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Bladder Cancer

High-Risk Non–Muscle-Invasive Bladder Cancer: Reduced Induction Courses of BCG

As reported by Katims et al in JAMA Oncology, long-term follow-up of a single-center phase II study showed good outcomes with two induction courses of bacillus Calmette-Guérin (BCG) without maintenance in patients with high-risk non–muscle-invasive bladder cancer. The strategy markedly reduced the...

Bladder Cancer

Final Results of the POUT Trial: Adjuvant Chemotherapy vs Surveillance After Nephroureterectomy for Upper Tract Urothelial Cancer

As reported in the Journal of Clinical Oncology by Alison Jane Birtle, MD, MBBS, MRCP, FRCR, and colleagues, final results of the UK-based phase III POUT trial showed survival benefits with adjuvant platinum-based chemotherapy vs surveillance after radical nephroureterectomy in patients with upper...

Issues in Oncology
Prostate Cancer
Bladder Cancer
Kidney Cancer

Insufficiencies Discovered in Patient-Reported Outcomes Data From Genitourinary Cancer Clinical Trials

Investigators may have found a significant unmet need for improved analyses and reporting of patient-reported outcomes in genitourinary cancer clinical trials, according to a recent study published by Paravathaneni et al in eClinicalMedicine. Background Genitourinary cancers affect over 444,000...

bladder cancer

Andrea B. Apolo, MD, on Urothelial Carcinoma: Phase III Findings on Pembrolizumab vs Observation

Andrea B. Apolo, MD, of the National Cancer Institute, National Institutes of Health, discusses the results of the AMBASSADOR Alliance A031501 study, which showed adjuvant pembrolizumab improved disease-free survival vs observation for patients with high-risk muscle-invasive urothelial carcinoma after radical surgery. According to Dr. Apolo, the findings support adjuvant pembrolizumab as a new treatment option for this population (Abstract LBA531).

bladder cancer

Rohit K. Jain, MD, MPH, on Urothelial Carcinoma: New Data on Cabozantinib Plus Pembrolizumab

Rohit K. Jain, MD, MPH, of the H. Lee Moffitt Cancer Center and Research Institute, discusses a novel phase II trial of pembrolizumab plus cabozantinib. The study showed this combination may be efficacious as first-line therapy for patients with metastatic urothelial carcinoma, including those who are ineligible for cisplatin. Further investigation with a focus on predictive biomarkers is ongoing (Abstract 539).

bladder cancer

Bishoy M. Faltas, MD, on Upper Tract Urothelial Carcinoma: How Biology Shapes Therapy

Bishoy M. Faltas, MD, of Weill Cornell Medicine, discusses the biology of upper tract urothelial carcinoma and how it affects treatment, noting that most of these tumors are luminal papillary with a T-cell–depleted immune contexture driven by FGFR3 activation. Phase III trials have confirmed the predicted differential effects of FGFR3 inhibitors in this type of tumor compared with bladder cancer based on biological differences.

bladder cancer
genomics/genetics

David H. Aggen, MD, PhD, on Advanced Bladder Cancer: HER2 and PD-L1 Immunohistochemistry and HER2 Genomic Alterations

David H. Aggen, MD, PhD, of Memorial Sloan Kettering Cancer Center, discusses reportedly the first data to describe an inverse correlation between HER2 immunohistochemistry expression and PD-L1 combined positive score. According to Dr. Aggen, these and other findings by his team may provide a foundation for further HER2-directed advanced bladder cancer studies (Abstract 538).

bladder cancer

Michiel S. Van Der Heijden, MD, PhD, on Metastatic Urothelial Carcinoma: Phase III Trial Data on Enfortumab Vedotin Plus Pembrolizumab vs Chemotherapy

Michiel S. Van Der Heijden, MD, PhD, of the Netherlands Cancer Institute, discusses phase III results from the global EV-302 study, showing that enfortumab vedotin-ejfv plus pembrolizumab improves outcomes in patients with previously untreated locally advanced metastatic urothelial carcinoma compared with chemotherapy. Overall survival benefit was observed across select prespecified subgroups. According to Dr. Van Der Heijden, this immunotherapy combination is a potential new standard of care for first-line locally advanced metastatic urothelial carcinoma (Abstract LBA530).

bladder cancer
immunotherapy

Syed Muneeb Alam, MD, on Urothelial Carcinoma: Microsatellite Instability and Response to Immune Checkpoint Blockade

Syed Muneeb Alam, MD, of Memorial Sloan Kettering Cancer Center, discusses study findings evaluating links among microsatellite instability status, tumor mutational burden, and response to immune checkpoint blockade in patients with microsatellite instability–high urothelial carcinoma (Abstract 536).

