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Article: Multidisciplinary Discussion for Fibrotic Hypersensitivity Pneumonitis with a Positive Antigen Avoidance.

Okuda, Ryo / Takemura, Tamiko / Misumi, Toshihiro / Hagiwara, Eri / Ogura, Takashi

2023 Volume 16, Page(s) 473–479

Abstract: Background: In the two fibrotic hypersensitivity pneumonitis (fHP) diagnostic guidelines, the multidisciplinary discussion (MDD) is required to be performed in diagnosis of fHP, as in idiopathic pulmonary fibrosis (IPF) diagnostic guideline. Although ... ...

Abstract	Background: In the two fibrotic hypersensitivity pneumonitis (fHP) diagnostic guidelines, the multidisciplinary discussion (MDD) is required to be performed in diagnosis of fHP, as in idiopathic pulmonary fibrosis (IPF) diagnostic guideline. Although some patients with fHP can improve disease condition during antigen avoidance, which can facilitate the diagnosis of fHP, it is unclear if MDD is necessary in all patients with suspected fHP who improved an antigen avoidance. Objective: To investigate the diagnosis of fHP via MDD with positive antigen avoidance tests (AATs) and the clinical diagnosis with positive AATs. Methods: A single-center, retrospective study was conducted. Between 2012 and 2019, patients with fHP were enrolled in the study. Patients in the MDD diagnostic group consisted of patients diagnosed with MDD, including histopathology findings and positive ATTs, and patients in the clinical diagnostic group were diagnosed by two respiratory physicians and had positive ATTs. Results: AAT was performed on 72 of 219 patients, and 58 had positive AATs. The study included 37 patients in the MDD diagnosis group and 21 patients in the clinical diagnosis group. No significant differences in overall survival (OS) were detected between the two groups (HR: 1.99 [95% CI: 0.82‒4.83], Conclusion: In patients with positive AATs, the disease progression of the MDD diagnostic and the clinical diagnostic groups were similar. Therefore, MDD could not be necessary in all patients with suspected fHP who had positive AATs.
Language	English
Publishing date	2023-05-04
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2494877-9
ISSN	1178-6965
ISSN	1178-6965
DOI	10.2147/JAA.S409042
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Article ; Online: Multiple imputation for longitudinal data using Bayesian lasso imputation model.

Yamaguchi, Yusuke / Yoshida, Satoshi / Misumi, Toshihiro / Maruo, Kazushi

Statistics in medicine

2022 Volume 41, Issue 6, Page(s) 1042–1058

Abstract: Multiple imputation is a promising approach to handle missing data and is widely used in analysis of longitudinal clinical studies. A key consideration in the implementation of multiple imputation is to obtain accurate imputed values by specifying an ... ...

Abstract	Multiple imputation is a promising approach to handle missing data and is widely used in analysis of longitudinal clinical studies. A key consideration in the implementation of multiple imputation is to obtain accurate imputed values by specifying an imputation model that incorporates auxiliary variables potentially associated with missing variables. The use of informative auxiliary variables is known to be beneficial to make the missing at random assumption more plausible and help to reduce uncertainty of the imputations; however, it is not straightforward to pre-specify them in many cases. We propose a data-driven specification of the imputation model using Bayesian lasso in the context of longitudinal clinical study, and develop a built-in function of the Bayesian lasso imputation model which is performed within the framework of multiple imputation using chained equations. A simulation study suggested that the Bayesian lasso imputation model worked well in a variety of longitudinal study settings, providing unbiased treatment effect estimates with well-controlled type I error rates and coverage probabilities of the confidence interval; in contrast, ignorance of the informative auxiliary variables led to serious bias and inflation of type I error rate. Moreover, the Bayesian lasso imputation model offered higher statistical powers compared with conventional imputation methods. In our simulation study, the gains in statistical power were remarkable when the sample size was small relative to the number of auxiliary variables. An illustration through a real example also suggested that the Bayesian lasso imputation model could give smaller standard errors of the treatment effect estimate.
MeSH term(s)	Bayes Theorem ; Bias ; Computer Simulation ; Data Interpretation, Statistical ; Humans ; Longitudinal Studies ; Models, Statistical
Language	English
Publishing date	2022-01-21
Publishing country	England
Document type	Journal Article
ZDB-ID	843037-8
ISSN	1097-0258 ; 0277-6715
ISSN (online)	1097-0258
ISSN	0277-6715
DOI	10.1002/sim.9315
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Article ; Online: Prognosis of IPF patients with comorbid lung cancer: Preventing immortal time bias will make the analysis more valuable.

