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Poll

What is your main challenge for the identification of AEs with immunotherapy?

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Lack of patient/caregiver knowledge regarding irAEs
   
AEs with immunotherapy are different to those with chemotherapy
   
The timing of irAEs with immunotherapy is not predictable
   
Other
   

Tutorial

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Poll

Which perioperative strategy do you think will have the biggest impact on MIBC treatment?

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Adjuvant immunotherapy monotherapy
   
Perioperative immunotherapy ± chemotherapy
   
Perioperative immunotherapy plus antibody–drug conjugate
   
Other
   

Tutorial

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Poll

In your clinical practice, how many patients with MIBC are deemed cisplatin ineligible?

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<20%
   
20–40%
   
40–60%
   
>60%
   
 
Expert Interviews
Bladder Cancer, Genitourinary Cancer, Immunotherapy CE/CME accredited

touchEXPERT OPINIONS
Experts answer questions with in-depth advice on the current clinical landscape and how new therapies and guidance might impact regional clinical practice. Useful tips below will show how to navigate the activity. Close

Advancing the treatment of muscle-invasive bladder cancer: Updates on immunotherapy in the perioperative setting

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Dr Laura Mertens is a urologist at the Netherlands Cancer Institute in Amsterdam, The Netherlands. read more

Dr Merten’s main expertise is clinical oncological urology, particularly focusing on bladder cancer, and research on optimizing bladder cancer imaging. Her long-term career goal is to improve the outcome of patients with invasive bladder cancer.

Dr Mertens’s career in urology started with a PhD in urology/surgical oncology at the Netherlands Cancer Institute. Her research, mentored by Prof. Simon Horenblas and Dr Bas van Rhijn, focused on enhancing imaging and treatment of bladder cancer, including several international collaborations on the value of FDG-PET/CT for preoperative staging.

After her PhD, Dr Mertens did her clinical training in urology at Amsterdam University Medical Center. Subsequently, she did a clinical fellowship in oncological urology at the Netherlands Cancer Institute (Prof. Henk van der Poel and Dr Bas van Rhijn). She is involved in the European Association of Urology Muscle-Invasive Bladder Cancer Guidelines panel and the Young Academic Urologists Working Group Urothelial.

Dr Laura Mertens discloses: Advisory board or panel fees from Janssen and Merck (relationships terminated). Grants/research support from Pfizer.

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Prof. Thomas Powles is Director of the Barts Cancer Centre, one of the UK’s largest cancer centres, and a professor of genitourinary oncology at the Queen Mary University of London, UK. read more

Prof. Powles has led a number of clinical trials and translational oncology projects that have appeared in major journals. He has had a key role in the development of biomarkers and new drug strategies in genitourinary cancer, including multiple EMA and FDA approvals. In 2023, Prof. Powles was named in ‘Nature’s 10’, a list of the most influential global scientists.

Prof. Powles has over 300 peer-reviewed publications. He has presented data at plenary sessions at major meetings and received the bladder cancer award at the American Society of Clinical Oncology Genitourinary Cancers Symposium in 2018. Prof. Powles hosts multiple podcasts and has an active role on social media, with over 10,000 followers on X.

Prof. Powles leads the European Society for Medical Oncology (ESMO) guidelines for renal and bladder cancer and was the track chair for non-prostate genitourinary cancer in 2021. He has previously been part of the steering committee for the educational and scientific tracks for ESMO meetings, including co-chairing the ESMO Immuno-Oncology Congress from 2019 to 2021. 

Prof. Thomas Powles discloses: Advisory board or panel fees from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Ipsen, Johnson & Johnson, Merck/Merck Sharp & Dohme, Merck Serono, Novartis, Pfizer, Roche and Seattle Genetics. Consultancy fees from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Gilead, Incyte, Ipsen, Johnson & Johnson, Mashup, Merck/Merck Sharp & Dohme, Merck Serono, Novartis, Pfizer, Roche and Seattle Genetics. Grants/research support fees from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Ipsen, Johnson & Johnson, Merck/Merck Sharp & Dohme, Merck Serono, Novartis, Pfizer, Roche and Seattle Genetics.

