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1.
Cancer Discov ; 2024 Jul 18.
Artigo em Inglês | MEDLINE | ID: mdl-39023403

RESUMO

The SCRUM-Japan MONSTAR-SCREEN consortium is a nationwide molecular profiling project employing artificial intelligence-driven multi-omics analyses for patients with advanced malignancies, aiming to develop novel therapeutics and diagnostics and deliver effective drugs to patients. Concurrently, studies assessing molecular residual disease-based precision medicine for resectable solid tumors, including CIRCULATE-Japan, are ongoing. The substantial data generated by these platforms are stored within a state-of-the-art supercomputing infrastructure, VAPOR CONE. Since 2015, our project has registered over 24,000 patients as of December 2023. Among 16,144 patients with advanced solid tumors enrolled in MONSTAR-SCREEN projects, 5.0% participated in matched clinical trials, demonstrating a 29.2% objective response rate and 14.8-month median survival (95% confidence interval, 13.4-16.3), for patients treated in the matched clinical trials. Notably, patients who received matched therapy demonstrated significantly prolonged overall survival compared with those who did not (hazard ratio 0.77; 95% confidence interval, 0.71-0.83).

2.
Clin Colorectal Cancer ; 23(2): 111-117, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38679555

RESUMO

The extraction of data that contribute to regulatory approval from real-world data (RWD) is difficult because of the lack of a standardized data format and extraction methodology. Additionally, when real-world evidence (RWE) is used as an external control group, the similarity between internal and external control data is not evaluated. To investigate the data extraction methodology for the external control data of rare molecular subtypes, we have initiated the "REALISE" study. In this study, we aim to elucidate the "relevance" and "reliability" of RWD/RWE necessary for regulatory approval. As most databases are not designed for regulatory use in the creation phase, we will investigate retrospective methodologies to ensure RWD/RWE reliability. This study will compare the "relevance" and "reliability" of the ARCAD global database, SCRUM-Japan Registry, SCRUM-Japan observational study, and Flatiron Health RWD, and statistically analyze the differences and similarities among the four databases. We will also examine the methodology for extracting sufficiently relevant data from the SCRUM-Japan observational study. Additionally, if the reliability of the RWD/RWE does not reach the required level for regulatory approval, we will examine the methodologies to ensure the "reliability" of the SCRUM-Japan observational study for regulatory approval. The obtained results will be submitted to the "Consultation for Development of Registry" in the Pharmaceuticals and Medical Devices Agency, and we will discuss the standard methodology. The procedures and findings identified in the REALISE study will be organized from the perspectives of "database construction," "data analysis," and "outcome evaluation" and will be issued as "the draft guidelines."


Assuntos
Bases de Dados Factuais , Humanos , Reprodutibilidade dos Testes , Bases de Dados Factuais/estatística & dados numéricos , Sistema de Registros/estatística & dados numéricos , Estudos Retrospectivos , Japão , Projetos de Pesquisa/normas
3.
JCO Precis Oncol ; 7: e2200653, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36996376

RESUMO

PURPOSE: Genomic profiling programs have been implemented to apply next-generation sequencing (NGS) for facilitating trial enrollment. SCRUM-Japan GI-SCREEN is a large-scale genomic profiling program in advanced gastrointestinal cancers using a validated genomic assay with the goal of facilitating enrollment in targeted clinical trials, generating real-world data, and performing clinicogenomic analysis for biomarker discovery. PATIENTS AND METHODS: Genotyping of tumor tissue samples from 5,743 patients with advanced gastrointestinal cancers enrolled in GI-SCREEN was centrally performed with NGS. Patients were enrolled in matched trials of targeted agents affiliated with GI-SCREEN on the basis of genotyping results. RESULTS: A total of 11 gastrointestinal cancers were included, with colorectal cancer being the most common. The median age ranged from 59 to 70.5 years across cancer types. Patients enrolled after initiation of first-line treatment had significantly longer overall survival (OS) than that before treatment initiation with a median survival time difference of 8.9 months and a hazard ratio (HR) ranging from 0.25 to 0.73 across cancer types, demonstrating an immortal time bias. One hundred and forty-nine patients received matched therapies in clinical trials on the basis of their identified alterations. Among patients with colorectal cancer harboring actionable alterations, the median OS was significantly longer in patients who received matched therapies in trials than in those who did not (HR, 0.52; 95% CI, 0.26 to 1.01; P = .049). Cancer-specific pathway alterations were significantly associated with shorter survival and related to primary resistance to matched trial therapies. CONCLUSION: Our genomic profiling program led to patient enrollment in targeted clinical trials and improved survival of patients with colorectal cancer who received matched therapies in clinical trials. To avoid immortal time bias, precautions are needed when using data from patients who have undergone NGS testing after initiation of the evaluated treatment line.


