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bladder cancer

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...

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

Expert Point of View: Matthew J. Milosky, MD

FORMAL STUDY discussant Matthew J. Milosky, MD, of the University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, said there had been few drug approvals in advanced bladder cancer until 5 new checkpoint inhibitors were approved over the past 2 years. “Although these agents...

Bladder Cancer

Antibody-Drug Conjugate 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...

Kidney Cancer
Bladder Cancer
Prostate Cancer
Hepatobiliary Cancer

Conference Highlights From the 2019 Gastrointestinal and Genitourinary Cancers Symposiums

THIS YEAR saw a huge turnout and a large number of scientific abstracts presented at both the 2019 Gastrointestinal (GI) Cancers Symposium, held on January 17–19, and the 2019 Genitourinary (GU) Cancers Symposium, held on February 14–16, both in San Francisco. The GU Cancers Symposium attracted...

Bladder Cancer

Expert Point of View: Matthew I. Milowsky, MD

FORMAL STUDY discussant Matthew I. Milowsky, MD, of the University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, said there had been few drug approvals in advanced bladder cancer until 5 new checkpoint inhibitors were approved over the past 2 years. “Although these agents...

Bladder Cancer

Antibody-Drug Conjugate 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...

Solid Tumors
Bladder Cancer

Johns Hopkins Greenberg Bladder Cancer Institute Awards Research Grants to Women’s Bladder Cancer Projects

The Johns Hopkins Greenberg Bladder Cancer Institute awarded research grants to four projects that focus on bladder cancer treatments in women and how biology could offer new targets for cancer therapy.The Institute awards grants of $25,000 to $50,000. David McConkey, PhD, Director of the...

bladder cancer

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...

bladder cancer
immunotherapy

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).

bladder cancer

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).

bladder cancer

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.

bladder cancer

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).

bladder cancer

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 Cancer
Immunotherapy

Bladder Cancer: Strategies to Address Checkpoint Inhibitor Failure

CHECKPOINT INHIBITORS have rapidly become the standard of care as second-line treatment, and in some patients first-line treatment, of advanced bladder cancer. However, the majority of patients do not respond and eventually experience disease progression; these patients will need subsequent...

bladder cancer

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...

breast cancer
gynecologic cancer
lymphoma
pancreatic cancer
gastroesophageal cancer
bladder cancer
symptom management
gastrointestinal cancer

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...

Bladder Cancer
Immunotherapy

Expert Point of View: Shahrokh Shariat, MD

“BACILLUS CALMETTE-GUÉRIN (BCG) failures are quite common, with a 66% recurrence rate at 5 years, and about 25% of patients will have disease progression,” explained formal discussant Shahrokh Shariat, MD, Chair of the Department of Urology at Medical University, Vienna, and Adjunct Professor at...

Bladder Cancer
Immunotherapy

Pembrolizumab Shows Antitumor Activity in Non–Muscle Invasive Bladder Cancer

THE ANTI–PROGRAMMED cell death protein 1 (anti–PD-1) checkpoint inhibitor pembrolizumab (Keytruda) was found to have antitumor activity in patients with high-risk non–muscle invasive bladder cancer who were nonresponsive to bacillus Calmette-Guérin (BCG), according to the preliminary results of the ...

bladder cancer
immunotherapy

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...

bladder cancer
kidney cancer
immunotherapy

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 treatment-naive advanced or metastatic clear-cell RCC; and immunotherapy for urothelial cancer for both first- line cisplatin-ineligible and second-line therapy after cisplatin chemotherapy.

bladder cancer
immunotherapy

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 Geurin–unresponsive bladder cancer with high risk for disease progression.

bladder cancer

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...

Hepatobiliary Cancer
Lung Cancer
Bladder Cancer

Recent Drug Approvals and Revisions in Prescribing Information

THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) issued the following approvals and prescribing information revisions in August 2018. Lenvatinib Approved for Unresectable Hepatocellular Carcinoma THE FDA approved lenvatinib (Lenvima) for the first-line treatment of patients with unresectable...

bladder cancer
immunotherapy

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...

bladder cancer

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...

Bladder Cancer
Immunotherapy

No Survival Benefit for Atezolizumab inPD-L1–Positive Urothelial Cancer

As reported in The Lancet by Thomas Powles, MD, of Barts Cancer Institute, Queen Mary University of London, and colleagues, the phase III IMvigor211 trial showed no survival benefit for atezolizumab vs physician’s choice of chemotherapy in platinum-treated locally advanced or metastatic urothelial...

colorectal cancer
kidney cancer
hepatobiliary cancer
lung cancer
pancreatic cancer
issues in oncology
bladder cancer

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...

bladder cancer

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...

bladder cancer
immunotherapy

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...

bladder cancer

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...

bladder cancer

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).

bladder cancer
immunotherapy

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 ...

bladder cancer

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 ...

bladder cancer

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...

