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Syed A. Hussain, MD, on Muscle-Invasive Bladder Cancer: NEO-BLADE Trial of Nintedanib Plus Chemotherapy
Syed A. Hussain, MD, of the University of Sheffield, discusses phase II findings comparing nintedanib or placebo in combination with gemcitabine and cisplatin in locally advanced muscle-invasive bladder cancer. The data showed that adding nintedanib was safe and well tolerated, with a significant...
Jonathan E. Rosenberg, MD, on Locally Advanced or Metastatic Urothelial Carcinoma: Enfortumab Vedotin Plus Pembrolizumab
Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discusses study results which showed that, in first-line cisplatin-ineligible patients with metastatic urothelial carcinoma, enfortumab vedotin/pembrolizumab demonstrated activity and durability, with a manageable safety profile...
Thomas Powles, MD, PhD, and Enrique Grande, MD, PhD, on Urothelial Carcinoma: Atezolizumab and Platinum-Based Chemotherapy
Thomas Powles, MD, PhD, of Queen Mary University of London, and Enrique Grande, MD, PhD, of MD Anderson Cancer Center, Madrid, discuss findings of the phase III IMvigor130 trial on the efficacy and safety of atezolizumab as monotherapy or combined with platinum-based chemotherapy vs placebo plus...
Thomas Powles, MD, PhD, on Metastatic Urothelial Cancer: Durvalumab Plus Targeted Treatments
Thomas Powles, MD, PhD, of Queen Mary University of London, discusses the first study to examine immunotherapy and targeted treatment combinations with a personalized approach in bladder cancer. FGF, TORC1/2, and PARP inhibitors were explored in combination with durvalumab in selected patients...
Conditional Reprogramming of Urine Cultures for Bladder Cancer
A research team led by investigators from Georgetown University Medical Center and Fudan University in China has devised a noninvasive and individualized technique for detecting and treating bladder cancer. Their findings were published by Jiang et al in Protein & Cell. The method uses a...
Study Identifies Key Biologic Features of Upper Tract Urothelial Carcinoma
A new study published by Robinson et al in Nature Communications aimed to learn more about the biologic characteristics of upper tract urothelial carcinoma to help develop more targeted therapies. “We discovered the defining biologic characteristics of [upper tract urothelial tumors] that...
Christopher Sweeney, MBBS, and Ian D. Davis, MBBS, PhD, on ANZUP: Taking a Multidisciplinary Approach to Prostate, Kidney, Bladder, Testicular, and Penile Cancers
Christopher Sweeney, MBBS, of Dana-Farber Cancer Institute, and Ian D. Davis, MBBS, PhD, of Monash University and Eastern Health, discuss the Australian and New Zealand Urogenital and Prostate Cancer Trials Group, working globally to speed clinical research in and treatment of urogenital cancers.
Brian C. Baumann, MD, on Locally Advanced Bladder Cancer: Adjuvant Radiotherapy After Radical Cystectomy
Brian C. Baumann, MD, of Washington University School of Medicine, discusses study findings suggesting postoperative radiotherapy may be an option for patients with locally advanced bladder cancer after radical cystectomy who are unable or unwilling to use adjuvant chemotherapy (Abstract 4507).
Matt D. Galsky, MD, on Urothelial Cancer: Pembrolizumab vs Placebo After First-Line Chemotherapy
Matt D. Galsky, MD, of The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai, discusses phase II study findings that show switch maintenance with pembrolizumab significantly improves progression-free survival in the metastatic setting (Abstract 4504).
Jonathan E. Rosenberg, MD, on Urothelial Carcinoma: Adding Bevacizumab to Gemcitabine and Cisplatin
Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discusses results from the phase III Alliance trial, which showed that adding bevacizumab to gemcitabine and cisplatin did not improve overall survival in patients with metastatic urothelial carcinoma, but did improve...
Neeraj Agarwal, MD, and Thomas W. Flaig, MD, on Muscle-Invasive Bladder Cancer: Predicting Response to Neoadjuvant Chemotherapy
Neeraj Agarwal, MD, of Huntsman Cancer Institute, University of Utah Health Care, and Thomas W. Flaig, MD, of the University of Colorado, discuss phase II findings on a novel predictive biomarker of response to the two accepted neoadjuvant regimens for muscle-invasive bladder cancer:...
Daniel P. Petrylak, MD, on Urothelial Cancer: Enfortumab Vedotin Monotherapy for Locally Advanced or Metastatic Disease
Daniel P. Petrylak, MD, of Yale School of Medicine, discusses study results on enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors (Abstract LBA4505).
