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Objectives: Bladder cancer, especially non‐muscle invasive bladder cancer (NMIBC), is one of the most costly cancers owing to its long‐term management. Photodynamic diagnosis‐assisted transurethral resection of bladder tumor (PDD‐TURBT) reduces the risk of intravesical recurrence. However, its impact on healthcare economics in Japan remains unclear. We evaluated the comprehensive medical costs of Japanese healthcare economics regarding PDD‐TURBT. Methods: This large‐scale, multicenter, retrospective study included a dataset of 1531 patients who were diagnosed with primary NMIBC who underwent initial TURBT between April 2006 and June 2021. A one‐to‐one propensity‐score matching analysis was used for an unbiased comparison based on postTURBT follow‐up periods. The total medical costs, including hospitalization, surgical procedures for TURBT and salvage radical cystectomy, adjuvant intravesical therapies, and follow‐up examinations, were compared between white light (WL)‐TURBT and PDD‐TURBT groups. Results: After propensity‐score matching, 468 patients each of WL‐ and PDD‐TURBT groups were matched. Total costs were 510 337 128 and 514 659 328 ¥ in WL‐ and PDD‐TURBT groups, respectively. The costs of adjuvant intravesical therapies, follow‐up examinations, and salvage radical cystectomy in PDD‐TURBT group were equivalent to or lower than those in WL‐TURBT group. Furthermore, total costs of high‐ and highest‐risk NMIBC in PDD‐TURBT group were either equivalent or lower compared to those in WL‐TURBT group. Conclusions: The total costs associated with PDD‐TURBT were higher compared to WL‐TURBT, while there is the potential of PDD‐TURBT to reduce the burden on healthcare economics in limited cases. [ABSTRACT FROM AUTHOR]

Background: Apalutamide-associated skin adverse events are more common in the Japanese than in the global population. However, limited clinical data have hampered further understanding. This real-world study investigated the clinical characteristics of skin adverse events in patients with advanced prostate cancer. Methods: We retrospectively reviewed 119 patient records from 16 institutions in Japan. Skin adverse events were graded according to the Common Terminology Criteria for Adverse Events (v5.0). The incidence and characteristics of skin adverse events (along with the clinical risk factors for their incidence, worsening, and recurrence) were evaluated. Results: Fifty-five patients (46.2%) experienced skin adverse events. The median times to the incidence and remission of skin adverse events were 62 and 30 days, respectively. Grade 3 skin adverse events were observed in 15 patients (12.6%). The median time from the first incidence to apalutamide interruption was significantly longer in patients with progression to grade 3 skin adverse events than in those without such a progression (8 vs. 0 days, p = 0.005). Skin adverse events were observed in 45.2% of patients who resumed apalutamide treatment (median treatment interruption time: 31.5 days). Sixteen patients (13.4%) permanently discontinued apalutamide due to skin adverse events. No significant clinical risk factors for the incidence, worsening and recurrence of apalutamide-associated skin adverse events were observed. Conclusions: Nearly half of the Japanese patients in this study experienced skin adverse events following apalutamide administration. The time to apalutamide discontinuation after the incidence of skin adverse events was positively correlated with the worsening of these events. [ABSTRACT FROM AUTHOR]

Background: Japanese men receiving apalutamide often experience skin-adverse events (AEs), possibly requiring treatment interruption or dose reduction. However, concerns have arisen regarding the impact of these adjustments on the efficacy of apalutamide. Our study evaluated the efficacy, safety, and persistence of apalutamide in men with metastatic castration-sensitive prostate cancer (mCSPC)., Methods: We retrospectively reviewed the medical records of 108 men with mCSPC from 14 Japanese institutions. The primary outcomes were the efficacy of apalutamide: prostate-specific antigen (PSA) response (50%, 90% and < 0.2 decline) and progression to castration-resistant prostate cancer (CRPC). The secondary outcomes were the skin-AE and compliance of apalutamide., Results: PSA50%, PSA90% and PSA < 0.2 declines were observed in 89.8, 84.3 and 65.7%, and the median time to CRPC progression was not reached. PSA < 0.2 decline and an initial full dose of apalutamide were significantly associated with a longer time to CRPC. The most common AE was skin-AE (50.9%), and there was no association between the occurrence of skin-AE and the time to CRPC (P = 0.72). The median apalutamide persistence was 29 months, which was longer in the initial full dose recipients than in the reduced dose recipients. The dosage is reduced in about 60% of patients within the first year of treatment in the initial full dose recipients., Conclusions: Our findings indicate the effectiveness of apalutamide in Japanese men with mCSPC, despite a substantial portion requiring dose reduction within a year among the initial full dose recipients., (© The Author(s) 2023. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: More than 10 years have passed since the first nationwide study on the reasons for tooth extraction in Japan. In the present study, we conducted the second nationwide survey to update the previous data., Methods: This was a descriptive study. A sample population consisting of 5,250 dentists was selected by systematic random sampling using the 2018 membership directory of the Japan Dental Association. The reason for each permanent tooth extraction was documented by each dentist during a period of 1 week from June 4 to June 10, 2018. A questionnaire was provided for documentation. Reasons for tooth extraction were categorised into 6 groups as follows: caries, periodontal disease, fracture, orthodontics, impacted teeth, and others., Results: A total of 2345 identified dentists responded to the questionnaire (recovery rate: 44.8%). Information on 7809 extracted teeth from 6398 patients was obtained. Periodontal disease was the main reason for tooth extraction for both sexes (men: 40.4%, women: 34.9%). Caries accounted for 30.2% of tooth extractions among men and 29.0% among women. Periodontal disease was predominant in the groups older than 55 years of age. Dental fracture accounted for 16.8% of tooth extractions among men and 19.2% among women., Conclusions: Caries and periodontal disease are still the main reasons for tooth extraction in Japan. Moreover, dentists should note that fractures accounted for approximately one-fifth of permanent tooth extractions after the age of 45 years., Competing Interests: Conflict of Interest None disclosed., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

