論文 - 樋之津　史郎

A new electronic medical record database linked to claims data and discharge abstract data (the RWD database) in Japan: Study design and profile.

Yasuyuki Okumura, Takashi Fujiwara, Hironobu Tokumasu, Takeshi Kimura, Shiro Hinotsu

Annals of clinical epidemiology   6 ( 3 ) 58 - 64  2024年  [国内誌]

　概要を見る

BACKGROUND: This article aims to introduce the Real World Database-a new clinical database in Japan. METHODS: The Health, Clinic, and Education Information Evaluation Institute and Real World Data Co., Ltd. began developing the Real World Database in 2015. This is an electronic medical record database linked to claims data and discharge abstract data from medical institutions in Japan. The institutions agreed to collect data from 218 medical institutions as of June 2021. RESULTS: In 2019, 82 medical institutions provided data, which showed that 2,184,666 patients received treatment at medical institutions. There were also 334,437 inpatients with at least one hospital stay and 2,011,628 outpatients with at least one visit. More than 200 laboratory test results were available. DISCUSSION: This database is a potential data source for producing descriptive studies, comparative effectiveness studies, studies of adverse effects, and prediction studies. CONCLUSIONS: The Real World Database provides an opportunity and strategy to produce real-world evidence for Japan.

DOI PubMed

Trends in Head and Neck Cancer Mortality from 1999 to 2019 in Japan: An Observational Analysis.

Tsukasa Higashionna, Keisaku Harada, Akinari Maruo, Takahiro Niimura, Elizabeth Tan, Quynh Thi Vu, Takayoshi Kawabata, Soichiro Ushio, Hirofumi Hamano, Makoto Kajizono, Yoshito Zamami, Keisuke Ishizawa, Ko Harada, Shiro Hinotsu, Mitsunobu R Kano, Hideharu Hagiya, Toshihiro Koyama

Cancers   15 ( 15 )  2023年07月  [国際誌]

　概要を見る

Globally, the numbers of head and neck cancer (HNC) cases and related deaths have recently increased. In Japan, few studies have examined crude or age-adjusted HNC mortality rates. Therefore, this study aimed to determine the trends in crude and age-adjusted mortality rates for HNC per million individuals in Japan from 1999 to 2019. Data on HNC-associated deaths were extracted from the national death certificate database using the International Classification of Diseases, Tenth Revision (n = 156,742). HNC mortality trends were analysed using joinpoint regression models to estimate annual percentage change (APC) and average APC (AAPC). Among men, no significant change was observed in the age-adjusted death rate trend from 1999 to 2014; however, a marked decrease was observed from 2014 to 2019. No changing point was observed in women. Age-adjusted mortality rates continuously decreased over the 21-year period, with an AAPC of -0.7% in men and -0.6% in women. In conclusion, the overall trend in age-adjusted rates of HNC-associated deaths decreased, particularly among men, in the past 5 years. These results will contribute to the formulation of medical policies to develop targeted screening and prevention programmes for HNC in Japan and determine the direction of treatment strategies.

DOI PubMed

Increasing disparities in cancer screening among people with severe mental illness during the COVID-19 pandemic.

Masaki Fujiwara, Yuto Yamada, Taichi Shimazu, Naoki Nakaya, Shiro Hinotsu, Maiko Fujimori, Yosuke Uchitomi, Masatoshi Inagaki

Schizophrenia research   258   18 - 20  2023年07月  [国際誌]

DOI PubMed

A multicenter, retrospective observational study investigating baseline characteristics and clinical outcomes in patients with hormone-sensitive prostate cancer treated with primary androgen deprivation therapy.

