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Bladder Cancer
Immunotherapy

Expert Point of View: Philip J. Saylor, MD

Philip J. Saylor, MD, Attending Physician at Massachusetts General Hospital and Assistant Professor at Harvard Medical School, Boston, commented on this study. “The results that were presented are clearly exciting and cause us to look forward to a likely phase III study of this strategy. The high...

Bladder Cancer
Immunotherapy

Early Data Show Activity for Enfortumab Vedotin Plus Pembrolizumab in Advanced Bladder Cancer

It may be possible to use a platinum-free combination as first-line treatment for advanced or metastatic urothelial carcinoma in cisplatin-ineligible patients, if results of the phase Ib/II EV-103 trial hold up. The combination of the newly approved antibody-drug conjugate (enfortumab vedotin) and...

Bladder Cancer

Adjuvant Gemcitabine/Platinum-Based Chemotherapy vs Surveillance for Upper Tract Urothelial Carcinoma: POUT Trial

In the phase III POUT trial, reported in The Lancet, Alison Birtle, MD, and colleagues found that adjuvant gemcitabine/platinum chemotherapy was associated with improved disease-free survival vs surveillance in patients with locally advanced urothelial carcinoma of the upper urinary tract. As...

Lung Cancer
Lymphoma
Bladder Cancer
Head and Neck Cancer
Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

FDA Pipeline: Priority Reviews in Lung Cancers, Lymphoma

This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for non–small cell and small cell lung cancers, as well as for diffuse large-B cell lymphoma (DLBCL); Breakthrough Therapy designation to an antibody-drug conjugate for bladder cancer; and a double Fast...

Immunotherapy
Bladder Cancer

Pembrolizumab for BCG-Unresponsive, High-Risk Non–Muscle Invasive Bladder Cancer

On January 8, 2020, pembrolizumab was approved for treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.1,2...

bladder cancer
immunotherapy

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 life, meriting further evaluation in a randomized trial (Abstract 491).

bladder cancer

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 improvement in progression-free and overall survival at 1 and 2 years (Abstract 438).

immunotherapy
bladder cancer

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 (Abstract 441).

Bladder Cancer
Immunotherapy

2020 GU Cancers Symposium: Enfortumab Vedotin Plus Pembrolizumab in Bladder Cancer

In patients with metastatic urothelial carcinoma, platinum chemotherapy is the standard of care in the first-line setting; however, for patients who are ineligible for platinum treatment, the alternative standard—gemcitabine plus carboplatin—can be poorly tolerated and have limited durability and...

Bladder Cancer
Kidney Cancer
Prostate Cancer
Issues in Oncology

2020 GU Cancers Symposium: Fear of Recurrence, Patients’ Prognostic Understanding Examined in Genitourinary Cancers

In studies to be presented at the 2020 Genitourinary Cancers Symposium (Abstracts 649 and 665), researchers examined the prevalence of fear of cancer recurrence in patients with renal cell carcinoma and evaluated the prognostic understanding patients with genitourinary cancer possess of their...

Bladder Cancer

Enfortumab Vedotin in Metastatic Urothelial Carcinoma

In the phase I EV-101 trial reported in the Journal of Clinical Oncology, Rosenberg et al found that the antibody-drug conjugate enfortumab vedotin had no maximum tolerated dose and was active in patients with metastatic urothelial carcinoma at the dose selected for phase II evaluation. The agent...

Bladder Cancer

TIVO-3: Third- or Fourth-Line Tivozanib vs Sorafenib in Metastatic Renal Cell Carcinoma

As reported in The Lancet Oncology by Brian I. Rini, MD, and colleagues, the phase III TIVO-3 trial has shown a statistically significant increase in progression-free survival with tivozanib vs sorafenib as a third- or fourth-line treatment for advanced renal cell carcinoma. Study Details The...

Bladder Cancer

Enfortumab Vedotin-ejfv for Previously Treated Advanced Urothelial Cancer

On December 18, 2019, the antibody-drug conjugate enfortumab vedotin-ejfv (PadcevTM) was granted accelerated approval for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed cell death protein 1 (PD-1) or programmed cell...

Bladder Cancer
Hepatobiliary Cancer

FDA Pipeline: Fast Track/Orphan Drug Designation for Cholangiocarcinoma Treatment, Breakthrough Device Designation for Bladder Cancer Test

This week, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to infigratinib for patients with advanced or metastatic cholangiocarcinoma with a certain genetic mutation, and Orphan Drug designation to the treatment for patients with cholangiocarcinoma. The FDA also granted...

