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Bladder Cancer
Immunotherapy

KEYNOTE-361: First-Line Pembrolizumab With or Without Chemotherapy vs Chemotherapy Alone in Advanced Urothelial Carcinoma

As reported in The Lancet Oncology by Thomas Powles, MD, PhD, and colleagues, the phase III KEYNOTE-361 trial has shown no significant improvement in progression-free or overall survival with first-line pembrolizumab plus platinum-based chemotherapy vs chemotherapy alone in patients with advanced...

Issues in Oncology
Bladder Cancer
Lung Cancer
Skin Cancer

Inclusion of Patients With Brain Metastases in Phase III Trials in Advanced Breast Cancer, Lung Cancer, and Melanoma

In a study reported in a research letter in JAMA Oncology, Corbett et al found that the majority of phase III trials investigating systemic therapy in patients with advanced lung cancer, breast cancer, and melanoma over the past 20 years have excluded or restricted enrollment of those with brain...

Bladder Cancer
Immunotherapy

CheckMate 274: Adjuvant Nivolumab in High-Risk Muscle-Invasive Urothelial Carcinoma

As reported in The New England Journal of Medicine by Dean F. Bajorin, MD, and colleagues, an interim analysis of the phase III CheckMate 274 trial has shown improved disease-free survival with adjuvant nivolumab vs placebo among all patients with high-risk muscle-invasive urothelial carcinoma who...

Bladder Cancer
Immunotherapy

Choice of First-Line Platinum Chemotherapy Does Not Significantly Impact Efficacy of Second-Line Immunotherapy in Advanced Urothelial Carcinoma

In a presentation of real-world data given during the 2021 ASCO Annual Meeting, Miron et al concluded that the choice of first-line platinum chemotherapy did not result in a significant difference in overall survival benefit among patients with advanced bladder cancer who were able to go on to...

Bladder Cancer
Immunotherapy

Pembrolizumab in BCG-Unresponsive High-Risk Non–Muscle Invasive Bladder Cancer: KEYNOTE-057

As reported in The Lancet Oncology by Arjun V. Balar, MD, and colleagues, the phase II KEYNOTE-057 trial showed that pembrolizumab produced enduring responses in a cohort of patients with high-risk non–muscle invasive bladder cancer unresponsive to bacillus Calmette-Guérin (BCG) who were ineligible ...

Bladder Cancer
Immunotherapy

Does the Addition of Bevacizumab to Gemcitabine/Cisplatin for Metastatic Urothelial Carcinoma Improve Survival?

As reported in the Journal of Clinical Oncology by Jonathan E. Rosenberg, MD, and colleagues, the phase III CALGB 90601/Alliance trial has shown no improvement in overall survival with the addition of bevacizumab to gemcitabine/cisplatin in patients with metastatic urothelial carcinoma.  Study...

Issues in Oncology
Immunotherapy
Breast Cancer
Bladder Cancer
Gastrointestinal Cancer
Hepatobiliary Cancer

FDA ODAC Meeting Focuses on ‘Dangling’ Accelerated Approvals of Anti–PD-1/PD-L1 Antibodies

In a perspective in The New England Journal of Medicine, Julia A. Beaver, MD, and Richard Pazdur, MD, of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE), discussed issues surrounding “dangling” accelerated approvals of anti–PD-1/PD-L1 antibodies—ie, approvals for...

Bladder Cancer
Immunotherapy

Enfortumab Vedotin-ejfv After PD-1 or PD-L1 Inhibitor Therapy for Cisplatin-Ineligible Patients With Advanced Urothelial Carcinoma

As reported in The Lancet Oncology by Evan Y. Yu, MD, and colleagues, findings in a cohort of the phase II EV-201 study showed a high response rate with the nectin-4–directed antibody-drug conjugate enfortumab vedotin-ejfv in cisplatin-ineligible patients with advanced or metastatic urothelial...

Bladder Cancer
Immunotherapy

Sacituzumab Govitecan-hziy for Patients With Pretreated Metastatic Urothelial Carcinoma

In a cohort of the phase II TROPHY-U-01 trial reported in the Journal of Clinical Oncology, Scott T. Tagawa, MD, MS, and colleagues found that the antibody-drug conjugate sacituzumab govitecan-hziy produced responses in patients with metastatic urothelial carcinoma progressing after platinum-based...