2019 ASCO: Enfortumab Vedotin Shows Activity in Previously Treated, Locally Advanced or Metastatic Urothelial Cancer
The single-arm, phase II EV-201 trial showed treatment with enfortumab vedotin—an agent targeting Nectin-4, a protein found in 97% of urothelial cancers—produced responses in 44% of patients with locally advanced or metastatic forms of urothelial cancer. Patients had previously been...
CheckMate 032: Extended Follow-up of Nivolumab and Nivolumab/Ipilimumab Cohorts in Previously Treated Metastatic Urothelial Carcinoma
As reported in the Journal of Clinical Oncology by Sharma et al, follow-up of the cohort receiving nivolumab at 1 mg/kg plus ipilimumab at 3 mg/kg the phase I/II CheckMate 032 trial showed the regimen produced high levels of activity in platinum-treated, unresectable, locally advanced or metastatic ...
Does Quitting Smoking Affect Risk of Bladder Cancer in Postmenopausal Women?
A large study of postmenopausal women indicated that quitting cigarette smoking was associated with significantly reduced risk of bladder cancer. The most significant reduction in risk occurred in the first 10 years after quitting, with a modest but continued decline in later years. These results...
AUA 2019: Studies Highlight Potential Bladder Cancer Risks
Electronic cigarettes (e-cigarettes), exposure to certain environmental factors, and human papillomavirus (HPV) infection may increase the risk of developing bladder cancer, according to new data presented this week at the 2019 Annual Meeting of the American Urological Association (AUA). The...
AUA 2019: OLYMPUS Trial Assesses Mitomycin Gel in Low-Grade Upper Tract Urothelial Carcinoma
Findings from a secondary analysis of the phase III OLYMPUS trial were presented by Kleinmann et al during the Plenary Session at the 2019 American Urological Association (AUA) Annual Meeting (Abstract LBA-16). Results showed that instillation of UGN-101, an investigational formulation of mitomycin ...
FDA Grants Accelerated Approval to Erdafitinib for Metastatic Urothelial Carcinoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to erdafitinib (Balversa) for patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations that has progressed during or following platinum-containing...
EAU 2019: Early Menopause in Smokers May Be Linked to Increased Risk of Bladder Cancer
New research has shown that experiencing menopause before the age of 45 is associated with a higher risk of bladder cancer; this higher risk was even more notable in smokers. The study, which looked at health outcomes in more than 220,000 patients, was presented by Abufaraj et al at the European...
Nicholas Vogelzang, MD, on Urothelial Cancer: Results From a Trial on Lenvatinib Plus Pembrolizumab
Nicholas Vogelzang, MD, of the Comprehensive Cancer Centers of Nevada, discusses phase Ib/II findings on pembrolizumab and lenvatinib given to 20 patients with metastatic transitional cell carcinoma of the bladder who had received no prior checkpoint inhibitor therapy (Abstract 11).
Thomas Powles, MD, PhD, on Urothelial Carcinoma: Results From the RANGE Trial on Ramucirumab and Docetaxel
Thomas Powles, MD, PhD, of Queen Mary University of London, discusses phase III study findings on ramucirumab plus docetaxel vs placebo plus docetaxel in patients with advanced platinum-refractory urothelial carcinoma (Abstract 353).
Jason A. Efstathiou, MD, DPhil, on Bladder Cancer: What Is the Best Treatment Option?
Jason A. Efstathiou, MD, DPhil, of Massachusetts General Hospital, discusses the debate over treating muscle-invasive bladder cancer with radical cystectomy vs trimodality therapy.
Brian C. Baumann, MD, on Bladder Cancer: Trial Results on Adjuvant Chemoradiotherapy vs Adjuvant Radiotherapy Alone
Brian C. Baumann, MD, of Washington University School of Medicine, discusses phase III study findings on adjuvant sequential chemotherapy plus radiotherapy vs adjuvant radiotherapy alone for locally advanced bladder cancer after radical cystectomy (Abstract 351).
2019 GU Cancers Symposium: Adjuvant Sequential Chemotherapy Plus Radiotherapy vs Radiotherapy Alone for Locally Advanced Bladder Cancer
A phase III Egyptian trial presented by Zaghloul et al (Abstract 351) at the 2019 Genitourinary Cancers Symposium focused on the benefit of adjuvant chemotherapy in patients with locally advanced bladder cancer treated with postoperative radiotherapy. Researchers compared postoperative radiotherapy ...
