment. In second-line treatment, antibiotics were switched to MEPM or PIPC/TAZ, and episodes were further randomized for treatment with or without concomitant IVIG at 100 mg/kg/day (maximum 5 g/day) for 3 consecutive days. Results: The total success rate of second-line treatment was 50.0% (52.0% in PIPC/ TAZ and 47.2% in MEPM with or without IVIG, P=0.826). The success rates of patients treated with (IVIG+ group) and without IVIG (IVIG− group) were 53.8 and 46.7%, respectively (P=0.662). In the IVIG+ group, the success rate of patients younger than 8 years old was 78.6%, which was significantly higher than that of those aged 8 years and older (40.0%, P=0.043). Conclusion PIPC/TAZ and MEPM were equally effective as second-line treatment. Concomitant IVIG was also effective, particularly in patients younger than 8 years.

Objective: To evaluate the efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This Phase 2 open-label, single-arm study enrolled Japanese women with homologous recombination deficiency-positive relapsed, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of therapy. The starting dose of niraparib was 300 mg administered once daily in continuous 28-day cycles until objective progressive disease, unacceptable toxicity, consent withdrawal or discontinuation. The primary endpoint, objective response rate (ORR), was assessed by the investigator using RECIST version 1.1. Safety evaluations included the incidence of treatment-emergent adverse events (TEAEs), including serious TEAEs. Results: Twenty women were enrolled and the confirmed ORR in the full analysis set (FAS) was 35.0% (7/20), consisting of 1 complete response and 6 partial responses. Disease control rate in the FAS was 90.0%. The most frequently reported TEAEs (>50%) were anemia, nausea, and platelet count decreased. One patient (5.0%) had TEAEs leading to discontinuation of niraparib whereas reductions or interruptions were reported in 14 (70.0%) and 15 (75.0%) patients, respectively. The median dose intensity (202.9 mg daily) corresponded to a relative dose intensity of 67.6%. Conclusion Efficacy and safety of niraparib in heavily pretreated Japanese women was comparable to that seen in an equivalent population of non-Japanese women. No new safety signals were identified.

BACKGROUND: Food allergy (FA) is a common disease in children, and its prevalence has increased in developed countries. The impact of overweight on children health also becomes an important social problem. However, the relationship between overweight and FA is still unclear. We examined the association between overweight and the prevalence of FA among Japanese children. METHODS: We analyzed data obtained using a self-administered questionnaire from 1772 Japanese children. Weight groups according to body mass index cutoff points proposed by the International Obesity Task Force were used to create two groups: overweight and non-overweight. Children were separated into four age groups (3-6 years, 6-9 years, 9-12 years, and 12-15 years) to examine age differences. We performed univariate and multivariate logistic models to examine the association between overweight and FA. RESULTS: The prevalence of FA was significantly higher in boys (10.6%, p = 0.014) than girls (4.5%) and girls (7.9%, p = 0.012) than boys (2.5%) for 6-9 and 12-15 age groups, respectively. While the prevalence of FA was significantly higher in overweight than non-overweight girls (26.1%, p = 0.005) in the 12-15 age group, no significant difference was found in boys. In girls, overweight was significantly associated with FA after adjustment for age and asthma (odds ratio 1.99, 95% confidence interval 1.01-3.89, p = 0.046). CONCLUSIONS Our results showed that being overweight was significantly associated with a higher prevalence of FA in girls, but not in boys. Further prospective studies are necessary to find the causal relationship between overweight and FA.
Adolescent ; Body Mass Index ; Child ; Child, Preschool ; Cross-Sectional Studies ; Female ; Food Hypersensitivity/epidemiology* ; Humans ; Japan/epidemiology* ; Male ; Overweight/epidemiology* ; Prevalence ; Sex Factors