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Showing 101 - 150FDA Grants Breakthrough Therapy Designation to Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer
On March 26, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to enfortumab vedotin, an antibody-drug conjugate (ADC), for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors. Breakthrough Therapy ...
EAU 2018: Survey Shows Greater Suicide Rate in Patients With Urologic Cancers
A major UK survey has shown that patients with urologic cancer—such as prostate, bladder, or kidney cancer—are five times more likely to commit suicide than people without cancer. The analysis also shows that patients with cancer generally are around three times more likely to commit...
Alterations in DNA Damage Response and Repair Genes and Response to PD-1/PD-L1 Inhibitors in Advanced Urothelial Cancer
In a study reported in the Journal of Clinical Oncology, Teo et al found that alterations in DNA damage response and repair (DDR) genes, particularly known or likely deleterious alterations, were associated with response to programmed cell death protein 1 (PD-1)/programmed cell death ligand 1...
FDA Grants Breakthrough Therapy Designation to Erdafitinib for the Treatment of Metastatic Urothelial Cancer
On March 15, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to erdafitinib for the treatment of urothelial cancer. Urothelial cancer, most frequently in the bladder, is the sixth most common type of cancer in the United States. A Breakthrough Therapy ...
Long-Term Outcomes With PD-L1 Inhibition in Metastatic Urothelial Cancer
As reported by Petrylak et al in JAMA Oncology, long-term follow-up of patients in a phase I study expansion cohort indicated enduring clinical benefit and maintained tolerability of atezolizumab (Tecentriq) in patients with metastatic urothelial carcinoma. Study Details The study involved...
Gregory R. Pond, PhD, on Urothelial Cancer: Advance in Prognosis
Gregory R. Pond, PhD, of McMaster University, discusses a new six-factor prognostic model for patients with advanced urothelial carcinoma receiving post platinum atezolizumab (Abstract 413).
Jonathan E. Rosenberg, MD, on Urothelial Carcinoma: Results From the CheckMate 032 Trial
Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discusses longer-term efficacy and safety findings on nivolumab monotherapy in metastatic urothelial carcinoma (Abstract 414).
Thomas Powles, MD, on Urothelial Carcinoma: Results From the IMvigor211 Trial
Thomas Powles, MD, of Barts Cancer Institute, discusses phase III study findings on atezolizumab vs chemotherapy in platinum-treated locally advanced or metastatic urothelial carcinoma, with an emphasis on immune biomarkers, tumor mutational burden, and clinical outcomes (Abstract 409).
John J. Coen, MD, on Bladder Cancer: Results From the NRG/RTOG 0712 Trial
John J. Coen, MD, of 21st Century Oncology, discusses phase II study findings on selective bladder preservation with twice-daily radiation plus fluorouracil/cisplatin or daily radiation plus gemcitabine for patients with muscle-invasive bladder cancer (Abstract 408).
Joaquim Bellmunt, MD, PhD, on Urothelial Cancer: Results From the KEYNOTE-045 Trial
Joaquim Bellmunt, MD, PhD, of the Dana-Farber Cancer Institute, discusses phase III 2-year follow-up findings on pembrolizumab vs investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (Abstract 410).
2018 GU CANCERS SYMPOSIUM: New Model Predicts Survival for People With Bladder Cancer Receiving Immunotherapy
Researchers have developed a model to predict overall survival for people with advanced urothelial cancers treated with the immune checkpoint inhibitor atezolizumab (Tecentriq). The model, which is based on six clinical factors, may help inform treatment decisions for use of atezolizumab in these...
Joaquim Bellmunt, MD, PhD, on Bladder Cancer: The Future of Immunotherapies
Joaquim Bellmunt, MD, PhD, of Dana-Farber Cancer Institute, discusses refining treatment choices with new combinations and sequencing strategies.
