Intravesical bacillus Calmette-Guérin therapy prevents tumor progression and death from superficial bladder cancer: ten-year follow-up of a prospective randomized trial.

Herr, Harry W.; Schwalb, David M.; Zhang, Zuo‐Feng; Sogani, Pramod C.; Fair, William R.; Whitmore, Willet F.; Oettgen, Herbert F.

doi:10.1200/jco.1995.13.6.1404

Cited by 281 publications

(128 citation statements)

References 12 publications

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“…Because many high-grade cancers are identified before muscle invasion, it is not unreasonable to believe that a screening strategy could detect these cancers. 14,23 The advantage of BladderChek and other recently developed urine-based markers is the increase in sensitivity, specificity, and PPV compared with hemoglobin dipstick. 9,10 This allows improved detection of cancer and fewer unnecessary work-ups.…”

Section: Discussionmentioning

confidence: 99%

Should we screen for bladder cancer in a high‐risk population?

Lotan

Svatek

Sagalowsky

2006

Cancer

113

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BACKGROUND.The U.S. Food and Drug Administration recently approved screening high‐risk patients for bladder cancer using urine‐based markers. The cost and life‐years saved associated with bladder cancer screening were evaluated.METHODS.A Markov model was created to estimate cumulative cancer‐related costs and efficacy of screening (vs. no screening) of a high‐risk population for bladder cancer using a urine‐based tumor marker over a 5‐year period. Assumptions were based on literature review of survival and progression rates for patients with bladder cancer and costs associated with different bladder cancer disease states.RESULTS.Screening for bladder cancer in a population with a 4% incidence of bladder cancer resulted in a gain of 3.0 life years per 1000 subjects at a cost savings of $101,000 for the population, assuming a 50% downstaging in the screened population from muscle‐invasive to nonmuscle‐invasive disease. One‐way sensitivity analyses found that screening is the most cost‐effective strategy if cancer incidence is >1.6%, tumor marker costs <$126, marker sensitivity is >26%, marker specificity is >54%, downstaging with screening is >20%, and office cystoscopy costs <$694. Varying costs of cystectomy, transurethral resection of bladder tumor (TURBT), chemotherapy, end‐of‐life care, costs of metastatic disease, and a computed tomography scan over a wide range did not affect the superiority of screening.CONCLUSIONS.The model found that urine‐based markers are cost‐effective in a high‐risk population. Prospective randomized trials in a completely asymptomatic high‐risk cohort are indicated before bladder cancer screening can be recommended. Cancer 2006. © 2006 American Cancer Society.

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Section: Discussionmentioning

confidence: 99%

Should we screen for bladder cancer in a high‐risk population?

Lotan

Svatek

Sagalowsky

2006

Cancer

113

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“…Factors affecting response include the presence of high grade papillary disease or CIS, primary vs. recurrent disease, solitary vs. multifocal tumor, granulomatous inflammatory response in the bladder and delayed hypersensitivity skin test response to purified protein derivative [1]. Ten to 22% of patients who fail an initial induction course of BCG may be salvaged with a second induction course [2,3]. Recently, the addition of a single 3 week maintenance course of BCG increased the complete response rate at 6 months from 68% to 84% compared to patients who receive only a 6-week induction course [4].…”

Section: Introductionmentioning

confidence: 99%

Failure to achieve a complete response to induction BCG therapy is associated with increased risk of disease worsening and death in patients with high risk non-muscle invasive bladder cancer

