Bladder Cancer COE Articles

Articles

FDA ALERT: RE: Label Updates in Clinical Trials for Some Patients Taking Pembrolizumab or Atezolizumab as Monotherapy to Treat Urothelial Cancer with Low Expression of PD-L1
San Francisco, CA USA (UroToday.com) FDA Update: The FDA is restricting the use of Keytruda and Tecentriq for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy.

This results from decreased survival associated with the use of Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as single therapy (monotherapy) compared to platinum-based chemotherapy in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).

Published June 22, 2018
FDA Breakthrough Therapy Designation for Erdafitinib in the Treatment of Metastatic Urothelial Cancer
TRUCKEE, CA (UroToday.com) The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for erdafitinib in the treatment of urothelial cancer. Urothelial cancer, most frequently in the bladder, is the sixth most common type of cancer in the U.S. A Breakthrough Therapy Designation is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

Published March 16, 2018
Phase II Trial of Continuous Treatment with Sunitinib in Patients with High-Risk (BCG-refractory) Non-Muscle Invasive Bladder Cancer - Expert Commentary
Treatment of patients with non-muscle invasive bladder cancer (NMIBC) who are unable to receive intravesical with Bacillus Calmette Guerin (BCG) remains a challenge.
Published September 10, 2020
TURBT More Important Than Ever
Non-muscle invasive bladder cancer (NMIBC) will account for 75% of the 79,000 new cases of bladder cancer expected to be diagnosed in 2017. Fortunately, most cases can be successfully treated and carry a relatively good prognosis. However, depending on the grade and stage at initial diagnosis, as many as 60% of patients with NMIBC can experience orthotopic tumor recurrence within the first year after initial resection and up to 78% can recur within five years.

Published April 20, 2017
[Concurrent renal cell carcinoma and urothelial carcinoma: long-term follow-up study of 24 cases].

Objective: To investigate the clinical manifestation, diagnosis, treatment and outcome of simultaneous occurrence of renal cell carcinoma and urothelial carcinoma. Methods: Twenty-four consecutive patients with synchronous renal cell carcinoma and urothelial carcinoma treated in our center from March 2005 to December 2015 were retrospectively reviewed.

Published April 4, 2017
A Care Bundle to Improve Perioperative Mitomycin Use in Non-Muscle-Invasive Bladder Cancer – Beyond the Abstract
There is good quality evidence that instillation of a chemotherapeutic agent such as mitomycin into the bladder within twenty-four hours of an initial transurethral bladder tumour resection reduces the rate of recurrences and prolongs recurrence-free intervals in patients with non-muscle invasive bladder cancer. Most guideline panels recommend this practice. However, despite this evidence and recommendations, there is considerable disparity in the actual use of intravesical chemotherapy amongst urologists. The reasons are manifold and include lack of awareness of the benefits, non-availability of the drug, delay in procurement from pharmacies, fear of side effects and complications, reimbursement issues and wariness of deep resections leading to extravasation.
Published April 16, 2018
A Golden Age of Bladder Cancer Drug Development
Recent years have seen an explosive rate of transformative advances in both pre-clinical and clinical urothelial carcinoma research. With the public dissemination of comprehensive molecular data from The Cancer Genome Atlas (TCGA) urothelial carcinoma cohort, the global urothelial carcinoma research community now has the initial road map of the key biological themes that drive carcinogenesis, growth, invasion, and metastasis.¹
Written by: Noah M. Hahn, MD
References:
1. Comprehensive molecular characterization of urothelial bladder carcinoma. Nature 507:315-22, 2014
2. Bellmunt J, de Wit R, Vaughn DJ, et al: Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma. N Engl J Med 376:1015-1026, 2017
3. Patel MR, Ellerton J, Infante JR, et al: Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial. Lancet Oncol 19:51-64, 2018
4. Powles T, O'Donnell PH, Massard C, et al: Efficacy and safety of durvalumab in locally advanced or metastatic urothelial carcinoma: Updated results from a phase 1/2 open-label study. JAMA Oncology 3:e172411, 2017
5. Rosenberg JE, Hoffman-Censits J, Powles T, et al: Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. The Lancet 387:1909-1920, 2016
6. Sharma P, Retz M, Siefker-Radtke A, et al: Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. The Lancet Oncology 18:312-322, 2017
7. Rosenberg JE, Sridhar SS, Zhang J, et al: Updated results from the enfortumab vedotin phase 1 (EV-101) study in patients with metastatic urothelial cancer (mUC). Journal of Clinical Oncology 36:4504-4504, 2018
8. Siefker-Radtke AO, Necchi A, Park SH, et al: First results from the primary analysis population of the phase 2 study of erdafitinib (ERDA; JNJ-42756493) in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRalt). J Clin Oncol 36, 2018
Published July 12, 2019
A Nomogram to Stratify Intermediate-Risk Non-Muscle-Invasive Bladder Cancer for Adjuvant Therapy - Expert Commentary
There is a need for accurate nomograms for predicting oncological outcomes in intermediate-risk non–muscle-invasive bladder cancer (NMIBC) patients. Such accurate tools can be used to guide decision making for appropriate adjuvant therapy.
Published August 10, 2020
A Phase I Study of Enfortumab Vedotin in Japanese Patients with Locally Advanced or Metastatic Urothelial Carcinoma - Expert Commentary

