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Bladder Cancer COE

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
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
ASCO 2017: Astellas and Seattle Genetics Announce Updated Enfortumab Vedotin Phase 1 Data in Metastatic Urothelial Cancer
Chicago, IL (UroToday.com) Updated phase 1 data for enfortumab vedotin (ASG-22ME) studied as monotherapy treatment for metastatic urothelial cancer (mUC) was highlighted in an oral presentation at the American Society of Clinical Oncology (ASCO) 52^nd Annual Meeting in Chicago.

Published June 6, 2017
ASCO 2017: Cancer predisposing germline mutations in patients with urothelial cancer of the renal pelvis, ureter and bladder.
Chicago, IL (UroToday.com) Heritable genes in urothelial cancers (UC) have not been studied extensively, except for the mismatch-repair pathway (MMR) (e.g. MSH2) typically associated with primary UC involving the renal pelvis/ureter (Lynch syndrome). According to epidemiologic studies, 30% of UC have some heritable fraction.
Published June 2, 2017
ASCO 2017: DNA damage repair and response gene alterations and response to PD1/PDL1 blockade in platinum-treated metastatic urothelial carcinoma
Chicago, IL (UroToday.com) Recent introduction of PD/PDL1 immune checkpoint inhibitors (ICI) has redefined the treatment landscape of metastatic urothelial carcinoma. Different potential biomarkers of treatment responses have been proposed.
Published June 2, 2017
ASCO 2017: Expanding the Actionable Landscape: Bladder Cancer Genomics - Introduction
Chicago, IL (UroToday.com) Dr. McConkey gave a most interesting introductory talk to the topic of bladder cancer genomics research. He pointed out the current ongoing genomic revolution in bladder cancer, consisting of completion of large scale genomic projects such as The Cancer Genome Atlas (TCGA), discovery of the basal and luminal subtypes of bladder cancer, extensive research in DNA damage and repair mutations and correlation to neo-antigens and overall mutational burden.

Published June 2, 2017
ASCO 2017: Management Strategies for Nonurothelial Bladder Cancer
Chicago, IL (UroToday.com) Dr. Aragon-Ching is a Medical Oncologist at Inova Schar Cancer Institute in Falls Church, VA, USA, and provided an excellent overview of current literature and management of non-urothelial bladder cancers. She focused only on pure non-urothelial bladder cancers – discussion of urothelial variants and mixed bladder cancers are not included in this talk.

Published June 4, 2017
ASCO 2017: Phase II trial of atezolizumab in BCG-unresponsive non-muscle invasive bladder cancer
Chicago, IL (UroToday.com) At the genitourinary cancer poster session at the 2017 ASCO annual meeting, Dr. Singh and colleagues presented the design of their phase II trial of atezolizumab in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
Published June 5, 2017
ASCO 2017: Subclonal mutational heterogeneity and survival in cisplatin-resistant muscle-invasive bladder cancer
Chicago, IL (UroToday.com) Based on Level 1 evidence demonstrating cancer-specific survival benefit, neoadjuvant cisplatin-based chemotherapy (NAC) remains the standard of care for patients with muscle-invasive bladder urothelial cancer (MIBC). However, the 5-7% survival benefit along with the associated theoretical risk of treatment delay (in patients who don’t respond to NAC) and adverse events had led to significant underutilization. Better understanding of patient response to NAC will help guide potential adjunct therapy or alternative therapy.

Published June 2, 2017
ASCO 2017: Unlocking the Genome: Insights Into Risk and Response in Bladder Cancer
Chicago, IL (UroToday.com) Dr. Bishoy Faltas from Weill Cornell Medical College concluded the Bladder Cancer Genomics session with a nice summary of the 4 abstracts presented today and his take on the current status of the field.

