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As reported by Elizabeth R. Plimack, MD, of Fox Chase Cancer Center, Temple Health, and colleagues 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. In the...
A novel approach using intravesical gene therapy showed promising activity in a phase II trial that enrolled patients with bacillus Calmette-Guérin (BCG)-refractory or -relapsed nonmuscle invasive bladder cancer.1 The rate of high-grade relapse-free survival at 12 months was 35% in patients treated ...
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, 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, of the University of California, Los Angeles, discusses induction and maintenance BCG therapy in non–muscle-invasive bladder cancer.
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, 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, of the Dana-Farber Cancer Institute, discusses study findings on apatorsen plus docetaxel vs docetaxel alone in platinum-resistant metastatic urothelial cancer. (Abstract 289)
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...
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...
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...
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...
Phase I Study Title: Ethacrynic Acid Elimination in Nonmuscle Invasive Bladder Cancer Patients Undergoing Transurethral Resection Study Type: Phase I/interventional/single-group assignment Study Sponsor and Collaborators: University of Kansas Medical Center Purpose: To provide quantitative...
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...
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...
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...
Radical cystectomy with urinary diversion is the standard of care for muscle invasive bladder cancer.1 Meta-analyses of prospective data have shown a 5% overall survival benefit at 5 years for those receiving neoadjuvant systemic chemotherapy prior to cystectomy.2,3 We currently know of two...
In a study reported in Nature Genetics, Bishoy M. Faltas, MD, of Weill Cornell Medicine, and colleagues identified factors in the clonal evolution of chemotherapy-resistant urothelial carcinoma.1 As stated by the investigators: “Chemotherapy-resistant urothelial carcinoma has no uniformly curative...
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 ...
In the phase I/II CheckMate 032 trial reported in The Lancet Oncology, Padmanee Sharma, MD, of The University of Texas MD Anderson Cancer Center, and colleagues found that nivolumab (Opdivo) was active in locally advanced or metastatic urothelial carcinoma progressing after platinum-based therapy....
Immunotherapy with anti–PD-1 (programmed cell death protein 1) and anti–PD-L1 (programmed cell death ligand 1) agents continues to advance in metastatic urothelial cancer, with positive showings in two clinical trials presented at the 2016 European Society for Medical Oncology (ESMO) Congress. The...
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...
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, ...
What are the factors that add up to the best outcomes for patients who have surgery to treat cancer? Looking for a better way to measure quality of care and share best practices in surgical oncology, a team from Roswell Park Cancer Institute developed a quality assessment tool and validated it in a ...
The phase III KEYNOTE-045 trial, investigating the use of the anti–PD-1 (programmed cell death protein 1) therapy pembrolizumab (Keytruda) in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival, according to a news release issued by Merck. In...
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 ...
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,...
Sumanta K. Pal, MD, of the City of Hope, discusses phase II findings on the efficacy and safety of nivolumab monotherapy in patients with metastatic urothelial cancer who have received prior treatment. Follow him on Twitter: @montypal
Arjun V. Balar, MD, of the NYU Perlmutter Cancer Center, discusses preliminary phase II study findings on pembrolizumab as first-line therapy for advanced/unresectable or metastatic urothelial cancer. (Abstract LBA32)
In a National Cancer Data Base analysis reported in the Journal of Clinical Oncology, Seisen et al found that high-intensity local treatment was associated with an overall survival benefit in patients with metastatic urothelial carcinoma of the bladder. Quoc-Dien Trinh, MD, of Brigham and Women’s...
What are the factors that add up to the best outcomes for patients who have surgery to treat cancer? Looking for a better way to measure quality of care and share best practices in surgical oncology, a team from Roswell Park Cancer Institute developed a quality assessment tool and validated it in a ...
Sumanta K. Pal, MD, has had a longer career in oncology than many other colleagues his age. Perhaps the reason for that may center on his starting college at the age 13 and medical school at the age of 17. Today this internationally recognized leader in genitourinary cancers is Assistant Professor ...
