A5069555817- Cancer Immunotherapy and Biomarkers
- Bladder and Urothelial Cancer Treatments
- Statistical Methods in Clinical Trials
- Urinary and Genital Oncology Studies
- Advanced Causal Inference Techniques
- Statistical Methods and Inference
- Endometriosis Research and Treatment
- Health Systems, Economic Evaluations, Quality of Life
- Epigenetics and DNA Methylation
- Esophageal Cancer Research and Treatment
- Uterine Myomas and Treatments
- Blood Pressure and Hypertension Studies
- Ubiquitin and proteasome pathways
- Colorectal Cancer Treatments and Studies
- Renin-Angiotensin System Studies
- Cardiovascular Health and Disease Prevention
- Hormonal Regulation and Hypertension
- Multi-Criteria Decision Making
- Blood Coagulation and Thrombosis Mechanisms
- Sodium Intake and Health
- HIV Research and Treatment
- Cancer survivorship and care
- Hemophilia Treatment and Research
- RNA Interference and Gene Delivery
- HIV/AIDS drug development and treatment
Sun Yat-sen Memorial Hospital
2025
Sun Yat-sen University
2025
Boehringer Ingelheim (China)
2021-2023
AbbVie (United States)
2019-2021
Asan Medical Center
2018
University of Ulsan
2018
Dana-Farber Cancer Institute
2018
Université Laval
2018
Ulsan College
2018
Merck & Co., Inc., Rahway, NJ, USA (United States)
2010-2017
Patients with advanced urothelial carcinoma that progresses after platinum-based chemotherapy have a poor prognosis and limited treatment options.In this open-label, international, phase 3 trial, we randomly assigned 542 patients cancer recurred or progressed to receive pembrolizumab (a highly selective, humanized monoclonal IgG4κ isotype antibody against programmed death 1 [PD-1]) at dose of 200 mg every weeks the investigator's choice paclitaxel, docetaxel, vinflunine. The coprimary end...
Purpose In the phase III KEYNOTE-045 study ( ClinicalTrials.gov identifier: NCT02256436), pembrolizumab significantly prolonged overall survival compared with investigator's choice of chemotherapy in patients previously treated advanced urothelial cancer. Here, we report results health-related quality-of-life (HRQoL) analyses from trial. Patients and Methods were randomly assigned 1:1 to 200 mg or docetaxel 75 mg/m2, paclitaxel 175 vinflunine 320 mg/m2 administered intravenously every 3...
AngII (angiotensin II) may contribute to cardiovascular risk in obesity via adverse effects on insulin sensitivity and endothelial function. In the present study, we examined of ARB receptor blocker) therapy (losartan, 100 mg/day) function 53 subjects with stage I hypertension, abdominal impaired fasting glucose. The study design was a randomized double-blinded parallel placebo-controlled multi-centre trial 8 weeks duration. We used hyperinsulinaemic-euglycaemic clamp technique measure...
4501 Background: Second-line chemotherapies (chemo) for advanced UC have limited clinical benefit (OS, 7-9 mo). Data from the open-label, phase 3 KEYNOTE-045 study (NCT02256436) showed significantly longer OS with pembro v chemo (median, 10.3 7.4 mo; hazard ratio [HR], 0.73; P = 0.002) in recurrent, UC. a planned survival analysis are presented. Methods: Pts had histologically or cytologically confirmed UC, progression after platinum, ECOG PS 0-2, measurable disease (RECIST v1.1), and ≤2...
### O1 Combinatorial CD8+ and PD-L1+ cell densities correlate with response improved survival in non-small lung cancer (NSCLC) patients treated durvalumab #### Sonja Althammer1, Keith Steele2, Marlon Rebelatto2, Tze Heng Tan1, Tobias Wiestler1, Guenter Schmidt1, Brandon Higgs2, Xia
TPS4571 Background: Paclitaxel, docetaxel, and vinflunine are commonly used as second-line therapy for advanced urothelial cancer, but median OS is only 7-9 months. The PD-1 pathway plays a key role in evading the tumor immune response. Pembrolizumab highly selective anti–PD-1 monoclonal antibody designed to block interaction between its ligands PD-L1 PD-L2. In KEYNOTE-012, pembrolizumab 10 mg/kg every 2 weeks (Q2W) provided 24% ORR (RECIST v1.1, central review) an acceptable safety profile...