Assuntos
Neoplasias Colorretais , Neoplasias Gastrointestinais , Humanos , Pessoa de Meia-Idade , Idoso , Japão , Neoplasias Gastrointestinais/tratamento farmacológico , Neoplasias Gastrointestinais/genética , Transdução de Sinais , Genômica , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/genética
4.
Clin Colorectal Cancer ; 22(1): 45-52, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36376197

RESUMO

Utilizing real-world data (RWD) for effective clinical implementation is becoming more and more appealing as the cost of drug development rises, especially for patients with rare diseases and rare molecular subtypes for whom conducting randomized controlled trials is challenging. If a regulatory approval methodology based on RWD as an external control group can be established, drug development for rarer fractions can be accelerated by lowering costs and time, as well as reducing physical and emotional burdens on both patients and healthcare professionals. Since 2017, we have been prospectively collecting the clinical data of standard therapies in patients with rare molecular fractions under the SCRUM-Japan Registry platform, which is a qualified registry utilized as external control data for regulatory submission. Based on the results of the phase II TRIUMPH study (UMIN000027887) and the extracted data from the SCRUM-Japan Registry, the pharmaceutical company submitted an application for pertuzumab and trastuzumab in patients with HER2-positive metastatic colorectal cancer in April 2021. Pertuzumab and trastuzumab were approved as expanded indications on March 28, 2022, as 6 cases out of 14 extracted from the SCRUM-Japan Registry were classified and utilized as "evaluation material" under the review process of the Pharmaceuticals and Medical Devices Agency (PMDA). Through the TRIUMPH study and the SCRUM-Japan Registry, we have paved the way for regulatory approval of RWD in Japan. In future, we must define the steps for constructing regulatory-grade registries and the method/process for utilizing RWD by accumulating case experiences.


Assuntos
Neoplasias da Mama , Neoplasias Colorretais , Humanos , Feminino , Receptor ErbB-2 , Anticorpos Monoclonais Humanizados/uso terapêutico , Trastuzumab/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/etiologia , Neoplasias da Mama/tratamento farmacológico
5.
Artigo em Inglês | WPRIM (Pacífico Ocidental) | ID: wpr-1001239

RESUMO

Comprehensive knowledge of quantitative and qualitative research systematizes scholarly research and enhances the quality of research output. Scientific researchers must be familiar with them and skilled to conduct their investigation within the frames of their chosen research type. When conducting quantitative research, scientific researchers should describe an existing theory, generate a hypothesis from the theory, test their hypothesis in novel research, and re-evaluate the theory. Thereafter, they should take a deductive approach in writing the testing of the established theory based on experiments. When conducting qualitative research, scientific researchers raise a question, answer the question by performing a novel study, and propose a new theory to clarify and interpret the obtained results. After which, they should take an inductive approach to writing the formulation of concepts based on collected data. When scientific researchers combine the whole spectrum of inductive and deductive research approaches using both quantitative and qualitative research methodologies, they apply mixed-method research. Familiarity and proficiency with these research aspects facilitate the construction of novel hypotheses, development of theories, or refinement of concepts.