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Ms Lindsay Diamond is an advanced practitioner provider manager at the Icahn School of Medicine at Mount Sinai and a nurse practitioner at Mount Sinai Hospital, New York, NY, USA. She is also an adjunct professor at the Phillips School of Nursing at Mount Sinai. read more

As a nurse practitioner, Ms Diamond coordinates the care of patients with genitourinary (GU) cancers throughout the interdisciplinary system and is the clinical nurse practitioner and sub-investigator on all clinical trials in this area.

Since 2022, Ms Diamond has been a guest lecturer at the New York University Rory Meyers College of Nursing, where she lectures on GU cancers each semester. She was nominated for the CURE® 2022 Extraordinary Healer® Award for Oncology Nursing.

Ms Lindsay Diamond discloses: Speaker’s bureau fees from Exelixis.

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  • A practice aid is available for this activity in the Toolkit
  • Downloads including slides are available for this activity in the Toolkit
Learning Objectives

After watching this activity, participants should be better able to:

  • Summarize the ongoing clinical trials and latest clinical trial data for immunotherapy in the perioperative setting for patients with MIBC
  • Discuss the use of immunotherapy in the perioperative setting for MIBC, including practical considerations for its implementation in clinical practice
  • Describe appropriate patient monitoring and side effect management for patients with MIBC receiving immunotherapy in the perioperative setting
Overview

In these short interviews, three experts highlight the key data for immunotherapy in the perioperative setting for muscle-invasive bladder cancer (MIBC), practical considerations for its use in clinical practice, and how possible side effects can be monitored for and managed. They also consider the role of the multidisciplinary team in implementing this treatment modality.

This activity is jointly provided by USF Health and touchIME. read more

Target Audience

This activity has been designed to meet the educational needs of oncologists, urologists and oncology nurses involved in the management of patients with MIBC.

USF Accreditation

Disclosures

USF Health adheres to the Standards for Integrity and Independence in Accredited Continuing Education. All individuals in a position to influence content have disclosed to USF Health any financial relationship with an ineligible organization. USF Health has reviewed and mitigated all relevant financial relationships related to the content of the activity. The relevant relationships are listed below. All individuals not listed have no relevant financial relationships.

Faculty

Dr Laura Mertens discloses: Advisory board or panel fees from Janssen and Merck (relationships terminated). Grants/research support from Pfizer.

Prof. Thomas Powles discloses: Advisory board or panel fees from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Ipsen, Johnson & Johnson, Merck/Merck Sharp & Dohme, Merck Serono, Novartis, Pfizer, Roche and Seattle Genetics. Consultancy fees from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Gilead, Incyte, Ipsen, Johnson & Johnson, Mashup, Merck/Merck Sharp & Dohme, Merck Serono, Novartis, Pfizer, Roche and Seattle Genetics.Grants/research support fees from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Ipsen, Johnson & Johnson, Merck/Merck Sharp & Dohme, Merck Serono, Novartis, Pfizer, Roche and Seattle Genetics.

Ms Lindsay Diamond discloses: Speaker’s bureau fees from Exelixis.

Content reviewer

Danielle Walker, DNP, APRN, AGNP-C has no financial interests/relationships or affiliations in relation to this activity.

Touch Medical Contributors

Hannah Fisher has no financial interests/relationships or affiliations in relation to this activity.

USF Health Office of Continuing Professional Development and touchIME staff have no financial interests/relationships or affiliations in relation to this activity.

Requirements for Successful Completion

In order to receive credit for this activity, participants must review the content and complete the post-test and evaluation form. Statements of credit are awarded upon successful completion of the post-test and evaluation form.

If you have questions regarding credit please contact cpdsupport@usf.edu

Accreditations

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 a joint providership of USF Health and touchIME. USF Health is accredited by the ACCME to provide continuing medical education for physicians.

