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

Malmström, Per‐Uno; Sylvester, Richard; Crawford, David; Friedrich, Martin; Krege, Susanne; Rintala, Erkki; Solsona, E.; Stasi, Savino M. Di; Witjes, J. Alfred

doi:10.1016/j.eururo.2009.04.038

Cited by 568 publications

(379 citation statements)

References 19 publications

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“…134 Recently, a meta-analysis using individual patient data from 9 randomized studies including 2820 patients with nonmuscle-invasive bladder cancer was performed, comparing the efficacy of BCG and MMC. 135 Overall, no difference in time to first recurrence occurred; patients who had received BCG maintenance, however, had a 32% decrease in risk of recurrence compared with MMC, but those receiving BCG without maintenance had a 28% increased risk of recurrence compared with MMC. 135 No significant difference was found for progression, overall survival, or cancerspecific survival between the 2 groups.…”

Section: Nonmuscle-invasive Diseasementioning

confidence: 99%

Bladder Cancer in 2010: How Far have We Come?

Jacobs¹,

Lee

Montie

2010

CA: A Cancer Journal for Clinicians

300

275

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Bladder cancer is the fourth most common cancer and ranks eighth as a cause of death from cancer among men in the United States. Although guidelines assist in treatment, the art of managing bladder cancer, such as the decision to use neoadjuvant chemotherapy and the timing of cystectomy, is still variable. Bladder cancer has a propensity to recur, and with recurrence, a significant number of cases progress, which makes the early detection of high-risk patients imperative. Advances in detection, surveillance, and treatment of bladder cancer are reviewed in this article.

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Section: Nonmuscle-invasive Diseasementioning

confidence: 99%

Bladder Cancer in 2010: How Far have We Come?

Jacobs¹,

Lee

Montie

2010

CA: A Cancer Journal for Clinicians

300

275

View full text Add to dashboard Cite

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“…13 In a meta-analysis, a 32% reduction in tumour recurrence for BCG maintenance compared to MMC was found. 4 MMC should be considered a less effective alternative treatment for patients intolerant to BCG.…”

Section: Discussionmentioning

confidence: 99%

“…6 Intravesical mitomycin-C (MMC) for NMIBC has been widely studied. 4 Several studies have demonstrated the benefit of chemohyperthermia (C-HT) over intravesical chemotherapy alone. 6 To enhance the efficacy of MMC, two different methods for intravesical C-HT delivering have been introduced: microwave-induced heating (Synergo, Medical Enterprises, Amsterdam, Netherlands) and conductive heat (UniThermia, Elmedical, Hod-Hasharon, Israel).…”

Section: Introductionmentioning

confidence: 99%

“…3 Instillation of bacillus Calmette-Guérin (BCG) is considered more effective than chemotherapy for NMIBC, representing the first-line option in high-risk patients. 3,4 BCG and intravesical chemotherapy are acceptable alternatives for intermediate-risk patients. 3,4 Although BCG has demonstrated superiority than chemotherapy, it needs to be balanced with side effects.…”

Section: Introductionmentioning

confidence: 99%

“…3,4 BCG and intravesical chemotherapy are acceptable alternatives for intermediate-risk patients. 3,4 Although BCG has demonstrated superiority than chemotherapy, it needs to be balanced with side effects. 5 Due to side effects and failure of BCG, new chemotherapy agents and device-assisted instillation have been tested in high-risk patients.…”

Section: Introductionmentioning

confidence: 99%

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Intravesical bacillus Calmette-Guérin versus chemohyperthermia for high-risk non-muscle-invasive bladder cancer

Ekin¹,

Akarken

Zorlu³

et al. 2015

CUAJ

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Introduction: Patients with high-risk non-muscle invasive bladder cancer (NMIBC) need adjuvant intravesical treatment after surgery. Although bacillus Calmette-Guérin (BCG) is highly effective, new adjuvant treatments to decrease recurrences and toxicity have been studies. We performed a retrospective propensity score-matched study to compare the efficacy of BCG and chemohyperthermia (C-HT). Methods: We included 1937 patients diagnosed with bladder cancer between January 2004 and January 2014. The primary efficacy endpoint was recurrence-free interval. Patients treated with C-HT were matched with patients treated with BCG using propensity score-matched analysis. Cox-regression models were used to estimate the association between intravesical treatments and the presence of recurrence and progression. Results: Of the 710 patients treated with intravesical treatments, 40 and 142 were eligible for inclusion in C-HT and BCG groups, respectively. Following case matching, there were no differences in patient or tumour characteristics between treatment groups. The 2-year recurrence-free interval in C-HT and BCG groups were 76.2% and 93.9%, respectively (p = 0.020). C-HT treatment (hazard ratio [HR] 5.42; 95% confidence interval [CI] 1.11-26.43; p = 0.036) and high-grade tumour (HR 4.60; 95% CI 1.01-20.88; p = 0.048) are associated with an elevated odds of tumour recurrence. In multivariate Cox-regression analysis, there was no significant difference between C-HT and BCG in the odds of recurrence (p = 0.054). There were no differences in progression between C-HT and BCG. Conclusion: C-HT is not as effective treatment as BCG in high-risk NMIBC patients who are BCG-naive. Although, there were no significant difference in the odds of recurrence, recurrence-free interval is significantly improved by the administration of BCG.