IMvigor211 Trial: Atezolizumab vs Chemotherapy in Platinum-Treated Advanced Urothelial Carcinoma
The phase III IMvigor211 trial showed no survival benefit for atezolizumab (Tecentriq) vs physician's choice of chemotherapy in platinum-treated locally advanced or metastatic urothelial carcinoma with programmed death-ligand 1 (PD-L1) expression ≥ 5%. Findings were reported in The Lancet by...
First-Line Immunotherapy for Cisplatin-Ineligible Patients With Advanced Urothelial Cancer
As reported in The Lancet Oncology by Balar et al, first-line pembrolizumab (Keytruda) produced durable responses in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer in the phase II KEYNOTE-052 trial. The trial supported the accelerated approval...
ESMO 2017: KEYNOTE-045: Updated Results Support Pembrolizumab as Second-Line Treatment in Advanced Urothelial Cancer
Mature results from the KEYNOTE-045 trial presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid (Abstract LBA37_PR) confirmed significantly longer survival in patients with advanced urothelial cancer who received the checkpoint inhibitor pembrolizumab after initial...
Adjuvant Chemotherapy vs Observation After Neoadjuvant Therapy and Radical Cystectomy for Bladder Cancer
In an analysis reported in JAMA Oncology, Seisen et al found that adjuvant chemotherapy was associated with a survival benefit vs observation in patients with adverse prognostic features after neoadjuvant therapy and radical cystectomy for urothelial carcinoma of the bladder. Study Details The...
Recombinant Adenovirus Interferon-α With Syn3 in BCG-Refractory or Relapsed Non–Muscle Invasive Bladder Cancer
A phase II study has shown activity of recombinant adenovirus interferon-α with Syn3 (rAd-IFNα/Syn3), a replication-deficient recombinant adenovirus gene transfer vector, in patients with high-grade bacillus Calmette-Guerin (BCG)-refractory or -relapsed non–muscle invasive bladder ...
Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma
Updated results of a phase I/II study of durvalumab (Imfinzi) in locally advanced or metastatic urothelial carcinoma were reported by Powles et al in JAMA Oncology. Data from the ongoing study supported the recent approval of durvalumab as second-line treatment in this setting on the basis of...
Treatment of Nonmetastatic Muscle-Invasive Bladder Cancer: AUA/ASCO/ASTRO/SUO Guideline
As reported in the Journal of Oncology Practice by Chang et al, for the first time for any type of malignancy, the American Urological Association (AUA), ASCO, American Society for Radiation Oncology (ASTRO), and Society of Urologic Oncology (SUO) have formulated an evidence-based guideline on...
Elizabeth R. Plimack, MD, on Advanced Urothelial Cancer: Expert Perspective
Elizabeth R. Plimack, MD, of Fox Chase Cancer Center, discusses highlights of three important abstracts on advanced and metastatic urothelial cancer presented at the 2017 ASCO Annual Meeting. (Abstracts 4501, 4503, 106)
European Commission Approves Nivolumab for Previously Treated, Locally Advanced, Unresectable or Metastatic Urothelial Cancer
On June 2, the European Commission (EC) approved nivolumab (Opdivo) for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. This makes nivolumab the first immuno-oncology agent approved in the European Union ...
David I. Quinn, MBBS, PhD, on Urothelial Cancer: Results from KEYNOTE-045
David I. Quinn, MBBS, PhD, of the University of Southern California, gives his expert perspective on the planned survival analysis from a phase III open-label study of pembrolizumab vs paclitaxel, docetaxel, or vinflunine in recurrent, advanced urothelial cancer. (Abstract 4501)
Dean F. Bajorin, MD, and Peter H. O’Donnell, MD, on Urothelial Cancer: Results From Two KEYNOTE Trials
Dean F. Bajorin, MD, of Memorial Sloan Kettering Cancer Center, and Peter H. O’Donnell, MD, of The University of Chicago Medical Center, discuss their study findings on treating advanced urothelial cancer with pembrolizumab, paclitaxel, docetaxel, or vinflunine. (Abstracts 4501 and 4502)
AUA 2017: Phase III Study of Blue Light Cystoscopy With Optical Imaging Agent in Bladder Cancer
New phase III study results of blue light flexible cystoscopy (BLFC) with an optical imaging agent (Hexvix/Cysview) were presented by Daneshmand et al during a late-breaking plenary session at the 2017 American Urological Association (AUA) Annual Meeting (Abstract PPTLBA-02). Major Findings The...
