Management of BCG failure in non-muscle-invasive bladder cancer − the present and the future
Authors:
J. Horňák; A. Brisuda; M. Babjuk
Authors‘ workplace:
Urologická klinika 2. lékařská fakulta Univerzity Karlovy a Fakultní nemocnice v Motole, Praha
Published in:
Rozhl. Chir., 2022, roč. 101, č. 3, s. 108-113.
Category:
Review
doi:
https://doi.org/10.33699/PIS.2022.101.3.108–113
Overview
Bladder neoplasms are still among the most common cancer types in the Czech Republic. Even though the majority (more than 90%) of bladder tumours are of urothelial origin, the group is vastly heterogeneous in terms of biological behaviour and thus also progression of the disease. Adequate adjuvant treatment is the cornerstone of the therapy in high-risk patients for disease recurrence, particularly those with a high risk of progression to a muscle-invasive disease (T2 and higher). Intravesical BCG immunotherapy still remains such a therapy. It is a standard therapy with well-established efficacy as regards the recurrence rate and a reduced risk of progression. Nevertheless, radical cystectomy is recommended in patients in whom this therapy fails. Considering the non-negligible morbidity and mortality associated with this type of surgery, intensive research efforts have been put forth to develop new bladder preserving strategies. This article outlines the main bladder preserving strategies that are currently explored.
Keywords:
Bladder cancer – BCG failure
Sources
1. Novotvary ČR. Praha: Ústav zdravotnických informací a statistiky České republiky. 1989. ISSN 1210-857X.
2. Compérat E, Larré S, Roupret M, et al. Clinicopathological characteristics of urothelial bladder cancer in patients less than 40 years old. Virchows Archiv 2015;466:589–594.
3. Babjuk M, Burger M, Compérat E, et al. European Association of Urology Guidelines on non-muscle-invasive bladder cancer (TaT1 and carcinoma in situ) Edn. Presented at the EAU Annual Congress Milan 2021. ISBN 978-94-92671-13-4.
4. Lamm DL. Long-term results of intravesical therapy for superficial bladder cancer. Urol Clin North Am. 1992 Aug;19(3):573−580. doi:10.1016/S0094- 0143(21)00424-9.
5. Dvořáček J, Babjuk M, Babjuk J. Onkourologie. Praha, Galén 2005. ISBN 80- 7262-349-4.
6. Lamm D, Persad R, Brausi M, et al. Defining progression in non muscle invasive bladder cancer: it is time for a new, standard definition. J Urol. 2014 Jan;191(1):20−27. doi 10.1016/j.juro.2013.07.102. Epub 2013 Aug 22. PMID: 23973937.
7. Hušek P, Pacovská J, Broďák M. BCG – historie, mechanismus účinku, indikace, účinnost, dávkování. Urologie pro praxi [online] 2019;20(4):157−160. ISSN 12131768. doi:10.36290/uro.2019.069.
8. Witjes JA. Management of BCG failures in superficial bladder cancer: A review. Eur Urol. 2006 May;49(5):790−797. doi:10.1016/j.eururo.2006.01.017. Epub 2006 Jan 24. PMID: 16464532.
9. Zhang N, Jiang G, Liu X, et al. Prediction of bacillus Calmette-Guerin response in patients with bladder cancer after transurethral resection of bladder tumor by using genetic variation based on genomic studies. Biomed Res Int. 2016;2016:9859021. doi:10.1155/2016/9859021.
10. Shariat SF, Karakiewicz PI, Palapattu GS, et al. Outcomes of radical cystectomy for transitional cell carcinoma of the bladder: a contemporary series from the Bladder Cancer Research Consortium. J Urol. 2006 Dec;176(6 Pt 1):2414−22; discussion 2422. doi:10.1016/j.juro.2006.08.004. PMID: 17085118.
11. Witjes JA, Bruins HM, Cathomas R, et al. European Association of Urology Guidelines on muscle-invasive and metastatic bladder cancer: Summary of the 2020 Guidelines. Eur Urol. 2021;79:82−104. doi:10.1016/j.eururo.2020.03.055.