Enfortumab Vedotin (EV) is a novel antibody-drug conjugate targeting Nectin-4, which is overexpressed in urothelial cancer. A recent study published by Takahashi et al. in Investigational New Drugs studied EV in locally advanced/metastatic urothelial cancer in a phase I study (NCT03070990).¹ The researchers included patients who were diagnosed with locally advanced or metastatic urothelial carcinoma and were cisplatin-ineligible or failed at least one chemotherapy treatment. Nine patients were randomly assigned to Arm A to receive EV at 1.0 mg/kg, and eight patients were assigned to Arm B to receive EV at 1.25 mg/kg on days 1, 8, and 15 of 28-day cycles.

Published January 6, 2020
A Urine-Based Methylation Test for Bladder Cancer — Expert Commentary
Early identification of bladder cancer (BC) is critical for improving clinical outcomes. Developing urine-based molecular biomarkers is an area of active research. A recent study published in Urologic Oncology: Seminars and Original Investigations described a urine-based methylation analysis of TWIST1, NID2, RUNX3, GATA4, and FOXE1 in urinary cell pellet DNA as a biomarker.
Published June 23, 2020
Adjuvant Chemotherapy in Patients with Urothelial Carcinoma and Adverse Pathologic Features Receiving Prior Neoadjuvant Chemotherapy and Radical Cystectomy - Expert Commentary
Neoadjuvant chemotherapy is a standard of care for patients with cisplatin-eligible muscle-invasive urothelial carcinoma. For patients who do not receive neoadjuvant chemotherapy, there is evidence of a benefit associated with cisplatin-based adjuvant chemotherapy after radical cystectomy for patients with pT3/T4 and/or pN⁺ bladder cancer. It is unknown whether additional adjuvant chemotherapy is beneficial for patients with adverse pathological features after neoadjuvant chemotherapy and radical cystectomy.

Published September 2, 2017
ASCO 2020: JAVELIN Bladder 100 Phase III Results: Maintenance Avelumab + Best Supportive Care vs BSC Alone After Platinum-Based First-Line Chemotherapy in Advanced Urothelial Carcinoma

(UroToday.com) Advanced urothelial carcinoma resulted in over 200,000 deaths across the world in 2018. Though the majority of patients eligible for such therapy respond to platinum-based chemotherapy, disease progression occurs relatively quickly and a half or less of patients receive second-line treatment. Though PD-L1/PD-1 immune checkpoint blockade (ICB) agents are standard 2^nd-line therapy for disease progression after platinum, not all patients receive this therapy and only a minority of patients have a durable clinical benefit. Avelumab, an antibody against PD-L1, is approved in the second-line post-platinum treatment setting.

Published May 31, 2020
ASCO 2020: Pembrolizumab for the Treatment of Patients with Bacillus Calmette-Guérin Unresponsive, High-Risk Non–Muscle-Invasive Bladder Cancer: Over Two Years Follow-Up of KEYNOTE-057
(UroToday.com) Patients with nonmuscle-invasive bladder cancer are at high risk of recurrence and progression. In particular, patients with high-grade disease and those with carcinoma in situ are at notably elevated risk. As a result, both the European Association of Urology and the American Urological Association/Society of Urologic Oncology guidelines on nonmuscle-invasive bladder cancer recommend adjuvant treatment, typically with intravesical Bacillus Calmette-Guérin (BCG), in a risk-adapted fashion for these patients. While the use of BCG is well established and guideline-recommended, many patients either fail to initially respond or fail to maintain response to this approach. Treatment options for patients with BCG unresponsive or refractory disease are much less clear but include radical cystectomy, further intravesical therapy including intravesical chemotherapy, systemic therapy, and clinical trials.

Published May 30, 2020
ASCO GU 2018: Lessons Learned From New Guidelines and How They Have Changed Management of Muscle-Invasive Bladder Cancer
San Francisco, CA (UroToday.com) Dr. Holzbeierlein began his discussion on the new muscle-invasive bladder cancer (MIBC) guidelines,¹ a collaborative multi-disciplinary effort led by Dr. Sam Chang that involved input from all the major organizations, including AUA, ASCO, ASTRO, and patient advocates. The final analysis was built on prior work by Dr. Chou’s AHRQ systematic reviews (through 2015).