Yamada, Sho / Ikeda, Satoshi / Misumi, Toshihiro / Sekine, Akimasa / Ogura, Takashi

Respirology (Carlton, Vic.)

2022 Volume 28, Issue 2, Page(s) 196–197

MeSH term(s)	Humans ; Lung Neoplasms/complications ; Lung Neoplasms/epidemiology ; Prognosis ; Idiopathic Pulmonary Fibrosis/complications ; Idiopathic Pulmonary Fibrosis/epidemiology
Language	English
Publishing date	2022-12-12
Publishing country	Australia
Document type	Letter ; Comment
ZDB-ID	1435849-9
ISSN	1440-1843 ; 1323-7799
ISSN (online)	1440-1843
ISSN	1323-7799
DOI	10.1111/resp.14436
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Article ; Online: Immune Checkpoint Inhibitor-Induced Pneumonitis in Patients With Non-Small Cell Lung Cancer and Preexisting Interstitial Lung Diseases: Really Mild and Easily Manageable?

Ikeda, Satoshi / Misumi, Toshihiro / Kato, Terufumi / Okamoto, Hiroaki / Ogura, Takashi

Chest

2022 Volume 162, Issue 1, Page(s) e65–e66

MeSH term(s)	Carcinoma, Non-Small-Cell Lung/drug therapy ; Humans ; Immune Checkpoint Inhibitors ; Lung Diseases, Interstitial/chemically induced ; Lung Neoplasms/drug therapy ; Pneumonia/chemically induced ; Retrospective Studies
Chemical Substances	Immune Checkpoint Inhibitors
Language	English
Publishing date	2022-06-15
Publishing country	United States
Document type	Letter ; Research Support, Non-U.S. Gov't ; Comment
ZDB-ID	1032552-9
ISSN	1931-3543 ; 0012-3692
ISSN (online)	1931-3543
ISSN	0012-3692
DOI	10.1016/j.chest.2022.02.057
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Ui III Zs.45: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Laparoscopic repair of hepatic herniation through a ventral incisional hernia: a case report.

Misumi, Toshihiro / Nishihara, Masahiro / Sugino, Keizo / Kawasaki, Yukari

Journal of medical case reports

2021 Volume 15, Issue 1, Page(s) 56

Abstract: Background: Ventral incisional hernia is a common problem after abdominal surgery. Most patients with these hernias present with greater omentum and gastrointestinal prolapse. However, hepatic herniation through a ventral incisional hernia is a rare ... ...

Abstract	Background: Ventral incisional hernia is a common problem after abdominal surgery. Most patients with these hernias present with greater omentum and gastrointestinal prolapse. However, hepatic herniation through a ventral incisional hernia is a rare phenomenon that has been seldom reported in the literature. We report the case of a ventral incisional hernia with hepatic herniation treated with laparoscopic repair. Case presentation: A 68-year-old Japanese women with a history of myocardial resection for hypertrophic cardiomyopathy 1 year earlier was admitted to our hospital with symptoms of vomiting and epigastric pain. Physical examination showed a 4-cm epigastric mass. Abdominal computed tomography revealed left hepatic lobe herniation through the lower edge of a mid-sternal incision. We diagnosed the patient with a ventral incisional hernia with hepatic herniation. The patient underwent laparoscopic hernia repair. During an 18-month follow-up, no recurrence or symptoms have been observed. Conclusions: To the best of our knowledge, this is the first case report of laparoscopic repair of ventral incisional hernias with hepatic herniation. Laparoscopic repair was useful and suitable for this rare herniation due to its minimally invasive nature and ability to achieve sufficient visibility of the surgical field. Laparoscopic repair could be a potential treatment option for elective surgery for this disease, which is often treated conservatively.
MeSH term(s)	Aged ; Female ; Hernia, Ventral/diagnostic imaging ; Hernia, Ventral/surgery ; Herniorrhaphy ; Humans ; Incisional Hernia/surgery ; Laparoscopy ; Recurrence ; Surgical Mesh
Language	English
Publishing date	2021-02-12
Publishing country	England
Document type	Case Reports ; Journal Article
ZDB-ID	2269805-X
ISSN	1752-1947 ; 1752-1947
ISSN (online)	1752-1947
ISSN	1752-1947
DOI	10.1186/s13256-021-02682-z
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Article: [Integration Process of Clinical Trial Data in ARCAD-Asia].

