Adjuvant intravesical therapy in intermediate-risk non-muscle-invasive bladder cancer

Ekaterina Laukhtina; Paolo Gontero; Marko Babjuk; Marco Moschini; Jeremy Yuen-Chun Teoh; Morgan Rouprêt; Quoc-Dien Trinh; Piotr Chlosta; Péter Nyirády; Mohammad Abufaraj; Francesco Soria; Jakob Klemm; Kensuke Bekku; Akihiro Matsukawa; Shahrokh F Shariat

doi:10.1111/bju.16371

Adjuvant intravesical therapy in intermediate-risk non-muscle-invasive bladder cancer

BJU Int. 2024 Apr 16. doi: 10.1111/bju.16371. Online ahead of print.

Authors

Ekaterina Laukhtina¹, Paolo Gontero², Marko Babjuk^{1

3}, Marco Moschini⁴, Jeremy Yuen-Chun Teoh⁵, Morgan Rouprêt⁶, Quoc-Dien Trinh⁷, Piotr Chlosta⁸, Péter Nyirády⁹, Mohammad Abufaraj¹⁰, Francesco Soria², Jakob Klemm^{1

11}, Kensuke Bekku^{1

12}, Akihiro Matsukawa^{1

13}, Shahrokh F Shariat^{1

14

3

15

16

9

10

17}

Affiliations

¹ Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
² Division of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, Turin, Italy.
³ Department of Urology, Second Faculty of Medicine, Charles University, Prague, Czech Republic.
⁴ Department of Urology, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy.
⁵ S.H. Ho Urology Centre, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China.
⁶ Sorbonne University, GRC 5 Predictive Onco-Uro, AP-HP, Urology, Pitie-Salpetriere Hospital, Paris, France.
⁷ Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
⁸ Department of Urology, Jagiellonian University, Cracow, Poland.
⁹ Department of Urology, Semmelweis University, Budapest, Hungary.
¹⁰ Division of Urology, Department of Special Surgery, The University of Jordan, Amman, Jordan.
¹¹ Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
¹² Department of Urology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.
¹³ Department of Urology, Jikei University School of Medicine, Tokyo, Japan.
¹⁴ Karl Landsteiner Institute of Urology and Andrology, Vienna, Austria.
¹⁵ Department of Urology, The University of Texas Southwestern Medical Center at Dallas, Dallas, TX, USA.
¹⁶ Department of Urology, Weill Cornell Medical College, New York, NY, USA.
¹⁷ Research Center for Evidence Medicine, Urology Department Tabriz University of Medical Sciences, Tabriz, Iran.

PMID: 38627025
DOI: 10.1111/bju.16371

Abstract

Objective: To evaluate the impact of adjuvant therapy on oncological outcomes in patients with intermediate-risk non-muscle-invasive bladder cancer (NMIBC), as due to the poorly-defined and overlapping diagnostic criteria optimal decision-making remains challenging in these patients.

Patients and methods: In this multicentre study, patients treated with transurethral resection of bladder tumour for Ta disease were retrospectively analysed. All patients with low- or high-risk NMIBC were excluded from the analysis. Associations between adjuvant therapy administration with recurrence-free survival (RFS) and progression-free survival (PFS) rates were assessed in Cox regression models.

Results: A total of 2206 patients with intermediate-risk NMIBC were included in the analysis. Among them, 1427 patients underwent adjuvant therapy, such as bacille Calmette-Guérin (n = 168), or chemotherapeutic agents, such as mitomycin C or epirubicin (n = 1259), in different regimens up to 1 year. The median (interquartile range) follow-up was 73.3 (38.4-106.9) months. The RFS at 1 and 5 years in patients treated with adjuvant therapy and those without were 72.6% vs 69.5% and 50.8% vs 41.3%, respectively. Adjuvant therapy was associated with better RFS (hazard ratio [HR] 0.79, 95% confidence interval [CI] 0.70-0.89, P < 0.001), but not with PFS (P = 0.09). In the subgroup of patients aged ≤70 years with primary, single Ta Grade 2 <3 cm tumours (n = 328), adjuvant therapy was not associated with RFS (HR 0.71, 95% CI 0.50-1.02, P = 0.06). While in the subgroup of patients with at least one risk factor including patient age >70 years, tumour multiplicity, recurrent tumour and tumour size ≥3 cm (n = 1878), adjuvant intravesical therapy was associated with improved RFS (HR 0.78, 95% CI 0.68-0.88, P < 0.001).

Conclusion: In our study, patients with intermediate-risk NMIBC benefit from adjuvant intravesical therapy in terms of RFS. However, in patients without risk factors, adjuvant intravesical therapy did not result in a clear reduction in the recurrence rate.

Keywords: BCG; NMIBC; adjuvant; chemotherapy; intravesical.