MP16-01: Replacing ReTUR with Cystoscopy in High-Grade T1 NMIBC Patients: Confirmatory Results from the HuNIRe Trial
Friday, May 3, 2024 1:00 PM to 3:00 PM · 2 hr. (US/Central)
221B
Abstract
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Full Abstract and Figures
Author Block
Alessio Finocchiaro*, Roberto Contieri, Paolo Casale, Nicolò Maria Buffi, Alberto Saita, Giovanni Lughezzani, Marco Paciotti, Vittorio Fasulo, Massimo Lazzeri, Giorgio Guazzoni, Andrea Piccolini, Rodolfo Hurle, Milan, Italy
Introduction
According to the European Association of Urology (EAU) guidelines, a second resection (ReTUR) is indicated for all T1 non-muscle invasive bladder cancers (NMIBC), regardless of the completeness of the initial resection and/or of the presence of detrusor muscle in the pathological specimen. However, the effective impact of ReTUR on oncological outcomes remains uncertain. We previously reported the feasibility and safety of replacing ReTUR with urine cytology (UC) and in-office flexible cystoscopy in selected T1 non-muscle-invasive bladder cancer. The aim of this study is to confirm our findings and present the associated oncological outcomes.
Methods
This is an ongoing prospective multicenter trial enrolling patients diagnosed with HG T1 BC from 5 Italian hospitals. In case of complete tumor resection at initial TUR, HG T1 patients underwent a strict follow-up consisting of UC at 4-6 weeks and an in-of?ce ?exible white-light and narrow-banding cystoscopy at 6-8 weeks. In case of a positive UC or evidence of recurrence at post-cystoscopy (PC) ReTUR was performed within 2 weeks. Otherwise, patients started the BCG induction course without any additional resection. Patients with a macroscopic incomplete initial resection or in case of absence of detrusor muscle underwent standard ReTUR within 40 days.
Results
Overall, 89 patients were enrolled between May 2020 and January 2023, of them 70 entered the protocol. Median age was 76 years (IQR 68-80). A total of 47 patients (68%) had negative UC and cystoscopy after TUR and thus started BCG directly while 23 (32%) patients had positive UC or cystoscopy and underwent PC ReTUR. With a median follow-up of 17.5 months (IQR 13.6-24), 18 patients recurred and 2 progressed. Considering the entire cohort, the 2-year RFS and PFS were 64% (95% CI: 46-76) and 97% (95% CI: 88-99), respectively. KM curves did not show differences in RFS between patients who avoided ReTUR and those who underwent PC-ReTUR (p=0.8). (Figure) Not surprisingly, at Cox regression analysis concomitant CIS at diagnosis was associated with a higher risk of undergoing PC ReTUR (HR 5.3, 95% CI: 0.98-28.78, P=0.05).
Conclusions
Our ongoing results confirm that avoiding initial ReTUR in HG T1 patients and selectively offering it promptly only to those with a positive cystoscopy or UC is not associated with worse cancer outcomes. Longer follow-up and larger sample sizes are necessary to validate these results.
Source Of Funding
None
Author Block
Alessio Finocchiaro*, Roberto Contieri, Paolo Casale, Nicolò Maria Buffi, Alberto Saita, Giovanni Lughezzani, Marco Paciotti, Vittorio Fasulo, Massimo Lazzeri, Giorgio Guazzoni, Andrea Piccolini, Rodolfo Hurle, Milan, Italy
Introduction
According to the European Association of Urology (EAU) guidelines, a second resection (ReTUR) is indicated for all T1 non-muscle invasive bladder cancers (NMIBC), regardless of the completeness of the initial resection and/or of the presence of detrusor muscle in the pathological specimen. However, the effective impact of ReTUR on oncological outcomes remains uncertain. We previously reported the feasibility and safety of replacing ReTUR with urine cytology (UC) and in-office flexible cystoscopy in selected T1 non-muscle-invasive bladder cancer. The aim of this study is to confirm our findings and present the associated oncological outcomes.
Methods
This is an ongoing prospective multicenter trial enrolling patients diagnosed with HG T1 BC from 5 Italian hospitals. In case of complete tumor resection at initial TUR, HG T1 patients underwent a strict follow-up consisting of UC at 4-6 weeks and an in-of?ce ?exible white-light and narrow-banding cystoscopy at 6-8 weeks. In case of a positive UC or evidence of recurrence at post-cystoscopy (PC) ReTUR was performed within 2 weeks. Otherwise, patients started the BCG induction course without any additional resection. Patients with a macroscopic incomplete initial resection or in case of absence of detrusor muscle underwent standard ReTUR within 40 days.
Results
Overall, 89 patients were enrolled between May 2020 and January 2023, of them 70 entered the protocol. Median age was 76 years (IQR 68-80). A total of 47 patients (68%) had negative UC and cystoscopy after TUR and thus started BCG directly while 23 (32%) patients had positive UC or cystoscopy and underwent PC ReTUR. With a median follow-up of 17.5 months (IQR 13.6-24), 18 patients recurred and 2 progressed. Considering the entire cohort, the 2-year RFS and PFS were 64% (95% CI: 46-76) and 97% (95% CI: 88-99), respectively. KM curves did not show differences in RFS between patients who avoided ReTUR and those who underwent PC-ReTUR (p=0.8). (Figure) Not surprisingly, at Cox regression analysis concomitant CIS at diagnosis was associated with a higher risk of undergoing PC ReTUR (HR 5.3, 95% CI: 0.98-28.78, P=0.05).
Conclusions
Our ongoing results confirm that avoiding initial ReTUR in HG T1 patients and selectively offering it promptly only to those with a positive cystoscopy or UC is not associated with worse cancer outcomes. Longer follow-up and larger sample sizes are necessary to validate these results.
Source Of Funding
None