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Aligned Care in Bladder Cancer - Module 2: Muscle-Invasive Bladder Cancer - Curative Intent Pathways

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Description

This program is supported by an independent education grant from MSD. This online education program has been designed solely for healthcare professionals in the US. The content is not intended for healthcare professionals in any other country.

Credits: AMA PRA Category 1 Credits™ (0.50.00 hours)

Type of activity: Enduring material (On-demand)

Launch date: 3 July 2026

Expiration date: 23 December 2027

Estimated time to complete this activity: 30 minutes

This is Module 2 of a three-part on-demand series: Module 1 and Module 3.

Join leading bladder cancer experts Dr. Petros Grivas and Dr. Benjamin Garmezy for this accredited online teaching session. Using three progressive, case-based role-play scenarios, this session explores the "ideal vs. real" complexities of managing bladder cancer across diverse practice environments.

By adopting specific hospital, community, and rural perspectives, the faculty will illustrate how to translate diagnostic findings into guideline-aligned treatment decisions despite real-world system constraints. Participants will gain practical insights into navigating resource limitations, strengthening multidisciplinary care coordination, and implementing escalation pathways for NMIBC, MIBC, and metastatic disease to ensure consistent, high-quality care in every setting.

Prefer to read instead? Read our Key Clinical Summary here.

Session Overview

  • Navigating High-Risk NMIBC Escalation: Contrast guideline-ideal TURBT and BCG timing with the practical realities of rural care, focusing on safe treatment adaptations when pathology or resection access is limited.
  • Preserving Curative Intent in MIBC: Identify strategies to maintain the cisplatin-to-cystectomy sequence despite systemic barriers, including imaging delays, surgical access gaps, and patient travel constraints.
  • Systemic Therapy & Referral Triggers: Define clear "treat here vs. refer now" criteria for advanced urothelial carcinoma to manage monitoring logistics and follow-up care across diverse clinical settings.

Who Should Attend?

This program is designed for healthcare professionals in the US, directly involved in diagnosing, staging, and managing bladder cancer and making treatment-planning decisions across community, rural, and hospital settings, including:

  • Urologists (generalists, community urologists, and academic specialists)
  • Medical Oncologists involved in bladder cancer management
  • Advanced Practice Providers (nurse practitioners, physician associates) in urology and oncology
  • Urology Nurses and Oncology Nurses
  • Primary Care Clinicians in community or rural settings who participate in referral decisions
  • Allied Health Professionals supporting bladder cancer coordination and follow-up

Faculty

Petros Grivas, MD, PhD is an oncologist with expertise in treating genitourinary cancers such as bladder cancer, prostate cancer and testicular cancer. His clinical research helped lead to FDA approval of new drugs to treat the most common type of bladder cancer. Dr. Grivas currently leads clinical trials that investigate the use of checkpoint inhibitors. These immunotherapy drugs release the brakes on a patient’s immune system and help it mount a better response to cancer.

Benjamin Garmezy, MD is a board-certified medical oncologist and the Associate Director of Genitourinary Research at Sarah Cannon Research Institute (SCRI). With a deep clinical interest in prostate, kidney, bladder, and testicular cancers, he oversees the development of novel investigational therapies. A frequent faculty member at major international congresses including ASCO and ESMO, Dr. Garmezy has published extensively on clinical trial design and has authored over 50 abstracts focused on advancing the standard of care in GU oncology.

Continuing Education Information

Commercial support: This activity received monetary support through an independent education grant from MSD.

This continuing education activity will be provided by AffinityCE and MedAll. This activity will provide continuing education credit for physicians. A statement of participation is available to other attendees.

Faculty Disclosure Statement / Conflict of Interest

Petros Grivas, MD has disclosed financial interests or relationships within the past 24 months with the following ineligible companies: Consulting for MSD, BMS, AstraZeneca, EMD Serono, Pfizer, Janssen, Roche, Astellas Pharma, Gilead Sciences, Strata Oncology AbbVie, Bicycle Therapeutics, Replimune, Daiichi Sankyo, Foundation Medicine, Eli Lilly, Urogen, Tyra, Natera; Research funding paid to institution EMD Serono, Acrivon Therapeutics, ALX Oncology, MSD, Gilead Sciences, Genentech. These disclosures are made in accordance with ACCME standards to ensure transparency and objectivity in continuing education. Dr. Grivas may reference any unlabeled or unapproved uses of products during the presentation. He will disclose to the audience when this discussion takes place.