Solid Tumors
Bladder Cancer
Global Cancer Care

Oncologists Launch Global Society to Improve Clinical Research, Standardize Treatment, and Improve Patient Education About Rare Genitourinary Tumors

Late this past year, a group of oncologists led by Philippe E. Spiess, MD, MS, FRCS(C), FACS, Assistant Chief of Surgical Services and Senior Member in the Department of Genitourinary Oncology at Moffitt Cancer Center and Professor in the Department of Urology at the University of South Florida;...

Bladder Cancer
Lung Cancer
Immunotherapy

FDA Pipeline: Priority Reviews of Treatments for Bladder and Lung Cancers

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review designation to treatments for surgically resected, high-risk, muscle-invasive urothelial carcinoma and epidermal growth factor receptor exon 20 insertion mutation–positive metastatic non–small cell lung cancer (NSCLC)....

Bladder Cancer
Immunotherapy

FDA ODAC Votes in Favor of Retaining Accelerated Approval for Bladder Cancer Treatments

Roche has announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favor of maintaining the accelerated approval of atezolizumab for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for...

Issues in Oncology
Bladder Cancer
Prostate Cancer

YouTube Videos on Bladder Cancer: Study Focuses on Quality of Content

Social media platforms are valuable tools for educating patients about serious health topics, but they can also spread false and biased information with potentially harmful results, according to recent research published by Stacy Loeb, MD, MSc, and colleagues in European Urology. Researchers...

Kidney Cancer
Bladder Cancer
Prostate Cancer
Immunotherapy

Genitourinary Oncology Highlights 2020–2021 Almanac

Landmark changes in the treatment of genitourinary cancers have occurred over the past year, as summarized in this year’s Genitourinary Oncology Almanac from The ASCO Post. Starting with our area of focus, metastatic renal cell carcinoma, the saga continues with two more positive phase III trials...

Bladder Cancer
Gynecologic Cancers
Hepatobiliary Cancer
Solid Tumors
Colorectal Cancer
Immunotherapy

FDA Pipeline: Recent Designations in Urothelial Cancer, Cervical Cancer, Cholangiocarcinoma, and More

Recently, the U.S. Food and Drug Administration (FDA) issued regulatory decisions related to treatments for urothelial cancer, cervical cancer, cholangiocarcinoma, solid tumors, and colorectal cancer. Acceptance of Two Supplemental Biologics License Applications for Enfortumab Vedotin-ejfv in...

bladder cancer

Enrique Grande, MD, PhD, on Urothelial Carcinoma: Treatment With Atezolizumab, Platinum, and Gemcitabine

Enrique Grande, MD, PhD, of The University of Texas MD Anderson Cancer Center, Madrid, discusses phase III overall survival results from the IMvigor130 study of atezolizumab plus platinum and gemcitabine vs placebo plus platinum and gemcitabine in patients with previously untreated metastatic urothelial carcinoma (Abstract CT187).

Bladder Cancer
Immunotherapy

FDA Grants Accelerated Approval to Sacituzumab Govitecan-hziy for Advanced Urothelial Cancer

On April 13, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy) for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor....

Bladder Cancer

EV-301 and EV-201 Trials: Enfortumab Vedotin-ejfv Improves Survival in Metastatic Urothelial Cancer

Enfortumab vedotin-ejfv continues to move the needle forward as a validated treatment option for advanced urothelial carcinoma. At the 2021 Genitourinary Cancers Symposium, results from the phase III EV-301 study1 and EV-201 Cohort 22 provided support for the use of this agent in both patients...

Bladder Cancer
Immunotherapy

Adjuvant Atezolizumab in Muscle-Invasive Urothelial Carcinoma: IMvigor010

As reported in The Lancet Oncology by Joaquim Bellmunt, MD, PhD, and colleagues, the phase III IMvigor010 trial showed no improvement in disease-free survival with adjuvant atezolizumab vs observation in patients with muscle-invasive urothelial carcinoma. Study Details In the open-label trial, 809...

