Adelphi Real World Metastatic Urothelial Cancer Disease Specific Programme: Study of Real-world Data to Evaluate Patient Characteristics, Treatment Pattern and Healthcare Resource Utilisation of Locally Advanced or Metastatic Urothelial Cancer (La/mUC) at First-line Setting Post Avelumab Reimbursement in South Korea and Saudi Arabia

Cancer in the bladder lining (urothelial cancer) can be treated in many ways. One way is to directly attack cancer cells. Enfortumab vedotin is a treatment that can do this. Another way is to help the body's immune system find and attack cancer cells. Avelumab is a treatment that can do this. Both treatments were recently approved in some countries.
Doctors have standard clinical practice guidelines to help them treat people with cancer. This study is about collecting information on how adults with urothelial cancer are treated in standard clinical practice. The people in this study will have locally advanced or metastatic urothelial cancer. Locally advanced means the cancer has spread to tissue close by.
Metastatic means the cancer has spread to other parts of the body.
The goal of this study is to learn how people with urothelial cancer receive medical care in clinics in South Korea and Saudi Arabia. The main goals are to learn more about the people receiving treatments, and the treatments they receive.
This study is about collecting information only. The individual's doctor decides on treatment, not the study sponsor (Astellas).
Information will be collected from the people's medical records. This will include 12 months before treatment starts, and during treatment. Also, doctors will answer questions in interviews and surveys about how they care for people with urothelial cancer.

开始日期2024-08-29

申办/合作机构

Astellas Pharma Singapore Pte Ltd.

NCT04553029 / CompletedN/A

A Cross-sectional Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate To-severe Menopause-related Vasomotor Symptoms (MR-VMS)

The purpose of this study is to estimate the prevalence of Vasomotor Symptoms (VMS) and prevalence of moderate to severe VMS in peri-menopausal women and post-menopausal women aged 40-65 in East Asia (China, South Korea and Taiwan) and the proportion of the following subpopulations: Hormone Replacement Therapy (HRT)-eligible and willing to take HRT; HRT-eligible and HRT-averse (i.e. not willing to take HRT); HRT-ineligible due to contra-indications/high-risk; and HRT-stoppers.
The study will also assess Health Related Quality of Life (HRQoL) and VMS related productivity loss among perimenopausal and post-menopausal women with moderate-to-severe MR-VMS and the respondents' attitudes toward prescription treatments.

开始日期2020-09-09

申办/合作机构

Astellas Pharma Singapore Pte Ltd.

NCT03903094 / CompletedN/A

A Retrospective Database Analysis of Anticholinergic Burden Among the Elderly With and Without Overactive Bladder in Australia and South Korea

Outpatients with at least one dispensing record of any medication will be included in the study. An index date will be assigned to each participant and prescription records for anticholinergics will be used in the study.

开始日期2019-03-07

申办/合作机构

Astellas Pharma Singapore Pte Ltd.

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2024-03-01·Neurourology and Urodynamics

Safety and efficacy of an α₁‐blocker plus mirabegron compared with an α₁‐blocker plus antimuscarinic in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia and overactive bladder: A systematic review and network meta‐analysis

Review

作者: Chung, Eric ; Herschorn, Sender ; Tarcan, Tufan ; Sumarsono, Budiwan ; Abdul Hadi, Farid ; Steup, Achim ; Jiang, Yuan-Hong

AbstractAimAntimuscarinics and the β3‐adrenoreceptor agonist, mirabegron, are commonly used for treating patients with overactive bladder (OAB) and α1‐adrenoreceptor antagonists (α1‐blockers) are the main pharmacological agents used for treating lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). As these conditions commonly occur together, the aim of this systematic review was to identify publications that compared the use of an α1‐blocker plus mirabegron with an α1‐blocker plus antimuscarinic in men with LUTS secondary to BPH and OAB. A meta‐analysis was subsequently conducted to explore the safety and efficacy of these combinations.MethodsIncluded records had to be from a parallel‐group, randomized clinical trial that was ≥8 weeks in duration. Participants were male with LUTS secondary to BPH and OAB. The indirect analyses that were identified compared an α1‐blocker plus OAB agent with an α1‐blocker plus placebo. The PubMed/Medical Literature Analysis and Retrieval System Online, the Excerpta Medica Database, the Cochrane Central Register of Controlled Trials, and the ClinicalTrials.gov registry were searched for relevant records up until March 5, 2020. Safety outcomes included incidences of overall treatment‐emergent adverse events (TEAEs) and urinary retention, postvoid residual volume, and maximum urinary flow (Qmax). Primary efficacy outcomes were micturitions/day, incontinence episodes/day, and urgency episodes/day, and secondary outcomes were Overactive Bladder Symptom Score and International Prostate Symptom Score. A Bayesian network meta‐analysis approach was used for the meta‐analysis.ResultsOut of a total of 1039 records identified, 24 were eligible for inclusion in the meta‐analysis. There were no statistically significant differences between the α1‐blocker plus mirabegron and α1‐blocker plus antimuscarinic groups in terms of the comparisons identified for all the safety and efficacy analyses conducted. Numerically superior results were frequently observed for the α1‐blocker plus mirabegron group compared with the α1‐blocker plus antimuscarinic group for the safety parameters, including TEAEs, urinary retention, and Qmax. For some of the efficacy parameters, most notably micturitions/day, numerically superior results were noted for the α1‐blocker plus antimuscarinic group. Inconsistency in reporting and study variability were noted in the included records, which hindered data interpretation.ConclusionThis systematic review and meta‐analysis showed that an α1‐blocker plus mirabegron and an α1‐blocker plus antimuscarinic have similar safety and efficacy profiles in male patients with LUTS secondary to BPH and OAB. Patients may, therefore, benefit from the use of either combination within the clinical setting.