6.
World J Clin Cases ; 10(6): 2023-2029, 2022 Feb 26.
Artigo em Inglês | MEDLINE | ID: mdl-35317161

RESUMO

BACKGROUND: A congenital intrahepatic portosystemic shunt (IPSVS) is a rare vascular abnormality that is characterized by an anomalous intrahepatic venous tract that connects the intrahepatic portal vein with the hepatic venous system. Hepatic encephalopathy is an indication for IPSVS embolization, which is technically challenging because rapid blood flow through shunts can induce the migration of embolization material to systemic veins. This case report discusses the efficacy of percutaneous balloon-occluded retrograde transvenous obliteration for treating patients with IPSVSs. CASE SUMMARY: A 75-year-old woman presented with a six-month history of repeated hepatic encephalopathy due to an IPSVS without liver cirrhosis. We successfully embolized the IPSVS using percutaneous balloon-occluded retrograde transvenous obliteration with interlocking detachable coils. After the procedure, the patient exhibited no symptoms of hepatic encephalopathy for 14 mo. CONCLUSION: Balloon-occluded retrograde transvenous obliteration with detachable coils can be effective for the endovascular treatment of an IPSVS.

7.
Ann Vasc Surg ; 75: 205-216, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33819584

RESUMO

BACKGROUND: To evaluate outcomes of endovascular treatment (EVT) using a combination of multiple endovascular techniques for acute lower limb ischemia (ALLI) and to compare outcomes based on vessel type and artery location. METHODS: A total of 95 consecutive patients with ALLI (mean age, 72.0 years; 65 males; 104 lower limbs) who received emergency EVT using a combination of multiple endovascular techniques including thrombolysis, aspiration thrombectomy, stenting, and balloon angioplasty with or without surgical thromboembolectomy, between January 2005 and December 2017 were included. Vessel type was classified into native artery occlusion (native occlusion) and bypass graft occlusion (graft occlusion), including prosthetic and vein graft. Additionally, native arteries were categorized into below-knee occlusion and non-below-knee occlusion. Technical success, perioperative death (POD), ALLI-related death, amputation, amputation-free survival (AFS), and complications were compared according to vessel type (native occlusion vs. graft occlusion) and artery location (below-knee occlusion vs. non-below-knee occlusion). RESULTS: Of all patients with ALLI, 16.8% underwent a single endovascular technique, whereas 83.2% underwent a combination of multiple endovascular techniques. The technicalsuccess, POD, and ALLI-related death rates in the total number of patients were 94.7%, 11.6%, and 4.2%, respectively. A total of 67 patients (75 limbs) and 28 patients (29 limbs) were classified as having native occlusion and graft occlusion (prosthetic, 24 limbs; vein, 5 limbs), respectively. No significant differences in technical success (native occlusion: 92.5% vs. graft occlusion: 100%), POD (14.9% vs. 3.6%), and ALLI-related death (6.0% vs. 0%) were noted between native occlusion and graft occlusion. However, the 30-day AFS rate of native occlusion was significantly lower than that of graft occlusion (75.2% vs. 96.3%, P=0.01). The amputation rate (P=0.03) and AFS rate (P=0.03) of below-knee occlusion were significantly worse for below-knee occlusion patients than for non-below-knee occlusion patients. CONCLUSIONS: EVT using multiple endovascular techniques for ALLI is effective and safe. A combination of multiple endovascular techniques is crucial for successful treatment. However, native occlusion may have a lower AFS rate than graft occlusion, and below-knee occlusion may have a higher risk of amputation than non-below-knee occlusion.


Assuntos
Implante de Prótese Vascular , Procedimentos Endovasculares , Oclusão de Enxerto Vascular/cirurgia , Isquemia/cirurgia , Perna (Membro)/irrigação sanguínea , Doença Arterial Periférica/cirurgia , Veias/transplante , Doença Aguda , Adulto , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Oclusão de Enxerto Vascular/diagnóstico por imagem , Oclusão de Enxerto Vascular/mortalidade , Oclusão de Enxerto Vascular/fisiopatologia , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Intervalo Livre de Progressão , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Grau de Desobstrução Vascular , Veias/diagnóstico por imagem , Veias/fisiopatologia
8.
Cancer Sci ; 112(1): 314-322, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33075166