Bladder Cancer

Nivolumab: First Adjuvant Immunotherapy to Show Survival Benefit in High-Risk Muscle-Invasive Urothelial Cancer

Adjuvant therapy with nivolumab, an anti–PD-1 immune checkpoint inhibitor, after radical surgery improved disease-free survival in high-risk muscle-invasive urothelial cancer regardless of PD-L1 status, according to the results of the CheckMate 274 randomized phase III trial presented at the 2021...

bladder cancer
immunotherapy

Arlene O. Siefker-Radtke, MD, on Urothelial Bladder Cancer: New Settings for Immune Checkpoint Inhibitors

Arlene O. Siefker-Radtke, MD, of The University of Texas MD Anderson Cancer Center, discusses the changing therapeutic landscape in which atezolizumab, avelumab, and pembrolizumab have either been approved or are under review for treating urothelial bladder cancer in the metastatic, superficial, and adjuvant settings.

Breast Cancer
Bladder Cancer
Gastrointestinal Cancer
Hepatobiliary Cancer
Lung Cancer
Immunotherapy

FDA Oncologic Drugs Advisory Committee to Review Status of Six Indications Granted Accelerated Approval

Recently, the U.S. Food and Drug Administration (FDA) announced that the agency will hold a public meeting of the Oncologic Drugs Advisory Committee on April 27 to 29 to discuss six indications granted accelerated approval that have since reported results from confirmatory trials that have not...

Bladder Cancer
Immunotherapy

Atezolizumab’s Indication in Previously Treated Metastatic Bladder Cancer Is Withdrawn

Genentech, a member of the Roche Group, announced on March 8 that the company is voluntarily withdrawing the U.S. indication for atezolizumab (Tecentriq) in patients with prior platinum-treated metastatic urothelial carcinoma. This decision was made in consultation with the U.S. Food and Drug...

Bladder Cancer

Enfortumab Vedotin-ejfv in Previously Treated Advanced Urothelial Carcinoma

As reported in The New England Journal of Medicine by Powles et al, a prespecified interim analysis of the phase III EV-301 trial has shown improved overall survival with enfortumab vedotin-ejfv vs investigator choice of chemotherapy in patients with previously treated advanced urothelial...

bladder cancer
immunotherapy

Tracy L. Rose, MD, on Bladder Cancer: Gemcitabine, Cisplatin, and Pembrolizumab as Neoadjuvant Therapy

Tracy L. Rose, MD, of the University of North Carolina at Chapel Hill, discusses phase II results of gemcitabine and split-dose cisplatin plus pembrolizumab as neoadjuvant therapy prior to radical cystectomy for patients with muscle-invasive bladder cancer. The trial showed this combination treatment is generally safe and may improve pathologic downstaging, but further study is warranted (Abstract 396).

bladder cancer

Elizabeth R. Plimack, MD, on Bladder Cancer Highlights From the 2021 Genitourinary Cancers Symposium

Elizabeth R. Plimack, MD, of Fox Chase Cancer Center, discusses key abstracts discussed at this year’s meeting on bladder cancer and offers her views on the latest trends and findings (Abstracts 391, 393, 434).

Bladder Cancer

Hypofractionated vs Conventionally Fractionated Radiotherapy for Locally Advanced Bladder Cancer

In an individual patient-level meta-analysis of two phase III trials reported in The Lancet Oncology, Choudhury et al found that a hypofractionated radiotherapy regimen was associated with improved invasive locoregional control and similar toxicity vs a standard fractionation regimen in patients...

bladder cancer
kidney cancer
prostate cancer

Christopher Sweeney, MBBS, and Thomas Powles, MD, PhD, on Treating GU Malignancies: Expert Views

A spirited discussion ensued when we asked Christopher Sweeney, MBBS, of Dana-Farber Cancer Institute, and Thomas Powles, MD, PhD, of Cancer Research UK Barts Centre, to compare notes on how they treat bladder, prostate, and kidney cancers.

Lung Cancer
Bladder Cancer
Hematologic Malignancies

FDA Pipeline: Priority Reviews in KRAS G12C–Mutated NSCLC, Non–Muscle-Invasive Bladder Cancer

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for KRAS G12C­–mutated non­–small cell lung cancer (NSCLC) and high-risk, bacillus Calmette-Guérin–unresponsive non–muscle-invasive bladder cancer. A new drug application for a therapy for Waldenström’s...

bladder cancer
immunotherapy

Monika Joshi, MD, on Urothelial Cancer of the Bladder: Durvalumab and Radiotherapy for Localized Disease

Monika Joshi, MD, of Penn State Hershey Cancer Institute, discusses phase II results from the DUART study, which explored the efficacy of concurrent durvalumab, a checkpoint inhibitor, and radiation therapy followed by adjuvant durvalumab in patients with localized urothelial cancer of the bladder (Abstract 398).

bladder cancer

Daniel M. Geynisman, MD, on Bladder Cancer: Risk-Enabled Treatment After Neoadjuvant Chemotherapy

Daniel M. Geynisman, MD, of Fox Chase Cancer Center, discusses phase II results from the RETAIN BLADDER study, which sequenced bladder tumor samples while treating patients with neoadjuvant methotrexate, vinblastine, doxorubicin, and cisplatin chemotherapy. The goal was to increase metastasis-free survival and also preserve the bladder and quality of life (Abstract 397).