Satoru Taguchi, Mizuki Onozawa, Shiro Hinotsu, Taketo Kawai, Takeshi Mitomi, Satoshi Uno, Haruki Kume

Japanese journal of clinical oncology   53 ( 10 ) 957 - 965  2023年07月  [国際誌]

　概要を見る

OBJECTIVE: This multicenter, retrospective, observational study investigated baseline characteristics and clinical outcomes in patients with hormone-sensitive prostate cancer who received primary androgen deprivation therapy, using Japan Study Group of Prostate Cancer registry data. METHODS: Among patients in the Japan Study Group of Prostate Cancer registry, those who initiated primary androgen deprivation therapy and were aged 20 years or older were enrolled in this study. The primary endpoint was time to disease progression, defined as time from primary androgen deprivation therapy initiation to either prostate-specific antigen or clinical progression. Secondary endpoints included prostate-specific antigen progression-free survival, prostate-specific antigen response (90% or greater reduction from baseline) and distribution of second-line treatment. RESULTS: Of the 2494 patients (goserelin, n = 564; leuprorelin, n = 1148; surgical castration, n = 161; degarelix, n = 621), those who received degarelix had higher prostate-specific antigen levels and Gleason scores and were at a more advanced clinical stage than those receiving goserelin or leuprorelin. The median time to disease progression (identical to the prostate-specific antigen progression-free survival result) was not reached for goserelin and leuprorelin, 52.7 months for surgical castration and 54.0 months for degarelix. Although baseline prostate-specific antigen values in the degarelix cohort were higher than those of the leuprorelin or goserelin cohorts, prostate-specific antigen responses were not different among the three cohorts. Regarding second-line treatment, the largest patient group received degarelix followed by leuprorelin (n = 195). CONCLUSIONS: This study clarified patient characteristics and long-term effectiveness of primary androgen deprivation therapy in real-world clinical practice. Japanese urologists appear to select appropriate primary androgen deprivation therapy based on patient background and tumour characteristics, with degarelix largely reserved for higher risk patients.

DOI PubMed

Global trends of seasonal influenza-associated mortality in 2001-2018: A longitudinal epidemiological study.

Hideharu Hagiya, Yuka Osaki, Michio Yamamoto, Takahiro Niimura, Ko Harada, Tsukasa Higashionna, Hirofumi Hamano, Yoshito Zamami, Shiro Hinotsu, Toshihiro Koyama

The Journal of infection   87 ( 3 ) e54-e57  2023年06月  [国際誌]

DOI PubMed

Perceptions toward issues in cancer care for people with mental illness among psychiatric care providers: A questionnaire study.

Yuto Yamada, Masaki Fujiwara, Tsuyoshi Etoh, Riho Wada, Shinichiro Inoue, Yoshiko Mimaki, Masafumi Kodama, Yusaku Yoshimura, Shigeo Horii, Takanori Matsushita, Maiko Fujimori, Taichi Shimazu, Naoki Nakaya, Shiro Hinotsu, Masahiro Tabata, Kenji Tamura, Yosuke Uchitomi, Norihito Yamada, Kiwamu Nagoshi, Masatoshi Inagaki

Psycho-oncology   32 ( 7 ) 1022 - 1029  2023年04月  [国際誌]

　概要を見る

OBJECTIVES: To reduce cancer care disparities in people with mental illness, this study aimed to quantify psychiatric care providers' perceptions regarding issues that are insufficiently addressed or difficult to address. METHODS: Psychiatric care providers at 23 psychiatric hospitals in Japan were surveyed using mail questionnaires. Respondents were asked to rate 15 items with four categories related to insufficiencies/difficulties in cancer care for patients with mental illness on a five-point Likert scale. We analyzed the proportion of respondents who answered "insufficient/difficult" for each item. RESULTS: A total of 255 (76.3%) psychiatric care providers responded. For questions related to the skills and attitudes of psychiatric professionals, 48.3%-58.4% of respondents perceived that efforts for supporting cancer screening and treatment were insufficient. For the questions related to collaborations between cancer and psychiatric care providers, 75.3% of respondents perceived that inpatient visits between psychiatric and cancer hospitals were insufficient. For the questions related to in-psychiatric-hospital medical systems, 50.2%-87.2% of respondents perceived that support for screening, diagnosis/treatment, and palliative care for psychiatric inpatients were insufficient/difficult. 41.9%-57.4% of respondents perceived that social services in the community were insufficient. CONCLUSIONS: This study clarified the level of insufficiency/difficulty perceived by psychiatric care providers regarding issues related to cancer care for people with mental illness. Psychiatric care providers are required to have knowledge and skills in cancer screening and treatment. To improve access to cancer prevention, treatment, and palliative care, it may be helpful to establish systems to promote coordination between cancer hospitals and psychiatric hospitals.