RESUMO

FMS-like tyrosine kinase 3 (FLT3) plays a key role in hematopoiesis. However, the oncogenic role of FLT3 amplification in patients with metastatic colorectal cancer (mCRC) remains unclear. Here, we aimed to evaluate the characteristics, prognosis, and treatment efficacy of an FLT3 inhibitor (regorafenib) in patients with mCRC with FLT3 amplifications. Tumor tissue samples from 2329 patients were sequenced using NGS in the Nationwide Cancer Genome Screening Project in Japan. The effects of clinicopathological features, co-altered genes, prognosis, and efficacy of regorafenib were investigated. Between April 2015 and June 2018, 85 patients with mCRC with FLT3 amplification were observed. There were no differences in baseline characteristics between patients with or without FLT3 amplification. The frequency of RAS or other gene co-alterations was inversely correlated with the copy number status. Median survival time in patients with FLT3 amplification was significantly shorter compared with those with non-FLT3 amplification. Further investigations of FLT3 amplification as a potential treatment target in mCRC are warranted.


Assuntos
Adenocarcinoma/genética , Antineoplásicos/uso terapêutico , Neoplasias Colorretais/genética , Compostos de Fenilureia/uso terapêutico , Piridinas/uso terapêutico , Tirosina Quinase 3 Semelhante a fms/genética , Adenocarcinoma/tratamento farmacológico , Adenocarcinoma/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/patologia , Feminino , Amplificação de Genes , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
9.
Nat Med ; 26(12): 1859-1864, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33020649

RESUMO

Comprehensive genomic profiling enables genomic biomarker detection in advanced solid tumors. Here, to evaluate the utility of circulating tumor DNA (ctDNA) genotyping, we compare trial enrollment using ctDNA sequencing in 1,687 patients with advanced gastrointestinal (GI) cancer in SCRUM-Japan GOZILA (no. UMIN000016343), an observational ctDNA-based screening study, to enrollment using tumor tissue sequencing in the same centers and network (GI-SCREEN, 5,621 patients). ctDNA genotyping significantly shortened the screening duration (11 versus 33 days, P < 0.0001) and improved the trial enrollment rate (9.5 versus 4.1%, P < 0.0001) without compromising treatment efficacy compared to tissue genotyping. We also describe the clonal architecture of ctDNA profiles in ~2,000 patients with advanced GI cancer, which reinforces the relevance of many targetable oncogenic drivers and highlights multiple new drivers as candidates for clinical development. ctDNA genotyping has the potential to accelerate innovation in precision medicine and its delivery to individual patients.


Assuntos
Biomarcadores Tumorais/sangue , DNA Tumoral Circulante/sangue , Neoplasias Gastrointestinais/sangue , Medicina de Precisão , Adulto , DNA Tumoral Circulante/genética , DNA de Neoplasias/sangue , Neoplasias Gastrointestinais/genética , Neoplasias Gastrointestinais/patologia , Genótipo , Sequenciamento de Nucleotídeos em Larga Escala , Humanos , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Mutação/genética
10.
CVIR Endovasc ; 3(1): 42, 2020 Aug 23.
Artigo em Inglês | MEDLINE | ID: mdl-32830301

RESUMO

BACKGROUND: Balloon-assisted transcatheter arterial embolization (TAE) using n-butyl cyanoacrylate (NBCA) and lipiodol (Lp) mixture is a new endovascular treatment technique for iatrogenic arterial bleeding by groin puncture. It is less invasive compared to surgical repair, and NBCA migration into the circulation can be prevented by temporary balloon occlusion of the parent artery without ultrasound-guidance. This study aimed to report on the technical aspects and evaluate the efficacy and safety of fluoroscopically guided balloon-assisted transcatheter arterial embolization using NBCA for iatrogenic arterial bleeding by groin puncture. MATERIALS AND METHODS: The study included five patients (mean age 54.6 years; 3 male and 2 female) with iatrogenic arterial bleeding by groin puncture. We performed transcatheter arterial embolization using NBCA while occluding the responsible artery with a balloon catheter during the embolization to prevent NBCA migration. Two sheaths were inserted into the common femoral artery. A microcatheter was advanced into the pseudoaneurysm or extravasation via the contralateral sheath. A balloon catheter was advanced into the responsible artery until the balloon portion covered the leakage site via another sheath. After balloon inflation, the NBCA and Lip mixture was slowly injected until the pseudoaneurysm, or the extravasation was filled without touching the balloon. The microcatheter was removed immediately after the filling. We assessed technical success, overall success, and complications. RESULTS: The injured arteries were the external iliac artery (n = 1), the common femoral artery (n = 2), and the proximal portion of the superficial femoral artery (n = 2). NBCA was injected once in four cases and twice in one case where complete hemostasis could not be achieved with one injection. The technical and overall success rate was 100% with no complications, including distal embolization of NBCA. CONCLUSIONS: Balloon-assisted TAE using NBCA is a feasible, effective, and safe treatment for iatrogenic arterial bleeding by groin puncture. It may also be applicable in other arterial bleeding situations where the potential risk of distal embolization can be decreased by applying the balloon-assisted technique.