12. Ferguson JE 3rd, Kamat AM. It‘s all about the perspective: Removing bias when co-managing patients with high-grade T1 bladde rcancer and localized prostate cancer − a competing risks analysis. Urol Oncol. 2018 Feb;36(2):39−42. doi:10.1016/j.urolonc.2017.10.019. Epub 2017 Nov 20. PMID: 29158136.
13. Skinner EC, Goldman B, Sakr WA, et al. SWOG S0353: Phase II trial of intravesical gemcitabine in patients with non muscle invasive bladder cancer and recurrence after 2 prior courses of intravesical bacillus Calmette-Guérin. J Urol. 2013;190:1200–1204.
14. Di Lorenzo G, Perdonà S, Damiano R, et al. Gemcitabine versus bacille Calmette- Guérin after initial bacille Calmette- Guérin failure in non-muscle-invasive bladder cancer: a multicenter prospective randomized trial. Cancer 2010 Apr 15;116(8):1893−900. doi:10.1002/ cncr.24914. PMID: 20162706.
15. Steinberg G, Bahnson R, Brosman S, et al. Efficacy and safety of valrubicin for the treatment of bacillus Calmette-Guerin refractory carcinoma in situ of the bladder. The Valrubicin Study Group. J Urol. 2000;163:761–767.
16. Dinney CP, Greenberg RE, Steinberg GD. Intravesical valrubicin in patients with bladder carcinoma in situ and contraindication to or failure after bacillus Calmette- Guérin. Urol Oncol 2013;31:1635–1642.
17. Cookson MS, Chang SS, Lihou C, et al. Use of intravesical valrubicin in clinical practice for treatment of nonmuscle-invasive bladder cancer, including carcinoma in situ of the bladder. Ther Adv Urol. 2014;6:181–191.
18. Laudano MA, Barlow LJ, Murphy AM, et al. Long-term clinical outcomes of a phase I trial of intravesical docetaxel in the management of non-muscle-invasive bladder cancer refractory to standard intravesical therapy. Urology 2010;75:134–137.
19. Barlow LJ, McKiernan JM, Benson MC. Long-term survival outcomes with intravesical docetaxel for recurrent non muscle invasive bladder cancer after previous bacillus Calmette-Guérin therapy. J Urol. 2013 Mar;189(3):834−839. doi: 10.1016/j. juro.2012.10.068. Epub 2012 Oct 30. PMID: 23123371.
20. Kim HS, Seo HK. Emerging treatments for bacillus Calmette–Guérin-unresponsive non-muscle-invasive bladder cancer. Investig Clin Urol. 2021 Jul;62(4):361−377.
21. McKiernan JM, Holder DD, Ghandour RA, et al. Phase II trial of intravesical nanoparticle albumin bound paclitaxel for the treatment of non muscle invasive urothelial carcinoma of thebladder after bacillus Calmette-Guérin treatment failure. J Urol. 2014;192:1633–1638.
22. Cockerill PA, Knoedler JJ, Frank I, et al. Intravesical gemcitabine in combination with mitomycin C as salvage treatment in recurrent non-muscle-invasive bladder cancer. BJU Int 2016;117:456–462.
23. Steinberg RL, Thomas LJ, Brooks N, et al. Multi-institution evaluation of sequential gemcitabine and docetaxel as rescue therapy for non muscle invasive bladder cancer. J Urol. 2020;203:902–909.
24. Hendricksen K. Device-assisted intravesical therapy for non-muscle invasive bladder cancer. Transl Androl Urol. 2019;8:94– 100.
25. Chiancone F, Fabiano M, Fedelini M, et al. Outcomes and complications of hyperthermic intravesical chemotherapy using mitomycin C or epirubicin for patients with non-muscleinvasive bladder cancer after bacillus Calmette- Guérin treatment failure. Cent European J Urol. 2020;73(3):287−294. doi:10.5173/ ceju.2020.0148. Epub 2020 Aug 6. PMID: 33133655; PMCID: PMC7587473.