Bladder Cancer

Sacituzumab Govitecan Plus Pembrolizumab in Metastatic Urothelial Cancer Progressing After Platinum-Based Chemotherapy

In a cohort of the phase II TROPHY-U-01 trial (cohort 3) reported in the Journal of Clinical Oncology, Petros Grivas, MD, PhD, and colleagues found that the combination of sacituzumab govitecan-hziy and pembrolizumab showed activity in patients with metastatic urothelial cancer and disease...

bladder cancer

Amanda Nizam, MD, on Urothelial Carcinoma: Study Results on Enfortumab Vedotin and Avelumab

Amanda Nizam, MD, of the Cleveland Clinic, discusses results from the UNITE study, which shows patients with advanced urothelial cancer who were treated with enfortumab vedotin-ejfv (EV) after switch maintenance avelumab had outcomes consistent with data with EV in platinum- and immune checkpoint inhibitor–refractory disease (Abstract 537).

Bladder Cancer
Immunotherapy

Use of Adjuvant Nivolumab in Patients With Muscle-Invasive Urothelial Carcinoma: CheckMate 274

Subsequent systemic therapy with the immune checkpoint inhibitor nivolumab may offer overall survival benefit in patients with muscle-invasive urothelial carcinoma who underwent surgery to remove their tumors, according to recent findings presented by Geynisman et al at the 2024 ASCO Genitourinary...

Bladder Cancer

AMBASSADOR: Pembrolizumab in Muscle-Invasive and Locally Advanced Urothelial Carcinoma

Patients with muscle-invasive urothelial cancer and a high risk of recurrence after surgery may have a new treatment option. The Alliance for Clinical Trials in Oncology announced positive results from the phase III AMBASSADOR (A031501) trial for the adjuvant treatment of patients with localized...

Bladder Cancer

FDA Approves Erdafitinib for Locally Advanced or Metastatic Urothelial Carcinoma

On January 19, the U.S. Food and Drug Administration (FDA) approved the FGFR inhibitor erdafitinib (Balversa) for adult patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose...

Bladder Cancer

Muscle-Invasive Bladder Cancer: 5-Year Survival With dd-MVAC

As reported in The Lancet Oncology by Pfister et al, a 5-year analysis of the French phase III VESPER trial showed no improvement in overall survival with dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC) vs gemcitabine and cisplatin (GC) in the total perioperative...

Bladder Cancer

Overall Survival With Atezolizumab/Chemotherapy vs Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Carcinoma

In a final overall survival analysis of the phase III IMvigor130 trial reported in The Lancet Oncology, Enrique Grande, MD, and colleagues found no significant advantage in overall survival with atezolizumab plus chemotherapy vs chemotherapy alone in the first-line treatment of patients with...

Bladder Cancer

IMvigor130: Atezolizumab vs Chemotherapy in Locally Advanced or Metastatic Urothelial Carcinoma

In the final overall survival analysis from the phase III IMvigor130 trial reported in The Lancet Oncology, Aristotelis Bamias, MD, and colleagues found no significant advantage in overall survival with atezolizumab monotherapy vs chemotherapy in untreated patients with locally advanced or...

Bladder Cancer

FDA Approves Enfortumab Vedotin-ejfv With Pembrolizumab for Locally Advanced or Metastatic Urothelial Cancer

On December 15, 2023, the Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial cancer. The FDA previously granted accelerated approval to this combination for patients...

bladder cancer

Mark D. Tyson, MD, MPH, on High-Risk Non–Muscle-Invasive Bladder Cancer: A Potential New Treatment

Mark D. Tyson, MD, MPH, of the Mayo Clinic School of Graduate Medical Education, discusses the first results from BOND-003, a phase III study of intravesical cretostimogene grenadenorepvec monotherapy for patients with high-risk non–muscle-invasive bladder cancer that does not respond to Bacillus Calmette-Guérin (BCG) immunotherapy. Recently, the U.S. Food and Drug Administration granted cretostimogene monotherapy Fast Track status in BCG-unresponsive carcinoma in situ with or without Ta/T1 papillary disease.