Published June 2, 2017
ASCO 2018: Clinical Complete Response to Neoadjuvant Chemotherapy for Muscle-Invasive Bladder Cancer
Chicago, IL (UroToday.com) Over the past 15 years, results of several randomized controlled trials have cemented neoadjuvant platinum-based chemotherapy followed by radical cystectomy as the gold standard treatment for muscle-invasive bladder cancer (MIBC) [1,2]. Grossman and colleagues randomized 317 patients with stage T2-T4a bladder cancer to radical cystectomy alone vs three cycles of methotrexate, vinblastine, doxorubicin and cisplatin followed by radical cystectomy [1]. In the intention-to-treat analysis, the median OS among patients assigned to radical cystectomy alone was 46 months, compared with 77 months for patients assigned to combination therapy (p=0.06 two-sided stratified log-rank test).

Published June 2, 2018
ASCO 2018: First-Line Pembrolizumab in Cisplatin Ineligible Advanced Urothelial Cancer-KEYNOTE-052
Chicago, IL (UroToday.com) Over the last several years, pembrolizumab has provided encouraging results across several malignancies, including advanced/metastatic urothelial carcinoma. Last year, initial outcomes of the phase II KEYNOTE-052 study reported that among 370 patients receiving at least one dose of pembrolizumab, 89 (24%, 95%CI 20-29) patients had a centrally assessed objective response, and 74 (83%) of 89 patients had ongoing responses over a median follow-up of 5 months (IQR 3.0-8.6) [1]. Additionally, a PD-L1-expression cutoff of 10% was associated with a higher frequency of response to pembrolizumab: 42 (38%, 95%CI 29-48) of 110 patients had an objective response. Based on these results, pembrolizumab was granted FDA approval for the treatment of cisplatin-ineligible patients with advanced urothelial carcinoma. Dr. Vuky and colleagues at ASCO 2018 annual meeting presented long-term follow-up analysis of KEYNOTE-052.

Published June 2, 2018
ASCO GU 2017: BC2001 long-term outcomes: A phase III randomized trial of chemoradiotherapy versus radiotherapy (RT) alone and standard RT versus reduced high-dose volume RT in muscle-invasive bladder cancer - Session Highlights
Orlando, Florida USA (UroToday.com) This year’s genitourinary cancer symposium allowed for Emma Hall to present long-term results from BC20001. Given that BC2001 showed that that reduced high dose volume RT rather than standard RT did not significantly reduce late side effects at limited follow up, the long term results have been anticipated [Huddart 2013].
Published February 20, 2017
ASCO GU 2017: Characterizing the costs of complications after cystectomy: Can we target the primary drivers? - Session Highlights
Orlando, Florida USA (UroToday.com) Dr. Matthew Mossanen from Brigham and Women’s Hospital targeted the thromboembolic events, soft tissue and GI complications as primary cost drivers following radical cystectomy. Motivation for this study stemmed from recognising the high complication rate of cystectomy being as high as 64% at 90 days and that radical cystectomy and care for bladder cancer as a whole is one of the more expenisive diseases to care for. This study looked at financial cost of different categories of complication following radical cystectomy to identify primary forces driving expenditures.

Published February 20, 2017
ASCO GU 2017: Health-related quality of life (HRQoL) in the KEYNOTE-045 study of pembrolizumab versus investigator-choice chemotherapy for previously treated advanced urothelial cancer - Session Highlights
Orlando, Florida USA (UroToday.com) The use of immunotherapy for advanced urothelial cancer continued to gain attention and excitement at this years genitourinary cancer symposium. Adding to this momentum is results from KEYNOTE-045 showing that pembrolizumab is better tolerated and more effective than standard cytotoxic chemotherapy.