DOI PubMed

ガイドライン・取扱い規約作成における関連学会との連携

石塚 修, 井川 掌, 樋之津 史郎, 西山 博之, 松本 洋明, 三塚 浩二

日本泌尿器科学会雑誌 ( (一社)日本泌尿器科学会 )  113 ( Suppl. ) S62 - S64  2022年11月

A novel ZC4H2 variant in a female with severe respiratory complications.

Tomohiro Wakabayashi, Miyako Mizukami, Kojiro Terada, Aki Ishikawa, Shiro Hinotsu, Masaki Kobayashi, Koji Kato, Tomoo Ogi, Takeshi Tsugawa, Akihiro Sakurai

Brain & development   44 ( 8 ) 571 - 577  2022年09月  [国際誌]

　概要を見る

INTRODUCTION: An X-linked ZC4H2 variant is associated with a variety of phenotypes that have abnormalities related to external malformation and neurodevelopment. There have been no reports on severe respiratory dysfunction resulting in surgical treatments not being possible due to the deformity resulting from in this disease. Here we report a female with arthrogryposis multiplex congenita with a severe respiratory complication. CASE: A two-year-old girl had arthrogryposis multiplex congenita at delivery and subsequently had hypotonia and feeding difficulty. A novel ZC4H2 frameshift variant was identified by whole-exome sequencing in her genome. At eight months, she had recurrent aspiration pneumonia. A tracheostomy and gastrostomy were required; however, surgical intervention was not possible because of her short neck and complicated airway. CONCLUSION: We compared this case with previous reports. The truncation group had more described phenotypes than the non-truncation group. The patient had the most severe respiratory dysfunction in truncating variant.

DOI PubMed

Nephrectomy Is Not Associated with Increased Risk of Mortality or Acute Kidney Injury after High-Grade Renal Trauma: A Propensity Score Analysis of the Trauma Quality Improvement Program (TQIP). Letter.

Keiko Fujino, Tetsuya Shindo, Shiro Hinotsu, Naoya Masumori

The Journal of urology     101097JU0000000000002892  2022年08月  [国際誌]

DOI PubMed

Health-related quality of life with enzalutamide versus flutamide in castration-resistant prostate cancer from the AFTERCAB study.

Hiroji Uemura, Kazuki Kobayashi, Akira Yokomizo, Shiro Hinotsu, Shigeo Horie, Yoshiyuki Kakehi, Norio Nonomura, Osamu Ogawa, Mototsugu Oya, Kazuhiro Suzuki, Atsushi Saito, Keiko Asakawa, Satoshi Uno, Seiji Naito

International journal of clinical oncology    2022年08月  [国内誌]

　概要を見る

BACKGROUND: Patient-reported outcome (PRO) measures can provide valuable information in evaluating patients' health-related quality of life (HRQoL). Post hoc analysis of the AFTERCAB study was conducted to evaluate the HRQoL benefit of enzalutamide plus androgen deprivation therapy (ADT) compared to flutamide plus ADT for the treatment of patients with castration-resistant prostate cancer (CRPC) in Japan. METHODS: The open-label AFTERCAB study was conducted from November 2016 to March 2020 in Japanese men aged ≥ 20 years with asymptomatic or mildly symptomatic CRPC. Patients received enzalutamide plus ADT or flutamide plus ADT, respectively, as first-line alternative androgen therapy (AAT). HRQoL was analyzed through the Functional Assessment of Cancer Therapy-Prostate, EuroQoL 5-Dimension 5-Level instruments, Brief Pain Inventory-Short Form, and Brief Fatigue Inventory. The longitudinal changes in HRQoL, HRQoL deterioration based on minimally important difference (MID), and time to HRQoL deterioration were evaluated for first-line AAT. RESULTS: Overall, HRQoL between the enzalutamide and flutamide groups was similar during first-line treatment. No statistically significant HRQoL difference in change from baseline to week 61 (least square mean difference; p value) was observed. Furthermore, proportions of pain progression, symptom worsening, and HRQoL deterioration based on MID, were not significantly different between groups. CONCLUSIONS: The results were similar in all subscales of each PRO, demonstrating similar HRQoL deterioration based on MID criteria between the enzalutamide and flutamide groups.