USF Health designates this enduring material for a maximum of 0.75 AMA PRA Category 1 CreditTM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Advanced Practice Providers

Physician Assistants may claim a maximum of 0.75 Category 1 credits for completing this activity. NCCPA accepts AMA PRA Category 1 CreditTM from organizations accredited by ACCME or a recognized state medical society.

The AANPCP accepts certificates of participation for educational activities approved for AMA PRA Category 1 CreditTM by ACCME-accredited providers. APRNs who participate will receive a certificate of completion commensurate with the extent of their participation.

Nurses

USF Health is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation.

A maximum of 0.75 contact hours may be earned by learners who successfully complete this continuing professional development activity. USF Health, the accredited provider, acknowledges touchIME as the joint provider in the planning and execution of this CNE activity.

This activity is awarded 0.75 ANCC pharmacotherapeutic contact hour.

Date of original release: 19 December 2024. Date credits expire: 19 December 2027.

If you have any questions regarding credit, please contact cpdsupport@usf.edu

EBAC® Accreditation

touchIME is an EBAC® accredited provider since 2023.

This programme is accredited by the European Board for Accreditation of Continuing Education for Health Professionals (EBAC®) for 0.75 hour of effective education time.

The Accreditation Council for Continuing Medical Education (ACCME®), and the Royal College of Physicians and Surgeons of Canada hold an agreement on mutual recognition on substantive equivalency of accreditation systems with EBAC®.

Through an agreement between the European Board for Accreditation of Continuing Education for Health Professionals and the American Medical Association (AMA), physicians may convert EBAC® CE credits to AMA PRA Category 1 CreditTM. Information on the process to convert EBAC® credit to AMA credit can be found on the AMA website. Other health care professionals may obtain from the AMA a certificate of having participated in an activity eligible for conversion of credit to AMA PRA Category 1 CreditTM.

Faculty Disclosure Statement/Conflict of Interest Policy

In compliance with EBAC® guidelines, all speakers/chairpersons participating in this programme have disclosed or indicated potential conflicts of interest which might cause a bias in the presentations. The Organizing Committee/Course Director is responsible for ensuring that all potential conflicts of interest relevant to the event have been mitigated and declared to the audience prior to the CME activities.

Requirements for Successful Completion

Certificates of Completion may be awarded upon successful completion of the post-test and evaluation form. If you have completed one hour or more of effective education through EBAC® accredited CE activities, please contact us at accreditation@touchime.org to receive your EBAC® CE credit certificate. EBAC® grants 1 CE credit for every hour of education completed.

Date of original release: 19 December 2024. Date credits expire: 19 December 2026.

Time to Complete: 51 minutes

If you have any questions regarding the EBAC® credits, please contact accreditation@touchime.org 

This activity is CE/CME accredited

To obtain the CE/CME credit(s) from this activity, please complete this post-activity test.

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Topics covered in this activity

Bladder Cancer / Genitourinary Cancer / Immunotherapy
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touchEXPERT OPINIONS
Advancing the treatment of muscle-invasive bladder cancer: Updates on immunotherapy in the perioperative setting
0.75 CE/CME credit

Question 1/5
In the phase III NIAGARA trial in patients with MIBC, what was the OS rate at 24 months in patients treated with neoadjuvant durvalumab + cisplatin–gemcitabine followed by radical cystectomy + adjuvant durvalumab?

MIBC, muscle-invasive bladder cancer; OS, overall survival.

NIAGARA is a phase III, open-label randomized trial where cisplatin-eligible patients with MIBC were assigned to receive either neoadjuvant durvalumab plus gemcitabine–cisplatin, followed by RC and adjuvant durvalumab (durvalumab group, n=533), or neoadjuvant gemcitabine–cisplatin followed by RC alone (comparison group, n=530). The estimated OS at 24 months was 82.2% in the durvalumab group and 75.2% in the comparison group (hazard ratio for death 0.75; p=0.01).

Abbreviations

MIBC, muscle-invasive bladder cancer; OS, overall survival; RC, radical cystectomy.

