Teikyo University Hospital, Mizonokuchi
UniversityKawasaki, Japan
Research output, citation impact, and the most-cited recent papers from Teikyo University Hospital, Mizonokuchi. Aggregated across the NobleBlocks index of 300M+ scholarly works.
Top-cited papers from Teikyo University Hospital, Mizonokuchi
Extensive molecular analyses of ependymal tumors have revealed that supratentorial and posterior fossa ependymomas have distinct molecular profiles and are likely to be different diseases. The presence of C11orf95-RELA fusion genes in a subset of supratentorial ependymomas (ST-EPN) indicated the existence of molecular subgroups. However, the pathogenesis of RELA fusion-negative ependymomas remains elusive. To investigate the molecular pathogenesis of these tumors and validate the molecular classification of ependymal tumors, we conducted thorough molecular analyses of 113 locally diagnosed ependymal tumors from 107 patients in the Japan Pediatric Molecular Neuro-Oncology Group. All tumors were histopathologically reviewed and 12 tumors were re-classified as non-ependymomas. A combination of RT-PCR, FISH, and RNA sequencing identified RELA fusion in 19 of 29 histologically verified ST-EPN cases, whereas another case was diagnosed as ependymoma RELA fusion-positive via the methylation classifier (68.9%). Among the 9 RELA fusion-negative ST-EPN cases, either the YAP1 fusion, BCOR tandem duplication, EP300-BCORL1 fusion, or FOXO1-STK24 fusion was detected in single cases. Methylation classification did not identify a consistent molecular class within this group. Genome-wide methylation profiling successfully sub-classified posterior fossa ependymoma (PF-EPN) into PF-EPN-A (PFA) and PF-EPN-B (PFB). A multivariate analysis using Cox regression confirmed that PFA was the sole molecular marker which was independently associated with patient survival. A clinically applicable pyrosequencing assay was developed to determine the PFB subgroup with 100% specificity using the methylation status of 3 genes, CRIP1, DRD4 and LBX2. Our results emphasized the significance of molecular classification in the diagnosis of ependymomas. RELA fusion-negative ST-EPN appear to be a heterogeneous group of tumors that do not fall into any of the existing molecular subgroups and are unlikely to form a single category.
We developed a minimally invasive technique of releasing the piriformis muscle under endoscopic control for entrapment neuropathy of the sciatic nerve because of tension and contraction of the piriformis muscle. This surgical technique was performed in patients who fulfilled at least 5 of 9 diagnostic criteria we established and who did not respond to conservative therapy for 6 months or more. Although a cavity was maintained using a disposable syringe (10 mL) with a cut tip, an arthroscope (4 mm in diameter) was inserted at an oblique viewing angle of 30 degrees, and the muscle was identified. The area from the musculotendinous junction to the muscle was gradually incised using a special scraper. In particular, pain disappeared simultaneously with release of the piriformis muscle during surgery. With this technique, an adequate cavity can be produced and maintained in a manner similar to that in posterior endoscopic surgery for intervertebral disc herniation. This technique is useful for reducing postoperative pain and allows early return to activity.
OBJECT: Various kinds of trunk braces have been used to achieve bone healing in cases of pediatric lumbar spondylolysis. However, the optimal brace for achieving bone healing is unclear. The purpose of the present study was to determine in what types of spondylolysis bone healing can be achieved and how long it takes. METHODS: In this prospective study, 63 pars interarticularis defects (spondylolysis) among 37 patients who were younger than 18 years (mean 13.5 ± 2.7 years) were treated using a hard brace. The youngest patient was 8 years old. Based on the results of CT scanning, the lyses were classified into 3 categories: early, progressive, and terminal defects. Progressive defects were further divided into 2 types according to STIR MRI findings: those with high signal intensity at the adjacent pedicle and those with low signal intensity (that is, a normal appearance). A hard brace, such as a molded plastic thoracolumbosacral orthosis, was used to immobilize the trunk. Approximately every 3 months, CT scanning was performed to evaluate bone healing until approximately 6 months. RESULTS: The union rates were 94%, 64%, 27%, and 0% for the early, progressive with high signal intensity, progressive with low signal intensity, and terminal defects, respectively. It was noted that no terminal defect was healed using conservative treatment. The mean time to healing among the defects that showed bone healing was 3.2, 5.4, and 5.7 months for the early, progressive with high signal intensity, and progressive with low signal intensity groups, respectively. CONCLUSIONS: Patients with early-stage defects are the best candidates for conservative treatment with a hard brace because more than 90% of such cases can be healed in 3 months.
