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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.

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
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
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

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
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
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
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 ...

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

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).

bladder cancer
immunotherapy

Thomas Powles, MD, on Urothelial Carcinoma: Results From the IMvigor211 Trial

Thomas Powles, MD, of Barts Cancer Institute, discusses phase III study findings on atezolizumab vs chemotherapy in platinum-treated locally advanced or metastatic urothelial carcinoma, with an emphasis on immune biomarkers, tumor mutational burden, and clinical outcomes (Abstract 409).

bladder cancer

John J. Coen, MD, on Bladder Cancer: Results From the NRG/RTOG 0712 Trial

John J. Coen, MD, of 21st Century Oncology, discusses phase II study findings on selective bladder preservation with twice-daily radiation plus fluorouracil/cisplatin or daily radiation plus gemcitabine for patients with muscle-invasive bladder cancer (Abstract 408).

bladder cancer

Joaquim Bellmunt, MD, PhD, on Urothelial Cancer: Results From the KEYNOTE-045 Trial

Joaquim Bellmunt, MD, PhD, of the Dana-Farber Cancer Institute, discusses phase III 2-year follow-up findings on pembrolizumab vs investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (Abstract 410).

Bladder Cancer
Immunotherapy

Avelumab in Advanced Urothelial Carcinoma: Further Study Needed to Clarify its Role

AS REVIEWED in this issue of The ASCO Post, Patel and colleagues have presented data from the phase I JAVELIN study evaluating avelumab (Bavencio) in platinum-refractory patients with advanced urothelial carcinoma.1 The drug is active with durable responses when compared with historical...

Bladder Cancer
Immunotherapy

Avelumab Active in Advanced Urothelial Carcinoma After Platinum Failure

AS REPORTED in The Lancet Oncology by Manish R. Patel, MD, of Florida Cancer Specialists/Sarah Cannon Research Institute, and colleagues, the anti–programmed cell death ligand 1 (PD-L1) antibody avelumab (Bavencio) produced durable responses in patients with locally advanced or metastatic...

bladder cancer
immunotherapy

2018 GU CANCERS SYMPOSIUM: New Model Predicts Survival for People With Bladder Cancer Receiving Immunotherapy

Researchers have developed a model to predict overall survival for people with advanced urothelial cancers treated with the immune checkpoint inhibitor atezolizumab (Tecentriq). The model, which is based on six clinical factors, may help inform treatment decisions for use of atezolizumab in these...

bladder cancer

Joaquim Bellmunt, MD, PhD, on Bladder Cancer: The Future of Immunotherapies

Joaquim Bellmunt, MD, PhD, of Dana-Farber Cancer Institute, discusses refining treatment choices with new combinations and sequencing strategies.

Bladder Cancer
Immunotherapy

Pembrolizumab in Advanced Urothelial Carcinoma

On May 18, 2017, pembrolizumab (Keytruda) was granted regular approval for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant...

bladder cancer
immunotherapy

IMvigor211 Trial: Atezolizumab vs Chemotherapy in Platinum-Treated Advanced Urothelial Carcinoma

The phase III IMvigor211 trial showed no survival benefit for atezolizumab (Tecentriq) vs physician's choice of chemotherapy in platinum-treated locally advanced or metastatic urothelial carcinoma with programmed death-ligand 1 (PD-L1) expression ≥ 5%. Findings were reported in The Lancet by...

Bladder Cancer

Arif Kamal, MD, MBA, MHS, Named Visionary in Hospice and Palliative Medicine

ARIF KAMAL, MD, MBA, MHS, Associate Professor of Medicine and Business Administration and Physician Director of Quality at the Duke Cancer Institute, was recently named by the American Academy of Hospice and Palliative Medicine as 1 of the 30 most influential leaders in hospice and palliative...

Bladder Cancer

Expert Point of View: Yohann Loriot, MD, PhD

FORMAL DISCUSSANT of the RANGE trial at the ESMO 2017 Congress, Yohann Loriot, MD, PhD, of the Institut Gustave Roussy and University of Paris-Saclay, Villejuif, Paris, said that although the study met its primary endpoint, he was not sure the absolute improvement in progression-free survival is...

Bladder Cancer

Positive Early Data on Second-Line Ramucirumab/Docetaxel in Platinum-Refractory Advanced Urothelial Cancer

RAMUCIRUMAB (CYRAMZA) added to docetaxel improved progression-free survival and almost doubled the overall response rate compared with docetaxel alone in patients with advanced or metastatic urothelial cancer that has progressed on platinum-based chemotherapy. These results of the phase III RANGE...

Bladder Cancer

Expert Point of View: Maria De Santis, MD

THE 2017 EUROPEAN SOCIETY for Medical Oncology (ESMO) Congress spokesperson Maria De Santis, MD, of the University of Warwick, Coventry, and Queen Elizabeth Hospital, Cancer Center, in Birmingham, UK, said the survival advantage in KEYNOTE-045 updated results was noteworthy.  “These results...