Published February 20, 2017
ASCO GU 2017: Intravesical rAD-IFNa/Syn3 for patients with high-grade, Bacillus Calmette-Guerin (BCG) refractory or relapsed non-muscle invasive bladder cancer: a phase II randomized study - Session Highlights
Orlando, Florida USA (UroToday.com) Stephen Boorjian, Mayo clinic, discussed the results of the above trial. The trial was funded by FDK Therapies and conducted exclusively through the SUO-CTC.
Published February 18, 2017
ASCO GU 2017: Muscle-invasive bladder cancer: Molecular subtypes and response to neoadjuvant chemotherapy. - Session Highlights
Orlando, Florida USA (UroToday.com) There was much discussion and excitement at this year’s genitourinary cancer symposium regarding the ability of genomic classifiers to predict response to neoadjuvant chemotherapy. Through a fantastic demonstration of collaboration, molecular subtypes in bladder cancer based on gene expression have been widely accepted.
Published February 20, 2017
ASCO GU 2017: Optimizing Outcomes in Muscle-Invasive and Metastatic Bladder Cancer - Session Highlights
Orlando, Florida USA (UroToday.com) Elizabeth Plimack, Fox Chase Cancer Center, discussed the molecular predictors of response to neoadjuvant chemotherapy. Predictive biomarker in indicative of outcome or invention or prognostic based on history.
Published February 17, 2017
ASCO GU 2017: Optimizing Outcomes in Muscle-Invasive and Metastatic Bladder Cancer - Medical Oncologist’s Perspective - Session Highlights
Orlando, Florida USA (UroToday.com) Jonathan Rosenberg, Memorial Sloan Kettering, discussed chemotherapy. There is no role for carboplatin and cisplatin based regimens should be utilized. Pathological downstaging is associated with high cure rate with pT2 having overall survival in the Memorial Sloan series at 90% v37%, respectively.
Published February 18, 2017
ASCO GU 2017: Optimizing Outcomes in Muscle-Invasive and Metastatic Bladder Cancer - Radiation Oncology Perspective - Session Highlights
Orlando, Florida USA (UroToday.com) Ann Henry, University of Leeds, discussed bladder preservation strategies. Trimodality treatment with radical transurethral resection of bladder tumor (TURBT), chemotherapy and radiotherapy can have comparable outcomes to radical cystectomy.
Published February 17, 2017
ASCO GU 2017: Optimizing Outcomes in Muscle-Invasive and Metastatic Bladder Cancer - Surgeon’s Perspective - Session Highlights
Orlando, Florida USA (UroToday.com) Matthew Tollefson, Mayo Clinic, discussed a case of a 62 year old man with 3cm bladder tumor HG pT1 tumor with micropapillary features. Given the variant histology, there are concerns regarding aggressiveness and patients may choose from intravesical treatments to neoadjuvant chemotherapy followed by radical cystectomy to upfront radical cystectomy.
Published February 18, 2017
ASCO GU 2017: Optimizing Outcomes in Muscle-Invasive and Metastatic Bladder Cancer - Urologist Perspective - Session Highlights
Orlando, Florida USA (UroToday.com) Eugene Lee, University of Kansas, discussed the principles of surgery. Transurethral resection of the bladder tumor is of upmost importance. Resect all disease with wide margin with adequate muscle in the specimen. Examination under anesthesia provided vital information regarding concern for extravesical disease and pelvic fixation. Pathology report should have grade, stage with avoidance of ‘non-invasive’ in the report, documentation of whether muscle in specimen, histologic detail including presence or absence of lymphovascular invasion, CIS and/or variant histology.