Bladder Cancer
Immunotherapy

Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma

Updated results of a phase I/II study of durvalumab (Imfinzi) in locally advanced or metastatic urothelial carcinoma were reported by Thomas Powles, MD, of Barts Cancer Institute, Queen Mary University of London, and colleagues in JAMA Oncology. Data from the ongoing study supported the recent...

bladder cancer

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...

bladder cancer
immunotherapy

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...

bladder cancer

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....

Bladder Cancer
Kidney Cancer
Prostate Cancer

GU Symposium Focuses on Prognostic Model in Urothelial Cancer, Novel Therapies for Prostate and Kidney Cancers

THE 2018 GENITOURINARY Cancers Symposium hosted an international audience of oncologists and other stakeholders to hear about the latest advances in the field. We have included coverage of many of the top news stories from the meeting in previous issues of The ASCO Post. Here are summaries of a few ...

bladder cancer

FDA Grants Breakthrough Therapy Designation to Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer

On March 26, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to enfortumab vedotin, an antibody-drug conjugate (ADC), for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors. Breakthrough Therapy ...

kidney cancer
prostate cancer
bladder cancer

EAU 2018: Survey Shows Greater Suicide Rate in Patients With Urologic Cancers

A major UK survey has shown that patients with urologic cancer—such as prostate, bladder, or kidney cancer—are five times more likely to commit suicide than people without cancer. The analysis also shows that patients with cancer generally are around three times more likely to commit...

bladder cancer
immunotherapy

Alterations in DNA Damage Response and Repair Genes and Response to PD-1/PD-L1 Inhibitors in Advanced Urothelial Cancer

In a study reported in the Journal of Clinical Oncology, Teo et al found that alterations in DNA damage response and repair (DDR) genes, particularly known or likely deleterious alterations, were associated with response to programmed cell death protein 1 (PD-1)/programmed cell death ligand 1...

Bladder Cancer
Immunotherapy

Pembrolizumab Survival Advantage Upheld in Advanced Urothelial Carcinoma

Patients with recurrent urothelial cancer had sustained improvement in overall survival at 2 years after they received second-line treatment with pembrolizumab (Keytruda) vs chemotherapy, according to an updated survival analysis of the phase III KEYNOTE-045 trial presented at the 2018...

bladder cancer

FDA Grants Breakthrough Therapy Designation to Erdafitinib for the Treatment of Metastatic Urothelial Cancer

On March 15, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to erdafitinib for the treatment of urothelial cancer. Urothelial cancer, most frequently in the bladder, is the sixth most common type of cancer in the United States. A Breakthrough Therapy ...

Bladder Cancer

EXPERT POINT OF VIEW: Timothy Gilligan, MD

“POUT IS an impressive study, given that the authors were able to complete a trial in this relatively rare cancer. We still need overall survival data to determine the role of adjuvant chemotherapy for upper tract urothelial cancer. We need to know if it makes people live longer or have a better...

Bladder Cancer

Adjuvant Chemotherapy for Upper Tract Urothelial Cancer

ADJUVANT CHEMOTHERAPY achieved robust improvements in disease-free survival and metastasis-free survival compared with surveillance in the phase III POUT study of patients with upper tract urothelial cancer.1 Further, there was an early trend toward improved overall survival with adjuvant...

bladder cancer
immunotherapy

Long-Term Outcomes With PD-L1 Inhibition in Metastatic Urothelial Cancer

As reported by Petrylak et al in JAMA Oncology, long-term follow-up of patients in a phase I study expansion cohort indicated enduring clinical benefit and maintained tolerability of atezolizumab (Tecentriq) in patients with metastatic urothelial carcinoma.  Study Details The study involved...

bladder cancer
immunotherapy

Gregory R. Pond, PhD, on Urothelial Cancer: Advance in Prognosis

Gregory R. Pond, PhD, of McMaster University, discusses a new six-factor prognostic model for patients with advanced urothelial carcinoma receiving post platinum atezolizumab (Abstract 413).

bladder cancer
immunotherapy

Jonathan E. Rosenberg, MD, on Urothelial Carcinoma: Results From the CheckMate 032 Trial

Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discusses longer-term efficacy and safety findings on nivolumab monotherapy in metastatic urothelial carcinoma (Abstract 414).

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