Bando, Hideaki / Takeda, Yuriko / Misumi, Toshihiro / Suzuki, Motoko / Wakabayashi, Masashi / Ohtsu, Atsushi / Yoshino, Takayuki

Gan to kagaku ryoho. Cancer & chemotherapy

2023 Volume 50, Issue 10, Page(s) 1021–1026

Abstract: In Europe and the United States, the Foundation Aide et Recherche en Cancérologie Digestive(ARCAD)database project was initiated in 2006 and 43,488 patient data(IPD)for metastatic colorectal cancer from 59 trials have been collected and constructed as ... ...

Abstract	In Europe and the United States, the Foundation Aide et Recherche en Cancérologie Digestive(ARCAD)database project was initiated in 2006 and 43,488 patient data(IPD)for metastatic colorectal cancer from 59 trials have been collected and constructed as the integrated database. The ARCAD-Asia was launched in 2021 and has been actively collecting Asian clinical trials and converted IPD are stored into the integrated database. In addition, the ARCAD-Asian data are transferred to ARCAD and IPD are integrated to ARCAD global database. All the data are shared with 3 data centers of ARCAD-Asia and ARCAD, located in France, the United States and Japan. In the ARCAD database, there are 1,673 IPD treated with placebo in a salvage line setting. We are now planning to utilize placebo IPD as the synthetic control arms(SCAs)to compare the efficacies of active agents. Furthermore, we will continue to collect the Asian IPD and will expand the cancer type, leading to more comprehensive global database.
MeSH term(s)	Humans ; Asia ; Colonic Neoplasms ; Colorectal Neoplasms/pathology ; Databases, Factual ; Rectal Neoplasms ; Clinical Trials as Topic
Language	Japanese
Publishing date	2023-11-25
Publishing country	Japan
Document type	English Abstract ; Journal Article
ZDB-ID	604842-0
ISSN	0385-0684
ISSN	0385-0684
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Article ; Online: Trends in oncology drug lags in Japan from 2001 to 2020: A cross-sectional study.

Maeda, Hideki / Hara, Asuka / Ofuchi, Momoka / Shingai, Riko / Misumi, Toshihiro / Murai, Yuna

Clinical and translational science

2023 Volume 16, Issue 12, Page(s) 2665–2674

Abstract: Anticancer drugs are essential in the treatment of serious diseases, but their applications are limited by drug lags. This study investigated the characteristics of anticancer drugs approved in Japan over the past 20 years and compared the drug lag ... ...

Abstract	Anticancer drugs are essential in the treatment of serious diseases, but their applications are limited by drug lags. This study investigated the characteristics of anticancer drugs approved in Japan over the past 20 years and compared the drug lag trends between Japan and the US. We assessed the changes in drug lag between Japan and the US and the factors affecting the drug lags using publicly available data for anticancer drugs approved in Japan from January 2001 to December 2020. A total of 299 anticancer drugs were approved in Japan in the last 20 years. The approval lag median between the US and Japan was 498 days (16.6 months), peaking in 2002, and decreasing annually thereafter. The minimum approval lag was 173.5 days (5.7 months) in 2018. Multivariate regression analysis revealed that "global simultaneous strategy," "catch-up strategy," and "immunotherapy" are major factors shortening the drug lag. In the past decade, 226 anticancer drugs were approved in Japan. The drug lag for anticancer drugs between Japan and the US peaked in 2002, after which it declined sharply to less than a year. However, the lag was shortest in 2018.
MeSH term(s)	Humans ; Cross-Sectional Studies ; Japan ; Time Factors ; Drug Approval ; Antineoplastic Agents/therapeutic use
Chemical Substances	Antineoplastic Agents
Language	English
Publishing date	2023-10-17
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2433157-0
ISSN	1752-8062 ; 1752-8054
ISSN (online)	1752-8062
ISSN	1752-8054
DOI	10.1111/cts.13660
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Article ; Online: Optimizing Sequential Treatment With EGFR Tyrosine Kinase Inhibitor With a Simulation of the T790M Mutation Rate in

