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Beyond the Abstract - Radical cystectomy for BCG failure: Has the timing improved in recent years? by Mark S. Soloway, MD and Mohan Arianayagam, FRACS (Urol)

BERKELEY, CA (UroToday.com) - Approximately 70% of patients with newly diagnosed bladder cancer (BC) present with stage Ta, CIS or T1.(1)

Transurethral resection of a bladder tumor (TURBT) is required to establish stage and grade, which are critical to formulating a treatment plan. While sometimes erroneously classified as “superficial” Ta, CIS and T1 tumors are a heterogeneous group with varying prognoses. We feel that all high-grade (particularly grade 3) non-muscle invasive bladder cancers (NMIBC) should be treated, as a high percentage of patients with high grade T1 BC progress to muscle invasive BC.(2) Up to one third of patients with high grade T1 BC, initially treated with BCG, require radical cystectomy (RC) and 20 – 30% die of metastatic disease.(2, 3, 4)

 

Over the last couple of years all of our patients with high grade T1 BC undergo a repeat TURBT. The goals are twofold – to establish that the muscle is free of tumor and to render the patient T0 as BCG is most efficacious when the bladder is free of tumor. This is followed by 6 instillations of BCG and subsequent cystoscopy and urine cytology.

If patients have a complete response after BCG, then we usually recommend one year of maintenance BCG with 3 instillations every 3 to 4 months interspersed with regular cystoscopy and cytology. There is limited evidence to suggest maintenance BCG is beneficial after one year.

Patients who recur after BCG are a management dilemma.

Firstly, what is BCG failure? As our patients are T0 prior to BCG then a new or recurrent tumour at the first cystoscopy post-BCG should be considered treatment failure and radical cystectomy (RC) should be emphasized if the patient is a surgical candidate. If a recurrence is noted after one 6-week cycle of BCG should the patient undergo TURBT and then receive more BCG or should the patient proceed to RC? If the recurrence is high-risk, i.e. high grade or T1, then RC should be advocated. However, continued bladder preserving approaches are still used with repeat TUR and BCG.

Unfortunately, the consequences of disease progression are significant and persisting with bladder preservation may compromise long-term survival. The 5-year cancer specific survival for patients with muscle invasive BC (MIBC) is <70%.(5) Patients who fail BCG also have a poorer prognosis compared to stage matched controls.(5) In addition we found that in our series more than 10% of patients who were initially diagnosed with NMIBC and received BCG had lymph node metastases at RC.(6) In contrast, NMIBC is a more curable disease with 5 year cancer specific survival exceeding 90%.(7) These figures are compelling and indicate that delaying cystectomy until patients develop MIBC compromises survival.

The decision to proceed to early RC becomes harder when patients have medical co-morbidities. Smoking, cardiovascular disease, peripheral vascular disease and pulmonary diseases are very common in the bladder cancer population. Despite the advances in medical care and surgical technique the complication rate of cystectomy is over 30% with 90 day mortality of 1-5%.(8) Thus proceeding to cystectomy promptly after failure of a single course of BCG is a difficult decision, especially in elderly patients with co-morbidities. Quality of life issues also make RC a difficult choice especially in younger patients.

We performed a retrospective review of our radical cystectomy database and selected all RC patients who had previously received BCG. They were divided into two separate groups 1993-2002 (77 patients) and 2003-2007 (75 patients). The rate of >T2 BC was found to be higher in the more contemporary group (52% vs. 43%) suggesting that RC is not being performed earlier as we would have hoped.(6)

Hence, it is imperative that BCG failure is recognized early as we may be compromising patient survival by continuing with bladder preserving strategies in the face of recurrent or persistent high grade BC. At this stage we have no reliable molecular markers to assess the risk of progression. Age, prior bladder tumor history, high grade, T1 stage and recurrence at first cystoscopy are the primary indicators we have.(9) Thus, we advocate early radical cystectomy in patients who have recurrent or persistent BC after a single six-week course of BCG. To persist with bladder preservation will compromise survival.

 

References:

  1. Kaufman DS, Shipley WU, Feldman AS. Bladder cancer. Lancet. 2009 Jul 18;374(9685):239-49.
  2. Cookson MS, Herr HW, Zhang ZF, Soloway S, Sogani PC, Fair WR. The treated natural history of high risk superficial bladder cancer: 15-year outcome. J Urol. 1997 Jul;158(1):62-7.
  3. Shahin O, Thalmann GN, Rentsch C, Mazzucchelli L, Studer UE. A retrospective analysis of 153 patients treated with or without intravesical bacillus Calmette-Guerin for primary stage T1 grade 3 bladder cancer: recurrence, progression and survival. J Urol. 2003 Jan;169(1):96-100; discussion
  4. Nieder AM, Simon MA, Kim SS, Manoharan M, Soloway MS. Radical cystectomy after bacillus Calmette-Guerin for high-risk Ta, T1, and carcinoma in situ: defining the risk of initial bladder preservation. Urology, 67(4):737-741, 2006
  5. Schrier BP, Hollander MP, van Rhijn BW, Kiemeney LA, Witjes JA. Prognosis of muscle-invasive bladder cancer: difference between primary and progressive tumours and implications for therapy. Eur Urol. 2004 Mar;45(3):292-6.
  6. Soloway MS, Hepps D, Katkoori D, Ayyathurai R, Manoharan M. Radical cystectomy for BCG failure: has the timing improved in recent years? BJU Int. 2010 Nov 10.
  7. Herr HW, Sogani PC. Does early cystectomy improve the survival of patients with high risk superficial bladder tumors? J Urol. 2001 Oct;166(4):1296-
  8. Hayn MH, Hellenthal NJ, Hussain A, Stegemann AP, Guru KA. Defining Morbidity of Robot-Assisted Radical Cystectomy Using a Standardized Reporting Methodology. Eur Urol. 2010 Nov 10.
  9. Fernandez-Gomez J, Solsona E, Unda M, Martinez-Pineiro L, Gonzalez M, Hernandez R, et al. Prognostic factors in patients with non-muscle-invasive bladder cancer treated with bacillus Calmette-Guerin: multivariate analysis of data from four randomized CUETO trials. Eur Urol. 2008 May;53(5):992-1001.

 

Written by:
Mark S. Soloway, MD and Mohan Arianayagam, FRACS (Urol) as part of Beyond the Abstract on UroToday.com. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc... of their research by referencing the published abstract.

 

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