Bladder Cancer

Erdafitinib vs Chemotherapy in Previously Treated, FGFR-Mutated Advanced Urothelial Carcinoma

As reported in The New England Journal of Medicine by Yohann Loriot, MD, PhD, and colleagues, cohort 1 of the phase III THOR trial has shown improved overall survival with erdafitinib vs chemotherapy in patients with locally advanced, unresectable, or metastatic urothelial carcinoma with...

Bladder Cancer
Immunotherapy

Disitamab Vedotin in Previously Treated Patients With Advanced HER2-Positive Urothelial Carcinoma

In a combined analysis of two Chinese phase II trials (RC48-C005 and RC48-C009) reported in the Journal of Clinical Oncology, Sheng et al found that the antibody-drug conjugate disitamab vedotin—an anti-HER2 antibody conjugated with monomethyl auristatin—produced promising results in patients with...

Bladder Cancer

Two Studies Show Improved Survival With Novel Front-Line Combinations in Advanced Urothelial Carcinoma

Two phase III trials presented at a Presidential Symposium during the European Society for Medical Oncology (ESMO) Congress 2023 showed an overall survival benefit for patients with advanced urothelial cancer. The results from both studies were hailed as practice-changing. The EV-302/KEYNOTE-A39...

Bladder Cancer

Two Studies Show Improved Survival With Novel Front-Line Combinations in Advanced Urothelial Carcinoma

Two phase III trials presented at a Presidential Symposium during the European Society for Medical Oncology (ESMO) Congress 2023 showed an overall survival benefit for patients with advanced urothelial cancer. The results from both studies were hailed as practice-changing. The EV-302/KEYNOTE-A39...

Bladder Cancer
Immunotherapy

Nivolumab Plus Gemcitabine and Cisplatin May Improve Survival in Patients With Metastatic Urothelial Carcinoma

Researchers have found that nivolumab in combination with a chemotherapy regimen may improve the rate of survival in patients with metastatic urothelial carcinoma, according to new findings simultaneously published by van der Heijden et al in The New England Journal of Medicine and presented at the ...

Bladder Cancer

Erdafitinib Demonstrates Improved Responses in FGFR-Altered Advanced Urothelial Carcinoma

Targeted treatment with the fibroblast growth factor receptor (FGFR) inhibitor erdafitinib improved responses and overall survival compared to standard chemotherapy for patients with advanced or metastatic urothelial carcinoma with FGFR alterations. Results from the phase III THOR trial, led by...

Bladder Cancer
Immunotherapy

Adjuvant Pembrolizumab May Offer Survival Benefit Over Observation in Patients With Muscle-Invasive or Locally Advanced Urothelial Carcinoma

The Alliance Data and Safety Monitoring Board has determined that adjuvant pembrolizumab may improve disease-free survival in patients with localized muscle-invasive urothelial carcinoma and locally advanced urothelial carcinoma, according to the Alliance for Clinical Trials in Oncology. ...

Bladder Cancer
Immunotherapy

Urothelial Carcinoma: Perioperative PD-L1 Inhibition Plus Neoadjuvant Chemotherapy

In a Swiss phase II study (SAKK 06/17) reported in the Journal of Clinical Oncology, Richard Cathomas, MD, and colleagues found that the addition of perioperative durvalumab to neoadjuvant chemotherapy resulted in improved event-free and overall survival in patients with muscle-invasive urothelial...

Bladder Cancer
Genomics/Genetics

Diagnosing Early-Stage Bladder Cancer in Patients With Hematuria: Novel mePENK Test

Researchers have found that the new PENK methylation (mePENK) test could potentially pave the way for a breakthrough in early bladder cancer detection in patients with hematuria, according to a novel study published by Oh et al in The Journal of Molecular Diagnostics. The findings could reduce the...

Bladder Cancer
Immunotherapy

Expert Point of View: Xin Gao, MD

Xin Gao, MD, Assistant Professor, Harvard Medical School, Genitourinary Cancers Program, Mass General Cancer Center, commented on the results from TROPHY-U-01 cohort 2. “These data add to the overall data on the efficacy of sacituzumab govitecan in patients with metastatic urothelial cancer. This...

Bladder Cancer
Immunotherapy

Sacituzumab Govitecan-hziy Achieves Response After Disease Progression on Immune Checkpoint Inhibitor in Metastatic Urothelial Cancer

Treatment with the antibody-drug conjugate sacituzumab govitecan-hziy achieved an objective response rate of 32% in platinum-ineligible patients with metastatic urothelial cancer who experienced disease progression on an immune checkpoint inhibitor, according to the primary analysis of the...

