Kasa invaze olmayan BCG-refraktör mesane kanserinde güncel tedaviler

Kasa invaziv olmayan mesane kanseri (KİOMK) için birinci basamak tedavi intravezikal Bacillus Calmette-Guerin’dir (BCG). BCG’ye rağmen, tekrarlayan veya ilerleyen mesane kanseri için acilen alternatif tedavilere ihtiyaç vardır. BCG-refraktör Mesane kanserinde radikal sistektomi altın standart tedavidir. Hastaya bağlı nedenler ile(komorbidite, operasyon istememe gibi) sistektomi yapılamadığında diğer tedavilere başlanmalıdır. İntravezikal gemstabin, taksanlar, kombinasyon tedavileri , aşılar, gen terapisi gibi birçok klinik çalışma, bir sonraki adımı belirlemede kritik öneme sahiptir. Radikal sistektomiye alternatif, iyi tasarlanmış birçok yeni tedavi çalışması halen devam etmektedir. Yakın gelecekte rutin klinik uygulamaya girmesi beklenmektedir. Yeni tedaviler ile beraber mesane kanser tedavisinde önemli değişiklikler olacaktır.

Anahtar Kelimeler:

Kasa İnvaze olmayan mesane kanseri, BCG-Refraktör, Radikal sistektomi, intravezikal tedaviler

Current intravesical therapies BCG-failure in non-muscle-invasive bladder cancer

The first-line treatment for non-muscle invasive bladder cancer (NMIBC) is intravesical Bacillus CalmetteGuerin (BCG). Despite BCG, alternative treatments are urgently required for recurrent or progressive bladder cancer. Cystectomy is the gold standard treatment in BCG failure in bladder cancer. When cystectomy can not be performed for reasons related to the patient, other treatments should be started. Many clinical studies such as intravesical gemcitabine, taxanes or combination treatment, new therapeutic agents,..etc are critical in determining the next step. Alternative to radical cystectomy, well designed and many new treatment studies are still ongoing. They seem ready for routine clinical practice in the near future. We believe that NMIBC treatment modalities will change in the near future.

Keywords:

Non-muscle invasive bladder cancer, BCG-refractory, Radical cystectomy, intravesical teratments,