Over the last 13 years starting from 1975 when the first improved cholangiofiberscope was developed at the Teikyo University Hospital, 216 patients with retained biliary tract stones and 93 patients with intrahepatic stones have been seen; stone extraction was successful in 210 and 83 cases with percutaneous cholangioscopy, the success rate being 97.2 and 89.4% respectively. In particular, the advent of sophisticated technology for smashing stones, such as electrohydraulic lithotripsy, and cholangiofiberscope instrumentation have certainly helped to improve the therapeutic results in biliary tract stones. Today it can be claimed that visible stones are readily removable with percutaneous cholangioscopy. Moreover, percutaneous transhepatic cholangioscopy has been proved to be an indispensable tool for the management of intrahepatic stones and benign or malignant biliary tract diseases. Another advantage of percutaneous transhepatic cholangioscopy is that it may be indicated, even in patients in whom the transduodenal approach is considered too difficult to apply. The author firmly believes that even better therapeutic results can be expected if this endoscopic approach becomes more routine.
A retroperitoneal laparoscopic (retroperitoneoscopic) lateral approach to achieve decompression for a far lateral disk lesion in the lumbar spine or to remove a paravertebral neurinoma without disrupting the facet is described. The operating space is maintained using a powered mechanical lift and a flat inflatable retractor mainly to make a longitudinal separation between the psoas major and the quadratus lumborum. This technique has been performed successfully in 22 cases using retroperitoneoscopy. The best indications of this new procedure are lateral disk herniation at the L5-S1 level or around the conus medullaris at the L1-L2 level. The described procedure provides adequate exposure necessary for extraforaminal exploration, discectomy, and nerve root decompression, and it is sufficient for treating extreme lateral lumbar herniation localized to the L1-S1 level and spinal nerve root tumors.
We have reported previously that p95c, a novel 95-kDa cytosolic protein, was the target of autoantibodies in sera of patients with autoimmune hepatic diseases. We studied 30 sera that were shown previously to immunoprecipitate a 95 kDa protein from [(35)S]-methionine-labelled HeLa lysates and had a specific precipitin band in immunodiffusion. Thirteen sera were available to test the ability of p95c antibodies to inhibit nuclear envelope assembly in an in vitro assay in which confocal fluorescence microscopy was also used to identify the stages at which nuclear assembly was inhibited. The percentage inhibition of nuclear envelope assembly of the 13 sera ranged from 7% to 99% and nuclear envelope assembly and the swelling of nucleus was inhibited at several stages. The percentage inhibition of nuclear assembly was correlated with the titre of anti-p95c as determined by immunodiffusion. To confirm the identity of this autoantigen, we used a full-length cDNA of the p97/valosin-containing protein (VCP) to produce a radiolabelled recombinant protein that was then used in an immunoprecipitation (IP) assay. Our study demonstrated that 12 of the 13 (93%) human sera with antibodies to p95c immunoprecipitated recombinant p97/VCP. Because p95c and p97 have similar molecular masses and cell localization, and because the majority of sera bind recombinant p97/VCP and anti-p95c antibodies inhibit nuclear assembly, this is compelling evidence that p95c and p97/VCP are identical.