DOI PubMed

Summary of the Clinical Practice Guidelines for Penile Cancer 2021 by the Japanese Urological Association.

Takahiro Yamaguchi, Yutaka Sugiyama, Toshiaki Tanaka, Tomokazu Kimura, Yasushi Yumura, Masahiro Nakano, Takayuki Sugiyama, Noriyoshi Miura, Masato Goya, Akira Yamamoto, Satoru Takahashi, Yuji Miura, Toyonori Tsuzuki, Naoya Masumori, Hiroyuki Nishiyama, Masahiro Yao, Takuya Koie, Hideaki Miyake, Takashi Saika, Seiichi Saito, Tetsuo Akimoto, Tsutomu Tamada, Yuichi Ando, Satoru Takahashi, Takaaki Suzuki, Shiro Hinotsu, Tomomi Kamba

International journal of urology : official journal of the Japanese Urological Association   29 ( 8 ) 780 - 792  2022年08月  [国際誌]

　概要を見る

Penile cancer is a rare cancer for which no medical guidelines have been established before in Japan. These guidelines aim to standardize, as much as possible, the therapeutic modality for penile cancer, for which empirical evidence is limited on a global scale, thereby bolstering therapeutic outcomes for patients with penile cancer. The new guidelines conform to the Minds Guide for Developing Clinical Practice Guidelines (2017) as much as possible. However, virtually no randomized comparative studies and meta-analyses based on such randomized studies have been conducted. Therefore, only the findings available at present were listed after conducting an exhaustive literature review of items with extremely low evidence levels and for which bodies of evidence and grades of recommendation were not evaluated. Clinical questions were set for items with a relatively large number of studies, including retrospective studies. However, since it is virtually impracticable to summarize bodies of evidence by systematic reviews, recommendation grades and evidence levels were discussed and determined by the consensus panel of the Preparatory Committee. The following were outlined: epidemiological, pathological, diagnostic, therapeutic, follow-up, and quality of life-related findings. Additionally, seven clinical questions were established to determine recommendation grades and evidence levels. We hope that these guidelines will prove to be useful to medical professionals engaged in clinical practice related to penile cancer in Japan and anticipate that critical reviews of the guidelines will lead to further refinement of the next edition.

DOI PubMed

Issues of cancer care in people with mental disorders as perceived by cancer care providers: A quantitative questionnaire survey.

Yuto Yamada, Masaki Fujiwara, Tsuyoshi Etoh, Riho Wada, Shinichiro Inoue, Masafumi Kodama, Yusaku Yoshimura, Shigeo Horii, Takanori Matsushita, Maiko Fujimori, Taichi Shimazu, Naoki Nakaya, Shiro Hinotsu, Masahiro Tabata, Kenji Tamura, Yosuke Uchitomi, Norihito Yamada, Masatoshi Inagaki

Psycho-oncology   31 ( 9 ) 1572 - 1580  2022年06月  [国際誌]

　概要を見る

OBJECTIVES: To reduce cancer care disparities, this study aimed to clarify the difficulties in cancer care for people with mental disorders as perceived by cancer care providers. METHODS: Cancer care providers at 17 designated cancer hospitals in Japan were surveyed using mail questionnaires. Respondents were asked to rate 29 items related to difficulties or insufficiencies in cancer care for patients with mental disorders on a five-point Likert scale. We analyzed the proportion of respondents who answered "difficult/insufficient" in each item. We also calculated the proportions of responders stratified according to the presence of psychiatric support systems within their hospitals. RESULTS: A total of 388 (58.4%) cancer care providers responded. Among the issues related to "difficulties in diagnosing and treating cancer," support for decision-making, assessment of treatment adherence, and assessment of physical symptoms were perceived as most difficult (73.5%-81.5% of respondents). Among the issues related to 'difficulties or insufficiencies in collaboration among multidisciplinary health care providers,' the issue of advance consultation and sharing information with the patient's primary psychiatric care provider was perceived as most difficult (52.2%). Among the issues related to "insufficiencies of in-hospital and community medical systems," education to provide reasonable accommodation was perceived as most insufficient (47.4%). The perceived difficulties of over half of the issues varied significantly between hospitals depending on the level of psychiatric support systems. CONCLUSIONS: This study clarified the difficulties of cancer care in patients with mental disorders as perceived by cancer care providers. Some issues may be resolved by psychiatric liaison teams.

