Recurrence, Progression and Success in Stage Ta Grade 3 Bladder Tumors Treated With Low Dose Bacillus Calmette-Guerin Instillations

Lebrét, Thierry; Bohin, Denis; Kassardjian, Z; Hervé, Jean-Marie; Molinié, Vincent; Barré, Philippe; Lugagne, Pierre-Marie; Botto, Henry

doi:10.1016/s0022-5347(05)67973-6

Cited by 86 publications

(22 citation statements)

References 30 publications

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“…Herr [6] followed 125 such patients for 15 years and observed progression in 39%, and Lebret et al [30] reported 25% progression in 4 years. Therefore, grade seems to be an important risk factor for progression.…”

Section: Discussionmentioning

confidence: 99%

Recurrence and Progression of T1G3 Transitional Cell Carcinoma of the Bladder Treated with Intravesical Bacillus Calmette-Guérin

et al. 2005

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Objective: To examine the incidence of recurrence and progression in patients with stage T1, grade-3 carcinoma of the bladder treated with endovesical bacillus Calmette-Guérin (BCG) after complete transurethral resection. Material and Methods: From May 1995 to June 2002, 937 patients with superficial bladder cancer underwent transurethral resection. 46 patients (4.9%) had T1G3 tumors. All patients received endovesical BCG therapy 2–3 weeks after transurethral resection, given in 6 sessions as weekly instillations of 120 ml Pasteur strain BCG in 50 ml saline. Success was defined by normal cytology and cystoscopy, and normal bladder biopsies. Recurrent tumors were resected and a second or third cycle of therapy was given according to pathological status. Progressive tumors were managed by radical cystectomy, radiotherapy and/or chemotherapy depending on the nature of the tumor or clinical status of the patient. Results: During follow-up 60.7% of the patients (28 of 46) remained tumor free after only 1 BCG cycle and 73.9% (34 of 46) after the third BCG cycle, and the bladder was preserved in all. Muscle-invasive progression was noted in 10 (21.7%) patients at the end of the BCG cycles. Radical cystectomy was done in 10 patients. The tumor-free survival rate of all patients including those who underwent cystectomy is 84.8% (39 of 46) with a median follow-up of 61 (range 39–118) months. Conclusion: Adjuvant immunotherapy with BCG after complete transurethral resection of the bladder tumor represents a highly effective treatment for bladder preservation in stage pT1, grade-3 carcinoma of the bladder. pT1G3 tumors with early high-grade recurrence after failed immunotherapy should be regarded as candidates for early radical cystectomy.

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Section: Discussionmentioning

confidence: 99%

Recurrence and Progression of T1G3 Transitional Cell Carcinoma of the Bladder Treated with Intravesical Bacillus Calmette-Guérin

et al. 2005

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“…Three used short courses of six weekly instillations [11][12][13], whilst the other three added a 12-month maintenance therapy [14][15][16]. The former yielded recurrence rates of 26-47% and progression rates of 9-25%; the latter studies, using maintenance therapy, gave recurrence rates of 16-23% and progression rates of 0-13.7%.…”

Section: Discussionmentioning

confidence: 99%

Long‐term follow‐up of a randomized prospective trial comparing a standard 81 mg dose of intravesical bacille Calmette‐Guérin with a reduced dose of 27 mg in superficial bladder cancer