In a phase I/II study reported in the Journal of Clinical Oncology, Massard et al found that the anti–PD-L1 (programmed cell death ligand 1) antibody durvalumab was active in patients with previously treated advanced urothelial bladder cancer. Objective response appeared to be confined to patients...
In a National Cancer Data Base analysis reported in the Journal of Clinical Oncology, Seisen et al found that high-intensity local treatment was associated with an overall survival benefit in patients with metastatic urothelial carcinoma of the bladder. Study Details The study included data from...
Atezolizumab (Tecentriq), an anti–programmed cell death ligand 1 (PD-L1) inhibitor, achieved durable responses as first-line treatment in cisplatin-ineligible patients with metastatic urothelial carcinoma in a primary analysis of a phase II trial. These data represent an unmet need, because...
Bristol-Myers Squibb Company announced June 27 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to nivolumab (Opdivo) for the potential indication of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a...
A strategy of matching molecular abnormalities in patients’ tumors to therapies targeted to those abnormalities is gaining ground, according to preliminary results of the phase IIb MyPathway study presented at the 2016 ASCO Annual Meeting.1 These are still early days for this “matching” strategy,...
In a phase I/II study reported in the Journal of Clinical Oncology, Massard et al found that the anti–PD-L1 (programmed cell death ligand 1) antibody durvalumab was active in patients with previously treated advanced urothelial bladder cancer. Objective response appeared to be confined to...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.On May 18, 2016, the PD-L1 (programmed cell death ligand 1)...
Compared with a historic control rate, a phase II study of the programmed cell death ligand 1 (PD-L1) inhibitor atezolizumab (Tecentriq) has demonstrated clinically meaningful responses in patients with urothelial carcinoma who progressed after platinum-based chemotherapy.1 Hailed as a “major...
Sumanta K. Pal, MD, of City of Hope, and Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, discuss findings on BGJ398 in patients with previously treated advanced/metastatic urothelial carcinoma with FGFR3 alterations (Abstract 4517).
Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, and Toni K. Choueiri, MD, of the Dana-Farber Cancer Institute, discuss mutation burden—its role in response to treatment with PD-L1 immunotherapy and its impact on progression-free survival and overall survival, as well as the link between intrinsic expression subtypes and treatment outcome with atezolizumab (Abstract 104).
Arjun Vasant Balar, MD, of the Perlmutter Cancer Center at NYU Langone Medical Center, discusses findings on atezolizumab as first-line therapy in cisplatin-ineligible locally advanced/metastatic disease (Abstract LBA4500).
The anti–programmed cell death ligand 1 (PD-L1) immunotherapy atezolizumab (Tecentriq) is effective in patients with previously untreated advanced bladder cancer who are not eligible for the standard treatment with cisplatin. According to a nonrandomized phase II trial, atezolizumab shrank...
The American Urological Association (AUA), together with the Society for Urologic Oncology (SUO), has released a new clinical practice guideline on non–muscle-invasive bladder cancer. This new document outlines guidance on a variety of topics, including diagnosis and treatment, as well as a...
The recent study by Rosenberg et al in The Lancet—summarized in this issue of The ASCO Post—is a very important paper in the field of bladder cancer therapy.1 It is the first phase II trial in metastatic transitional cell carcinoma that demonstrates the single-agent activity of the...
In a phase II trial reported in The Lancet, Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, and colleagues found that the anti–PD-L1 (programmed cell death ligand 1) antibody atezolizumab produced durable responses in a marked proportion of patients with previously treated...
I like economies of scale, and thus it makes perfect sense that ASCO has set a formal process to allow potential endorsement of selected guidelines from other organizations, rather than redoing the whole process. Recently, we have seen the publication of a formal endorsement of the European...
As reported in the Journal of Clinical Oncology by Matthew I. Milowsky, MD, of the University of North Carolina Lineberger Comprehensive Cancer Center, and colleagues,1 ASCO has endorsed the European Association of Urology clinical practice guideline on muscle-invasive and metastatic bladder...
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to atezolizumab (Tecentriq) for the treatment of urothelial carcinoma, the most common type of bladder cancer. This is the first programmed cell death protein 1/programmed death ligand 1 (PD-1/PD-L1) inhibitor to be...