Bladder Cancer
Immunotherapy

Enfortumab Vedotin-ejfv Prolongs Survival in Patients With Metastatic Urothelial Carcinoma

Treatment with the antibody-drug conjugate enfortumab vedotin-ejfv has been found to significantly increase survival of patients with metastatic urothelial carcinoma, according to results from the phase III EV-301 clinical trial. These findings were presented by Thomas Powles, MD, PhD, and...

bladder cancer
immunotherapy

Thomas Powles, MD, PhD, on Urothelial Carcinoma: Enfortumab Vedotin-ejfv vs Chemotherapy

Thomas Powles, MD, PhD, of Cancer Research UK Barts Centre, discusses phase III results from the EV-301 trial, which showed that enfortumab vedotin is the first therapy to demonstrate a significant survival advantage over standard chemotherapy in patients with previously treated locally advanced or metastatic urothelial carcinoma (Abstract 393).

Bladder Cancer
Immunotherapy

CheckMate 274: Adjuvant Nivolumab May Improve Disease-Free Survival in Patients With Muscle-Invasive Urothelial Carcinoma

Treatment with the immunotherapy nivolumab with or without cisplatin-based chemotherapy following radical surgery significantly improved disease-free survival in patients with muscle-invasive urothelial carcinoma, irrespective of their PD-L1 status, according to a study that will be presented by...

Immunotherapy
Gastroesophageal Cancer
Gastrointestinal Cancer
Colorectal Cancer
Bladder Cancer
Skin Cancer
Sarcoma
Hepatobiliary Cancer

FDA Pipeline: Priority Reviews for Immunotherapies in Gastric Cancers, Anal Cancer

The U.S. Food and Drug Administration (FDA) recently granted Priority Review to nivolumab as either adjuvant or first-line therapy in several types of gastric cancers, as well as to a novel PD-1 inhibitor for locally advanced or metastatic squamous cell carcinoma of the anal canal. The FDA also...

Bladder Cancer

Feasibility Study of Radical Cystectomy vs Intravesical BCG for High-Grade, Non–Muscle Invasive Bladder Cancer

As reported in the Journal of Clinical Oncology by Catto et al, the BRAVO-Feasibility study showed that recruitment of patients with high-grade, non–muscle invasive bladder cancer into a randomized trial comparing radical cystectomy vs intravesical bacillus Calmette-Guérin (BCG) proved difficult,...

Bladder Cancer
Genomics/Genetics

Germline-Somatic Interactions in Advanced Urothelial Cancer and Their Role in Disease Progression

In a study reported in Nature Communications, Bishoy M. Faltas, MD, of the Department of Medicine, Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York, and colleagues identified common germline-somatic variant interactions in advanced urothelial cancer, with these...

Bladder Cancer
Genomics/Genetics

Spectrum of Germline-Somatic Interactions in Advanced Urothelial Cancer

In a study reported in Nature Communications, Vosoughi et al identified common germline-somatic variant interactions in advanced urothelial cancer, with these interactions appearing to play a central role in disease progression. As stated by the investigators, “The prevalence and the biologic...

Bladder Cancer
Immunotherapy

ESMO Immuno-Oncology 2020: Adjuvant Atezoliumab for Patients With Muscle-Invasive Urothelial Cancer and Presence of Postsurgical ctDNA

Patients with muscle-invasive urothelial cancer and postsurgical circulating tumor DNA (ctDNA) positivity have high risk of disease recurrence following cystectomy and experienced improved clinical outcomes with adjuvant atezolizumab as compared to patients undergoing observation. These...

Bladder Cancer
Immunotherapy

DANUBE Trial Reports No Survival Benefit With First-Line Durvalumab in Metastatic Urothelial Carcinoma

As reported in The Lancet Oncology by Thomas Powles, MD, of Barts Cancer Institute, Queen Mary University of London, and colleagues, the phase III DANUBE trial showed that durvalumab monotherapy did not prolong overall survival vs standard chemotherapy in previously untreated patients with...