11.
Intern Med ; 59(14): 1763-1767, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32669516

RESUMO

The patient was a 70-year-old man with idiopathic orbital inflammation (IOI) that appeared on the severely affected side of preceding myasthenia gravis (MG). The patient was diagnosed with MG 5 years prior to the onset of IOI. When IOI was diagnosed, an edrophonium test was negative. IOI was considered because he complained of left orbital pain, eyelid swelling, and cerebral MRI exhibited the enhanced lesions along the left orbital periosteum. A biopsy specimen revealed pathological findings compatible with IOI. The administration of corticosteroids was effective for improving the ocular symptoms. IOI should be considered when ocular symptoms deteriorated with soft tissue swelling/pain in MG patients.


Assuntos
Imunoglobulina G/análise , Miastenia Gravis/complicações , Órbita/imunologia , Pseudotumor Orbitário/etiologia , Idoso , Biópsia , Encéfalo/diagnóstico por imagem , Edrofônio , Humanos , Imageamento por Ressonância Magnética , Masculino , Órbita/diagnóstico por imagem , Órbita/patologia , Pseudotumor Orbitário/diagnóstico , Pseudotumor Orbitário/patologia , Periósteo/diagnóstico por imagem , Periósteo/patologia
12.
J Endovasc Ther ; 26(2): 269-272, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30799671

RESUMO

PURPOSE: To report an unusual case of an abdominal aortic aneurysm (AAA) rupture caused by migration of a Zenith stent-graft main body years after its separation from the suprarenal stent. CASE REPORT: A 72-year-old man underwent endovascular aneurysm repair with a Zenith stent-graft for an infrarenal AAA in year 2000. At that time, a femorofemoral bypass was performed because the left external iliac and common femoral arteries were dissected during treatment. In 2013, follow-up computed tomography (CT) showed disconnection of the uncovered proximal stent, which led to a type Ia endoleak. An additional Zenith main body and Large Palmaz XL balloon-expandable stent were deployed; the endoleak disappeared. In 2016, the patient had abdominal pain, and emergency CT showed AAA rupture caused by migration of the first main body deployed in 2000 under the distal edge of the contralateral (left) leg of the additional main body from 2013, which led to a type IIIa endoleak between the 2 main bodies. A converter and iliac legs were deployed to successfully seal the type IIIa endoleak. The patient remains well 18 months after the second repair; CT scans document stable stent-grafts and no endoleak. CONCLUSION: Physicians should be aware of the potential risk for AAA rupture caused by late main body migration after treatment for suprarenal stent separation from a Zenith stent-graft.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Ruptura Aórtica/etiologia , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Migração de Corpo Estranho/etiologia , Falha de Prótese , Stents , Idoso , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Ruptura Aórtica/diagnóstico por imagem , Ruptura Aórtica/cirurgia , Endoleak/diagnóstico por imagem , Endoleak/etiologia , Endoleak/cirurgia , Migração de Corpo Estranho/diagnóstico por imagem , Migração de Corpo Estranho/cirurgia , Humanos , Masculino , Reoperação , Fatores de Tempo , Resultado do Tratamento
13.
J Patient Saf ; 15(3): 251-256, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-27465298

