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EAU20 bladder cancer highlights

By Dr. Benjamin Pradere (FR)

The EAU20 Virtual Congress did an amazing job on topicality and debates about urothelial cancer. A Game-Changing session, a Plenary session, and, as the cherry on the cake, a Theme Week day were dedicated to bladder cancer (BCa). In these sessions, delegates learned from the best in the field and got an invaluable insight into the challenges that we will face in the upcoming years. The tremendous work done by all the speakers, chairmen, and the EAU Central Office have allowed us to benefit from the new digital experience that was EAU20. Among the fantastic talks and new studies presented, three moments have kept particularly our attention.

The NIMBUS study, a phase-III randomized trial assessing the potential reduction of the number of BCG instillations in high-grade NMIBC, was presented after its first discussion during the last ASCO. This study, of utmost importance during this complicated time of BCG shortage, proposed two different schedules:

This study concluded that reduced frequency of BCG is inferior to a standard BCG instillation schedule. Reduced frequency leads to a decreased time to recurrence and an increased number of recurrences.

Another great development in NMIBC treatment unfolded when Dr. Neal Shore (US) presented the results of the open-label phase-III study investigating nadofaragene in high-grade NMIBC (carcinoma in situ [CIS ± Ta/T1], or PD [Ta/T1 alone]) unresponsive to BCG. The medicine was administered once every 3 months up to 4 doses total in the initial 12 months. Patients without evidence of high-grade disease after 12 months were offered to continue the treatment. While the primary outcome was a complete response rate (CR) among patients with CIS, key secondary end points included rate and durability of high-grade-recurrence-free (HGRF) survival as well as safety after stratification between patients with CIS (n=107) and those with only papillary disease (n=50). In the primary efficacy analysis, the authors examined a complete response rate in the subset of patients with CIS which reached 53.4% after 12 months with all complete responses occurring in the first 3 months. In the efficacy analysis set, high-grade, recurrence-free survival and durability showed a 12-month recurrence-free survival of 24.3% in the CIS cohort and 43.8% in the papillary cohort. Concerning the tolerance, serious treatment adverse events were uncommon (8.9%), and AEs leading to discontinuation occurred in only 1.9% of patients. The majority of treatment-related adverse events were instillation site discharge, fatigue, bladder spasm, urinary urgency, and hematuria.

Prof. Joan Palou (ES) and Prof. Shahrokh Shariat (AT) had a great debate on immediate radical cystectomy for HR NMIBC. This topic remains one of the big challenges in the coming years as the early identification of the best candidates still needs to be further explored. The role of molecular medicine, especially with sequencing, could offer a bright future for our progress in tailored treatment in this era of precision medicine. For early cystectomy, the classical ‘cons’ including the risk of overtreatment and complications should be counterbalanced by the best survival in patients who underwent RC (CSS around 90%) but also by the possibility of performing function-sparing surgery.

In conclusion, we advise you to visit the EAU20 Virtual Congress website to watch the recorded sessions on bladder cancer.

The UROONCO BCa editorial board wishes you a great summer!