Lerner

Tangen

Sucharew

et al. 2009

Urologic Oncology: Seminars and Original Investigations

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Purpose-The Southwest Oncology Group conducted a randomized trial of induction BCG with or without maintenance BCG. In these additional retrospective analyses, our goal was to evaluate the association of a complete response (CR) or remaining with no evidence of disease (NED) versus no CR during induction therapy with subsequent survival after adjusting for other potential confounders. Among all patients randomized to maintenance treatment, we also wanted to identify combinations of baseline covariates in order to define prognostic groups for subsequent worseningfree survival.Methods-Outcome measures of worsening-free and overall survival were assessed using Kaplan Meier estimates and proportional hazards regression models. For the Classification and Regression Tree (CART) analysis, 434 patients randomized to maintenance vs. no therapy with complete covariate information were included.Results-Of the 593 evaluable patients, 341 were not randomized to maintenance BCG. Patients who achieved a prior complete response during induction BCG had a 5-year survival probability of 77% compared to 62% for patients who did not [Hazard ratio (HR) 0.60; 95% confidence interval (CI) 0.44, 0.81; p= 0.0008]. Prior CR retained significance when adjusted for age, gender, prior intravesical chemotherapy, and papillary disease versus CIS (HR=0.63; 95% CI: .46, .86; p=0.003). CART analysis identified 4 prognostic groups. Older patients (≥ 62 years old) previously treated with intravesical chemotherapy who failed to achieve a CR had a 5-fold higher risk of a worsening event relative to those who are younger (< 67 years old) and achieve a CR (HR=5.09; 95% CI: 3.37, 7.68; p<0.0001). Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Conclusion-Failure to achieve a complete response after induction BCG is associated with a significant risk of a worsening event and death for patients with CIS or Ta or T1 bladder cancer at increased risk of recurrence. NIH Public Access

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“…11 A single randomized trial of 86 patients with high-risk disease and 15-year follow-up demonstrated a survival advantage for BCG in conjunction with TUR. 4,12 Three meta-analyses concluded that BCG in conjunction with TUR reduced recurrence [13][14][15] and progression 16 of NMIBC but had no effect on overall (OS) or disease-specific survival. 16 The inability to demonstrate a survival advantage likely results from the major-ity of studies having relatively short follow-up, given the prolonged natural history of NMIBC and the low risk of progression from non-muscle-invasive to invasive disease.…”

Section: Introductionmentioning

confidence: 99%

Adjuvant Intravesical Bacillus Calmette-Guérin Therapy and Survival Among Elderly Patients With Non–Muscle-Invasive Bladder Cancer

Spencer

McBride

Hershman

et al. 2013

JOP

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Purpose: National guidelines recommend adjuvant intravesical Bacillus Calmette-Gué rin (BCG) therapy for higher-risk nonmuscle-invasive bladder cancer (NMIBC). Although a survival benefit has not been demonstrated, randomized trials have shown reduced recurrence and delayed progression after its use. We investigated predictors of BCG receipt and its association with survival for older patients with NMIBC. Patients and Methods:We identified individuals with NMIBC registered in the Surveillance, Epidemiology, and End Results-Medicare database from 1991 to 2003. We used logistic regression to compare those treated with BCG within 6 months of initial diagnosis with those not treated, adjusting for demographic and clinical factors. Cox proportional hazards modeling was used to analyze the association between BCG and overall survival (OS) and bladder cancer-specific survival (BCSS) for the entire cohort and within tumor grades. Results:Of 23,932 patients with NMIBC identified, 22% received adjuvant intravesical BCG. Predictors of receipt were stages T is and T 1 , higher grade, and urban residence. Age Ͼ 80 years, fewer than two comorbidities, and not being married were associated with decreased use. In the survival analysis, BCG use was associated with better OS (hazard ratio [HR], 0.87; 95% CI, 0.83 to 0.92) in the entire cohort and BCSS among higher-grade cancers (poorly differentiated: HR, 0.78; 95% CI, 0.72 to 0.85; undifferentiated: HR, 0.66; 95% CI, 0.56 to 0.77). Conclusion: Despite guidelines recommending its use, BCGis administered to less than one quarter of eligible patients. This large population-based study found improved OS and BCSS were associated with use of adjuvant intravesical BCG among older patients with NMIBC. Better-designed clinical trials focusing on higher-grade cancers are needed to confirm these findings.

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Intravesical bacillus Calmette-Guérin therapy prevents tumor progression and death from superficial bladder cancer: ten-year follow-up of a prospective randomized trial.

Abstract: This study shows that intravesical therapy with BCG delays tumor progression and death from tumor in patients who present with superficial bladder cancer.

Cited by 281 publications

References 12 publications

Should we screen for bladder cancer in a high‐risk population?

Should we screen for bladder cancer in a high‐risk population?

Failure to achieve a complete response to induction BCG therapy is associated with increased risk of disease worsening and death in patients with high risk non-muscle invasive bladder cancer

Adjuvant Intravesical Bacillus Calmette-Guérin Therapy and Survival Among Elderly Patients With Non–Muscle-Invasive Bladder Cancer

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