Published February 10, 2018
ASCO GU 2019: Genomic Insights and Biomarkers for Treatment Selection in Muscle-Invasive and Non-Muscle-Invasive Bladder Cancer
San Francisco, CA (UroToday.com) Dr. Yair Lotan presented on Genomic Insights and Biomarkers for Treatment Selection in Muscle-Invasive and Non-Muscle-Invasive Bladder Cancer. He discussed the role of markers in bladder cancer and how they add independent information that can impact patient care. The markers can either be prognostic which provide information about patient’s overall cancer outcome, regardless of therapy, or predictive markers that provide information about the effect of the therapeutic intervention and can be a target for therapy.
Published February 15, 2019
ASCO GU 2019: Multimodality Treatment in Challenging Cases of Urothelial Carcinoma: Case Panel Discussion
San Francisco, CA (UroToday.com) In this case panel discussion, 3 patient cases were reviewed highlighting important points in the management of bladder cancer. The text below includes a summary of each case presented and key points made by the panelists.

Case 1: Small Cell Bladder Cancer: 65-year-old man who presents feeling lethargic, 10 lb weight loss, poor appetite. He has microscopic hematuria. Cystoscopy and subsequent TURBT demonstrates small cell bladder cancer.
Published February 16, 2019
ASCO GU 2019: PIVOT-02 Study of NKTR-214 with Nivolumab in Metastatic Urothelial Carcinoma
San Francisco, CA (UroToday.com) Immune checkpoint inhibitors are approved both in the first line and second line for patients with metastatic urothelial carcinoma. In the first line, KEYNOTE 052 showed that pembrolizumab has significant anti-tumor activity for cisplatin ineligible patients with UC¹, for a 38% objective response rate for patients with a combined positive score of 10% or more (PD-L1 positive). Further analysis last year found that the benefit to checkpoint inhibition in the first line was restricted to patients with a high PD-L1 expression, as defined by CPS≥10 or PD-L1 IC ≥5%. In the second line, KEYNOTE 045 improved median overall survival compared with chemo (10.3 v 7.4 months; HR, 0.70; P < 0.001)².

Published February 20, 2019
ASCO GU 2019: Sacituzumab Govitecan (IMMU-132) in Patients with Previously Treated Metastatic Urothelial Cancer
San Francisco, CA (UroToday.com) Sacituzumab govitecan (SG) is a humanized antibody-drug conjugate, made from anti-Trop-2 monoclonal antibody linked with SN-38, the active metabolite of irinotecan.¹ Trop-2 is transmembrane glycoprotein encoded by the Tacstd2 gene, and is differentially expressed in a wide range of tumor types, including gastric, pancreatic, triple-negative breast, colonic, prostate, and lung cancer.² In hormone-receptor positive (HR+)/HER2- metastatic breast cancer (mBC), the overall response rate was 31% by local assessment, and the clinical benefit rate (PR+SD > 6 months) was 48%.³ In an early phase study with metastatic non-small cell lung cancer, 47 patients were treated and the objective response rate was 19% with a median response duration of 6.0 months.⁴
Published February 16, 2019
ASCO GU 2020: Safety and Efficacy of Nadofaragene Firadenovec (Adstiladrin®), an Intravesical Gene Therapy for the Treatment of High-grade BCG Unresponsive NMIBC

San Francisco, California (UroToday.com) For patients with BCG unresponsive non-muscle invasive bladder cancer, the standard of care for patients who are operative candidates is a radical cystectomy. However, not all patients may be cystectomy candidates, often for a multitude of reasons, including coexisting comorbidities as well as personal considerations and quality of life.¹ Thus, there is an unmet need in this space for better local or systemic therapies which may prevent progression of bladder cancer to muscle-invasive or metastatic disease.

Published February 14, 2020
Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial
Background: First-line chemotherapy for patients with cisplatin-ineligible locally advanced or metastatic urothelial carcinoma is associated with short response duration, poor survival, and high toxicity. This study assessed
atezolizumab (anti-programmed death-ligand 1 [PD-L1]) as treatment for metastatic urothelial cancer in cisplatinineligible patients.

Methods: For this single-arm, multicentre, phase 2 study, in 47 academic medical centres and community oncology practices in seven countries in North America and Europe, we recruited previously untreated patients with locally advanced or metastatic urothelial cancer who were cisplatin ineligible. Patients were given 1200 mg intravenous atezolizumab every 21 days until progression. The primary endpoint was independently confi rmed objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 (central review), assessed in prespecifi ed subgroups based on PD-L1 expression and in all patients. All participants who received one or more doses of atezolizumab were included in the primary and safety analyses. This study was registered with ClinicalTrials.gov, number NCT02108652.