FDA Pipeline: What’s New in Biosimilars, Drug Reviews, Designations, and More
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Approval for Pegfilgrastim Biosimilar The FDA recently approved a pegfilgrastim biosimilar, pegfilgrastim-cbqv (Udenyca). The biosimilar has been approved to decrease the incidence...
Cora N. Sternberg, MD, on Renal and Bladder Cancers: Focus on Immunotherapy
Cora N. Sternberg, MD, of San Camillo-Forlanini Hospital and the Israel Englander Institute of Precision Medicine at Weill Cornell, discusses results from the phase III CheckMate-025 study on nivolumab vs everolimus for mRCC; the CheckMate-214 study on nivolumab, ipilimumab, and sunitinib for...
Ronald de Wit, MD, PhD, on Bladder Cancer: Results From KEYNOTE-057
Ronald de Wit, MD, PhD, of the University Medical Center Rotterdam, discusses phase II findings on the efficacy of pembrolizumab in bacillus Calmette-Guérin–unresponsive bladder cancer with high risk for disease progression.
FDA Updates Prescribing Information for Pembrolizumab and Atezolizumab in Urothelial Carcinoma
On August 16, 2018, the U.S. Food and Drug Administration (FDA) updated the prescribing information for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) to require the use of an FDA-approved companion diagnostic test to determine programmed cell death ligand 1 (PD-L1) levels in tumor tissue...
VB4-845 Granted Fast Track Designation by FDA for Treatment of Non–Muscle Invasive Bladder Cancer
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VB4-845 for the treatment of bacillus Calmette-Guérin (BCG)–unresponsive, high-grade, non–muscle invasive bladder cancer. VB4-845 is currently being evaluated in a phase III registration...
STAG2 Genetic Test Could Reduce Overtreatment in Some Patients With Bladder Cancer
A new genetic test in bladder cancer could be key to reducing the cost of care while avoiding overtreatment in some patients, according to research published by Waldman et al in Clinical Cancer Research. Deciding whether to treat bladder cancer aggressively can be difficult—predictive...
FDA Restricts Use of Pembrolizumab or Atezolizumab to Treat Urothelial Cancer Due to Efficacy Concerns in Some Patients
As of June 20, the U.S. Food and Drug Administration (FDA) has restricted the use of pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. The restriction results from a...
2018 ASCO: Erdafitinib Shows Activity in FGFR3-Mutated Urothelial Cancer
In an international phase II trial led by researchers at The University of Texas MD Anderson Cancer Center, treatment with the oral FGFR inhibitor erdafitinib was well tolerated and achieved a robust response for patients with metastatic urothelial cancers harboring mutations in the FGFR3...
Toni K. Choueiri, MD, and Jonathan E. Rosenberg, MD: Bladder Cancer Roundup
Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, and Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discuss their perspectives on the top abstracts in bladder cancer presented at the 2018 ASCO Annual Meeting (Abstracts 4507, 4506, 4503, 4504).
FDA Identifies Efficacy Issue in Clinical Trials of Pembrolizumab or Atezolizumab as Monotherapy in Urothelial Cancer With Low Expression of PD-L1
On May 18, the U.S. Food and Drug Administration (FDA) alerted health-care professionals, oncology clinical investigators, and the public about decreased survival associated with the use of pembrolizumab (Keytruda) or atezolizumab (Tecentriq) as monotherapy in clinical trials to treat patients with ...
Intravesical Instillation of Gemcitabine Postsurgery May Aid in Preventing Bladder Cancer Recurrence
Flushing the bladder with a common chemotherapy drug immediately after surgery significantly reduces the chances of bladder cancer returning, according to a study by Messing et al published in JAMA and led by SWOG. First author Edward M. Messing, MD, is Professor of Urology and...
Results From Phase III RANGE Study of Ramucirumab in Advanced or Metastatic Urothelial Cancer
Eli Lilly and Company recently announced additional results from its global, randomized, double-blind, placebo-controlled phase III RANGE trial evaluating ramucirumab (Cyramza) in combination with docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose...
FDA Grants Fast Track Designation for TAR-200 in Muscle-Invasive Bladder Cancer
On April 3, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for TAR-200, a gemcitabine-releasing intravesical system (GemRIS), for the treatment of patients with organ-confined or locally advanced muscle-invasive bladder cancer who are unfit for curative-intent therapy....
FDA 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...
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 ...
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.
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...
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 ...
