22.07.2022
Wedel, Germany (22.07.2022) With its renowned experts, the Medscape satellite symposium1 sponsored by medac focused on the implementation of the latest recommendations in practice. The speakers Ashish M. Kamat (Houston, US), Jørgen Bjerggaard Jensen (Aarhus, DK) and Joan Palou (Barcelona, ES) discussed new recommendations and important aspects relevant to the management of patients with non-muscle-invasive bladder cancer (NMIBC) belonging to the intermediate, high and very high risk groups. BCG was confirmed as the therapy of choice for high-risk groups and, with the ongoing evolution of management, may even be an option for very high-risk patients who are unfit and refuse cystectomy.
Bjerggaard Jensen updated the audience on the treatment of NMIBC with neoadjuvant chemotherapy (chemoresection) referring to data in the new section 7.3 of the 2022 NMIBC guidelines 2. More than half of the patients with recurrent intermediate-risk NMIBC treated with dose-dense neoadjuvant mitomycin C show a complete response that is associated with a lower recurrence rate.3 Compared to the standard adjuvant treatment, this different schedule of mitomycin C opens up new opportunities to avoid invasive procedures and reduce side effects for patients with low-grade recurrent disease.4
The disease states of BCG failure are prognostically different (refractory, relapsing, unresponsive and intolerant). Many patients with NMIBC fall in the gap between BCG-naïve and BCG-unresponsive disease. The International Bladder Cancer Group recently introduced the term ‘BCG-exposed’, defined as HG recurrence after BCG treatment that does not meet the criteria for BCGU disease, and published recommendations for an optimal trial design.5
Palou devoted his lecture to patients with BCGU NMIBC. The definition of BCGU requires that patients receive “adequate BCG”, defined as at least 5 of 6 induction instillations plus at least 2 additional instillations, as a component of either maintenance or re-induction therapy.
The timing of radical cystectomy is a crucial consideration in patients with BCGU NMIBC in order to avoid progression to muscle-invasive stages. Therefore, bladder-preserving treatments need to be oncologically safe with a recommended focus on duration of response.
Patients with BCG-unresponsive (BCGU) NMIBC are assigned to the very high risk group for which early radical cystectomy represents the standard of care. For these patients, Palou presented current and upcoming bladder-preserving treatment options, among which intravesical device-assisted chemohyperthermia, sequential chemotherapy and the combination of BCG (‘prime’) and IL-15 superagonist N-803 (‘boost’) appear most promising.
With his lecture Kamat highlighted that the current EAU risk classification differs from the previous (2020) version and the current definition of AUA risk groups with respect to the risk group assignment of high-grade Ta tumours.6 A simplified definition has been proposed that classifies any high-grade tumour, including Ta, as high-risk. The new EAU21 risk classification may seem confusing; however, the available web-based EAU risk calculator allows for easy risk group assignment.7
Kamat focused on high-risk and very high-risk groups and showed that contemporary outcomes of patients receiving adequate BCG are better than expected from older reports, confirming BCG as a benchmark in clinical trials in the BCG-naïve setting.8 Since the EAU21 risk classification is based on NMIBC patients not treated with BCG, it overestimates the true risk of patients treated with adequate BCG immunotherapy according to the guidelines.
The symposium confirmed that BCG remains unchallenged as the therapy of choice for patients with high-risk NMIBC, and even for some with a very high risk who are unfit or refuse radical cystectomy.
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1 medac MEDSCAPE LIVE Satellite Symposium: “Expert Guidance in Non-Muscle-Invasive Bladder Cancer – Applying the Latest Recommendations to Clinical Practice” Sunday, July 3, 2022, 17:45 – 19:15 CET EAU 22. Available from URL: https://resource-centre.uroweb.org/resource-centre/EAU22?session_id=13036#show
2 EAU Guidelines. Edn. presented at the EAU Annual Congress Amsterdam 2022. ISBN 978-94-92671-16-5. URL: Non-muscle-invasive Bladder Cancer - CITATION INFORMATION - Uroweb (15.07.2022).
3 Skydt Lindgren M. et.al. EAU22 abstract A0236.
4 Skydt Lindgren M. et.al. EAU22 abstract A0236.
5 Roumiguié M, et al. Eur Urol. 2022 Jul; 82(1): 34-46. PMID: 34955291.
6 Bree KK, et al. All High-Grade Ta Tumors Should Be Classified as High Risk: Bacillus Calmette-Guérin Response in High-Grade Ta Tumors. J Urol. 2022 Aug; 208(2): 284-291. PMID: 35770498.
7 EAU risk calculator, www.nmibc.net; medac alternative: https://www.bc-care.com/healthcare-professionals/nmibc-toolbox/
8 Lobo N, et al. Eur Urol Oncol. 2022 Feb; 5(1): 84-91. PMID: 34920986.