Findings: Between June 9, 2014, and March 30, 2015, we enrolled 123 patients, of whom 119 received one or more doses of atezolizumab. At 17·2 months’ median follow-up, the objective response rate was 23% (95% CI 16 to 31), the complete response rate was 9% (n=11), and 19 of 27 responses were ongoing. Median response duration was not reached. Responses occurred across all PD-L1 and poor prognostic factor subgroups. Median progression-free survival was 2·7 months (2·1 to 4·2). Median overall survival was 15·9 months (10·4 to not estimable). Tumour mutation load was associated with response. Treatment-related adverse events that occurred in 10% or more of patients were fatigue (36 [30%] patients), diarrhoea (14 [12%] patients), and pruritus (13 [11%] patients). One treatment-related death (sepsis) occurred. Nine (8%) patients had an adverse event leading to treatment discontinuation. Immune-mediated events occurred in 14 (12%) patients.

Interpretation: Atezolizumab showed encouraging durable response rates, survival, and tolerability, supporting its therapeutic use in untreated metastatic urothelial cancer.

Funding: F Hoff mann-La Roche, Genentech.

Authors: Arjun V Balar, Matthew D Galsky, Jonathan E Rosenberg, Thomas Powles, Daniel P Petrylak, Joaquim Bellmunt, Yohann Loriot, Andrea Necchi, Jean Hoffman-Censits, Jose Luis Perez-Gracia, Nancy A Dawson, Michiel S van der Heijden, Robert Dreicer, Sandy Srinivas, Margitta M Retz, Richard W Joseph, Alexandra Drakaki, Ulka N Vaishampayan, Srikala S Sridhar, David I Quinn, Ignacio Durán, David R Shaff er, Bernhard J Eigl, Petros D Grivas, Evan Y Yu, Shi Li, Edward E Kadel III, Zachary Boyd, Richard Bourgon, Priti S Hegde, Sanjeev Mariathasan, AnnChristine Thåström, Oyewale O Abidoye, Gregg D Fine, Dean F Bajorin, for the IMvigor210 Study Group*

Go "Beyond the Abstract" - Read an article written by the authors for UroToday.com

Author Affiliations: Genitourinary Cancers Program, Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY, USA (A V Balar MD); The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA (M D Galsky MD); Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA (J E Rosenberg MD, D F Bajorin MD); Barts Cancer Institute ECMC, Barts Health and the Royal Free NHS Trust, Queen Mary University of London, London, UK (T Powles MD); Smilow Cancer Center, Yale University, New Haven, CT, USA (D P Petrylak MD); Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA (J Bellmunt MD); Département de médecine oncologique, Université Paris-Saclay and Gustave Roussy, Villejuif, France (Y Loriot MD); Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy (A Necchi MD); Sidney Kimmel Cancer Center at Jefferson, Philadelphia, PA, USA (J Hoffman-Censits MD); Department of Oncology, Clínica Universidad de Navarra, University of Navarra, Pamplona, Navarre, Spain (J L Perez-Gracia MD); MedstarGeorgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC, USA (N A Dawson MD); Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, Netherlands (M S van der Heijden MD); Division of Hematology/ Oncology, University of Virginia School of Medicine, Charlottesville, VA, USA (R Dreicer MD); Division of Oncology/Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA (S Srinivas MD); Department of Urology, Klinikum rechts der Isar, Technical University Munich, Munich, Germany (M M Retz MD); Department of Hematology/Oncology, Mayo Clinic, Jacksonville, FL, USA (R W Joseph MD); Department of Medicine, Division of Hematology and Oncology and Institute of Urologic Oncology, David Geffen School of Medicine, University of California, Los Angeles, CA, USA (A Drakaki MD); Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA (U N Vaishampayan MD); Department of Medical Oncology and Hematology, Princess Margaret Cancer Center, Toronto, ON, Canada (S S Sridhar MD); University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA (D I Quinn MD); Department of Medical Oncology, Hospital Universitario Virgen del Rocío and Institute of Biomedicine of Seville, Seville, Spain (I Durán MD); New York Oncology Hematology, Albany, NY, USA (D R Shaffer MD); British Columbia Cancer Agency, British Columbia, Vancouver, Canada (B J Eigl MD); Department of Hematology and Medical Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA (P D Grivas MD); Division of Oncology, Department of Medicine, University of Washington and Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA (E Y Yu MD); and Genentech, South San Francisco, CA, USA (S Li PhD, E E Kadel III BS,Z Boyd MSc, R Bourgon PhD, P S Hegde PhD, S Mariathasan PhD, AC Thåström PhD, O O Abidoye MD, G D Fine MD)