Surgical site infection (SSI) is an unfortunate and unpreventable complication of any surgical intervention including spinal surgery. Early deep SSI (EDSSI) after instrumented spinal fusion are particularly difficult to manage due to the implanted, and possibly infected, instrumentation. The purpose of this study is to retrospectively review patients who underwent spinal surgery, investigate the rate of EDSSI, identify patient-related and surgery-related risk factors and to assess the effectiveness of continuous indwelling irrigation on the eradication of these infections. A total of 814 patients (319 women and 495 men) who underwent spinal surgery were enrolled. Mean age at the initial surgery was 57.4 years old. Infections that penetrated the deep fascia within 1 month after the initial operation were considered as EDSSI. The rate of EDSSI, causal organisms, infection management and resolution were studied. Furthermore, we examined the patient-related and the operation-related risk factors. An overall incidence of EDSSI of 1.1% was found. In 177 patients with diabetes mellitus (DM), two patients (1.1%) developed EDSSI. In 28 patients receiving chronic haemodialysis (HD), two patients with infections (7.1%) were identified, which was statistically significantly greater than the other patient populations. Both operative time and intraoperative blood loss were significantly greater in patients with EDSSI than in non-infected patients. Furthermore, the rate of EDSSI in patients undergoing instrumented spinal fusion (3.8%) was significantly higher than that in the other patients. In the nine patients who developed EDSSI, the causal organisms were identified and treated by surgical debridement, antibiotic therapy and continuous indwelling surgical site irrigation. All infections resolved, and no recurrence has been observed at final follow-up. Removal of the instrumentation was required in only one patient. Based on our results, we believe that continuous surgical site irrigation is an effective adjunct in the surgical treatment for early SSI following spinal surgery.
Purpose . To compare optical coherence tomography angiography (OCT-A) and laser speckle flowgraphy (LSFG) for the diagnosis of normal-tension glaucoma (NTG). Methods . Twenty-eight eyes of 28 patients with NTG and 25 eyes of 25 normal subjects matched for age, refractive errors, systemic blood pressure, and central corneal thickness were evaluated. OCT-A was used to measure whole image vessel density, inside disc vessel density, and peripapillary vessel density; using LSFG, mean blur rate (MBR) inside the whole optic nerve head (ONH) area (MBR A ), and MBR of the vessel area (MBR V ) and tissue area (MBR T ) inside the ONH, were determined. Receiver operating characteristic (ROC) curves and areas under the ROC (AUROC) were used to assess the diagnostic ability of each variable. Results . The AUROC for OCT-A whole image vessel density (0.950) was significantly greater than that for OCT-A peripapillary vessel density (0.830) and for all LSFG parameters (MBR A = 0.793, MBR V = 0.601, and MBR T = 0.61) (<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M1"><mml:mi>P</mml:mi><mml:mo><</mml:mo><mml:mn>0.001</mml:mn></mml:math>). The AUROC for OCT-A inside disc vessel density (0.931) was significantly greater than that for all LSFG parameters (<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M2"><mml:mi>P</mml:mi><mml:mo><</mml:mo><mml:mn>0.005</mml:mn></mml:math>). Conclusions . OCT-A vessel density had a higher glaucoma diagnostic ability compared to all LSFG parameters in patients with NTG.
Low back pain (LBP) is the most prevalent musculoskeletal complaint among professional and amateur golfers; however, associated radiological changes in golf-related LBP have not been examined in the literature. We suspect that Modic Type 1 changes in the lumbar spine are linked to golf-related LBP. In this retrospective case series, four middle-aged golfers (one professional and three high-level amateurs) presented to our clinic with LBP. Inflammation of the right side of endplates in the lumbar spine was suspected based on Modic Type 1 changes detected by magnetic resonance imaging (MRI) in each patient. All four cases were diagnosed with right-sided endplate inflammation and administered intradiscal steroid injections with a non-steroidal anti-inflammatory drug (NSAID). Treatment swiftly alleviated LBP and diminished Modic Type 1 changes on follow-up MRI 3-6 months later in all four patients. We suggest that Modic Type 1 changes play a significant role in the diagnosis and treatment of golf-related LBP.