2023-11-15·Korean Journal of Transplantation

Optimal tacrolimus trough levels and allograft outcomes in kidney transplant recipients: insights from a multicenter real-world study in South Korea

作者: Park, Jae Berm ; Soliman, Mohamed ; Jo, Ae Jeong ; Min, Sangil ; Park, Sun Cheol ; Kim, Young Hoon ; Han, Ahram ; Lee, Joongyub ; Huh, Kyu Ha

2023-11-02·Blood

FLT3 Testing and Clonal Evolution in Patients with Acute Myeloid Leukemia: A Retrospective Cohort Study in Taiwan

作者: Tai, Yu-Yao ; Tien, Hwei-Fang ; Tsai, Xavier Cheng-Hong ; Chou, Wen-Chien ; Hou, Hsin-An ; Krishnan, Prabhuram

INTRODUCTION:Mutation of the FMS-like tyrosine kinase 3 ( FLT3) gene is one of the most common genetic alterations in acute myeloid leukemia (AML), while FLT3 internal tandem duplication (ITD) is a predictor of poor disease prognosis in patients. Timing of FLT3 mutation testing and the pattern of FLT3 clonal evolution are critical issues for ensuring that patients with FLT3 mutation-positive AML receive targeted therapy promptly, but data from real-world clinical practice are limited.AIM:This retrospective cohort study aimed to assess the turnaround time of FLT3 testing in two patient cohorts with non-M3 primary AML: newly diagnosed (ND) patients and those with relapsed or refractory disease (R/R). A further aim in the R/R cohort was to assess the pattern of FLT3 clonal evolution.METHODS:Eligible adult patients had evidence of new diagnosis of AML or R/R AML between 1 January 2009 and 31 December 2019 and had undergone at least one FLT3 test at National Taiwan University Hospital. Patients were followed up until either the end of the data period, loss to follow up (no records for 6 months), or death. We analyzed the time from the date of ordering FLT3 test to receipt of results (both cohorts) and the acquisition (negative at diagnosis, positive at R/R), loss (positive at diagnosis, negative at R/R), or maintenance (no change in status) of FLT3 mutation at R/R compared with status at diagnosis. We also explored the association between acquisition/loss/maintenance of FLT3 mutation at R/R and overall survival (OS) in the R/R cohort.RESULTS:From a total AML dataset of 1,789 patients, 659 and 223 were included in the ND and R/R cohorts, respectively ( Table 1). Demographics and clinical characteristics of the ND and R/R cohorts were similar. The most common type of AML was recurrent genetic abnormalities in both ND and R/R cohorts (50.7% and 67.7%, respectively); 45.8% and 48.0% of patients, respectively, had a normal karyotype; and NPM1 (21.1% and 16.6%, respectively), and IDH1/ IDH2 (18.5% and 15.2%, respectively) were the most common types of co-mutations detected. There was no difference in the turnaround time of FLT3 testing between the ND and R/R cohorts ( Table 1). Since 2020, FLT3 testing protocols have been further optimized to meet a 7-day turnaround time; additionally, almost all chemotherapy-fit patients with FLT3 mutation receive midostaurin in combination with 3+7 chemotherapy after reimbursement of midostaurin was implemented in Taiwan in February 2020.Of 164 patients with FLT3 tests at both diagnosis and R/R, most (75.6%, n=124) were FLT3 mutation-negative at diagnosis ( Table 1). At R/R, 27/124 (21.8%) acquired an FLT3 mutation and 12/40 (30.0%) patients lost their FLT3 mutation ( Table 1). Risk of mortality was increased in patients who acquired an FLT3 mutation (HR [95% CI] 1.59 [0.97, 2.62]), maintained their FLT3 mutation (1.52 [0.58, 2.56]), or lost their FLT3 mutation (1.22 [0.58, 2.56]), compared with those who were FLT3-mutation negative at both diagnosis and R/R ( Figure 1).CONCLUSIONS:This study provided information on the real-world landscape of FLT3 testing among patients with AML in Taiwan. The turnaround time of FLT3 testing in the current study was longer than the time reported in clinical trials, likely owing to different procedures in sampling arrangement and report delivery between real world and clinical trial settings.The distribution of FLT3 mutation and pattern of clonal evolution were largely consistent with previously published clinical studies. The higher prevalence of FLT3 mutation in the R/R cohort versus the ND cohort is in accordance with previous research showing that FLT3-ITD mutation is predictive of relapse. Patients with FLT3 mutation at R/R had a shorter OS, which indicates the importance of FLT3 testing at R/R diagnosis to optimize outcomes through targeted therapy.

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