Bladder Cancer
Immunotherapy

Expert Point of View: Kilian M. Gust, MD

Formal discussant Kilian M. Gust, MD, of the Medical University of Austria, Vienna, reminded listeners that JAVELIN Bladder 100 was designed at a time when no checkpoint inhibitor was approved for the treatment of metastatic urothelial cancer. In the past 5 years, five immune checkpoint inhibitors...

Bladder Cancer
Immunotherapy

Front-Line Avelumab Maintenance Improved Survival Across Subgroups With Advanced Urothelial Carcinoma

A strategy of front-line maintenance treatment with the PD-L1 inhibitor avelumab combined with best supportive care improved both progression-free and overall survival vs best supportive care alone across prespecified subgroups of patients with advanced or metastatic urothelial carcinoma that had...

Bladder Cancer
Immunotherapy

Expert Point of View: Richard Cathomas, MD

In his discussion of KEYNOTE-361 and the DANUBE trial, Richard Cathomas, MD, of Kantonsspital, Graubünden, Switzerland, said both studies yielded disappointing results. Overall, in these trials as well as current evidence from other trials, treatment of platinum-eligible (cisplatin or carboplatin)...

Bladder Cancer
Immunotherapy

Checkpoint Inhibitor and Chemotherapy Combinations Fail to Move Bar as First-Line Therapy for Advanced Urothelial Cancer

Two different phase III studies found that combining an anti–PD-1/PD-L1 checkpoint inhibitor (pembrolizumab in KEYNOTE-361) with platinum-based chemotherapy or with another checkpoint inhibitor (the anti–CTLA-4 antibody tremelimumab in DANUBE) failed to significantly improve overall or...

Bladder Cancer

Gemcitabine and Daily Radiation for Patients With Muscle-Invasive Bladder Cancer

Bladder preservation with trimodality therapy may be a safe and effective alternative to cystectomy for selected patients with muscle-invasive bladder cancer, according to results from a phase II trial presented by Coen et al at the virtual 2020 American Society for Radiation Oncology (ASTRO)...

Bladder Cancer
Immunotherapy

Co-Leader of Immunotherapy Trial Reflects on ‘Practice-Changing’ Results in Advanced Bladder and Other Urinary Tract Cancers

In a large, randomized clinical trial, researchers evaluated the immunotherapy drug avelumab for patients with advanced urothelial cancer. The findings of the trial, called the JAVELIN Bladder 100 study, are “very exciting,” even “practice-changing,” said the trial’s co-leader, Petros Grivas, MD,...

Bladder Cancer
Immunotherapy

Neoadjuvant Dual Checkpoint Blockade in Certain Patients With Localized Bladder Cancer

Neoadjuvant combination therapy with the anti–CTLA-4 therapy tremelimumab and the anti–PD-1 therapy durvalumab was well tolerated and showed early signs of activity in patients ineligible to receive cisplatin-based chemotherapy, all of whom had tumors with high-risk features that are associated...

Bladder Cancer

Urine-Based Liquid Biopsy May Perform Similarly to Urine Cytology in Detecting Urothelial Carcinoma

Analysis of DNA copy number variants in the cells exfoliated in urine showed improved sensitivity and similar specificity in detecting urothelial carcinoma compared to urine cytology, according to results published by Zeng et al in Clinical Cancer Research. “Urine cytology, which is widely used to...

Bladder Cancer

Nab-paclitaxel vs Paclitaxel in Platinum-Refractory Metastatic Urothelial Cancer

In a phase II trial reported in JAMA Oncology, Srikala S. Sridhar, MD, MSc, FRCPC, and colleagues found no difference in progression-free survival with nab-paclitaxel vs paclitaxel in patients with platinum-refractory metastatic urothelial cancer. Study Details In the investigator-initiated...

Bladder Cancer
Immunotherapy

Avelumab Maintenance Therapy in Advanced or Metastatic Urothelial Carcinoma

In the phase III JAVELIN Bladder 100 trial reported in The New England Journal of Medicine, Thomas Powles, MD, PhD, and colleagues found that maintenance treatment with avelumab plus best supportive care significantly improved overall survival vs best supportive care alone among patients whose...

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