Bladder Cancer
Immunotherapy

FDA Approves PD-1 Inhibitor for BCG-Unresponsive, High-Risk Non–Muscle Invasive Bladder Cancer

Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have...

Bladder Cancer
Immunotherapy

JAVELIN Bladder 100 Study of Avelumab for Urothelial Cancer Meets Primary Endpoint

The phase III JAVELIN Bladder 100 trial met its primary endpoint of overall survival at the planned interim analysis. In this study, patients with previously untreated locally advanced or metastatic urothelial carcinoma whose disease did not progress on induction chemotherapy and who were randomly...

Bladder Cancer

Does the Addition of Ramucirumab to Docetaxel Improve Overall Survival in Previously Treated Urothelial Carcinoma?

As reported in The Lancet Oncology by Daniel P. Petrylak, MD, and colleagues, the phase III RANGE trial has shown no significant improvement in overall survival with the addition of ramucirumab to docetaxel in patients with locally advanced or metastatic urothelial carcinoma previously treated...

Lung Cancer
Bladder Cancer
Colorectal Cancer
Hematologic Malignancies
Myelodysplastic Syndromes
Breast Cancer
Head and Neck Cancer
Immunotherapy

FDA Pipeline: Priority Reviews in SCLC, Bladder Cancer, Colorectal Cancer

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Reviews for treatments in extensive-stage small cell lung cancer (SCLC), non–muscle invasive bladder cancer, and BRAF V600E–mutant colorectal cancer. The Agency also recently issued multiple Breakthrough Therapy designations and ...

Bladder Cancer

FDA Approves Enfortumab Vedotin-ejfv for Previously Treated Advanced Urothelial Cancer

On December 18, the U.S. Food and Drug Administration (FDA) granted accelerated approval to enfortumab vedotin-ejfv (Padcev) for adult patients with locally advanced or metastatic urothelial cancer who have previously received neoadjuvant or adjuvant treatment with a programmed cell death protein 1 ...

Bladder Cancer

Does the Addition of Ramucirumab to Docetaxel Improve Overall Survival in Previously Treated Urothelial Carcinoma?

As reported in The Lancet Oncology by Daniel P. Petrylak, MD, and colleagues, the phase III RANGE trial has shown no significant improvement in overall survival with the addition of ramucirumab to docetaxel in patients with locally advanced or metastatic urothelial carcinoma previously treated with ...

Prostate Cancer
Breast Cancer
Bladder Cancer
Pancreatic Cancer
Kidney Cancer
Thyroid Cancer
Gynecologic Cancers
Immunotherapy

ESMO Congress 2019: Quick Takes From Key Clinical Trials

The ESMO Congress continues to grow as a pivotal platform for research in clinical oncology. At the ESMO Congress 2019, important findings were showcased in more than 2,200 studies, including 93 late-breaking abstracts. The ASCO Post summarized much of that news in separate articles over several...

Bladder Cancer

IMvigor130 Trial: Atezolizumab Plus Chemotherapy for Metastatic Urothelial Cancer

Treatment with atezolizumab plus chemotherapy extended progression-free survival by 1.9 months vs chemotherapy alone in patients with metastatic urothelial cancer, according to the early results of the IMvigor130 trial, which were presented at the European Society for Medical Oncology (ESMO)...

Prostate Cancer
Bladder Cancer
Hematologic Malignancies
Breast Cancer
CNS Cancers
Leukemia
Skin Cancer

FDA Pipeline: Advances in Prostate Cancer, Urothelial Cancer, Myelofibrosis, and More

In the past few weeks, the U.S. Food and Drug Administration (FDA) has issued regulatory decisions in prostate cancer, urothelial cancer, myelofibrosis, breast cancer, pediatric brain cancer, leukemia, and skin cancer. Breakthrough Therapy Designation for Niraparib in Metastatic...

Bladder Cancer
Immunotherapy

ESMO 2019: IMvigor130: Addition of Atezolizumab to Platinum-Based Chemotherapy in Advanced Urothelial Carcinoma

Patients with locally advanced or metastatic urothelial carcinoma demonstrated prolonged progression-free survival with the addition of atezolizumab to first-line platinum-based chemotherapy vs treatment with chemotherapy alone, according to phase III data from the IMvigor130 study presented by...

bladder cancer
immunotherapy

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 platinum-based chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (Abstract LBA14).

bladder cancer
immunotherapy

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 (Abstract 902O).