RESUMO

OBJECTIVES: There have been epidemiological studies of adverse events (AEs) among general patients but those of patients cared by cardiologist are not well scrutinized. We investigated the occurrence of AEs and medical errors (MEs) among adult patients with cardiology in Japan. METHODS: We conducted a cross-sectional study of adult outpatients at a Japanese teaching hospital from February through November 2006. We measured AE and ME incidents from patient report, which were verified by medical records, laboratory data, incident reports, and prescription queries. Two independent physicians reviewed the incidents to determine whether they were AEs or MEs and to assess severity and symptoms. RESULTS: We identified 144 AEs and 30 MEs (16.3 and 3.9 per 100 patients, respectively). Of the 144 AEs, 99 were solely adverse drug events (ADEs), 20 were solely non-ADEs, and the remaining 25 were both causes. The most frequent symptoms of ADEs were skin and allergic reactions due to medication. The most frequent symptoms of non-ADEs were bleeding due to therapeutic interventions. Among AEs, 12% was life threatening. Life-threatening AEs were 25% of non-ADEs and 5% of ADEs (P = 0.0003). Among the 30 MEs, 21MEs (70%) were associated with drugs. CONCLUSIONS: Adverse events were common among cardiology patients. Adverse drug events were the most frequent AEs, and non-ADEs were more critical than ADEs. Such data should be recognized among practicing physicians to improve the patients' outcomes.


Assuntos
Cardiologia/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Erros Médicos/tendências , Idoso , Estudos Transversais , Feminino , Humanos , Masculino
14.
Jpn J Clin Oncol ; 48(6): 559-564, 2018 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-29659903

RESUMO

BACKGROUND: To confirm the feasibility and explore the clinical applicability of amplicon sequencing by next generation sequencing (NGS) of biopsy samples from patients with advanced solid tumors, we conducted a prospective study. METHODS: Patients with unresectable, advanced, or recurrent solid tumors were included. Key eligibility criteria were as follows: 20 years or older, any planned systemic therapy, adequate lesion for biopsy, and written informed consent. Samples were fixed in 10% buffered formalin and embedded in paraffin. Cancer-derived DNA was extracted, and amplicon sequencing was performed using Ion AmpliseqTM Cancer Hotspot Panel version 1.0 or version 2.0 by central vendor. We evaluated the success rate of sequencing, and the proportion of the patients with actionable mutations. We organized an expert panel to share the results of targeted sequence, make annotations and reports, and discuss concomitant ethical/legal/social issues. RESULTS: A total of 232 patients were included, and 208 were successfully analyzed (success rate of 89.7%). The biopsy procedures were safe, with only one case of Grade 3 vasovagal reaction. The proportion of actionable/druggable mutations was 38.9% (81/208), which was not significantly different between the cancer panel version 1.0 and version 2.0 (P = 0.476). Expert panel could discuss the findings and make sufficient reports. CONCLUSIONS: We confirmed the feasibility of NGS-based amplicon sequencing using biopsy samples, making the basis for nationwide genome screening for cancer patients using biopsy samples. Our results suggest that focused panel may be sufficient to detect major mutations.


Assuntos
Genoma Humano , Sequenciamento de Nucleotídeos em Larga Escala/métodos , Mutação/genética , Neoplasias/genética , Adulto , Idoso de 80 Anos ou mais , Biópsia , Estudos de Viabilidade , Feminino , Humanos , Mutação INDEL/genética , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Adulto Jovem
15.
World J Gastroenterol ; 23(35): 6437-6447, 2017 Sep 21.
Artigo em Inglês | MEDLINE | ID: mdl-29085193

RESUMO

AIM: To evaluate the relationship between the location of hepatocellular carcinoma (HCC) and the efficacy of transarterial chemoembolization (TACE). METHODS: We evaluated 115 patients (127 nodules), excluding recurrent nodules, treated with TACE between January 2011 and June 2014. TACE efficacy was evaluated according to mRECIST. The HCC location coefficient was calculated as the distance from the central portal portion to the HCC center (mm)/liver diameter (mm) on multiplanar reconstruction images rendered (MPR) to visualize bifurcation of the right and left branches of the portal vein and HCC center. The HCC location coefficient was compared between complete response (CR) and non-CR groups in Child-Pugh grade A and B patients. RESULTS: The median location coefficient of HCC among all nodules, the right lobe, and the medial segment was significantly higher in the CR group than in the non-CR group in the Child-Pugh grade A patients (0.82 vs 0.62, P < 0.001; 0.71 vs 0.59, P < 0.01; 0.81 vs 0.49, P < 0.05, respectively). However, there was no significant difference in the median location coefficient of the HCC in the lateral segment between in the CR and in the non-CR groups (0.67 vs 0.65, P > 0.05). On the other hand, in the Child-Pugh grade B patients, the HCC median location coefficient in each lobe and segment was not significantly different between in the CR and in the non-CR groups. CONCLUSION: Improved TACE efficacy may be obtained for HCC in the peripheral zone of the right lobe and the medial segment in Child-Pugh grade A patients.