̃eiro¹,

Flores²,

Isorna³

et al. 2002

BJU International

194

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Objectives To determine the efficacy of a three-fold reduced dose (RD, 27 mg) of intravesical bacille CalmetteGuérin (BCG) against the standard dose (81 mg) in patients with superficial bladder cancer, assessing recurrence, progression and differences in toxicity. Patients and methods Five hundred patients with superficial bladder cancer (Ta, T1, Tis) were enrolled and randomly assigned to be treated after transurethral resection of all visible lesions with intravesical BCG Connaught strain (weeklyrsix and thereafter fortnightlyrsix) either with the standard or RD instillation. Results All but one of the 500 patients were evaluable for efficacy and toxicity (252 in the standard arm and 247 in the RD arm). The median follow-up was 69 months (maximum 104); 71 (28%) patients in the standard arm and 76 (31%) in the RD arm developed recurrences; the median time to recurrence has not yet been attained, but at 5 years the mean (SD) percentage of recurrence-free patients was 70.5 (3.12) and 70.4 (3.1) for the standard and RD arms, respectively. In patients presenting with multifocal tumours, the standard dose was more effective against recurrences than the RD (P=0.0151). In those with G3 and high-risk tumours overall, the superiority of the standard dose was marginal (P=0.060 and P=0.082). Twenty-nine (11.5%) tumours in the standard arm and 33 (13.3%) in the RD arm progressed to invasive disease; the median time to progression has not yet been attained, but the percentage of progression-free patients at 5 years was 88.8 (2.23) and 86.9 (2.31) for the standard and RD arms, respectively. The standard dose was more effective than the RD against progression only in patients with multifocal disease (P=0.048). Twelve (4.8%) cystectomies were performed in the standard and 15 (6.1%) in the RD arm. Currently, 106 (21.2%) patients have died, but only 38 (7.6%) from bladder cancer, i.e. 20 (7.9%) in the standard and 18 (7.5%) in RD arm. Overall the disease-specific death rate was lower for those patients who completed the scheduled treatment. The cause-specific survival at 5 years did not differ between the arms (P=0.76) but there was a trend toward better cause-specific survival for patients with multifocal tumours in the standard arm. Toxicity differed between the arms, significantly more patients having no toxicity in the RD arm, and fewer having delayed instillations or withdrawing. However, severe systemic toxicity occurred even in patients treated with the RD, in a similar proportion to those receiving the standard dose. Conclusion Overall, the RD gave similar results for recurrence and progression but with significantly less toxicity. However, patients with multifocal tumours fared better with the standard dose and there was a trend towards better recurrence rates in patients with highrisk tumours. We recommend continuing to use the standard dose for high-risk tumours, while we consider the reduced dose safe and effective for intermediaterisk lesions and for maintenance schedules.

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“…24,25 Some recent trials have demonstrated that a reduced regimen (one-third dose) may be as effective as standard dosing with fewer side effects. 26,27 Concern regarding BCG-related toxicity and disease progression has led to the study of other intravesical chemotherapeutic agents (Table 1) in the treatment of NMIBC, most notably mitomycin C (MMC). 9 However, large meta-analyses examining patients with Ta and T1 TCC have concluded that BCG is superior to intravesical chemotherapy in preventing tumor recurrence in patients at high risk 28,29 and when maintenance therapy is utilized.…”

Section: Bacillus Calmette-guerinmentioning

confidence: 99%

Emerging intravesical therapies for management of nonmuscle invasive bladder cancer

Smaldone¹,

Tomaszewski²

2010

OAJU

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Transitional cell carcinoma (TCC) is the second most common urologic malignancy, and 70% of patients present with superficial or nonmuscle invasive bladder cancer (NMIBC). Intravesical bacillus Calmette-Guerin (BCG) is the most effective agent for preventing disease recurrence, and the only therapy able to inhibit disease progression. However, recurrence rates as high as 30% and significant local and systemic toxicity have led to increased interest in alternative intravesical therapies. In patients refractory or intolerant to BCG, BCG-interferon α2b, gemcitabine, and anthracyclines (doxorubicin, epirubicin, valrubicin) have demonstrated durable clinical responses. Phase I trials investigating alternative cytotoxic agents, such as apaziquone, taxanes (docetaxel, paclitaxel), and suramin are reporting promising data. Novel immunomodulating agents have demonstrated promise as efficacious alternatives in patients refractory to BCG. Optimization of existing chemotherapeutic regimens using hyperthermia, photodynamic therapy, magnetically-targeted carriers, and liposomes remains an area of active investigation. Despite enthusiasm for new intravesical agents, radical cystectomy remains the treatment of choice for patients with NMIBC who have failed intravesical therapy and selected patients with naïve T1 tumors and aggressive features. This report provides a comprehensive review of contemporary intravesical therapy for NMIBC and refractory NMIBC, with an emphasis on emerging agents and novel treatment modalities.

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Recurrence, Progression and Success in Stage Ta Grade 3 Bladder Tumors Treated With Low Dose Bacillus Calmette-Guerin Instillations

Cited by 86 publications

References 30 publications

Recurrence and Progression of T1G3 Transitional Cell Carcinoma of the Bladder Treated with Intravesical Bacillus Calmette-Guérin

Recurrence and Progression of T1G3 Transitional Cell Carcinoma of the Bladder Treated with Intravesical Bacillus Calmette-Guérin

Long‐term follow‐up of a randomized prospective trial comparing a standard 81 mg dose of intravesical bacille Calmette‐Guérin with a reduced dose of 27 mg in superficial bladder cancer

Emerging intravesical therapies for management of nonmuscle invasive bladder cancer

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