Bladder Cancer
Issues in Oncology

The Fight Against Breast Cancer Illustrates the Health-Care Challenges of Women in Poverty

"Of all the forms of inequality, injustice in health is the most shocking and the most inhumane….” —Dr. Martin Luther King, Jr Progress has been made in expanding access to health care for low-income populations, but the quality of care still lags behind and can result in less successful outcomes...

bladder cancer

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...

bladder cancer

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...

Bladder Cancer

Johns Hopkins Awarded $3.2 Million NIH Grant for Early-Stage Bladder Cancer Research

Researchers at the Johns Hopkins Kimmel Cancer Center, the Greenberg Bladder Cancer Institute, the Bloomberg-Kimmel Institute for Cancer Immunotherapy, the Brady Urological Institute, and the Center for Computational Genomics at Johns Hopkins have received a $3.2 million grant from the National...

bladder cancer

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...

bladder cancer

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...

Bladder Cancer

New NCCN Guidelines for Patients®: Bladder Cancer

THE TREATMENT LANDSCAPE for bladder cancer has changed dramatically over the past few years, and the National Comprehensive Cancer Network® (NCCN®) recently announced the newly published NCCN Guidelines for Patients®: Bladder Cancer, created with funding through the NCCN Foundation. The guidelines...

lung cancer
gastroesophageal cancer
bladder cancer
gastrointestinal cancer
immunotherapy

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 ...

bladder cancer

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...

Bladder Cancer

Actively Recruiting Clinical Trials for Muscle-Invasive and Non–Muscle-Invasive Bladder Cancers

The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical research trials for both muscle-invasive and non–muscle-invasive bladder cancers. The studies listed here are evaluating the safety and efficacy of combinations of chemotherapy and...

Bladder Cancer
Immunotherapy

Enfortumab Vedotin After Checkpoint Inhibition in Metastatic Urothelial Cancer

A phase II study found that treatment with the antibody-drug conjugate enfortumab vedotin achieved responses in 44% of patients with locally advanced or metastatic urothelial cancer previously treated with platinum chemotherapy and a checkpoint inhibitor. This is a noteworthy study because it...

bladder cancer
kidney cancer
prostate cancer
solid tumors

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.

bladder cancer
immunotherapy

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...

bladder cancer

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).  

bladder cancer
immunotherapy

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).

bladder cancer
immunotherapy

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 progression-free survival (Abstract 4503).

bladder cancer

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: methotrexate/vinblastine/doxorubicin/cisplatin and gemcitabine/cisplatin (Abstract 4506).

bladder cancer
immunotherapy

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).

bladder cancer
immunotherapy

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...

bladder cancer
immunotherapy

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 ...

Solid Tumors
Bladder Cancer

Erdafitinib for Metastatic Urothelial Carcinoma

On April 12, 2019, erdafitinib was granted accelerated approval for patients with locally advanced or metastatic urothelial carcinoma with susceptible fibroblast growth factor receptor 3 (FGFR3) or FGFR2 genetic alterations, when the disease has progressed during or following platinum-containing...

Kidney Cancer
Prostate Cancer
Bladder Cancer

2019 Updates to NCCN Clinical Practice Guidelines in Genitourinary Oncology

The 24th Annual Conference of the National Comprehensive Cancer Network® (NCCN®) was held this past March in Orlando, Florida. Updates to a number of Clinical Practice Guidelines (NCCN Guidelines®) were reported, including three relevant to the field of genitourinary oncology: kidney cancer,...

Bladder Cancer
Immunotherapy

Lenvatinib Plus Pembrolizumab Shows Activity in Advanced Urothelial Cancer

THE COMBINATION of lenvatinib plus pembrolizumab has demonstrated antitumor activity in patients with advanced urothelial cancer, including patients receiving later-line treatment. Results of a phase Ib/II trial showed an objective response rate of 25% and a median progression-free survival of 5.4...

Bladder Cancer

Sacituzumab Govitecan Shows Activity in Heavily Pretreated Bladder Cancer

PRELIMINARY EVIDENCE suggests that the antibody-drug conjugate sacituzumab govitecan is active in patients previously treated with chemotherapy or checkpoint inhibitor therapy for metastatic urothelial cancer. These results from a phase I/II basket study of this agent were presented at the 2019...

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