Assuntos
Antineoplásicos/administração & dosagem , Carcinoma Hepatocelular/terapia , Quimioembolização Terapêutica/métodos , Neoplasias Hepáticas/terapia , Fígado/patologia , Idoso , Idoso de 80 Anos ou mais , Angiografia/métodos , Carcinoma Hepatocelular/diagnóstico por imagem , Carcinoma Hepatocelular/patologia , Quimioembolização Terapêutica/instrumentação , Cisplatino/administração & dosagem , Epirubicina/administração & dosagem , Óleo Etiodado/administração & dosagem , Feminino , Artéria Femoral/cirurgia , Artéria Hepática/diagnóstico por imagem , Humanos , Processamento de Imagem Assistida por Computador , Fígado/irrigação sanguínea , Fígado/diagnóstico por imagem , Neoplasias Hepáticas/diagnóstico por imagem , Neoplasias Hepáticas/patologia , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Tomografia Computadorizada Multidetectores , Veia Porta/diagnóstico por imagem , Critérios de Avaliação de Resposta em Tumores Sólidos , Estudos Retrospectivos , Taxa de Sobrevida
16.
Cardiovasc Intervent Radiol ; 40(7): 978-986, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-28184959

RESUMO

PURPOSE: To evaluate the usefulness and safety of endovascular treatments for acute upper limb ischemia (AULI) by using multiple techniques, and to compare catheter-directed thrombolysis (CDT) and percutaneous aspiration thromboembolectomy (PAT) as initial procedures. MATERIALS AND METHODS: The study included 18 patients (4 men and 14 women) with AULI, who underwent a total of 20 sessions of endovascular treatment using various endovascular techniques between January 2005 and April 2016. The patients were initially treated with CDT [n = 9, CDT-based group (C-G)], PAT [n = 6, PAT-based group (P-G)], or angioplasty (n = 3). In case of residual emboli, we performed additional endovascular techniques. We assessed technical success, clinical success, and complications. Additionally, we compared the urokinase dosage between the groups. RESULTS: The mean patient age was 74.4 years. Technical and clinical success was obtained in all patients. Among the 18 patients, 1 underwent CDT only, 2 underwent PAT only, 1 underwent angioplasty only, and 14 underwent multiple techniques. Two patients from the C-G experienced major complications (cerebellar hemorrhage 1; pseudo-aneurysm in a branch of the ulnar artery 1). The mean urokinase dosage was lower in the P-G than in the C-G (40,000 vs. 246,667 IU; Mann-Whitney U test, P = 0.004). CONCLUSION: Endovascular treatment is effective and safe for AULI. A combination of multiple endovascular techniques is important for successful treatment. PAT is suggested as an initial procedure among endovascular techniques, in terms of a lower dosage of urokinase and a lower complication rate. LEVEL OF EVIDENCE: IV, Case-control studies.


Assuntos
Angioplastia/métodos , Braço/irrigação sanguínea , Embolectomia/métodos , Procedimentos Endovasculares/métodos , Isquemia/terapia , Trombectomia/métodos , Terapia Trombolítica/métodos , Ativador de Plasminogênio Tipo Uroquinase/uso terapêutico , Doença Aguda , Adulto , Idoso , Terapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
17.
Eur Radiol ; 27(6): 2474-2481, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-27678134