PURPOSE: Laparoscopic proximal gastrectomy (LPG) is a function-preserving surgery performed on patients with cancer of the upper third of the stomach. However, if much of the ingested food passes through the jejunum, LPG might function broadly like a total gastrectomy. We devised a jejunogastrostomy with double-tract reconstruction (DTR) to ensure that most food flows easily to the remnant stomach. METHODS: A side-to-side jejunogastrostomy was created between the remnant stomach's posterior wall and the jejunum 10 cm below the esophagojejunostomy, and the common stab incision was also closed with a linear stapler. The jejunogastrostomy was created as a delta-shaped anastomosis by using only linear staplers. The 15 patients who underwent delta-shaped anastomosis from 2017 to 2018 were retrospectively reviewed to collect and analyze their surgical and postoperative outcomes, including nutritive conditions, in comparison to the reconstruction that was performed before then. RESULTS: Operative times and postoperative complications were not significantly different compared to the previous reconstruction. We confirmed significant differences in operative bleeding and passage of food through the remnant stomach. The level of nutritional indicators at the end of postoperative year one did not tend to be lower, but total weight loss (TWL) and %TWL were significantly lower. As expected, there was a correlation between differences in jejunogastrostomy type and postoperative malnutrition. CONCLUSIONS: This method devised for intracorporeal DTR provided patients with improved postoperative nutritional status by directing more food through the remnant stomach after LPG.
BACKGROUND/PURPOSE: The purpose of the present study was to assess long-term outcomes following liver resection for colorectal liver metastases (CRLM) with concurrent extrahepatic disease and to identify the preoperative prognostic factors for selection of operative candidates. METHODS: In this retrospective, multi-institutional study, 3820 patients diagnosed with CRLM during 2005-2007 were identified using nationwide survey data. Data of identified patients with concurrent extrahepatic lesions were analyzed to estimate the impact of liver resection on overall survival (OS) and to identify preoperative, prognostic indicators. RESULTS: Three- and 5-year OS rates after liver resection in 251 CRLM patients with extrahepatic disease (lung, n = 116; lymph node, n = 51; peritoneal, n = 37; multiple sites, n = 23) were 50.2% and 32.0%, respectively. Multivariate analysis revealed that a primary tumor in the right colon, lymph node metastasis from the primary tumor, serum carbohydrate antigen (CA) 19-9 level >37 UI/mL, the site of extrahepatic disease, and residual liver tumor after hepatectomy were associated with higher mortality. We proposed a preoperative risk scoring system based on these factors that adequately discriminated 5-year OS after liver resection in training and validation datasets. CONCLUSIONS: Performing R0 liver resection for colorectal liver metastases with treatable extrahepatic disease may prolong survival. Our proposed scoring system may help select appropriate candidates for liver resection.
OBJECTIVE: Intracranial aneurysm (IA) is considered a chronic inflammatory condition that affects intracranial arteries. Cyclooxygenase 2 (COX2) and prostaglandin E2 (PGE2) are considered potential targets of specific medical treatment for IAs. Previous studies have reported the elevated COX2 expression in the IA wall. However, not much has been studied about the upstream regulation of COX2 and PGE2, and the metabolism of arachidonic acid (AA) in human IAs. In this study, we aimed to elucidate the distribution of fatty acids in human IA walls for the first time. METHODS: Samples from 6 ruptured and 5 unruptured human IAs were surgically resected after the aneurysmal clipping and analyzed using desorption electrospray ionization imaging mass spectrometry. RESULTS: AA and AA-containing phospholipids were not detected in the unruptured IA walls. On the contrast, significantly larger amounts of AA and AA-containing phospholipids were detected in the ruptured IA walls compared to unruptured IA walls. CONCLUSIONS: This study showed for the first time that AA was not detected in unruptured human IA walls. Our findings suggest that the stability of the turnover of AA in human unruptured IA walls is sustained. In contrast, this study showed that larger amounts of AA and AA-containing phospholipids were detected in the ruptured IA walls. More cases and further analysis are necessary to interpret our present results.