Published February 18, 2017
ASCO GU 2017: Optimizing Outcomes in Muscle-Invasive and Metastatic Bladder Cancer - Urologist View - Session Highlights
Orlando, Florida USA (UroToday.com) Eugene Lee, University of Kansas, discussed preoperative risk stratification. These include comorbidity indices with limitations including subjective nature and not uniform. The ‘eyeball’ test includes patient age, wheelchair sign, posture, skin/turgor and gait.
Published February 18, 2017
ASCO GU 2017: Pembrolizumab as first-line therapy in cisplatin-ineligible advanced urothelial cancer: Results from the total KEYNOTE-052 study population. - Session Highlights
Orlando, Florida USA (UroToday.com) Until 2016, cisplatinum inelegible patients with advanced bladder cancer had poor outcomes due to limited effective therapies. This has been recognosied as an effective disease space for immunotherapies since recent FDA approval of checkpoint blockade for bladder cancer.
Published February 20, 2017
ASCO GU 2017: Quality of care in non-muscle invasive bladder cancer: optimizing surgical and medical therapies - Session Highlights
Orlando, Florida USA (UroToday.com) Karim Chamie, UCLA, discussed the quality care for non-muscle invasive bladder cancer. There is a significant health burden associated with bladder cancer care.
Published February 18, 2017
ASCO GU 2017: Resection margins after radical cystectomy at academic versus community cancer centers. - Session Highlights
Orlando, Florida USA (UroToday.com) At this years genitourinary cancer symposium, the importance of high volume centers in care for radical cystectomy patients was re-inforced by looking at the impact of academic centers on positive margin rates. Positive margin resection correlates with worse overall survival following cystectomy.
Published February 20, 2017
ASCO GU 2017: Urothelial Carcinoma: Year in Review - Session Highlights
Orlando, Florida USA (UroToday.com) Matthew Milowsky, University of North Carolina, presented the year in review in bladder cancer. Immuno-oncology developments include the IMVigor, Checkmate and KEYNOTE are to name a few. Prior to 2016 there were no agents studied in cisplatin refractory disease. IMVigor 210 assessed use of atezolumab with overall response rate at 10% with 86% of complete response ongoing.
Published February 18, 2017
ASCO GU 2018: Atezolizumab vs. Chemotherapy in Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma - Outcomes from the Phase III IMvigor211 Study
San Francisco, CA (UroToday.com) IMvigor211 is a global study of atezolizumab vs chemotherapy in platinum-treated metastatic urothelial carcinoma (Muc). The study did not meet its primary endpoint of overall survival (OS) in programmed death-ligand 1 (PD-L1)–selected patients (pts),¹ but exploratory analyses showed improved OS for atezo in the intent-to-treat (ITT) population. In this study the authors compared clinical outcomes in ITT and pre-specified PD-L1 subgroups with those in subgroups defined by immune transcriptional gene expression (tGE) signatures and tumor mutational burden (TMB).
Published February 10, 2018
ASCO GU 2018: Immune Checkpoint Inhibitors: Which One and Why?
San Francisco, CA (UroToday.com) Dr. Powles provided the first of two Keynote Lectures in Urothelial Carcinoma (UC). As the landscape in advanced bladder cancer has been rapidly changing with the introduction of immune checkpoint inhibitors (ICI), he provided an overview of ICI’s in UC at the current time and his input on which one to use.
Published February 10, 2018
ASCO GU 2018: New 6-factor prognostic model for patients with advanced urothelial carcinoma receiving post-platinum atezolizumab
San Francisco, CA (UroToday.com) The introduction of checkpoint inhibitors as a second line agent has been a game changer in the treatment of urothelial carcinoma patients. Following landmark results of the Keynote-045, the FDA has now approved of four other PD-1 and PD-L1 inhibitors. While some of these checkpoint inhibitors have validated the results of Keynote-045, some others have shown contradictory results (IMvigor210) leading some experts to wonder if the differences are patient related. A team of investigators involved with IMvigor210 have decided to use the available data from the trial to identify key predictive characteristics that may impact response and ultimately overall survival (0S) in UC patients who have failed platinum chemotherapy.

Published February 10, 2018
ASCO GU 2018: Nivolumab Monotherapy in Metastatic Urothelial Carcinoma: Longer-term Efficacy and safety Results from the CheckMate 032 Study
San Francisco, CA (UroToday.com) Few options exist for patients who fail front-line platinum-based chemotherapy for metastatic urothelial carcinoma (UC). With the advent of immunomodulatory (IO) agents, this era is finally coming to an end. An important study in this space is the ongoing CheckMate 032 trial. This 3-arm trial is a nonrandomized study of treating platinum-resistant metastatic UC with: 1. Nivolumab-only; 2. Nivolumab + ipilimumab (1mg/kg); 3. Nivolumab + ipilimumab (3mg/kg).