FDA Approves Pembrolizumab for Advanced or Metastatic Urothelial Carcinoma
Today, the U.S. Food and Drug Administration (FDA) granted regular approval to pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or...
AUA 2017: Studies Examine Bladder Cancer Risk and Mortality in E-Cigarette and Traditional Smokers
Data presented at the 2017 Annual Scientific Meeting of the American Urological Association (AUA) showed harmful links between the use of e-cigarettes and bladder cancer risk, and associated the smoking of traditional cigarettes to a higher risk of mortality among patients with bladder cancer. Even ...
FDA Grants Accelerated Approval to Avelumab for Urothelial Carcinoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (Bavencio) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant...
FDA Approves Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to durvalumab (Imfinzi) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease...
Second-Line Pazopanib vs Weekly Paclitaxel in Relapsed or Progressive Urothelial Cancer
A UK phase II trial comparing pazopanib (Votrient) with paclitaxel after failure of platinum-based therapy in patients with locally advanced or metastatic urothelial carcinoma was stopped early due to futility. These results were reported by Jones et al in the Journal of Clinical Oncology. Two...
FDA Grants Atezolizumab Accelerated Approval as Initial Treatment for Some Advanced Bladder Cancers
On April 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy. Atezolizumab was previously approved for people...
Elizabeth R. Plimack, MD, on Bladder Cancer: Management Updates
Elizabeth R. Plimack, MD, of Fox Chase Cancer Center, discusses selecting first- and second-line therapies for patients with advanced bladder cancer and the emerging data and role of immune checkpoint inhibitors.
Study Identifies How Cancer Cells May Develop Resistance to FGFR Inhibitors
A new study by researchers at The Ohio State University Comprehensive Cancer Center–Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC– James) has identified a mechanism by which cancer cells develop resistance to a class of drugs called fibroblast growth...
Pembrolizumab vs Chemotherapy in Second-Line Treatment of Advanced Urothelial Carcinoma
In a phase III KEYNOTE-045 trial reported in The New England Journal of Medicine, Bellmunt et al found that pembrolizumab (Keytruda) significantly improved overall survival vs investigator choice of chemotherapy as second-line treatment in patients with advanced urothelial cancer whose disease...
Roland Seiler, MD, on Bladder Cancer: Subtypes and Treatment Response (German Language Version) 
Roland Seiler, MD, of the University of British Columbia, discusses in German a way to identify molecular subtypes of muscle-invasive bladder cancer, the varying responses to cisplatin-based neoadjuvant chemotherapy, and which patients show the most benefit. (Abstract 281)
Karim Chamie, MD, on Bladder Cancer: Optimizing Surgical and Medical Therapies
Karim Chamie, MD, of the University of California, Los Angeles, discusses induction and maintenance BCG therapy in non–muscle-invasive bladder cancer.
Roland Seiler, MD, on Bladder Cancer: Subtypes and Treatment Response
Roland Seiler, MD, of the University of British Columbia, discusses a way to identify molecular subtypes of muscle-invasive bladder cancer, the varying responses to cisplatin-based neoadjuvant chemotherapy, and which patients show the most benefit. (Abstract 281)
Emma Hall, PhD, on Bladder Cancer: Results From the BC2001 Trial
Emma Hall, PhD, of the Institute of Cancer Research, London, discusses long-term outcomes with chemoradiotherapy vs radiotherapy alone, and standard vs reduced high-dose volume radiotherapy in muscle-invasive bladder cancer. (Abstract 280)
Toni K. Choueiri, MD, on Urothelial Cancer: Trial Results From Borealis-2
Toni K. Choueiri, MD, of the Dana-Farber Cancer Institute, discusses study findings on apatorsen plus docetaxel vs docetaxel alone in platinum-resistant metastatic urothelial cancer. (Abstract 289)
2017 GU Cancers Symposium: Updated Efficacy and Tolerability of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma
At the 2017 Genitourinary Cancers Symposium, Powles et al presented updated efficacy and safety data for durvalumab in patients with locally advanced or metastatic urothelial cancer (Abstract 286). Updated results from the phase I/II trial showed an objective response rate of 20.4% in all...