RESUMO

OBJECTIVES: To investigate haemodynamic changes in hepatocellular carcinoma (HCC) and liver under hepatic artery occlusion. METHODS: Thirty-eight HCC nodules in 25 patients were included. Computed tomography (CT) during hepatic arteriography (CTHA) with and without balloon occlusion of the hepatic artery was performed. CT attenuation and enhancement volume of HCC and liver with and without balloon occlusion were measured on CTHA. Influence of balloon position (segmental or subsegmental branch) was evaluated based on differences in HCC-to-liver attenuation ratio (H/L ratio) and enhancement volume of HCC and liver. RESULTS: In the segmental group (n = 20), H/L ratio and enhancement volume of HCC and liver were significantly lower with balloon occlusion than without balloon occlusion. However, in the subsegmental group (n = 18), H/L ratio was significantly higher and liver enhancement volume was significantly lower with balloon occlusion; HCC enhancement volume was similar with and without balloon occlusion. Rate of change in H/L ratio and enhancement volume of HCC and liver were lower in the segmental group than in the subsegmental group. There were significantly more perfusion defects in HCC in the segmental group. CONCLUSIONS: Hepatic artery occlusion causes haemodynamic changes in HCC and liver, especially with segmental occlusion. KEY POINTS: • Hepatic artery occlusion causes haemodynamic changes in hepatocellular carcinoma and liver. • Segmental occlusion decreased rate of change in hepatocellular carcinoma-to-liver attenuation ratio. • Subsegmental occlusion increased rate of change in hepatocellular carcinoma-to-liver attenuation ratio. • Hepatic artery occlusion decreased enhancement volume of hepatocellular carcinoma and liver. • Hepatic artery occlusion causes perfusion defects in hepatocellular carcinoma.


Assuntos
Carcinoma Hepatocelular/fisiopatologia , Hemodinâmica/fisiologia , Neoplasias Hepáticas/fisiopatologia , Idoso , Idoso de 80 Anos ou mais , Oclusão com Balão/métodos , Carcinoma Hepatocelular/diagnóstico por imagem , Carcinoma Hepatocelular/terapia , Quimioembolização Terapêutica/métodos , Angiografia por Tomografia Computadorizada/métodos , Feminino , Fluoroscopia/métodos , Artéria Hepática/diagnóstico por imagem , Humanos , Neoplasias Hepáticas/diagnóstico por imagem , Neoplasias Hepáticas/terapia , Masculino , Pessoa de Meia-Idade , Tomografia Computadorizada Multidetectores/métodos , Imagem Multimodal/métodos , Estudos Prospectivos
18.
Yonago Acta Med ; 59(3): 237-240, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-27708540

RESUMO

We report the case of a man in his 70s who suffered from intestinal infarction caused by acute portal vein and mesenteric vein thrombosis (PVMVT). Combination therapy with percutaneous transcatheter thrombectomy and surgical bowel resection was successfully performed, and a satisfactory outcome was achieved. Intestinal infarction caused by PVMVT can be fatal and has a high mortality rate even if surgical resection is performed. The combination therapy of interventional radiology and surgery might be a safe and effective method for patients with this life-threatening condition.

19.
Medical Education ; : 271-279, 2016.
Artigo em Japonês | WPRIM (Pacífico Ocidental) | ID: wpr-379291

RESUMO

<p>Abstract:</p><p></p><p> This study examined the ability of medical students to self-assess basic clinical competence and learning strategies including simulation-based medical education for sixth-year medical students (n=903) at nine universities in Japan. About 40% of 27 procedures to achieve clinical skills in a model curriculum were taught using simulators with or without clinical training in hospitals. We noted that significant numbers of procedures were not practiced through any learning strategies. Higher self-assessment scores were observed among students in 4 schools who had more frequent learning opportunities through simulation-based education than among those with less frequent opportunities in 5 schools.</p>

20.
Medical Education ; : 1-10, 2016.
Artigo em Japonês | WPRIM (Pacífico Ocidental) | ID: wpr-379272

RESUMO

<p></p><p>Aim and Method: We sent a questionnaire to clinical instructors of junior residents to examine the validity of the guidelines of the national board medical examination for physicians.</p><p>Results: They estimated that about 10% of the diseases listed in the guidelines were beyond the scope of the training for junior residents. In addition, the examination questions did not necessarily reflect the importance in the training.</p><p>Conclusion: These results suggest that there is a discrepancy between the national board medical examination and the content of postgraduate training.</p>

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