Published February 10, 2018
ASCO GU 2018: Two-year Follow-up: 3 KEYNOTE-045 Trial of Pembrolizumab vs Investigator’s Choice Chemotherapy in Recurrent, Advanced Urothelial Cancer
San Francisco, CA (UroToday.com) Based on interim results from the phase 3 KEYNOTE-045 study comparing pembrolizumab (pembro) vs. investigator’s choice (paclitaxel, docetaxel, or vinflunine) or chemotherapy (chemo), pembro was approved for the treatment of locally advanced or metastatic UC that has progressed during or after a platinum-containing regimen. The authors presented updated results after 2 years of follow-up.
Published February 10, 2018
ASCO GU 2018: Update on The Cancer Genome Atlas
San Francisco, CA (UroToday.com) Dr. Lerner provided the second Urothelial Carcinoma Keynote Lecture and provided an update on the current status of translational observations from mutational profiling of muscle invasive bladder cancer (MIBC). There has been significant much-publicized work in this field, and it hoping will lead to prime-time decision-making tools in the near future. Specifically he focused on the updates to TCGA data.

Published February 9, 2018
ASCO GU 2019: A Phase III, Randomized, Open-label, Multicenter, Global Study of Durvalumab and BCG versus BCG Alone in High-risk, BCG-naïve Non-muscle-invasive Bladder Cancer Patients - POTOMAC
San Francisco, CA (UroToday.com) While the standard of care for high-risk non-muscle invasive bladder cancer (NMIBC) is currently maximal transurethral resection of the bladder tumor (TURBT), followed by an induction course of BCG, recurrence rates can reach as high as 50% in this patient population. Because recurrence rates are high after induction BCG alone, the Dr. Maria De Santis from Charite University Hospital in Berlin, Germany, and her group sought to evaluate if combination anti-PD1 or anti-PDL-1 agents with BCG would lead to decreased recurrence rates and improved cancer-specific outcomes.
Published February 19, 2019
ASCO GU 2019: Immunotherapy Across Genitourinary Malignancies
San Francisco, CA (UroToday.com) Dr. James L. Gulley presented the Keynote Lecture for the GU ASCO 2019 annual symposium discussing immunotherapy across genitourinary malignancies. Dr. Gulley started by highlighting that GU cancers are the original immune responsive tumors, dating back to the 1980’s when interferon was used for renal cell carcinoma (RCC), to BCG for bladder cancer in 1990, and IL-2 for RCC in 1992. More recently, we have seen Sipuleucel-T for castrate-resistant prostate cancers (CRPC) in 2010, PD-1 and PD-L1 inhibitors for RCC in 2015 and in bladder cancer in 2016. As Dr. Gulley depicts, the pathway (with associated inhibitors) for immunogenic cell death are as follows:
Published February 15, 2019
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 2017: A Comparison of Post-Cystectomy Recurrence and Survival in NAC-Responsive MIBC vs. High-Risk NMIBC Patients
Boston, MA (UroToday.com) The study reported here was done in patients who all received cystectomy. The objective was to compare post-surgical outcomes of high-risk non-muscle invasive bladder cancer (NMIBC) to patients who received neoadjuvant chemotherapy (NAC) who were downstaged and did not respond to NAC.

Published May 26, 2017
AUA 2017: Is compliance to an enhanced recovery protocol after radical cystectomy associated with improved post operative outcomes?
Boston, MA (UroToday.com) Enhanced recovery after surgery has been shown to shorten length of stay for patients undergoing radical cystectomy. The objective of this study was to confirm the compliance with an enhanced recovery program was associated with post-operative outcomes. They used a composite compliance score to determine if 18 interventions were associated with the improved outcomes for 303 patients.

Published May 25, 2017
AUA 2017: Validation of VTE Score in Major Urologic Cancer Surgery
Boston, MA (UroToday.com) This study discussed the utility of the widely used Caprini Risk assessment score used to predict venous thromboembolism (VTE) and has been validated in surgical patients. The objective of this study was to validate the Caprini risk assessment model in a contemporary cohort of patients undergoing major urologic surgery. They looked at 90-day VTE rates for over 1,000,000 patients undergoing surgery.