Benjamin Garmezy, MD has disclosed financial interests or relationships within the past 24 months with the following ineligible companies: Consulting for Adaptimmune, Adicent Therapeutics, AIQ Global, Amgen, AstraZeneca, Bayer, Bicycle Tx, BioNTech, Bristol-Myers Squibb, Eisai, EMD Serono, Exelixis, Genentech/Roche, GlaxoSmithKline, Janssen, Merck, Monte Rosa Therapeutics, Novartis, Onviv, Pfizer, Rondo Therapeutics, Seagen, Specialty Networks, Takeda Pharmaceuticals, Xencor; Research funding paid to institution Abbvie, Accutar Biotechnology, Adcentrx Therapeutics, Adicet Therapeutics, Amgen, Arcus Biosciences, Arvinas, AstraZeneca, Avenzo Therapeutics, AVEO Oncology, Bicycle Therapeutics, Bristol-Myers Squibb, CRISPR Therapeutics, Daiichi Sankyo, Eikon Therapeutics, Exelixis, Roche/Genentech, Flare Therapeutics, GlaxoSmithKline, Halda Therapeutics, Harbour BioMed, HiberCell, IDEAYA Biosciences, Incyte, Janssen, Janux Therapeutics, Jubilant Therapeutics, Kineta, Kinnate BioPharma, Loxo, Merck, Mink Therapeutics, Novartis, Nuvation Bio, Pfizer, Profound Bio, Rise Therapeutics, Rondo Therapeutics, Takeda Therapeutics, Teon Therapeutics, TMUNITY Therapeutics, Xencor, Zenshine. These disclosures are made in accordance with ACCME standards to ensure transparency and objectivity in continuing education. Dr Garmezy does not intend to discuss non-FDA uses of drug products and/or devices.

AffinityCE staff, MedAll staff, as well as planners and reviewers, have no relevant financial relationships with ineligible companies to disclose.

Mitigation of Relevant Financial Relationships

AffinityCE adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of a CME activity, including faculty, planners, reviewers, or others, are required to disclose all relevant financial relationships with ineligible companies. Relevant financial relationships were mitigated by the peer review of content by non-conflicted reviewers prior to the commencement of the program.

Activity Accreditation for Health Professions

Physicians

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AffinityCE and MedAll. AffinityCE is accredited by the ACCME to provide continuing medical education for physicians.

AffinityCE designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Physician Assistants

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AffinityCE and MedAll. AffinityCE is accredited by the ACCME to provide continuing medical education for physicians.

AffinityCE designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credits™. Physician assistants should claim only the credit commensurate with the extent of their participation in the activity.

Nurse Practitioners

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AffinityCE and MedAll. AffinityCE is accredited by the ACCME to provide continuing medical education for physicians.

AffinityCE designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credits™. Nurse practitioners should claim only the credit commensurate with the extent of their participation in the activity.

Nurses & Other Professionals

All other health care professionals completing this continuing education activity will be issued a statement of participation indicating the number of hours of continuing education credit. This may be used for professional education CE credit. Please consult your accrediting organization or licensing board for their acceptance of this CE activity.

System Requirements

Mobile device (e.g., large-format smart phone; laptop or tablet computer) or desktop computer with a video display of at least 1024 × 768 pixels at 24-bit color depth, capable of connecting to the Internet at broadband or faster speeds, with a current version Internet browser and popular document viewing software (e.g., Microsoft Office, PDF viewer, image viewer) installed. Support for streaming or downloadable audio-visual materials (e.g., streaming MP4, MP3 audio) in hardware and software may be required to view, review, or participate in portions of the program.

Unapproved and/or off-label use disclosure

AffinityCE/MedAll requires CE faculty to disclose to the participants:

  • When products or procedures being discussed are off-label, unlabeled, experimental, and/or investigational (not US Food and Drug Administration [FDA] approved); and
  • Any limitations on the information presented, such as data that are preliminary or that represent ongoing research, interim analyses, and/or unsupported opinion.

CME Inquiries

For all CME policy-related inquiries, please contact us at ce@affinityced.com.

Participation Costs

There is no cost to participate in this program.

To Earn CME Credit:

1. Review the program materials

2. Click the green button on the right to "Claim CME credit"

3. Complete the Post-Test; this test features real-time learning. You will receive immediate feedback and rationales explaining the correct answers as you go. The requirement is 70% accuracy.

4. Once you have successfully passed the test and completed the required CME evaluation, your certificate will be available for download and emailed to you.

Disclaimer

This activity is intended for educational purposes only and does not establish a standard of care or replace clinical judgment. Any therapeutic or diagnostic strategies discussed must be evaluated in the context of each patient’s clinical circumstances, risks, and current evidence.