Published Online December 7, 2016 http://dx.doi.org/10.1016/ S0140-6736(16)32455-2
Published March 7, 2017
Atezolizumab as First-line Treatment in Cisplatin-ineligible Patients with Locally Advanced and Metastatic Urothelial Carcinoma: A Single-arm, Multicentre, Phase 2 Trial
BACKGROUND: First-line chemotherapy for patients with cisplatin-ineligible locally advanced or metastatic urothelial carcinoma is associated with short response duration, poor survival, and high toxicity. This study assessed atezolizumab (anti-programmed death-ligand 1 [PD-L1]) as treatment for metastatic urothelial cancer in cisplatin-ineligible patients.

METHODS: For this single-arm, multicentre, phase 2 study, in 47 academic medical centres and community oncology practices in seven countries in North America and Europe, we recruited previously untreated patients with locally advanced or metastatic urothelial cancer who were cisplatin ineligible.
Published December 12, 2018
AUA 2020: Surgical Techniques: Tips & Tricks: Oncology: Bladder Cancer Blue Light Cystoscopy
(UroToday.com) At the American Urological Association (AUA) 2020 Virtual annual meeting, Dr. Anne Schuckman discussed blue light cystoscopy for bladder cancer and several of her tips and tricks. Dr. Schuckman notes that there are over 75,000 new bladder cancer diagnoses per year, leading to more than 15,000 deaths. The prevalence of bladder cancer is >550,000 cases, making it the highest per capita treatment cost due to recurrent disease and multiple recurrences.
Published June 28, 2020
BCG Immunotherapy Versus Radical Cystectomy in Intermediate or High-Risk Non-Muscle Invasive Bladder Cancer Patients - Expert Commentary

Treatment options available for intermediate or high-risk non-muscle invasive bladder cancer include intravesical Bacillus Calmette-Guerin (BCG) and radical cystectomy.

Published February 5, 2020
BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry
Introduction
The purpose of this guidance is to assist sponsors in the development of drugs, including biologics, for the treatment of patients who have bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC). This guidance is intended for pharmaceutical sponsors, the academic community, and the public and provides a framework, based on current Food and Drug Administration (FDA) thinking, to facilitate the development of drugs to treat this patient population. This guidance discusses pathological diagnosis and staging, risk stratification, and trial design, including assessment of appropriate clinical endpoints. These issues were discussed at the FDA/American Urological Association Bladder Cancer Workshop held on May 6, 2013, and in published literature. ^2,3

Published September 27, 2018
Beyond Bladder Cancer: Bacillus Calmette-Guérin (BCG) Vaccination Revisited as a Strategy to Reduce COVID-19 Related Adverse Events in High Risk Health Care Workers and the Elderly

First Published April 2, 2020

The ongoing pandemic involving severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and its resulting coronavirus disease 2019 (COVID-19) has caused widespread infection worldwide, with over 660,000 confirmed cases as of March 28, 2020 and nearly 31,000 deaths.¹ Data from the Italian National Institute of Health (Istituto Superiore di Sanità [ISS]) where fatalities are thus far the highest suggest a fatality rate of 7.2%, significantly higher than that which has been observed in other countries.² Elderly patients are at greatest risk of mortality from COVID-19, and approximately 23% of the Italian populace is aged 65 years or older, making the country particularly vulnerable.²

Written by: Vikram M. Narayan, Paul Hegarty, Gianluca Giannarini, Rick Bangs, Stephanie Chisolm, and Ashish M. Kamat

References:
1. University JH. Johns Hopkins Center for Systems Science and Engineering Coronavirus Resource Center n.d.

2. Onder G, Rezza G, Brusaferro S. Case-Fatality Rate and Characteristics of Patients Dying in Relation to COVID-19 in Italy. JAMA 2020. doi:10.1001/jama.2020.4683.

3. Liang W, Guan W, Chen R, Wang W, Li J, Xu K, et al. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol 2020;21:335–7. doi:10.1016/S1470-2045(20)30096-6.

4. Moulton LH, Rahmathullah L, Halsey NA, Thulasiraj RD, Katz J, Tielsch JM. Evaluation of non-specific effects of infant immunizations on early infant mortality in a southern Indian population. Trop Med Int Heal 2005;10:947–55. doi:10.1111/j.1365-3156.2005.01434.x.

5. Aaby P, Roth A, Ravn H, Napirna BM, Rodrigues A, Lisse IM, et al. Randomized trial of BCG vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period? J Infect Dis 2011;204:245–52. doi:10.1093/infdis/jir240.