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Comparison of Sequential Intravesical Gemcitabine and Docetaxel vs Bacillus Calmette-Guérin for the Treatment of Patients With High-Risk Non–Muscle-Invasive Bladder Cancer

et al. 2023

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ImportanceDue to the ongoing bacillus Calmette-Guérin (BCG) shortage, sequential intravesical gemcitabine and docetaxel has been increasingly used as first-line therapy for high-risk non–muscle-invasive bladder cancer (NMIBC). However, data directly comparing these 2 therapies are lacking.ObjectiveTo compare the outcomes of patients with high-risk NMIBC treated with gemcitabine and docetaxel vs BCG.Design, Setting, and ParticipantsThis retrospective cohort study was conducted from January 1, 2011, to December 31, 2021. The median (IQR) duration of follow-up was 23 (12-33) months for patients receiving gemcitabine and docetaxel and 49 (27-79) months for patients receiving BCG. All patients were treated at the University of Iowa tertiary care center. A total of 312 patients with high-risk treatment-naive NMIBC were included; 174 patients were treated with BCG therapy and 138 were treated with gemcitabine and docetaxel therapy.ExposuresAfter undergoing complete transurethral resection of bladder tumor, patients received either sequential intravesical gemcitabine, 1 g, and docetaxel, 37.5 mg, or 1 vial of BCG. Induction treatments were administered once per week for 6 weeks. Maintenance regimens were initiated if the patient was disease free at the first follow-up visit.Main Outcomes and MeasuresThe primary outcome was high-grade recurrence-free survival (RFS). Survival probabilities were estimated using the Kaplan-Meier method. Cox regression models were used to evaluate the association of covariates with outcomes. Adverse events were reported using the Common Terminology Criteria for Adverse Events, version 5.ResultsAmong 312 patients, the median (IQR) age was 73 (66-79) years; 255 patients (81.7%) were male and 292 (93.6%) were White. Baseline clinicopathological characteristics such as sex, smoking status, and pretreatment tumor pathology were similar between treatment groups. High-grade RFS estimates were 76% (95% CI, 69%-82%) at 6 months, 71% (95% CI, 64%-78%) at 12 months, and 69% (95% CI, 62%-76%) at 24 months in the BCG group and 92% (95% CI, 86%-95%) at 6 months, 85% (95% CI, 78%-91%) at 12 months, and 81% (95% CI, 72%-87%) at 24 months in the gemcitabine and docetaxel group. Multivariable Cox regression analyses controlled for age, sex, treatment year, and presence of carcinoma in situ revealed that treatment with gemcitabine and docetaxel was associated with better high-grade RFS (hazard ratio, 0.57; 95% CI, 0.33-0.97; P = .04) and RFS (hazard ratio, 0.56; 95% CI, 0.34-0.92; P = .02) than treatment with BCG. Induction therapy for BCG was associated with greater treatment discontinuation than induction therapy for gemcitabine and docetaxel (9.2% vs 2.9%; P = .02).Conclusions and RelevanceIn this cohort study, gemcitabine and docetaxel therapy was associated with less high-grade disease recurrence and treatment discontinuation than BCG therapy. These findings suggest that, while awaiting results from an ongoing randomized clinical trial during the current BCG shortage, use of gemcitabine and docetaxel can be considered for recommendation in updated practice guidelines.

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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

Cited by 568 publications

References 19 publications

Bladder Cancer in 2010: How Far have We Come?

Bladder Cancer in 2010: How Far have We Come?

Intravesical bacillus Calmette-Guérin versus chemohyperthermia for high-risk non-muscle-invasive bladder cancer

Comparison of Sequential Intravesical Gemcitabine and Docetaxel vs Bacillus Calmette-Guérin for the Treatment of Patients With High-Risk Non–Muscle-Invasive Bladder Cancer

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