Abstract: Empyema is a state of purulent pleural effusion in the thoracic cavity. The principle of treatment is the administration of appropriate antibiotics and thoracic drainage. If thoracic drainage is insufficient, thoracic surgeons may perform surgical intervention. It is important that our readers, thoracic surgeons, understand the pathogenesis of empyema and know how to treat it. Medline was used to search for English literature related to “empyema” and “pleural infection”. Searches were limited to the years 2010–2020 and limited to human studies. There have been numerous reports on empyema over the last decade. Regarding guidelines, the British Thoracic Society issued guidelines for pleural disease in 2010. Regarding intrapleural fibrinolytic therapy, the results of Multicenter Intrapleural Sepsis Trial (MIST)—two were reported in 2011 following MIST-1 in 2005, demonstrating the usefulness of intrapleural fibrinolytic therapy. Subsequently, a RAPID (renal, age, purulence, infection source, and dietary factors) risk category was proposed in 2014 as a prognostic factor for pleural infection using MIST-1 and MIST-2 data. Regarding surgery, prospective comparative studies are scarce, but as retrospective reports, the frequency and prognosis of postoperative empyema following lung cancer surgery were reported in 2018. In open window thoracostomy, attention has been paid to using a vacuum-associated closure device to accelerate recovery. There have been numerous reports on empyema and significant progress has been made in the last decade. Further large-scale clinical studies need to be performed to improve the prognosis for empyema.
The prognosis of pancreatic ductal carcinoma (PDAC) with peritoneal metastasis remains dismal. Systemic chemotherapy alone may not be effective, and the combination of intraperitoneal chemotherapy with systemic chemotherapy is expected to prolong the overall survival in patients with peritoneal metastasis. We have designed a randomized phase III trial to confirm the superiority of intravenous (i.v.) and intraperitoneal (i.p.) paclitaxel (PTX) with S-1 relative to gemcitabine plus nab-PTX (GnP), which is the current standard therapy for patients with metastatic PDAC. A total of 180 patients will be accrued from 30 institutions within 3 years. Patients will be randomly assigned in a 1:1 ratio to receive either i.v. and i.p. PTX with S-1 or GnP (target of 90 patients per group). The primary endpoint is overall survival; secondary endpoints are progression-free survival, response rate, proportion with negative peritoneal washing cytology during chemotherapy, proportion requiring conversion surgery, and adverse event profiles. Japan Registry of Clinical Trials jRCTs051180199 ( https://jrct.niph.go.jp/ ).
Summary: Fourteen papers clearly describing morbidity and mortality are evaluated to assess the frequency of major operative and postoperative accidents or complications associated with laparoscopic cholecystectomy and the key technical points important in the prevention of bile duct injury which is the most common operative complication during laparoscopic cholecystectomy. A total of 108, 612 laparoscopic cholecystectomies were performed in these series. Technical complications relating to the cause of death were encountered in 22 out of 49 cases (44.9%) and the mortality rate was 0.02%. The most common reason for conversion was difficult adhesions around the gallbladder, unclear anatomy of Carot's triangle and bile duct injury. Moreover bile duct injury was the most common technical complication, although injury to the major vessels and intestine led to higher mortality rates than common bile duct injury. Almost all authors have postulated in their papers that the majority of these major complications occured at institutions operating on less than 100 cases. These facts suggest that technical complications can be minimized by guidelines for prevention of operative injury, namely adequate training and experience in humans. In this paper, our technique was introduced and the importance of how to explore Carot's triangle is emphasized to prevent bile duct injury.