6. Leentjens J, Kox M, Stokman R, Gerretsen J, Diavatopoulos DA, van Crevel R, et al. BCG Vaccination Enhances the Immunogenicity of Subsequent Influenza Vaccination in Healthy Volunteers: A Randomized, Placebo-Controlled Pilot Study. J Infect Dis 2015;212:1930–8. doi:10.1093/infdis/jiv332.

7. Arts RJW, Moorlag SJCFM, Novakovic B, Li Y, Wang S-Y, Oosting M, et al. BCG Vaccination Protects against Experimental Viral Infection in Humans through the Induction of Cytokines Associated with Trained Immunity. Cell Host Microbe 2018;23:89-100.e5. doi:10.1016/j.chom.2017.12.010.

8. Hegarty PK, Sfakianos JP, Giannarini G, DiNardo AR, Kamat AM. Coronavirus disease 2019 (Covid-19) and Bacillus Calmette-Guérin (BCG): what is the link? Eur Urol Oncol 2020 in press

Published April 2, 2020
Bladder Cancer BioMarkers: Optimal Utilization for Diagnosis and Recurrence

Published in Everyday Urology - Oncology Insights: Volume 1, Issue 3
Published Date: September 2016

Voided urine cytology has been the gold standard for detecting bladder cancer since 1945. Its specificity nears 90%, meaning that a positive result is highly reliable. But cytology is unreliable for detection of low grade tumors such that only about 20% to 30% of low grade bladder tumors are identified using cytology.
Published January 6, 2017
Bladder Cancer Immunotherapy: Establishing a Clinic of Excellence

Published in Everyday Urology - Oncology Insights: Volume 3, Issue 1
Published Date: March 2018

Until recently, decades had elapsed with little progress in treating metastatic urothelial cancer (mUC). Cisplatin-based chemotherapy, the best available treatment option, had a median overall survival (OS) of 12-15 months, an overall response rate (ORR) of 50-60%, and was curative in about 10% of cases, but also was associated with potentially serious toxicities.^{12, 13, 2, 7, 3}

Published August 14, 2018
Bladder Cancer Outcomes in Women Vary over Time - Expert Commentary
Understanding differences in bladder cancer outcomes between men and women can help physicians tailor optimal treatment and follow-up strategies.

Published November 11, 2019
Bladder Cancer: New Insights Into its Molecular Pathology - Beyond the Abstract
Bladder cancer is one of the most prevalent cancers worldwide. The majority of patients present with non-invasive bladder cancer, comprising non-invasive papillary carcinoma (Ta) and carcinoma in situ (CIS; Tis). Bladder cancer develops either via the FGFR3/RAS pathway (for Ta) or the TP53/RB1 pathway (for Tis). Non-invasive papillary carcinoma (Ta) develops from hyperplasia post FGFR3/HRAS mutation; then, it potentially progresses to invasive carcinoma after the inactivation of CDKN2A/TP53/RB1. Carcinoma that develops via this FGFR3/RAS pathway has been considered as the luminal type. CIS develops from dysplasia after the inactivation of TP53/RB1, followed by aggressive invasive carcinoma. Carcinoma that develops via the TP53/RB1 pathway has been considered as the basal type.
Published April 13, 2018
Blue Light Cystoscopy: Insights on Recurrence, Progression, and Clinical Management

Published in Everyday Urology - Oncology Insights: Volume 3, Issue 3

Published Date: September 2018

More than 81,000 individuals are diagnosed with bladder cancer in the United States every year, of whom 75% have non-muscle invasive disease.^1,2 Unfortunately, half these cases recur despite transurethral resection of bladder tumor (TURBT), and from 5% to 25% of repeated recurrences progress to muscle-invasive disease.^3,4,5

Published December 4, 2018
Brief Q&A for Patients by the International Bladder Cancer Group on the BCG Shortage
BCG: What to do when there is a Shortage