Published May 26, 2017
AUA 2018: Adherence to Bladder Cancer Guidelines and Issues with Implementation
San Francisco, CA (UroToday.com) To start the bladder cancer session at the SUO session, Dr. de Vere White discussed adherence to guidelines and implementation. As he notes, the goals of treating non-invasive papillary carcinoma (Ta) disease is to stop recurrence, whereas for T1 is to stop progression and reduce mortality.

Published May 21, 2018
AUA 2018: Comprehensive Characterization of Returns to the Operating Room following Radical Cystectomy
San Francisco, CA (UroToday.com) As part of the American College of Surgeons National Surgical Quality Improvement Program, several metrics are measured for improving patient safety and quality of care [1]. One important metric for major abdominal surgery is an “unplanned return to the operating room” within 30 days of the original procedure. Certainly, radical cystectomy fits this criterion and is an inherently morbid procedure, however there is a paucity of data assessing predictors of unplanned returns to the operating room. As such, the group from the Mayo Clinic lead by Dr. Lyon presented their institutional results assessing predictors of return to the operating room following radical cystectomy at the invasive bladder cancer session at the 2018 AUA.

Published May 19, 2018
AUA 2018: High Risk BCG Recurrent/Refractory Disease: Secondary Intravesical Therapy
San Francisco, CA (UroToday.com) Dr. Sima Porten from UCSF provided a discussion of secondary intravesical therapy for patients with high-risk BCG recurrence/refractory disease at the SUO bladder cancer session. Dr. Porten started by noting several important definitions:
- BCG refractory: patients who do not reach a disease-free state at 6 months after starting BCG (at least induction + maintenance) for high risk NMIBC (Ta/T1/CIS)
- BCG relapsing: patients who reach a disease-free state at 6 months, and continue on BCG, but later recur within 6 months of the last dose of BCG
Published May 21, 2018
AUA 2018: Impact of Post-Treatment Psychiatric Illness on Survival Outcomes Following Treatment for Patients with Muscle-Invasive Bladder Cancer
San Francisco, CA (UroToday.com) For people with new cancer diagnoses, initial psychological stress can be related to several factors including medical, patient-related, societal, and cultural factors [1]. Over 30 years ago, the Psychological Collaborative Oncology Group found that 53% of adult patients with cancer adjusted normally to the crisis of illness, however the remainder of patients met diagnostic criteria for a psychiatric disorder, most commonly adjustment disorder with depressed and/or anxious mood [2]. More contemporary studies suggest that major depression, delirium, adjustment disorder and anxiety disorders are prevalent in 10-34% of cancer patients.

Published May 18, 2018
AUA 2018: Oophorectomy at Time of Radical Cystectomy: Re-evaluating the Definition of Radical Cystectomy in Women
San Francisco, CA (UroToday.com) The classical teaching of performing a radical cystectomy for female patients is removal of the ovaries, uterus and anterior vaginal wall. This is also supported by the current American Urologic Association guidelines for muscle invasive bladder cancer (MIBC), presumably to mitigate the risk of concurrent or future ovarian cancer [1]. Recent data on oophorectomy has suggested an increased risk of all-cause mortality, cardiovascular disease, and osteoporosis in both premenopausal and postmenopausal women, in addition to the increased risk of cognitive impairment and diminished sexual function in premenopausal women. A recently published survey of Society of Urologic Oncology members found that 75% had performed an ovarian-sparing radical cystectomy, and that 14% were aware that salpingectomy alone reduces the risk of ovarian cancer [2].

Published May 19, 2018
AUA 2018: The Impact of Blue-Light Cystoscopy on Response to Induction BCG in Patients with High-Grade Non-Muscle Invasive Bladder Cancer
San Francisco, CA USA (UroToday.com) Recent randomized clinical trials have demonstrated the superiority of blue light cystoscopy (BLC) during transurethral resection of bladder tumor (TURBT) over regular white light cystoscopy in regard to early recurrence rates. This improvement is likely related to the resection of smaller lesions which are often missed in white light cystoscopy. Animal studies have shown that BCG effectiveness is improved by the presence of bladder cancer tumor cells in the bladder.
Published May 23, 2018
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

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