Nivolumab in Metastatic Urothelial Carcinoma After Platinum Therapy
As reported in The Lancet Oncology by Sharma et al, the phase II CheckMate 275 trial has shown nivolumab (Opdivo) to produce durable responses in patients with metastatic urothelial cancer who had received at least one prior platinum-based regimen. The study supported the recent accelerated...
FDA Accepts Two sBLAs for Pembrolizumab in Locally Advanced or Metastatic Urothelial Cancer
On February 3, the U.S. Food and Drug Administration (FDA) accepted for review two supplemental Biologics License Applications (sBLAs) for pembrolizumab (Keytruda) in patients with locally advanced or metastatic urothelial cancer. Specifically, the application for first-line use was accepted and...
FDA Approves Nivolumab in Locally Advanced or Metastatic Bladder Cancer
On February 2, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have...
Pembrolizumab Studied in Locally Advanced or Metastatic Urothelial Cancer
As reported by Plimack et al in The Lancet Oncology, pembrolizumab (Keytruda) has shown activity in patients in the locally advanced or metastatic urothelial carcinoma cohort included in the phase Ib KEYNOTE-012 trial. Study Details In the study, 33 patients with locally advanced or metastatic...
FDA Accepts sBLA and Grants Priority Review for Atezolizumab in Locally Advanced or Metastatic Urothelial Carcinoma
On January 9, the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin...
Survival Benefit Reported With Adjuvant Chemotherapy After Nephroureterectomy for Urothelial Carcinoma
In a National Cancer Database analysis reported in the Journal of Clinical Oncology, Seisen et al found that adjuvant chemotherapy after radical nephroureterectomy was associated with an overall survival benefit in patients with locally advanced or regional lymph node–positive upper tract...
Atezolizumab Shows Activity in First-Line Treatment of Cisplatin-Ineligible Patients With Advanced Urothelial Carcinoma
In a phase II trial reported in The Lancet, Balar et al found that first-line atezolizumab (Tecentriq) produced durable responses in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma. In the study, 119 patients from 47 sites in North America and Europe who were ...
SITC 2016: Immune Checkpoint Inhibitors Shrink Tumors in Some Patients With Metastatic Bladder Cancer
Combination immunotherapy is producing response rates ranging from 26% to 38% among patients with metastatic bladder cancer in the early stages of a three-arm clinical trial presented at the 2016 Society for Immunotherapy of Cancer (SITC) Annual Meeting in National Harbor, Maryland. “Until...
Low Vitamin D Levels May Be Linked to Increased Risk of Bladder Cancer
Vitamin D deficiency may be associated with an increased risk of developing bladder cancer, according to a systematic review of seven studies presented at the Society for Endocrinology Annual Conference in Brighton, United Kingdom. Though further clinical studies are needed to confirm the findings, ...
KEYNOTE-045 Studying Pembrolizumab in Advanced Bladder Cancer Meets Primary Endpoint and Stops Early
Merck announced October 21, 2016, that the phase III KEYNOTE-045 trial investigating the use of pembrolizumab (Keytruda), the company’s anti–PD-1 (programmed cell death protein 1) therapy in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall ...
ESMO 2016: Immunotherapy Shows Promising Results in First- and Second-Line Treatment of Metastatic Bladder Cancer in Two Trials
Immunotherapy has shown promising results in the first- and second-line treatment of metastatic bladder cancer in two phase II trials presented by Galsky et al and Balar et al at the 2016 European Society for Medical Oncology (ESMO) Congress in Copenhagen (Abstracts LBA31_PR and LBA32_PR,...