Introduction
Intravesical therapy may be an important component of the management of bladder cancer (BC). The delivery of anticancer medication directly into the bladder with a catheter placed into the bladder through the urethra has been a part of bladder cancer management for many decades. All patients with BC have an initial transurethral resection (TUR BT) which is designed to remove all of the tumor, when possible. The tumor tissue is then submitted to a pathologist for diagnosis. The pathology report states the tumor grade as well as the presence or absence of invasion into the muscular layer of the bladder. The urologist will review this information, and along with his/her understanding of the appearance of the bladder cancer as well as their impression of whether or not all of the tumor has been removed, decide about the treatment strategy.
Published February 14, 2019
Carcinoma In Situ of the Bladder with Plasmacytoid Features - Expert Commentary
Carcinoma in situ (CIS) is a distinct pathological entity. The significance of histological variants associated with CIS is not well-understood.
Published September 9, 2019
Chemotherapy Options for Metastatic Urothelial Cancer Patients Who Already Received Cisplatin for Localized Disease - Expert Commentary
Cisplatin-based chemotherapy is the preferred first-line for patients with metastatic urothelial cancer if they are cisplatin eligible. However, a significant proportion of these patients already receive cisplatin-based chemotherapy in the perioperative setting for their localized disease. It is unclear if re-challenge with platinum-based chemotherapy (PBC) is a better option compared to non-platinum based (NPBC) chemotherapy. A recent study published by Do et al. in Clinical Genitourinary Cancer investigated the efficacy of PBC versus NPBC first-line chemotherapy for patients with metastatic urothelial cancer who already received prior cisplatin-based chemotherapy for localized disease.

Published January 6, 2021
Clinical impact of postoperative loss in psoas major muscle and nutrition index after radical cystectomy for patients with urothelial carcinoma of the bladder.

Although the significance of preoperative nutritional status has been investigated, there is no report regarding the relationship of their postoperative changes on outcomes in patients who underwent radical cystectomy for bladder cancer.

Published April 3, 2017
Clinical Outcomes in Bladder Cancer Patients with Histological Variants - Expert Commentary

Urothelial carcinoma (UC) is the most common histology of bladder cancer. Histological variants (HV) of bladder cancer are less common but frequently more aggressive. A recent paper published by Takemoto et al. in Anticancer Researchstudied the biological features and the prognostic value of HV in bladder cancer patients.

Published October 20, 2020
Clinical Outcomes in Patients with Micropapillary Urothelial Carcinoma of the Bladder - Expert Commentary
Micropapillary (MP) is a histological variant of bladder cancer. As with most other histological variants of bladder cancer, the available data is derived from small case series and treatment is based on expert opinion. More knowledge about treatment and prognosis of MP UBC is needed to identify the optimal therapy for MP UBC.
Published May 15, 2019
Clinical Outcomes in Patients with Panurothelial Carcinoma Treated with Radical Nephroureterectomy Following Cystectomy for Metachronous Recurrence.

We report pathologic, functional, and oncologic outcomes in patients treated with radical nephroureterectomy following radical cystectomy.

We identified patients who underwent radical cystectomy then radical nephroureterectomy for metachronous urothelial recurrence at our institution between January 1995 and December 2014.

Published April 3, 2017
Clinical Outcomes of Adult Patients with Kidney, Bladder, and Prostate Rhabdomyosarcoma - Expert Commentary
Rhabdomyosarcoma (RMS) is a soft tissue tumor that commonly occurs in childhood and adolescence. It is less prevalent in adulthood, accounting for 2%–5% of adult soft tissue tumors. RMS has a higher propensity to occur in genitourinary organs in adults than in pediatric patients. The clinical outcomes of adult patients with kidney, bladder, and prostate RMS is unknown.

Published January 14, 2021
Clinicopathological Characteristics and Survival Outcomes in Micropapillary Urothelial Carcinoma of the Bladder — Expert Commentary
Micropapillary urothelial carcinoma (MPUC) is a rare and aggressive histological variant of urinary bladder cancer. A recent study published by Jin et al. in Cancer Medicine investigated the prognosis and survival rates of MPUC compared to conventional urothelial cancer (UC).
Published August 3, 2020
Conditional Reprogramming of Patient-derived Bladder Cancer Cells for Personalized Treatment Strategies – Expert Commentary
There is a broad spectrum of bladder cancer responsiveness to treatment in the clinic. The development of practical methods to provide accurate, individualized drug sensitivity information from each patient's tumor is needed to improve outcomes.
Published August 16, 2019
Contemporary treatment patterns and outcomes of sarcomatoid bladder cancer: Beyond the Abstract
In 2016, 750,000 bladder cancer survivors are estimated to live in the United States alone and over 75,000 new cases will be diagnosed.^1,2 The vast majority are urothelial tumors however a small proportion of these will be variant histologies. Sarcomatoid carcinoma (SaC) is such a subtype and is estimated to represent 0.3% of all urothelial cancers.³ Much of our knowledge about this disease is derived from case studies or single-institution reports of which have totaled fewer than 100 cases in the last several decades.^4-7

Published April 7, 2017
Contemporary Use Trends and Survival Outcomes in Patients Undergoing Radical Cystectomy or Bladder-Preservation Therapy for Muscle-Invasive Bladder Cancer - Expert Commentary
Bladder preservation therapy is a definitive treatment option for clinically localized bladder cancer. Previous studies demonstrated improved 10-year locoregional control when comparing chemo-radiotherapy with radiation therapy alone. However, evidence from prospective or randomized controlled trials comparing survival outcomes of patients treated with bladder preservation with those of patients receiving radical cystectomy is generally lacking.