Haratake, Naoki / Misumi, Toshihiro / Yamanaka, Takeharu / Seto, Takashi

JTO clinical and research reports

2020 Volume 1, Issue 4, Page(s) 100085

Abstract: Introduction: The mutation rate of T790M might change the effective therapeutic sequence of EGFR tyrosine kinase inhibitors (TKIs). This simulation estimates the T790M positivity rate required for first-line first- or second-generation EGFR TKI to ... ...

Abstract	Introduction: The mutation rate of T790M might change the effective therapeutic sequence of EGFR tyrosine kinase inhibitors (TKIs). This simulation estimates the T790M positivity rate required for first-line first- or second-generation EGFR TKI to exceed overall progression-free survival (PFS) of first-line osimertinib. Methods: The PFS of each treatment with EGFR TKIs as first-line treatment, with osimertinib as second-line treatment among T790M-positive cases, and chemotherapy as second-line treatment among T790M-negative cases was set based on phase 3 trials. Overall PFS A of "upfront osimertinib" and overall PFS B of "first- or second-generation EGFR TKIs followed by osimertinib or chemotherapy" were simulated at different T790M mutation rates, to estimate the T790M mutation rate at which PFS B exceeds PFS A. Results: Upfront osimertinib: In the setting of PFS of 19 months with first-line osimertinib, the median overall PFS A was 24.8 months (95% confidence interval [CI]: 21.6-28.0 mo). Upfront first- or second-generation EGFR TKI: When the T790M positivity rate was set to 50% and the PFS of second-line osimertinib was 10 months, the total median PFS (PFS B) was 20.2 months (95% CI: 17.5-22.9 mo). Even at a T790M mutation rate of 100%, PFS B (24.7 mo; 95% CI: 21.9-27.9 mo) was shorter than PFS A. Conclusions: Even with a T790M mutation rate of 100%, upfront osimertinib treatment is associated with better median PFS than the upfront treatment with first- or second-generation EGFR TKIs. Consistent with the results of the FLAURA trial, with regard to EGFR TKI monotherapy in the first-line treatment, upfront osimertinib would contribute to good prognosis.
Language	English
Publishing date	2020-08-21
Publishing country	United States
Document type	Journal Article
ISSN	2666-3643
ISSN (online)	2666-3643
DOI	10.1016/j.jtocrr.2020.100085
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Article: [Long-Term Survival in a Patient with Abdominal Wall Metastasis of Early Gastric Cancer-A Case Report].

Misumi, Toshihiro / Nishihara, Masahiro / Sugino, Keizo / Kawasaki, Yukari

Gan to kagaku ryoho. Cancer & chemotherapy

2020 Volume 46, Issue 13, Page(s) 2562–2564

Abstract: A 76-year-old man was diagnosed with type 1 early gastric cancer. Attempted ESD on the lesion resulted in perforation, and distal gastrectomy with D1+dissection was performed. After 1 year and 6 months, a mass measuring 2.4 cm appeared in the abdominal ... ...