DOI PubMed

Patients' acceptability and implementation outcomes of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia: a qualitative secondary analysis of a mixed-method randomised clinical trial.

Yuto Yamada, Masaki Fujiwara, Taichi Shimazu, Tsuyoshi Etoh, Masafumi Kodama, Ryuhei So, Takanori Matsushita, Yusaku Yoshimura, Shigeo Horii, Maiko Fujimori, Hirokazu Takahashi, Naoki Nakaya, Tempei Miyaji, Shiro Hinotsu, Keita Harada, Hiroyuki Okada, Yosuke Uchitomi, Norihito Yamada, Masatoshi Inagaki

BMJ open   12 ( 6 ) e060621  2022年06月  [国際誌]

　概要を見る

OBJECTIVES: We examined the efficacy of case management (CM) interventions to encourage participation in colorectal cancer screening for patients with schizophrenia. This study aimed to clarify patients' acceptability of the intervention and the helpful components of the intervention. Simultaneously, the study aimed to determine the acceptability, appropriateness and feasibility of the intervention from the perspective of psychiatric care providers. STUDY DESIGN AND SETTING: This study was a secondary qualitative analysis of a mixed-method randomised controlled trial that evaluated the efficacy of the CM approach to encourage participation in cancer screening for people with schizophrenia. The intervention comprised education and patient navigation for colorectal cancer screening. Interviews were conducted with patients who received the intervention and staff from two psychiatric hospitals in Japan who delivered the intervention. PARTICIPANTS: Of the 172 patients with schizophrenia who participated in the trial, 153 were included. In addition, three out of six providers were included. DATA COLLECTION AND ANALYSIS: Using a structured interview, the case manager asked participants about patient acceptability and the helpful components of the intervention. Content analysis was conducted for the responses obtained, and the number of responses was tabulated by two researchers. For the interviews with the providers, opinions obtained from verbatim transcripts were extracted and summarised. RESULTS: Forty-three of the 56 patients perceived that the intervention was acceptable. For the intervention component, inperson counselling with an explanation of the screening process by psychiatric care providers was most frequently reported by the patients as helpful (48 of the 68 respondents). Psychiatric care providers evaluated the intervention as acceptable, appropriate and easy to understand and administer. However, providing the intervention to all patients simultaneously was considered difficult with the current human resources. CONCLUSIONS: This study showed that the CM intervention was perceived as acceptable by patients and acceptable and appropriate by psychiatric care providers. TRIAL REGISTRATION NUMBER: UMIN000036017.

DOI PubMed

Are there differences in the characteristics of patients who respond to gemcitabine plus cisplatin chemotherapy and those who respond to pembrolizumab therapy for metastatic urothelial carcinoma? Multicenter retrospective study.

Tetsuya Shindo, Takeshi Maehana, Toshiaki Tanaka, Kohei Hashimoto, Ko Kobayashi, Atsushi Takahashi, Hiroshi Hotta, Yasuharu Kunishima, Keisuke Taguchi, Hitoshi Tachiki, Naoki Ito, Masanori Matsukawa, Ryuichi Kato, Shintaro Miyamoto, Shiro Hinotsu, Naoya Masumori

International journal of urology : official journal of the Japanese Urological Association    2022年06月  [国際誌]