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Antoni S, Ferlay J, Soerjomataram I, et al. Bladder cancer incidence and mortality: a global overview and recent trends. Eur Urol. 2017; 71(1):96-108.
Kulkarni GS, Hakenberg OW, Gschwend JE, et al. An updated critical analysis of the treatment strategy for newly diagnosed high-grade T1 (previously T1G3) bladder cancer. Eur Urol. 2010; 57(1):60-70.
Babjuk M, Böhle A, Burger M, et al. European Association of Urology guidelines on non-muscle-invasive bladder cancer (TaT1 and carcinoma In Situ)-2019 update. Eur Urol. 2019; 76(5):639-657.
Sylvester R, Meijden AP, Oosterlinck W, et al. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006; 49(3):466-477.
Lamm DL, Blumenstein BA, Crissman JD, et al. Maintenance bacillus Calmette-Guerin immunotherapy for recurrent TA, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group Study. J Urol. 2000; 163(4):1124-1129.
Malmström P, Sylvester R, Crawford D, et al. An individual patient data meta-analysis of the long-term outcome of randomised studies comparing intravesical mitomycin C versus bacillus Calmette-Guérin for non–muscle-invasive bladder cancer. Eur Urol. 2009; 56(2):247-256.
Thiel T, Ryk C, Renström-Koskela L, et al. Intravesical BCG treatment causes a long-lasting reduction of recurrence and progression in patients with high-risk non-muscle-invasive bladder cancer. World J Urol. 2019; 37(1):155-163.
Van der Meijden AP, Sylvester RJ, Oosterlinck W, et al. Maintenance Bacillus Calmette-Guerin for Ta T1 bladder tumors is not associated with increased toxicity: results from a European Organisation for Research and Treatment of Cancer Genito-Urinary Group Phase III Trial. Eur Urol. 2003; 44(4):429-434.
Shirakawa H, Kikuchi E, Tanaka N, et al. Prognostic significance of Bacillus Calmette‐Guérin failure classification in non‐muscle‐invasive bladder cancer. BJU Int. 2012; 110(6b):E216-E221.
Herr HW, Dalbagni G. Defining bacillus Calmette-Guerin refractory superficial bladder tumors. J Urol. 2003; 169(5):1706-1708.
Klaassen Z, Kamat AM, Kassouf W, et al. Treatment strategy for newly diagnosed T1 high-grade bladder urothelial carcinoma: new insights and updated recommendations. Eur Urol. 2018; 74(5):597-608.
Stein JP, Lieskovsky G, Cote R, et al. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001; 19(3):666-675.
Fritsche HM, Burger M, Svatek RS, et al. Characteristics and outcomes of patients with clinical T1 grade 3 urothelial carcinoma treated with radical cystectomy: results from an international cohort. Eur Urol. 2010; 57(2):300-309.
Canter D, Egleston B, Wong YN, et al. Use of radical cystectomy as initial therapy for the treatment of high-grade T1 urothelial carcinoma of the bladder: a SEER database analysis. Urol Oncol. 2013; 31(6):866-870.
Herr HW, Sogani PC. Does early cystectomy improve the survival of patients with high-risk superficial bladder tumors? J Urol. 2001; 166(4):1296-1299.
Denzinger S, Fritsche HM, Otto W, et al. Early versus deferred cystectomy for initial high-risk pT1G3 urothelial carcinoma of the bladder: do risk factors define feasibility of bladder-sparing approach? Eur Urol. 2008; 53(1):146-152.
Gontero P, Sylvester R, Pisano F, et al. Prognostic factors and risk groups in T1G3 non–muscle-invasive bladder cancer patients initially treated with bacillus Calmette-Guérin: results of a retrospective multicenter study of 2451 patients. Eur Urol. 2015; 67(1):74-82.
Brake M, Loertzer H, Horsch R, et al. Long-term results of intravesical bacillus Calmette-Guerin therapy for stage T1 superficial bladder cancer. Urology. 2000; 55(5):673-678.
Daniels MJ, Barry E, Schoenberg M, et al. Contemporary oncologic outcomes of second induction course BCG in patients with nonmuscle invasive bladder cancer. Urol Oncol. 2020; 38(1):5.e9-5.e16.
Malmstrom PU, Wijkström H, Lundholm C, et al. 5-year followup of a randomized prospective study comparing mitomycin C and bacillus Calmette-Guerin in patients with superficial bladder carcinoma. J Urol. 1999; 161(4):1124-1127.
Hayne D, Stockler P, McCombie SP, et al. BCG+MMC trial: adding mitomycin C to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer: a randomised phase III trial (ANZUP 1301). BMC cancer. 2015; 15(1):432.
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. J Urol. 2000; 163(3):761-767.
Lerner SP, Dinney C, Kamat A, et al. Clarification of Bladder Cancer Disease States Following Treatment of Patients with Intravesical BCG. Bladder cancer. 2015; 1(1):29-30.
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(5):181-191.
Dalbagni G, Russo P, Bochner B, et al. Phase II trial of intravesical gemcitabine in bacille Calmette-Guérin–refractory transitional cell carcinoma of the bladder. J Clin Oncol. 2006; 24(18):2729-2734.
Skinner EC, Goldman B, Sakr WA, et al. SWOG S0353: Phase II trial of intravesical gemcitabine in patients with nonmuscle invasive bladder cancer and recurrence after 2 prior courses of intravesical bacillus Calmette-Guerin. J Urol. 2013; 190(4):1200-1204.