Abstract	A 76-year-old man was diagnosed with type 1 early gastric cancer. Attempted ESD on the lesion resulted in perforation, and distal gastrectomy with D1+dissection was performed. After 1 year and 6 months, a mass measuring 2.4 cm appeared in the abdominal wall. Cytological examination revealed adenocarcinoma, and the patient was diagnosed with abdominal wall metastasis of gastric cancer. There were no evidences of recurrence in the other organs, and extraction was performed. After 6 months, 1 year, and 2 years, the same metastases were found in the abdominal wall, and repeated extractions were performed. All 4 masses had resulted from the metastasis of gastric cancer, but the patient has been alive without recurrence for 1 year and 6 months after the surgery.
MeSH term(s)	Abdominal Wall ; Adenocarcinoma/secondary ; Aged ; Dissection ; Gastrectomy ; Humans ; Male ; Neoplasm Recurrence, Local ; Stomach Neoplasms
Language	Japanese
Publishing date	2020-03-10
Publishing country	Japan
Document type	Case Reports ; Journal Article
ZDB-ID	604842-0
ISSN	0385-0684
ISSN	0385-0684
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Article ; Online: Impact of gestational diabetes mellitus diagnosed during the third trimester on pregnancy outcomes: a case-control study.

Shindo, Ryosuke / Aoki, Shigeru / Nakanishi, Sayuri / Misumi, Toshihiro / Miyagi, Etsuko

BMC pregnancy and childbirth

2021 Volume 21, Issue 1, Page(s) 246

Abstract: Background: In 2010, the International Association of Diabetes and Pregnancy Study Group (IADPSG) proposed new criteria indicating that gestational diabetes mellitus (GDM) can be diagnosed if the fasting threshold of ≤92 mg/dL, 1-h threshold of ≤180 mg/ ... ...

Abstract	Background: In 2010, the International Association of Diabetes and Pregnancy Study Group (IADPSG) proposed new criteria indicating that gestational diabetes mellitus (GDM) can be diagnosed if the fasting threshold of ≤92 mg/dL, 1-h threshold of ≤180 mg/dL, or 2-h threshold of ≤153 mg/dL are exceeded during the 75-g 2-h oral glucose tolerance test (OGTT) performed at 24-28 weeks of gestation. The World Health Organization (WHO) recommends using the proposed diagnostic threshold values of the IADPSG to diagnose GDM; however, it does not limit the timing of the 75-g OGTT. Since 2010 in Japan, GDM has been diagnosed using the same criteria as that proposed by the WHO. However, neither the JSOG nor the WHO has provided any evidence that it is appropriate to use a threshold beyond the range recommended by the IADPSG. Methods: This was a single-centre retrospective study based on the medical records and delivery registry database of our centre. We included women who underwent a 50-g glucose challenge test (GCT) with results < 140 mg/dL at 24-28 weeks of gestation and subsequently underwent a 75-g OGTT after 29 weeks of gestation with abnormal glucose tolerance suspected based on clinical findings. The reference values for the 75-g OGTT followed the IADPSG criteria. Subjects were classified into the normal glucose tolerance (NGT) group and the GDM group. The type of delivery and neonatal outcomes of the two groups were compared. A multivariable analysis was performed to match the backgrounds of both groups. Results: In total, the NGT and GDM group comprised 189 and 49 women, respectively. Emergency caesarean delivery rates were similar in the GDM and NGT groups (10.6 and 12.2%, respectively; adjusted odds ratio [OR], 1.25; 95% confidence interval [CI], 0.43-3.64; p = 0.74); however, the elective caesarean delivery rate was higher in the GDM group than in the NGT group (16.3 and 5.3%, respectively, adjusted OR, 3.60; 95% CI, 1.27-10.19; p = 0.01). No significant differences were observed in other maternal and neonatal outcomes between both groups. Conclusion: Although a diagnosis of GDM during the third trimester does not improve pregnancy outcomes, it increases the elective caesarean delivery rate.
MeSH term(s)	Adult ; Blood Glucose/analysis ; Case-Control Studies ; Cesarean Section/statistics & numerical data ; Diabetes, Gestational/blood ; Diabetes, Gestational/diagnosis ; Diabetes, Gestational/epidemiology ; Female ; Glucose Tolerance Test ; Humans ; Pregnancy ; Pregnancy Outcome ; Pregnancy Trimester, Third/blood ; Retrospective Studies ; Risk Factors ; Time Factors
Chemical Substances	Blood Glucose
Language	English
Publishing date	2021-03-24
Publishing country	England
Document type	Journal Article
ISSN	1471-2393
ISSN (online)	1471-2393
DOI	10.1186/s12884-021-03730-8
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