Reference

Powles T, et al. N Engl J Med. 2024;391:1773–86.

Question 2/5
Based on the results of the IMvigor010 trial, investigating adjuvant atezolizumab therapy vs observation in patients with MIUC, which of the following may be a potential biomarker for OS benefit with atezolizumab treatment?

ctDNA, circulating tumour DNA; MIUC, muscle-invasive urothelial cancer; OS, overall survival; PD-L1, programmed death-ligand 1; TMB, tumour mutation burden.

IMvigor010 is a phase III trial that evaluated adjuvant atezolizumab vs observation in patients with MIUC after radical surgery. The ctDNA biomarker-evaluable population included 300 in the atezolizumab arm and 281 in the observation arm. Patients with ctDNA-positive status showed evidence of longer OS with atezolizumab (29.8 months) vs observation (14.1 months; HR 0.59). Patients with ctDNA-negative status had similar OS between arms (HR 1.38). The updated OS data of IMvigor010 showed that ctDNA has both prognostic and predictive values as a biomarker for immunotherapy treatment.

Abbreviations

ctDNA, circulating tumour DNA; HR, hazard ratio; MIUC, muscle-invasive urothelial cancer; OS, overall survival.

Reference

Powles T, et al. Eur Urol. 2024;85:114–22.

Question 3/5
Your patient is a 64-year-old female with MIBC. She is eligible for platinum-based chemotherapy and is fit to undergo RC. Her comorbidities include rheumatoid arthritis, hypothyroidism and bradycardia. You are discussing the possibility of perioperative immunotherapy with her. Why might you be particularly cautious about considering this patient for an ICI?

ICI, immune checkpoint inhibitor; MIBC, muscle-invasive bladder cancer; RC, radical cystectomy.

Given the likelihood of autoimmune flare-ups, clinical decision-making on the use of ICIs for patients with existing autoimmunity should carefully weigh the severity and potential consequences of autoimmune disease exacerbation vs the potential benefits of ICI treatment.

Abbreviation

ICI, immune checkpoint inhibitor.

Reference

Brahmer JR, et al. J Immunother Cancer. 2021;9:e002435.

Question 4/5
You are discussing the possibility of adjuvant nivolumab with your patient with MIBC following radical cystectomy. When talking about the presentation of common irAEs seen with immunotherapy treatment, how would you best describe them?

AE, adverse event; irAE, immune-related AE; MIBC, muscle-invasive bladder cancer.

The presentation of common irAEs often differs from that of chemotherapy- related AEs. The timing of irAEs is not predictable, with the potential for events to occur and persist long after cessation of treatment.1 The side effects may involve any organ or system of the body; however, GI, dermatologic, hepatic, endocrine and pulmonary toxicities predominate.2

Abbreviations

AE, adverse event; GI, gastrointestinal; irAE, immune-related AE.

References

  1. Brahmer JR, et al. J Immunother Cancer. 2021;9:e002435.
  2. Schneider BJ, et al. J Clin Oncol. 2021;39:4073–126.
Question 5/5
Your patient recently started adjuvant nivolumab therapy and is experiencing grade 1 pruritus. Your first-line treatment was systemic corticosteroids, but there has been no improvement in their symptoms. According to the SITC clinical practice guideline on immune checkpoint inhibitor-related adverse events, what might you consider as your next step for this corticosteroid-refractory patient?

SITC, Society for Immunotherapy of Cancer.

The SITC clinical practice guideline on immune checkpoint inhibitor-related adverse events recommends that in patients who do not respond to initial corticosteroid therapy, second-line immunosuppressive therapy should be considered. However, the subsequent use of other immunosuppressive agents to treat corticosteroid- refractory irAEs carries potential risks, which clinicians should familiarize themselves with prior to administration.

Abbreviations

irAE, immune-related adverse event; SITC, Society for Immunotherapy of Cancer.

Reference

Brahmer JR, et al. J Immunother Cancer. 2021;9:e002435.

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