Published August 8, 2017
CUOS 2019: Bladder Preservation for Invasive Bladder Cancer: Lessons Learned and Future Perspectives
Toronto, Ontario (UroToday.com) In this discussion, the topic of bladder preservation was presented by Dr. Huddart from the Royal Marsden NHS Foundation Trust in the United Kingdom.

Muscle invasive bladder cancer, after diagnosis using TURBT, is usually treated with radical cystectomy with the option of neoadjuvant chemotherapy before surgery. However, another option is treatment with Radiotherapy with or without chemotherapy (radiosensitizer). These patients are then followed with cystoscopy, which can then lead to either salvage radical cystectomy for residual/recurrent invasive disease, or another TURBT with local treatment for the superficial disease recurrence.
Published January 13, 2019
CUOS 2019: Five-Year Outlook in the Management of Metastatic Urothelial Carcinoma
Toronto, Ontario (UroToday.com) In this discussion, Dr. Bellmunt presented the standard of care in second-line management of advanced bladder cancer and gave an update on targeted therapies. He also discussed some of the phase 2 and phase 3 trials with PD-1/PD-L1 inhibitors, and associated biomarkers.
Published January 12, 2019
Cytological Features of Micropapillary and Plasmacytoid Variants of Urothelial Carcinoma - Expert Commentary
The micropapillary and plasmacytoid variants are rare and aggressive urothelial carcinoma (UC) subtypes. The morphological features of these variants in urine cytology are not well described. A recent study published by Straccia et al. in Diagnostic Cytopathologyevaluated the urine cytology of 15 high-grade UC cases with plasmacytoid and micropapillary histology to define their cytomorphological characteristics. The study included six patients with the plasmacytoid variant and nine patients with the micropapillary variant. The cohort included three females and 12 males. The median age was 79 years (range 72-90 years).

Published February 27, 2020
Detection of TERT Promoter Mutations in Urine Precedes the Clinical Diagnosis of Bladder Cancer - Expert Commentary
There is a need for a non-invasive for early detection of bladder cancer (BC). Telomerase reverse transcriptase (TERT) promoter mutations are common in bladder cancer patients. A recent study by Hosen MI et al. in BioMedicine investigated the use of an amplicon-based Ion Torrent sequencing assay (UroMuTERT) and digital PCR assays to examine the use of TERT promoter mutations for BC screening.¹ In this case-control study, the investigators included 30 BC cases and 101 controls in the final analysis.
Published March 30, 2020
Diagnosing Bladder Cancer using Urinary Cell-Free microRNA - Expert Commentary
Although hematuria is the most common symptoms of bladder cancer (BC), it can be caused by many non-malignant conditions. The low sensitivity of voided urine cytology (VUC) and the invasiveness the cystoscopy, create an unmet need for a noninvasive test with high accuracy to detect BC in patients with hematuria.

Published October 24, 2018
Diagnosis and Pathology of Bladder Cancer

Diagnosis:
Clinical Presentation

There are no reliable screening tests available for detecting bladder cancer; hence the diagnosis is usually made based on clinical signs and symptoms. Painless hematuria – microscopic or gross – is the most common presentation and a hematuria investigation in an otherwise asymptomatic patient detects bladder neoplasm in roughly 20% of gross and 5% of microscopic cases.^1,2

Written by: Justin T. Matulay, MD and Ashish Kamat, MD, MBBS

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Published April 16, 2019
Does High-Risk Human Papilloma Virus Play a Role in the Development of Squamous Cell Carcinoma of the Bladder? - Expert Commentary
Squamous cell carcinoma (SCC) is the second most common histologic variant of bladder cancer. These tumors have pure squamous histology in the absence of any in situ urothelial component and are traditionally associated with conditions that cause chronic inflammation/irritation. A recent study published in Urology investigated the association between bladder SCC and Human Papilloma Virus (HPV).
Published September 25, 2020
Does Pre-Treatment Quality of Life Impact the Prognosis of Patients with Urothelial Carcinoma? - Expert Commentary
The relationship between the baseline quality of life (QOL) and clinical outcomes for urothelial cancer (UC) patients is not well defined. A recent study published by Suppanuntaroek et al. investigated the relationship between pre-treatment quality of life (QOL) and overall survival (OS) in UC patients. The authors included 125 non-metastatic UC patients who underwent a radical cystectomy or nephroureterectomy for non-metastatic UC (M0 group) and 80 metastatic UC who received chemotherapy for metastatic UC (M1 group) between June 2013 and May 2019.
Published February 19, 2020

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