Learners should consult authoritative clinical guidelines and approved product information when considering treatment decisions.

All materials are used with permission. The views expressed are those of the faculty and do not necessarily reflect those of the accredited providers, MedAll, or any supporters.

Content is accurate as of the date of release.

Learning objectives

Upon completion of this activity, participants should be better able to:

  1. Interpret key diagnostic and prognostic markers, including pathology, imaging, and clinical risk factors, to support risk assessment in diverse care settings.
  2. Apply diagnostic findings to determine when to escalate care, refer, or adjust treatment planning based on available local resources.
  3. Design and implement guideline-aligned treatment pathways for high-risk NMIBC, MIBC, and metastatic disease, accounting for workflow and access challenges in community and rural practices.
  4. Implement practical strategies to navigate resource limitations and strengthen care coordination to support consistent bladder cancer management.

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Computer generated transcript

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The following transcript was generated automatically from the content and has not been checked or corrected manually.

Before we begin, it's important that we share our disclosures with you, uh, and these are disclosures for, uh, consulting, research, funding, uh, etc. and you will find that in that slide. Now, I want to focus your attention on the learning objectives for today's sessions including uh how we can interpret key diagnostic and prognostic biomarkers including pathology, imaging, and clinical risk factors to support risk assessment at diverse care settings. We also want to, uh, after completing this important activity, to see if we're able to apply diagnostic findings to determine when to escalate care, refer, or adjust treatment planning based on available local resources. We also want to design and implement guideline-aligned treatment pathways for high-risk, non-muscle invasive, mass invasive bladder cancer, and metastatic eurothelial carcinoma, accounting for workflow and access challenges in community and rural practice settings. Last but not least, another objective is to implement practical strategies to navigate the resource limitations and strengthen care coordination to support consistent bladder cancer management. Now, let's turn our attention to muscle invasive bladder cancer after we discussed the non-muscle invasive disease state. Let's talk about muscle invasive disease. This has important implications, uh, as I mentioned, for treatment and prognosis, and, and the impetus to give new adjuvant cisplatin-based chemotherapy, uh, uh, over the years, uh, as standard of care, uh, for many years in this disease. muscle-based bladder cancer has been mainly because we aim to eradicate microscopic metastasis, micrometastasis, which actually represents the lethal phenotype of the disease, uh, and I think that's important because patients think about what they see, like the bladder cancer, the bladder tumor. At the same time, I share with the patients that I'm also worried about what they And we may not be able to see and that's it's potential presence of micrometastasis. Uh, so that's the main reason we give new adrenal systemic systemic-based chemotherapy over the years and of course, um, uh, this, uh, uh, is important because it allows patients to, uh, at least, uh, uh, go after uh potential presence of micrometastasis. While, uh, it's preserving the option of doing radical surgery and patients are getting radical surgery, um, after neoadjuvant systemic therapy, they do not need to recover, right after surgery, for example, the adjuvant setting, after radical surgery, you have to recover, right, from, uh, radical surgery, uh. And if you do systemic therapy before, uh, you do not need to have that recovery, uh, component. Again, nuanced with adjuvan, although I'm going to show you data that actually both phases seem important, both nuanced and adjuvant, this very operative therapy setting, and I will go to show you some important data in a second. I'm going to start with the Niagara Phase 3 trial and as I just mentioned a second ago, we live in the era of perioerative trials. So, management is based on neoadjuvant and adjuvant setting. You see here Niagara trial includes patients with muscle invasive bladder cancer, localized, resectable. Uh, the comparator is a neoadjuvant GEMCs chemotherapy with no planned adjuvant treatment. The experimental arm is Addition of durvalumab, antipedal one, in patients who are fit for cisplatin, of course, uh, 4 cycles of GEMSC's durvalumab or GEMC's neoadjuvantly radical surgery, and then in the experimental arm there were up to 8 monthly doses of durvalumab, uh, in those patients who could tolerate it, of course, and dual primary points, event-free survival, pathological complete response rate with overall survival being a key secondary point. Uh, you see here the certification factors, you see how the event-free survival was defined in the right lower corner. Interestingly, patients who opted selected to not have radical cystectomy if they choose to not undergo surgery. This actually was counted as an event in the study, uh, as per regulatory guidance or something to keep in mind. Event for survival, significant improvement, hazard ratio overall was 0.68 in the intent to treat population and if you break it