282 Background: In KEYNOTE-045 (NCT02256436) (N = 542), pembro 200 mg Q3W significantly improved OS over investigator’s choice of paclitaxel, docetaxel, or vinflunine as second-line therapy for advanced UC following platinum-based chemo (HR 0.73; P 0.0022). Fewer treatment-related AEs were reported with pembro. We present results the prespecified HRQoL analysis KEYNOTE-045. Methods: The EORTC QLQ-C30 instrument was administered electronically at cycles 1–4, then every 2 up to 1 y and 30 d...
TPS4572 Background: Standard first-line therapy for advanced urothelial cancer is cisplatin-based chemotherapy. Pts who are ineligible cisplatin therapy, mainly due to renal dysfunction and/or poor performance status, have limited treatment options. The programmed death receptor 1 (PD-1) pathway used by tumors suppress immune control. Pembrolizumab a highly selective, IgG4 anti-PD-1 humanized monoclonal antibody designed block the interaction between PD-1 and its ligands PD-L1 PD-L2. In...
In this post hoc analysis, we evaluated the impact of elagolix on dysmenorrhea and nonmenstrual pelvic pain across menstrual period (bleeding days) (nonbleeding) days.Data from two randomized, 6-month, placebo-controlled trials (Elaris Endometriosis (EM)-I EM-II) (150 mg once daily (QD) 200 twice (BID)) in premenopausal women with moderate to severe endometriosis-associated (N = 1686) were pooled. Women recorded presence severity or a electronic diary.At baseline, placebo group both...
4530 Background: In KEYNOTE-045 (NCT02256436) (N = 542), pembro 200 mg Q3W significantly improved OS over investigator’s choice of paclitaxel, docetaxel, or vinflunine as second-line therapy for advanced UC following platinum-based chemo (HR 0.73; P 0.0022). Fewer treatment-related AEs were reported with pembro. We present results the prespecified HRQoL analysis KEYNOTE-045. Methods: The EORTC QLQ-C30 instrument was administered electronically at cycles 1–4, then every 2 up to 1 y and 30 d...
Benefit-risk (BR) assessment is important to ensure safety and effectiveness of medical projects in clinical development post marketing surveillance. The evaluation the balance between benefits risks a drug fundamental all stakeholders involved development, registration, use drugs. Many quantitative approaches have been developed that may draw together data from different sources present them ways can aid decision-making. Among these approaches, multicriteria decision analysis (MCDA) one...
In oncology clinical trials, characterizing the long-term overall survival (OS) benefit for an experimental treatment is often unobservable if some patients in control group switch to drugs and/or other cancer treatments after disease progression. A key question raised by payers and reimbursement agencies how estimate true of on OS that would have been estimated there were no switches. Several commonly used statistical methods are available while adjusting switching, ranging from naive...
Background: The daily pain burden experienced by women with endometriosis has not been well studied. Objective: To characterize baseline among moderate-to-severe endometriosis-associated enrolled in phase 3 studies of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist. Study design: Data were pooled from the screening two randomized, double-blind, placebo-controlled clinical trials. After cessation medications, patients entered during which symptoms (dysmenorrhea,...
The treatment effects of the same therapy observed from multiple clinical trials can often be very different. Yet patient characteristics accounting for these differences may not identifiable in real world practice. There needs to an unbiased way combine results and report overall effect general population during development validation a new therapy. non-linear structure maximum partial likelihood estimates (log) hazard ratio defined with Cox proportional model leads challenges statistical...
In oncology clinical trials, characterizing the long-term overall survival (OS) benefit for an experimental drug or treatment regimen (experimental group) is often unobservable if some patients in control group switch to drugs and/or other cancer treatments after disease progression. A key question raised by payers and reimbursement agencies how estimate true of on that would have been estimated there were no switches. Several commonly used statistical methods are available while adjusting...