This report describes a validation study of data in the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) obtained by nationwide surveys on tooth extractions. The following 3 data sources on tooth extractions in Japan were compared: (1) the Nationwide Survey of the Reasons for Permanent Tooth Extractions in Japan (a previous survey conducted by the present authors); (2) the Statistics on Medical Care Activities in Public Health Insurance; and (3) the 4th NDB Open Data Japan. Source 1 was a nationwide survey conducted in 2018; sources 2 and 3 comprised data that are freely available for use by the public. In Source 1, 2,345 of 5,250 dentists approached responded to the questionnaire (recovery rate: 44.8%). The number of extracted teeth among younger age groups (aged 25-50 years) reported in Source 1 was lower than that in the other two sources. In contrast, the number of extracted teeth among older age groups reported in Source 1 was higher than that reported in the other two sources. However, when stratified by age group, all differences across the 3 sources regarding the mean annual number of tooth extractions were <0.05 teeth/year. The present results suggest that the NDB is a reliable resource for data on tooth extractions performed across the entire Japanese population.

Diabetes mellitus is closely related to oral health. We aimed to determine the relationship between diabetes mellitus and tooth extraction due to periodontal disease and dental caries. Japan's second nationwide survey data collected from 4 June to 10 June 2018 was used to identify reasons for tooth extraction among patients aged > 40 years. General dentists collected information on patients who underwent tooth extraction procedures, and the presence of diabetes mellitus was determined through interviews. Multivariable logistic regression was performed to investigate the relationship between diabetes mellitus and the reasons for tooth extraction, including periodontal disease and dental caries. In total, 2345 dentists responded to the survey (response rate 44.8%). We analyzed data on 4625 extracted teeth from 3750 patients (1815 males and 1935 females). Among patients with self-reported diabetes mellitus, 55.4% had extractions due to periodontal disease compared to 46.7% of such extractions among those without self-reported diabetes mellitus. Self-reported diabetes mellitus was significantly associated with tooth extraction due to periodontal disease. No significant differences were observed in dental caries according to self-reported diabetes mellitus status. This study provides further evidence of a significant association between diabetes mellitus and tooth extraction due to periodontal disease.

Coral microbial flora has been attracting attention because of their potential to protect corals from environmental stresses or pathogens. Although coral-associated bacteria are considered to be acquired from seawater, little is known about the relationships between microbial composition in corals and its surrounding seawater. Here, we tested several methods to identify coral-associated bacteria in coral and its surrounding seawater to detect specific types of Ruegeria species, some of which exhibit growth inhibition activities against the coral pathogen Vibrio coralliilyticus. We first isolated coral-associated bacteria from the reef-building coral Galaxea fascicularis collected at Sesoko Island, Okinawa, Japan, via random colony picking, which showed the existence of varieties of bacteria including Ruegeria species. Using newly constructed primers for colony PCR, several Ruegeria species were successfully isolated from G. fascicularis and seawater. We further investigated the seawater microbiome in association with the distance from coral reefs. By seasonal sampling, it was suggested that the seawater microbiome is more affected by seasonality than the distance from coral reefs. These methods and results may contribute to investigating and understanding the relationships between the presence of corals and microbial diversity in seawater, in addition to the efficient isolation of specific bacterial species from coral or its surrounding seawater., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

The Standard for Exchange of Nonclinical Data (SEND) has been adopted by the US FDA, which has required pharmaceutical companies who are developing new drugs for the US market to implement SEND. The Japan Pharmaceutical Manufacturers Association (JPMA) SEND Taskforce Team responded to this situation by starting a project to better understand the contents of SEND datasets. The project focused on domains generally included in the SEND domains for single- and repeat-dose general toxicology studies, and surveyed what kind of information are populated in which domains and in what way. The qualitative analysis of the results indicated that variations exist based on whether or not an individual variable was populated and on how the variable was populated. The Taskforce Team recommends reducing variations not only in the SEND datasets but also in the descriptions in the study protocol and/or final study report. Reduction of such variations should lead to higher quality datasets with powerful and increased searchability so that accumulated SEND datasets should become more valuable. These efforts would provide regulatory agencies with easier review of SEND datasets, which contributes to efficient development of new drug candidates., (Copyright © 2021 Elsevier Inc. All rights reserved.)