down, uh, the benefit seems to be present in patients with and without pathological complete response. Uh, so patients who achieved path CR and patients who did not achieve path CR, both of those patients subsets appear to derive benefit from durvalumab again given perioperatively pre and post-radical surgery, and you see the hazard ratios in those subsets. Same story here with overall survival that was also met, uh, uh, uh, the Duvalma addition preoperatively resulted in improved overall survival has a ratio of 0.75. In all comers in 10 to 3 population and you see here the breakdown of course these are underpowered uh exploratory analysis you can argue in a way because the number of events are small, uh, but what you see there that has a ratio of 0.72 and 0.84 are in the right direction for both patients with and without PACR in terms of. The perioperative development edition of course because the low number of events again these are uh immature uh uh follow up uh in the subsets but as I mentioned the trend is in the same direction with the overall population and in the world population there was conclusive benefit for overall survival uh with peroperative development. These are toxicities and of course, there's no surprise. We know across cancer types that if you add cisplatin, gemcitabine and sex inhibition, You may have, uh, you know, the risk of mulate adverse events from the Duvalu map. However, if you see the slide and we saw in publication and different data sets across conferences, the toxicity profile, uh, is consistent with what we, uh, with what we expect with chemotherapy alone, and, uh, the combination seems feasible and manageable. Of course, extra education is needed, but the combination seems to be feasible and the important point is, uh, that patients who go to Vallumab, uh, were able to undergo radical surgery to a similar rate, similar degree, uh, uh, compared to the GMC's new adjuvan alone. For example, 88% of patients underwent radical surgery with GMsis Duvalumab and 82% or so with GEMSis alone, so, uh, 83%. So overall the numbers look very similar, uh, in terms of, uh. The proportion of patients who underwent radical surgery. So in other words, the addition of durvalumab neoadjuvantly did not compromise the ability of patients to undergo curative intent radical surgery. So this is the summary of what I discussed so far for the Niagara trial. GEMCs plus Durvalumab is FDA approved, uh, as perioerative regimen, uh, Geis Durvalum neoadjuvantly and uh Durvalumab alone as uh adjuvant therapy up to 8 monthly doses, uh, and. Patients, of course, who can tolerate it and the majority of patients can tolerate the durvalumab, um, the, uh, uh, toxicity as expected with no new safety signals. And as I mentioned, that's a therapy option, uh, in the peroperative space, uh, localized muscle-based bladder cancer for patent eligible patients. Uh, of course, there are multiple ongoing clinical trials that looks, uh, uh, I, I think in the future, uh, and, uh, all these trials are, uh, going to shape and keep reshaping the landscape. I think if we look at the left, uh, upper corner, we have the Niagara trial. We're waiting for the, uh, GEMS Pembrolizumab. Uh, there was a press release that show that the GEMSC+ minus Pembro did not meet the prominent point. Um, we have to see the data, of course. GEMS+ minus the volume map is pending on the right and Fort Maveotin trials. I want to make the point that the Volga trial is going to be reported in the near future. That's a positive trial. It seems that Durvalma plus and Fortma Votin. Uh, uh, neoadjuvantly followed by radical surgery, followed by development adjuvantly, uh, seems to be, uh, prolonging overall survival and event-free survival compared to no perioperative therapy in cisplatin ineligible patients. We are awaiting the data from Volga. I'm going to show you data, uh, about, uh, keynote B15 and keynote 905. Uh, in the left lower corner, we have the modern trial is ongoing. It's a purely adjuvant. Trial based on CD DNA asking an escalation and the de-escalation question in the right lower corner is in vigor 0 11 that was presented by Professor Pauls at ESO 2025 and actually was a positive trial uh in patients who have positive CDDNA post radical cystectomy either from the beginning or they converted from negative to positive later in this DNA positive subset, uh. Atezolizumab was superior to placebo in terms of disease-free and overall survival, and that resulted in the FDA approval of otezolizumab in the adjuvant setting in patients with high risk of recurrence based on the pathologic states, if they have CDA positive status. Uh, and I think that's an important point is the DNA guided, uh, uh, therapy in the adjuvant setting. Uh, this result to the FDA approval of teszolizumab just recently based on the invigorous 011 trial. Of course, this trial, uh, uh, included patients who were immunotherapy naive, so we, uh we cannot extrapolate this data from the preoperative immunotherapy trials. Speaking about immunotherapy, perioperative trials, I will finish the uh doc here uh covering two important studies that are mirror image of each other and four of a doin plus chondrolizumab, EV Pembro as we call it in cisplatin eligible patients uh as a sandwich. Approach peroperative. Uh, you see 4 cycles, new adjuvant radical surgery, and then adjuvant therapy phase compared to neoadjuvant Jimsis, uh, 4 cycles with no planned adjuvant therapy. This trial was reported by Doctor Gals at AOGU 2226 a few months ago. It was a positive trial meant.