　概要を見る

OBJECTIVES: To evaluate factors to predict overall survival of metastatic urothelial carcinoma patients treated with gemcitabine plus cisplatin chemotherapy or pembrolizumab therapy. METHODS: We retrospectively evaluated two metastatic urothelial carcinoma cohorts treated with (i) gemcitabine plus cisplatin or (ii) pembrolizumab. The gemcitabine plus cisplatin cohort was treated from December 2005 through December 2014 while the pembrolizumab cohort was treated from January 2018 through December 2020. Using multivariate analyses, we evaluated the risk factors for overall survival in each cohort and compared them. None of the gemcitabine plus cisplatin cohort patients were treated with pembrolizumab. All patients in the pembrolizumab cohort were treated with prior platinum-based chemotherapy. RESULTS: There were 184 patients in the gemcitabine plus cisplatin cohort and 91 in the pembrolizumab cohort. The mean follow-up periods were 714 and 284 days, respectively. In multivariate analysis, the risk factors for overall survival in the gemcitabine plus cisplatin cohort were liver metastasis, worse Eastern Cooperative Oncology Group performance status (1 or more), no primary site resection, and a high prognostic index (1 or more). In the pembrolizumab cohort, liver metastasis, bone metastasis, and worse Eastern Cooperative Oncology Group-performance status (1 or more), and high prognostic index (1 or more) were the risk factors for overall survival. In the pembrolizumab cohort, patients with a complete response or partial response during prior platinum-based chemotherapy had better overall survival with the following pembrolizumab treatment than those with stable or progressive disease (P = 0.004). CONCLUSIONS: Considering the similarity of these risk factors in two sequential treatments, it may be possible to predict the response to pembrolizumab according to the response to prior chemotherapy.

DOI PubMed

統合失調症患者に対するがん検診勧奨法の質的評価 混合研究法を用いた無作為化比較試験の二次解析

山田 裕士, 藤原 雅樹, 島津 太一, 江藤 剛, 児玉 匡史, 宋 龍平, 松下 貴紀, 吉村 優作, 堀井 茂男, 藤森 麻衣子, 高橋 宏和, 中谷 直樹, 宮路 天平, 樋之津 史郎, 原田 馨太, 岡田 裕之, 内富 庸介, 山田 了士, 稲垣 正俊

精神神経学雑誌 ( (公社)日本精神神経学会 )  124 ( 4付録 ) S - 373  2022年04月

精神科臨床場面における多職種協働によるがん検診の受診勧奨法のランダム化比較試験

藤原 雅樹, 山田 裕士, 島津 太一, 児玉 匡史, 宋 龍平, 松下 貴紀, 吉村 優作, 堀井 茂男, 藤森 麻衣子, 高橋 宏和, 中谷 直樹, 掛田 恭子, 宮路 天平, 樋之津 史郎, 原田 馨太, 岡田 裕之, 内富 庸介, 山田 了士, 稲垣 正俊

精神神経学雑誌 ( (公社)日本精神神経学会 )  124 ( 4付録 ) S - 643  2022年04月

Prognostic usefulness of a modified risk model for solitary fibrous tumor that includes the Ki-67 labeling index.

Shintaro Sugita, Keiko Segawa, Noriaki Kikuchi, Tomoko Takenami, Tomomi Kido, Makoto Emori, Yukinori Akiyama, Kohichi Takada, Shiro Hinotsu, Tadashi Hasegawa

World journal of surgical oncology   20 ( 1 ) 29 - 29  2022年02月  [国際誌]

　概要を見る

BACKGROUND: Predicting the prognosis of patients with solitary fibrous tumor (SFT) is often difficult. The prognostic risk models developed by Demicco et al. are now the standard for evaluating the risk of SFT metastasis in the current World Health Organization classification of soft tissue and bone tumors. METHODS: In this study, we examined the prognostic usefulness of a modified version of the Demicco risk models that replaces the mitotic count with the Ki-67 labeling index. We compared the three-variable and four-variable Demicco risk models with our modified risk models using Kaplan-Meier curves based on data for 43 patients with SFT. RESULTS: We found a significant difference in metastasis-free survival when patients were classified into low-risk and intermediate/high-risk groups using the three-variable (P = 0.022) and four-variable (P = 0.046) Demicco models. There was also a significant difference in metastasis-free survival between the low-risk and intermediate/high-risk groups when the modified three-variable (P = 0.006) and four-variable (P = 0.022) models were used. CONCLUSION: Modified risk models that include the Ki-67 labeling index are effective for prediction of the prognosis in patients with SFT.

