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Nicholas D. James, PhD, MBBS, on Bladder Cancer: Cetuximab With Chemoradiotherapy
Nicholas D. James, PhD, MBBS, of The Institute of Cancer Research in London, discusses results from a phase I/II feasibility study that showed the combination of cetuximab, chemoradiation, fluorouracil, and mitomycin yields high bladder cancer control rates with acceptable toxicity and quality of...
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...
Gemcitabine/Eribulin in Cisplatin-Ineligible Metastatic Urothelial Carcinoma
In the final analysis from a phase II California Cancer Consortium trial (NCI-9653) reported in the Journal of Clinical Oncology, Sadeghi et al found the combination of gemcitabine and eribulin showed activity in cisplatin-ineligible patients with metastatic urothelial carcinoma. Study Details...
Enfortumab Vedotin in Platinum- and Anti–PD-1/L1–Pretreated Urothelial Carcinoma
In the phase II EV-201 trial reported in the Journal of Clinical Oncology, Rosenberg et al found the antibody-drug conjugate enfortumab vedotin showed high activity in patients with metastatic urothelial carcinoma who had previously received platinum-based therapy and anti–programmed cell...
Erdafitinib in FGFR-Altered Advanced Urothelial Carcinoma
As reported in The New England Journal of Medicine by Loriot et al, the fibroblast growth factor receptor 1-4 tyrosine kinase inhibitor erdafitinib showed activity in FGFR-altered advanced urothelial carcinoma. Study Details The study enrolled patients from sites in 14 countries between May...
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...
Ramucirumab Plus Pembrolizumab in Previously Treated Advanced Gastroesophageal Cancer, NSCLC, and Urothelial Carcinoma
Results from a phase IB trial expansion stage reported in The Lancet Oncology by Herbst et al showed the combination of ramucirumab plus pembrolizumab had manageable toxicity and antitumor activity in previously treated advanced gastroesophageal cancer, non–small cell lung cancer (NSCLC), and ...
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.
Adverse Events and Outcomes in Patients Receiving Anti–PD-1/PD-L1 Antibody Treatment for Advanced Urothelial Cancer
In an analysis reported in the Journal of Clinical Oncology, Maher et al found that treatment-related adverse events of special interest and immune-mediated adverse events were more common among patients with advanced urothelial cancer with vs without response to anti–programmed cell death...
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...
Ultradeep Sequencing of Plasma Cell-Free DNA in Bladder Cancer
In a study reported in the Journal of Clinical Oncology, Christensen et al found that identification of circulating tumor DNA (ctDNA) by ultradeep sequencing of plasma cell-free DNA was highly prognostic for outcome in bladder cancer and permitted early detection of relapse. The study...
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 ...
Bladder-Sparing Treatment Regimens for Muscle-Invasive Bladder Cancer
In a phase II trial (NRG/RTOG 0712) reported in the Journal of Clinical Oncology, Coen et al found that bladder-sparing treatment with twice-daily radiation plus fluorouracil/cisplatin (FCT) or once-daily radiation plus gemcitabine (GD) produced similar distant metastasis-free survival in patients...
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...
PURE-01 Trial: Neoadjuvant Immunotherapy in Muscle-Invasive Bladder Carcinoma
In the Italian phase II PURE-01 trial reported in the Journal of Clinical Oncology, Necchi et al found that neoadjuvant pembrolizumab (Keytruda) before radical cystectomy in muscle-invasive bladder carcinoma produced complete pathologic response (pT0) in 42% of patients, with pT0 being more common...
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.
Outcomes With Neoadjuvant Chemotherapy Regimens in Muscle-Invasive Bladder Cancer
In a single-center analysis reported in JAMA Oncology, Peyton et al found that neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) produced better outcomes than other standard neoadjuvant regimens in patients undergoing radical cystectomy for muscle-invasive...
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...
Large Disparities in Cancer Mortality Rates Found Among Different Racial/Ethnic Populations in New York State
According to the American Cancer Society, cancer is the leading cause of death for Hispanics and Asian/Pacific Islanders in the United States. However, their cancer burden is less than that of non-Hispanic whites and especially non-Hispanic blacks, who bear the most disproportionate share of the...
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 ...
Dose-Dense Neoadjuvant Chemotherapy in Muscle-Invasive Bladder Cancer
In a phase II trial reported in the Journal of Clinical Oncology, Iyer et al found that dose-dense neoadjuvant gemcitabine plus cisplatin produced a high response rate and was generally well tolerated in patients with planned radical cystectomy for muscle-invasive bladder cancer. Study Details In ...
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...
Health-Related Quality-of-Life Analysis of Anti–PD-1 Therapy vs Chemotherapy in Advanced Urothelial Cancer
As reported by Vaughn et al in the Journal of Clinical Oncology, a health-related quality-of-life analysis from the phase III KEYNOTE-045 trial in previously treated advanced urothelial cancer showed that patients treated with the anti–programmed cell death protein 1 immunotherapy...
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....