Bladder Cancer

CheckMate 274: Continued Disease-Free Survival Benefits With Adjuvant Nivolumab in High-Risk Urothelial Carcinoma

With longer-term follow-up, adjuvant nivolumab continued to demonstrate improved disease-free survival, non–urothelial tract recurrence–free survival, and distant metastasis–free survival vs placebo in patients with muscle-invasive urothelial carcinoma at high risk of recurrence after surgery,...

Bladder Cancer
Genomics/Genetics

Expert Point of View: Daniel P. Petrylak, MD

“Clinically, the implications [of the THOR trial] are clear in that all metastatic urothelial cancers should be tested for FGFR mutations,” stated invited discussant Daniel P. Petrylak, MD, of Yale School of Medicine. “This should be done at the beginning of treatment for metastatic disease, as it...

Bladder Cancer
Genomics/Genetics

THOR Trial: Erdafitinib Improves Outcomes vs Chemotherapy in FGFR-Altered Advanced Urothelial Carcinoma

Targeted treatment with the fibroblast growth factor receptor (FGFR) inhibitor erdafitinib significantly improved overall survival, progression-free survival, and objective response rates compared with investigator’s choice of chemotherapy in patients with advanced urothelial cancers and FGFR2/3...

Bladder Cancer
Kidney Cancer
Prostate Cancer

Genitourinary Oncology 2023 Almanac

It is an exciting time in the development of new treatments for urologic cancers. There have been a number of major changes both in advanced disease and in the perioperative setting over the past year. Urothelial and Bladder Cancers In urothelial cancer, at last, we have randomized data supporting...

Bladder Cancer

Bladder-Sparing Trimodal Therapy vs Radical Cystectomy in Patients With Clinically Node-Positive Nonmetastatic Bladder Cancer

In a retrospective study reported in the Journal of Clinical Oncology, Swinton et al found that bladder-sparing trimodal therapy with radical-dose radiotherapy was an effective alternative to radical cystectomy in patients with clinically node-positive nonmetastatic bladder cancer. As stated by the ...

Bladder Cancer
Genomics/Genetics

Expert Point of View: Daniel P. Petrylak, MD

“Clinically, the implications [of the THOR trial] are clear in that all metastatic urothelial cancers should be tested for FGFR mutations,” stated invited discussant Daniel P. Petrylak, MD, of Yale School of Medicine. “This should be done at the beginning of treatment for metastatic disease, as it...

Bladder Cancer
Genomics/Genetics

THOR Trial: Erdafitinib Improves Outcomes vs Chemotherapy in FGFR-Altered Advanced Urothelial Carcinoma

Targeted treatment with the fibroblast growth factor receptor (FGFR) inhibitor erdafitinib significantly improved overall survival, progression-free survival, and objective response rates compared with investigator’s choice of chemotherapy in patients with advanced urothelial cancers and FGFR2/3...

Bladder Cancer
Immunotherapy

First-Line Enfortumab Vedotin Plus Pembrolizumab in Cisplatin-Ineligible Patients With Locally Advanced or Metastatic Urothelial Cancer

As reported in the Journal of Clinical Oncology by O’Donnell et al, findings in a cohort of the phase Ib/II EV-103/KEYNOTE-869 study showed durable responses with first-line enfortumab vedotin-ejfv plus pembrolizumab in cisplatin-ineligible patients with locally advanced or metastatic urothelial...

Bladder Cancer
Issues in Oncology

CDCP1 May Be an Effective Therapeutic Target for Patients With Metastatic Bladder Cancer

Researchers have identified a new potential therapeutic target—the cell-surface tumor antigen CUB domain–containing protein 1 (CDCP1)—for patients with all subtypes of metastatic bladder cancer, according to findings presented by Chopra et al at the Society of Nuclear Medicine & Molecular...

Bladder Cancer
Genomics/Genetics

Loss of Y Chromosome in Men and Bladder Cancer Progression

Researchers have found that the loss of the Y chromosome, a common impact of the aging process in men, may help cancer cells evade the body’s immune system and result in aggressive bladder cancer—but it may also render the disease more vulnerable and responsive to immune checkpoint...