DOI PubMed

Enzalutamide + androgen deprivation therapy (ADT) versus flutamide + ADT in Japanese men with castration-resistant prostate cancer: AFTERCAB study.

Hiroji Uemura, Kazuki Kobayashi, Akira Yokomizo, Shiro Hinotsu, Shigeo Horie, Yoshiyuki Kakehi, Seiji Naito, Norio Nonomura, Osamu Ogawa, Mototsugu Oya, Kazuhiro Suzuki, Atsushi Saito, Satoshi Uno, Hideyuki Akaza

BJUI compass   3 ( 1 ) 26 - 36  2022年01月  [国際誌]

　概要を見る

Objectives: The objective of the study is to compare the efficacy and safety of alternative androgen therapy (AAT) with enzalutamide + androgen deprivation therapy (ADT) and flutamide + ADT in the treatment of Japanese men with metastatic or nonmetastatic castration-resistant prostate cancer (CRPC) who progressed despite combined androgen blockade (CAB) with bicalutamide + ADT. AAT treatment sequence was also investigated. Materials and methods: The open-label, Phase 4 AFTERCAB study (NCT02918968) was conducted from November 2016 to March 2020 in Japanese men aged ≥20 years with asymptomatic or mildly symptomatic CRPC. Patients were initially randomized to enzalutamide (160 mg/day) + ADT (enzalutamide first) or flutamide (375mg/day [125mg three times daily]) + ADT (flutamide first) as first-line therapy. Following prostate-specific antigen (PSA) progression, other disease progression, or discontinuation of first-line therapy due to an adverse event (AE), patients switched to the other treatment as second-line therapy. The primary endpoint was time to PSA progression with first-line therapy (TTPP1). Secondary endpoints included TTPP2 (TTPP1 + time to PSA progression with second-line therapy). AEs were monitored to assess safety. Results: Overall, 206 men were randomized (enzalutamide first, n = 102; flutamide first, n = 104) and stratified by study site and disease stage; 133 patients transitioned to second-line therapy (enzalutamide first, n = 48; flutamide first, n = 85). TTPP1 was significantly improved with enzalutamide first versus flutamide first (median 21.4 months vs. 5.8 months; hazard ratio [HR] 0.42; 95% confidence interval [CI] [0.29, 0.61]). TTPP2 was numerically improved with enzalutamide first versus flutamide first (median not reached vs. 21.2 months; HR 0.76; 95% CI [0.48, 1.19]). Both treatments were generally well tolerated, with AEs consistent with their known safety profiles. Conclusion: First-line AAT with enzalutamide + ADT provided a significant improvement in time to PSA progression versus flutamide + ADT. Enzalutamide + ADT may therefore be the preferred first-line AAT option in Japanese men with metastatic or nonmetastatic CRPC who progress despite CAB with bicalutamide + ADT.

DOI PubMed

Decrease in unscheduled pediatric outpatient visits due to SARS-CoV-2.

Tomohiro Wakabayashi, Yuta Sasaoka, Yoshiyuki Sakai, Shiro Hinotsu, Yukihiko Kawasaki

Pediatrics international : official journal of the Japan Pediatric Society   64 ( 1 ) e14748  2022年01月  [国際誌]

DOI PubMed

長期間無再発で経過した筋層非浸潤性膀胱癌術後患者における再発リスクの解析

平田 由里絵, 大澤 崇宏, 樋口 まどか, 樋之津 史郎, 原林 透, 望月 端吾, 榎並 宣裕, 能中 修, 信野 祐一郎, 菊地 央, 松本 隆児, 安部 崇重, 篠原 信雄

日本泌尿器科学会総会 ( (一社)日本泌尿器科学会総会事務局 )  109回   OP45 - 01  2021年12月