Bladder Cancer

Second-Line Pembrolizumab Extends Survival in Urothelial Cancer

PEMBROLIZUMAB (KEYTRUDA) extended survival by about 3 months in patients with advanced urothelial cancer whose disease progressed on platinum-based chemotherapy vs investigator’s choice of therapy, according to the mature results of the KEYNOTE-045 trial presented at the European Society for...

bladder cancer

First-Line Immunotherapy for Cisplatin-Ineligible Patients With Advanced Urothelial Cancer

As reported in The Lancet Oncology by Balar et al, first-line pembrolizumab (Keytruda) produced durable responses in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer in the phase II KEYNOTE-052 trial. The trial supported the accelerated approval...

Solid Tumors
Bladder Cancer

Avelumab in Locally Advanced or Metastatic Urothelial Carcinoma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 9, 2017, avelumab (Bavencio) was granted...

Solid Tumors
Bladder Cancer

Durvalumab in Advanced Urothelial Carcinoma Progressing After Platinum Therapy

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 1, 2017, durvalumab (Imfinzi) was granted...

bladder cancer

ESMO 2017: KEYNOTE-045: Updated Results Support Pembrolizumab as Second-Line Treatment in Advanced Urothelial Cancer

Mature results from the KEYNOTE-045 trial presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid (Abstract LBA37_PR) confirmed significantly longer survival in patients with advanced urothelial cancer who received the checkpoint inhibitor pembrolizumab after initial...

bladder cancer

Adjuvant Chemotherapy vs Observation After Neoadjuvant Therapy and Radical Cystectomy for Bladder Cancer

In an analysis reported in JAMA Oncology, Seisen et al found that adjuvant chemotherapy was associated with a survival benefit vs observation in patients with adverse prognostic features after neoadjuvant therapy and radical cystectomy for urothelial carcinoma of the bladder. Study Details The...

bladder cancer

Recombinant Adenovirus Interferon-α With Syn3 in BCG-Refractory or Relapsed Non–Muscle Invasive Bladder Cancer

A phase II study has shown activity of recombinant adenovirus interferon-α with Syn3 (rAd-IFNα/Syn3), a replication-deficient recombinant adenovirus gene transfer vector, in patients with high-grade bacillus Calmette-Guerin (BCG)-refractory or -relapsed non–muscle invasive bladder ...

Solid Tumors
Bladder Cancer

Atezolizumab in Patients With Advanced Urothelial Carcinoma Who Are Ineligible for Cisplatin

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 April 17, 2017, the programmed cell death ligand 1 (PD-L1)...

Prostate Cancer
Kidney Cancer
Bladder Cancer

Maha Hussain, MD, FACP, FASCO, Credits Collaboration for Her Contributions to Genitourinary Cancer

Internationally recognized genitourinary oncologist Maha Hussain, MD, FACP, FASCO, was born and reared in Baghdad, Iraq. “I came from a family that stressed the value of higher education and especially medicine. I have three uncles who are physicians, and my father encouraged my three siblings and...

bladder cancer

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 Powles et al in JAMA Oncology. Data from the ongoing study supported the recent approval of durvalumab as second-line treatment in this setting on the basis of...

bladder cancer

Treatment of Nonmetastatic Muscle-Invasive Bladder Cancer: AUA/ASCO/ASTRO/SUO Guideline

As reported in the Journal of Oncology Practice by Chang et al, for the first time for any type of malignancy, the American Urological Association (AUA), ASCO, American Society for Radiation Oncology (ASTRO), and Society of Urologic Oncology (SUO) have formulated an evidence-based guideline on...

Bladder Cancer

Pembrolizumab in Second-Line Therapy for Advanced Urothelial Carcinoma

THE TREATMENT OF metastatic urothelial carcinoma experienced a long period of stagnation until the recognition that targeting the programmed cell death protein 1 (PD-1) pathway could yield deep and durable responses.1-3 Cisplatin-based combination chemotherapy has been the reference standard for...

Bladder Cancer

Pembrolizumab Improves Overall Survival vs Chemotherapy in Second-Line Therapy for Advanced Urothelial Carcinoma

IN THE PHASE III KEYNOTE-045 trial reported in The New England Journal of Medicine, Joaquim Bellmunt, MD, PhD, of Dana-Farber Cancer Institute, and colleagues found that pembrolizumab (Keytruda) significantly improved overall survival vs investigator choice of chemotherapy as second-line treatment ...

Bladder Cancer

Avelumab in Refractory Metastatic Urothelial Carcinoma

The programmed cell death ligand 1 (PD-L1)–inhibitor avelumab (Bavencio) has shown activity in patients with refractory metastatic urothelial cancer, according to findings in a phase Ib study reported by Andrea B. Apolo, MD, of the Genitourinary Malignancies Branch, Center for Cancer Research,...

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