Bladder Cancer

Risk of Dementia and Mortality With BCG Vaccine in Non–Muscle-Invasive Bladder Cancer

In a study reported in JAMA Network Open, Weinberg et al found that receipt of the bacillus Calmette-Guérin (BCG) vaccine in patients with non–muscle-invasive bladder cancer was associated with a lower risk of Alzheimer’s disease and related dementias—as well as a lower risk of mortality—compared...

Bladder Cancer

5α-Reductase Inhibitor Use and Progression of Bladder Cancer in South Korean Males

In a Korean cohort study reported in JAMA Network Open, An et al found that men with prescriptions for 5α-reductase inhibitors prior to diagnosis of urothelial bladder cancer had better outcomes than those with no prior prescriptions. Study Details The study analyzed patient claims data from the...

Genomics/Genetics
Solid Tumors
Bladder Cancer

Erdafitinib Achieves Responses Across Multiple Cancer Types With FGFR Alterations

Three clinical trials demonstrated positive results from the targeted therapy erdafitinib for patients with multiple tumor types harboring FGFR alterations. The data were presented at the 2023 ASCO Annual Meeting. Erdafitinib is an oral medication that blocks the activity of FGFR signaling...

bladder cancer

Arlene O. Siefker-Radtke, MD, on Metastatic Urothelial Carcinoma: New Data on Erdafitinib and Cetrelimab From the NORSE Study

Arlene O. Siefker-Radtke, MD, of The University of Texas MD Anderson Cancer Center, discusses the combination of erdafitinib and cetrelimab, which demonstrated clinically meaningful activity and was well tolerated in cisplatin-ineligible patients with metastatic urothelial carcinoma and fibroblast growth factor receptor alterations (Abstract 4504).

bladder cancer

Arlene O. Siefker-Radtke, MD, on Metastatic Urothelial Carcinoma: New Data on Erdafitinib vs Chemotherapy From the THOR Study

Arlene O. Siefker-Radtke, MD, of The University of Texas MD Anderson Cancer Center, discusses phase III findings showing that for patients with advanced or metastatic urothelial carcinoma and FGFR alteration who already had been treated with a PD-(L)1 inhibitor, erdafitinib significantly improved overall and progression-free survival, as well as overall response rate, compared with investigator’s choice of chemotherapy (LBA4619).

bladder cancer

Christian Pfister, MD, PhD, on Bladder Cancer: New Overall Survival Data on Perioperative Chemotherapy

Christian Pfister, MD, PhD, of Rouen University Hospital, discusses phase III results from the VESPER trial, which showed that dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin provided a better overall survival rate at 5 years and improved disease-specific survival compared with gemcitabine as perioperative chemotherapy in patients with muscle-invasive bladder cancer (Abstract LBA4507). 

bladder cancer
immunotherapy

Shilpa Gupta, MD, on Urothelial Carcinoma: Long-Term Outcome of Enfortumab Vedotin Plus Pembrolizumab

Shilpa Gupta, MD, of Cleveland Clinic, discusses the results from the EV-103 study and the unmet need for effective first-line therapies in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma. After nearly 4 years of follow-up, the trial findings showed that enfortumab vedotin-ejfv plus pembrolizumab continues to demonstrate promising survival trends with rapid and durable responses in this population (Abstract 4505).

bladder cancer

Enrique Grande, MD, on Metastatic Urothelial Carcinoma: Updated Data From IMvigor130

Enrique Grande, MD, of The University of Texas MD Anderson Cancer Center, discusses new findings that show initial responses to induction therapy with atezolizumab plus platinum and gemcitabine did not seem to impact overall survival for patients with metastatic urothelial carcinoma. Cisplatin-treated patients appeared to derive a greater benefit with atezolizumab than did carboplatin-treated patients (Abstract 4503).

Bladder Cancer

Early Cessation of Neoadjuvant Chemotherapy May Lead to Worse Outcomes in Patients With Muscle-Invasive Bladder Cancer

Patients with muscle-invasive bladder cancer who receive fewer than three cycles of chemotherapy prior to cystectomy may have an increased risk of cancer recurrence and worse survival outcomes, according to the findings of a retrospective study presented by Chakraborty et al at the 2023 ASCO Annual ...

Bladder Cancer

Extended Lymphadenectomy May Not Benefit Patients With Clinically Localized Muscle-Invasive Bladder Cancer

Extended lymphadenectomy in patients undergoing radical cystectomy for clinically localized muscle-invasive bladder cancer was not associated with improved disease-free survival or overall survival and may increase the risk of adverse events and postsurgical mortality, according to new findings...

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