26. Kos B, Vásquez JL, Miklavčič D, et al. Investigation of the mechanisms of action behind Electromotive Drug Administration (EMDA) PeerJ 4:e2309.2016; doi:org/10.7 717/peerj.2309.
27. Kolaříková M. Fotodynamická terapie in vitro na nádorových buněčných liniích. Olomouc, 2020. Diplomová práce. Univerzita Palackého, Olomouc, Přírodovědecká fakulta.
28. Waidelich R, Stepp H, Baumgartner R, et al. Clinical experience with 5-aminolevulinic acid and photodynamic therapy for refractory superficial bladder cancer. J Urol. 2001;165(6 Pt 1):1904–1907.
29. Sathianathen NJ, Regmi S, Gupta S, et al. Immunooncology approaches to salvage treatment for non-muscle invasive bladder cancer. Urol Clin North Am. 2020;47:103–110.
30. Darvin P, Toor SM, Sasidharan NV, et al. Immune checkpoint inhibitors: recent progress and potential biomarkers. Exp Mol Med. 2018;50:1–11. doi:org10.1038/ s12276-018-0191-1.
31. Kim HS, Seo HK. Immune checkpoint inhibitors for urothelial carcinoma. Investig Clin Urol. 2018;59:285–296.
32. Kates M, Matoso A, Choi W, et al. Adaptive immune resistance to intravesical BCG in non-muscle invasive bladder cancer: implications for prospective BCG-unresponsive trials. Clin Cancer Res. 2020;26:882– 891.
33. Wright KM. FDA Approves pembrolizumab for BCG-unresponsive NMIBC. Oncology (Williston Park) 2020 Feb 20;34(2):44. PMID: 32645193.
34. Balar AV, Kulkarni GS, Uchio EM, et al. Keynote 057: Phase II trial of pembrolizumab (pembro) for patients (pts) with highrisk (HR) non muscle invasive bladder cancer (NMIBC) unresponsive to bacillus Calmette-Guérin (BCG). J Clin Oncol. 2019;37(7 Suppl):350.
35. Black PC, Tangen C, Singh P, et al. Phase II trial of atezolizumab in BCG-unresponsive non-muscle invasive bladder cancer: SWOG S1605 (NCT #02844816). J Clin Oncol. 2020;38(15 Suppl):5022.
36. Boorjian SA, Dinney CPN. SUO Clinical Trials Consortium. Safety and efficacy of intravesical nadofaragene firadenovec for patients with high-grade, BCG unresponsive non muscle invasive bladder cancer (NMIBC): results from a phase III trial. J Clin Oncol. 2020;38(6 Suppl):442.
37. Boorjian SA, Alemozaffar M, Konety BR, et al. Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial. Lancet Oncol. 2021;22:107– 117.
38. ClinicalTrials.gov Identifier: NCT04452591 https://clinicaltrials.gov/ct2/show/ NCT04452591.
39. Steinberg GD, Palou-Redorta J, Gschwend JE, et al. A randomized phase II study of erdafitinib (ERDA) versus intravesical chemotherapy (IC) in patients with high-risk non muscle invasive bladder cancer (HRNMIBC) with FGFR mutations or fusions, who recurred after bacillus Calmette- Guérin (BCG) therapy. J Clin Oncol. 2020;38(6 Suppl):TPS603.
40. Shore N, O‘Donnell M, Keane T, et al. PD03-02. Phase 3 results of vicinium in BCG-unresponsive non-muscle invasive bladder cancer. Journal of urology [online]. 2020;203(supplement 4) [cit. 2021- 11-14]. issn 0022-5347 doi:10.1097/ ju.0000000000000823.02.
Labels
Surgery Orthopaedics Trauma surgeryArticle was published in
Perspectives in Surgery
2022 Issue 3
Most read in this issue
- New trends in prostate cancer diagnostics
- Occult breast cancer: a case report and current management of treatment
- Penile amputation for sarcoma
- Risk of biochemical recurrence in patients with a positive surgical margin after radical prostatectomy