BACKGROUND: To collect large-scale data for further research to improve treatment outcomes in patients with colorectal liver metastasis (CRLM), the Joint Committee for Nationwide Survey on CRLM was established by the Japanese Society for Cancer of the Colon and Rectum and the Japanese society of Hepato-Biliary-Pancreatic Surgery. The joint committee was initiated to collect data since 2014 and has already reported data including the prognostic data of 3820 patients newly diagnosed with CRLM between 2005 and 2007. METHODS: The data of patients newly diagnosed with CRLM after 2013 are continuously being registered prospectively, and herein, we report the data of the patients newly diagnosed with CRLM in 2013 and 2014. RESULTS: The data of 3839 patients newly diagnosed with CRLM in 2013 and 2014 were registered from 156 departments (75%) of 152 institutions among 209 departments (from 201 institutions) that agreed to participate in this database system at its initiation. Finally, 3525 patients were enrolled in this study after a quality management process conducted by the joint committee. We report the comprehensive data obtained from 3525 patients, including clinicopathological findings, treatment strategies, and implementation status of chemotherapy. CONCLUSION: The joint committee will provide these raw data while updating prognostic data to researchers who will conduct meaningful studies that meet the aim of the joint committee.
BACKGROUND: The conventional H category-based classification for colorectal liver metastases (CRLM) was created by equal weighting of tumor number and tumor size; however, our previous nomogram to predict postoperative disease-free survival demonstrated that CRLM ≥5 as a parameter provided 4.5 times greater impact compared with a largest CRLM size >5 cm. METHODS: A total of 3815 patients newly diagnosed with CRLM between 2005 and 2007, including 2220 resectable cases, were investigated. Six groups were created based on largest lesion size (≤ 5 vs >5 cm) and lesion number (1, 2-4, and ≥5). RESULTS: The novel (n) H1, nH2, and nH3 categories were defined as solitary lesions with a size ≤5 cm; lesions other than nH1 or nH3; and ≥5 lesions with any lesion size, respectively. In the resectable cohort, the 5-year cumulative overall survival rates were 64.0%, 53.5%, and 42.6% in the nH1, nH2, and nH3 groups, respectively (P < .001), and no significant differences were observed between the conventional H2 and H3 categories. In the overall cohort, the discrimination ability of the two classifications were comparable. CONCLUSION: The novel H category-based classification might be beneficial in predicting overall survival in patients with CRLM independent of their resectability.
Background: In the FLAURA trial, superiority of osimertinib over the standard of care (SOC) was not demonstrated in Asian patients; SOC seemed favorable among Japanese patients (hazard ratio 1.39, 95% confidence interval 0.82–2.33). Three reasons are suggested: since rechallenge with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) is covered by health insurance in Japan, EGFR-TKI rechallenge rate was higher in SOC than in the osimertinib group, which resulted in a long-term sequential administration of EGFR-TKIs; treatment discontinuation rate was high in the osimertinib group due to adverse events such as interstitial pneumonia among Japanese patients. EGFR-TKIs enhance tumor antigen-specific cytotoxicity of T cells, especially first- and second-generation EGFR-TKIs, which are more active against various cells with wild-type EGFR, including regulatory T cells. Consequently, subsequent immune checkpoint inhibitor therapy seemed more promising in the SOC group. Therefore, optimal first-line EGFR-TKI for EGFR-mutant advanced lung cancer may not have been identified in Japanese patients. Methods: The Heat on Beat study is a randomized, open-label, multicenter, phase II study to compare OS between initial treatment with afatinib and osimertinib in treatment-naïve patients with advanced or recurrent EGFR-mutant NSCLC. Exploration of immunomonitoring through peripheral blood mononuclear cells will also be performed, before, during, and after treatment. Treatment-naïve EGFR mutation-positive non-small cell lung cancer (NSCLC) patients ( N = 100) will be randomized to two groups in a 1:1 ratio. The co-primary endpoints are 3-year survival rate and characterization of immune environment associated with response to afatinib, osimertinib, or immune checkpoint inhibitors. Enrollment will start in May 2020 at 28 sites in Japan and continue for 1 year, with 3-year follow-up. Discussion: Because there is no clinical trial comparing second- with third-generation EGFR-TKI for advanced EGFR-mutant NSCLC, our study would provide a major impact on clinical practice. Trial registration Japan Registry of Clinical Trials, jRCTs031190221, registered date: 25 February 2020, https://jrct.niph.go.jp/en-latest-detail/jRCTs031190221