Di Lorenzo G, Perdonà S, Damiano R, et al. Gemcitabine versus bacille Calmette‐Guerin after initial bacille Calmette‐Guerin failure in non‐muscle‐invasive bladder cancer: a multicenter prospective randomized trial. Cancer. 2010; 116(8):1893-1900.
Barlow L, McKiernan J, Sawczuk I, et al. A single‐institution experience with induction and maintenance intravesical docetaxel in the management of non‐muscle‐invasive bladder cancer refractory to bacille Calmette‐Guérin therapy. BJU Int. 2009; 104(8):1098-1102.
Barlow LJ, McKiernan JM, Benson MC. Long-term survival outcomes with intravesical docetaxel for recurrent nonmuscle invasive bladder cancer after previous bacillus Calmette-Guérin therapy. J Urol. 2013; 189(3):834-839.
McKiernan JM, Holder D, Ghandour RA, et al. Phase II trial of intravesical nanoparticle albumin bound paclitaxel for the treatment of nonmuscle invasive urothelial carcinoma of the bladder after bacillus Calmette-Guérin treatment failure. J Urol. 2014; 192(6):1633-1638.
Robins DJ, Sui W, Matulay JT, et al. Long-term survival outcomes with intravesical nanoparticle albumin-bound paclitaxel for recurrent non–muscle-invasive bladder cancer after previous bacillus Calmette-Guérin therapy. Urology. 2017; 103:149-153.
Maymi JL, Saltsgaver N, O’Donnell MA. 840: Intravesical sequential gemcitabine-mitomycin chemotherapy as salvage treatment for patients with refractory superficial bladder cancer. J Urol. 2006; Moderated Poster.
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(3):456-462.
Lightfoot AJ, Breyer BN, Rosevear HM, et al. Multi-institutional analysis of sequential intravesical gemcitabine and mitomycin C chemotherapy for non–muscle invasive bladder cancer. Urol Oncol. 2014; 32(1):35.e15-9.
Steinberg RL, Thomas LJ, O’Donnellet MA, et al. Sequential intravesical gemcitabine and docetaxel for the salvage treatment of non-muscle invasive bladder cancer. Bladder Cancer. 2015; 1(1):65-72.
DeCastro GJ, Sui W, Pak JS, et al. A phase I trial for the use of intravesical cabazitaxel, gemcitabine, and cisplatin (CGC) in the treatment of BCG-refractory nonmuscle invasive urothelial carcinoma of the bladder. J Urol. 2020; 204(2):247-253.
DeCastro GJ, Sui W, Pak JS, et al. Mp43-14 a phase 1 trial of intravesical cabazitaxel, gemcitabine, and cisplatin (cgc) for the treatment of non-muscle invasive bcg unresponsive urothelial carcinoma of the bladder. J Urol. 2019; 201(Supplement 4):e623-e623.
Ryan AA, Wozniak TM, Shklovskaya E, et al. Improved protection against disseminated tuberculosis by Mycobacterium bovis bacillus Calmette-Guerin secreting murine GM-CSF is associated with expansion and activation of APCs. J Immun. 2007; 179(12):8418-8424.
Steinberg RL, Nepple KG, Velaer KN, et al. Quadruple immunotherapy of Bacillus Calmette-Guérin, interferon, interleukin-2, and granulocyte-macrophage colony-stimulating factor as salvage therapy for non–muscle-invasive bladder cancer. Urol Oncol. 2017; 35(12):670.e7-670.e14.
Morales A, Chin JL, Ramsey EW. Mycobacterial cell wall extract for treatment of carcinoma in situ of the bladder. J Urol. 2001; 166(5):1633-1638.
Phillips NC, Filion MC. Therapeutic potential of mycobacterial cell wall-DNA complexes. Expert opinion on investigational drugs. 2001; 10(12): p. 2157-2165.
Morales A, Phadke K, Steinhoff G. Intravesical mycobacterial cell wall-DNA complex in the treatment of carcinoma in situ of the bladder after standard intravesical therapy has failed. J Urol. 2009; 181(3):1040-1045.
Morales A, Phadke K, Steinhoff G, et al. Efficacy and safety of MCNA in patients with nonmuscle invasive bladder cancer at high risk for recurrence and progression after failed treatment with bacillus Calmette-Guérin. J Urol. 2015; 193(4):1135-1143.
Liem EI, Crezee H, de la Rosette J, et al. Chemohyperthermia in non-muscle-invasive bladder cancer: An overview of the literature and recommendations. Int J Hyperthermia. 2016; 32(4):363-373.
Colombo R, Saloni A, Leib Z, et al. Long‐term outcomes of a randomized controlled trial comparing thermochemotherapy with mitomycin‐C alone as adjuvant treatment for non‐muscle‐invasive bladder cancer (NMIBC). BJU Int. 2011; 107(6):912-918.
Van der Heijden A, Kiemeneya LA, Gofrit ON, et al. Preliminary European results of local microwave hyperthermia and chemotherapy treatment in intermediate or high risk superficial transitional cell carcinoma of the bladder. Eur Urol. 2004; 46(1):65-72.
Liu Z, Ye Y, Xiangdong Li, et al. The effects of intra-arterial chemotherapy on bladder preservation in patients with T1 stage bladder cancer. World J Urol. 2018; 36(8):1191-1200.
Weiss C, Wolze C, Engehausen DG, et al. Radiochemotherapy after transurethral resection for high-risk T1 bladder cancer: an alternative to intravesical therapy or early cystectomy? J Clin Oncol. 2006; 24(15):2318-2324.
Siddiqui MR, Grant C, Sanfordet T, et al. Current clinical trials in non–muscle invasive bladder cancer. Urol Oncol. 2017; 35(8):516-527.