Background: The exosome-focused translational research for afatinib (EXTRA) study is the first trial to identify novel predictive biomarkers for longer treatment efficacy of afatinib in patients with epidermal growth factor receptor ( EGFR) mutation-positive nonsmall cell lung cancer (NSCLC) via a comprehensive association study using genomic, proteomic, epigenomic, and metabolomic analyses. Objectives: We report details of the clinical portion prior to omics analyses. Design: A prospective, single-arm, observational study was conducted using afatinib 40 mg/day as an initial dose in untreated patients with EGFR mutation-positive NSCLC. Dose reduction to 20 mg every other day was allowed. Methods: Progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were evaluated. Results: A total of 103 patients (median age 70 years, range 42–88 years) were enrolled from 21 institutions in Japan between February 2017 and March 2018. After a median follow-up of 35.0 months, 21% remained on afatinib treatment, whereas 9% had discontinued treatment because of AEs. The median PFS was 18.4 months, with a 3-year PFS rate of 23.3%. The median afatinib treatment duration in patients with final doses of 40 ( n = 27), 30 ( n = 23), and 20 mg/day ( n = 35), and 20 mg every other day ( n = 18) were 13.4, 15.4, 18.8, and 18.3 months, respectively. The median OS was not reached, with a 3-year OS rate of 58.5%. The median OS in patients who did ( n = 25) and did not ( n = 78) receive osimertinib during the entire course of treatment were 42.4 months and not reached, respectively ( p = 0.654). Conclusions: As the largest prospective study in Japan, this study confirmed favorable OS following first-line afatinib in patients with EGFR mutation-positive NSCLC in a real-world setting. Further analysis of the EXTRA study is expected to identify novel predictive biomarkers for afatinib. Trial registration: UMIN-CTR identifier (UMIN000024935, https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_his_list.cgi?recptno=R000028688
AIM: Subjective quality of life is a clinically relevant outcome that is strongly associated with the severity of clinical symptoms in individuals with ultra-high risk for psychosis and patients with recent-onset psychotic disorder. Our objective was to examine whether longitudinal changes in clinical symptoms are associated with quality of life in ultra-high risk individuals and patients with recent-onset psychotic disorder. METHODS: Individuals with ultra-high risk and patients with recent-onset psychosis disorder were recruited in the same clinical settings at baseline and were followed up with more than 6 months and less than 5 years later. We assessed five factors of clinical symptoms using the positive and negative syndrome scale, and quality of life using the World Health Organization quality of life questionnaire-short form. We used multiple regression to examine the relationships between clinical symptoms and quality of life while controlling for diagnosis, follow-up period, age, and sex. RESULTS: Data were collected from 22 individuals with ultra-high risk and 27 patients with recent-onset psychosis disorder. The multiple regression analysis results indicated that the more severe anxiety/depression was at baseline, the poorer the quality of life at follow-up. Further, improvement of anxiety/depression and disorganized thoughts were associated with improvement in quality of life. The difference in diagnosis did not affect the association between clinical symptoms and quality of life. CONCLUSION: These findings suggest that the improvement of anxiety/depression and disorganized thoughts is important in the early stages of psychosis before it becomes severe, affecting the quality of life.