Intravesical Gemcitabine in BCG-Refractory T1G3 Transitional Cell Carcinoma of the Bladder: A Pilot Study

Gacci, Mauro; Bartoletti, Riccardo; Cai, Tommaso; Nerozzi, Stefano; Pinzi, Novello; Repetti, Fabrizio; Viggiani, F.; Ghezzi, P; Nesi, Gabriella; Carini, Marco

doi:10.1159/000090870

Cited by 29 publications

(19 citation statements)

References 49 publications

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“…The same group of investigators reported a small series of selected BCG-resistant T1G3 patients, unsuitable for radical treatment, who were treated with gemcitabine and compared with 10 pT1G3 patients previously treated with further conservative endovesical BCG administration. 24 Of the 9 patients treated with gemcitabine, 3 were recurrence free after 13, 17, and 21 months, and 7 kept an intact bladder, with an overall survival rate of 100%. Among 10 patients treated with BCG instillation, 1 was recurrence free after 27 months, and 6 kept their bladders, with a survival rate of 80%.…”

Section: Toxicitymentioning

confidence: 94%

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Gemcitabine versus bacille Calmette‐Guérin after initial bacille Calmette‐Guérin failure in non‐muscle‐invasive bladder cancer

Lorenzo

Perdonà

Damiano

et al. 2010

Cancer

154

103

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BACKGROUND:The efficacy of intravesical gemcitabine was evaluated compared with repeated administration of bacille Calmette-Guérin (BCG) after BCG failure in high-risk, non-muscle-invasive bladder cancer (BC). METHODS: In this multicenter, prospective, randomized, phase 2 trial, eligible patients were those with high-risk non-muscle-invasive BC, failing 1 course of BCG therapy. All patients were randomly allocated to Group A, receiving intravesical gemcitabine (at a dose of 2000 mg/50 mL) twice weekly for 6 consecutive weeks and then weekly for 3 consecutive weeks at 3, 6, and 12 months, or Group B, receiving intravesical BCG (Connaught strain, 81 mg/50 mL) over a 6-week induction course and each week for 3 weeks at 3, 6, and 12 months. Outcome measures were recurrence rate, time to first recurrence, and progression rate. Treatment-related complications were also evaluated. RESULTS: Eighty participants were enrolled, 40 for each group 52.5% in Group A developed disease recurrence versus 87.5% of those in Group B (P ¼ .002). There was no statistically significant difference in mean time to the first recurrence (Group A, 3.9 months; Group B, 3.1 months; P ¼ .09). Kaplan-Meier analysis of 2-year recurrence-free survival showed significant differences between Group A and B (19% and 3%, respectively, P < .008). Seven of 21 (33%) patients in Group A and 13 of 35 (37.5%) patients in Group B had disease progression and underwent radical cystectomy (P ¼ .12). Both intravesical administrations were generally well tolerated. CONCLUSIONS: Gemcitabine might represent a second-line treatment option after BCG failure in high-risk non-muscle-invasive BC patients. Cancer 2010;116:1893-900.

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Section: Toxicitymentioning

confidence: 94%

“…Moreover, we followed the maintenance schedule suggested by Gacci et al 24 Of course, it is clear that no standard regimen exists in this setting, and the optimal frequency and duration of maintenance instillations remain unknown. Thus, further investigation addressing this issue is needed.…”

Section: Toxicitymentioning

confidence: 99%

Gemcitabine versus bacille Calmette‐Guérin after initial bacille Calmette‐Guérin failure in non‐muscle‐invasive bladder cancer

Lorenzo

Perdonà

Damiano

et al. 2010

Cancer

154

103

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“…This is lower than in the recent Phase II clinical trial comparing salvage intravesical gemcitabine (33% progression) vs. additional induction BCG (37.5% progression) in patients with recurrent NMIBC despite BCG at 2 years follow-up [11]. The rate of cystectomy was 62% at 5 years which is higher than previously published clinical trials which range from 33% to 56% at a follow-up of 1.5 to 3 years [11][12][13][14][15]. The differences are largely attributable to the fact that in our series we assumed perfect compliance and follow-up as well as strict adherence to NCCN guidelines, which are more aggressive than real-world settings.…”

Section: Discussionmentioning

confidence: 61%

“…The study population of 1300 virtual patients is significantly higher than most published series on BCG refractory patients which range from 20-100 patients [11][12][13][14][15]. Our virtual series contained 58% of patients with clinical stage T1 urothelial carcinoma prior to randomization which falls within the range of previous BCG failure trials where 47%-78% had cT1 tumors [11,15].…”

Section: Discussionmentioning

confidence: 99%

1064 a Novel Simulation Model of Non-Muscle Invasive Bladder Cancer a Platform for a Virtual Randomized Trial of Conservative Therapy vs Cystectomy in BCG Refractory Patients

Dinh¹,

Noah-Vanhoucke²,

Rengarajan³

et al. 2012

Journal of Urology

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Abstract.Introduction: There have been no randomized controlled trials (RCTs) evaluating the clinical or economic benefit of mitomycin C intravesical therapy vs. radical cystectomy in patients with high-risk non-muscle invasive bladder cancer (NMIBC). We used the Archimedes computational model to simulate RCT comparing radical cystectomy versus intravesical mitomycin C (MMC) therapy to evaluate the clinical and economic outcomes for BCG-refractory NMIBC as well demonstrate the utility of computer based models to simulate a clinical trial. Methods: The Archimedes model was developed to generate a virtual population using the Surveillance Epidemiology and End Results database, other clinical trials, and expert opinions. Patients selected were diagnosed with NMIBC (

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“…However, after further courses, the typical success rate of repeated BCG is <1020%. 41,62,63 After recognizing that BCG exerts its effects via cytokine stimulation, as well as response of type 1 T helper cells (T H 1) and T helper cell recruitment, the addi tion of cytokine therapy to BCG treatment has been tried. For example, IFNα2b functions by enhancing protein TRAIL release, augmenting the T H 1 response, increasing IFNγ release and reducing the expression of inflammationinhibiting proteins such as IL10.…”

Section: Options After Bcg Failurementioning

confidence: 99%

Consensus statement on best practice management regarding the use of intravesical immunotherapy with BCG for bladder cancer

et al. 2015

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| Multiple clinical trials have demonstrated that intravesical Bacillus Calmette-Guérin (BCG) treatment reduces recurrences and progression in patients with non-muscle-invasive bladder cancer (NMIBC). However, although BCG has been in use for almost 40 years, this agent is often underutilized and practice patterns of administration vary. This neglect is most likely caused by uncertainties about the optimal use of BCG, including unawareness of optimal treatment schedules and about patient populations that most benefit from BCG treatment. To address this deficit, a focus group of specialized urologic oncologists (urologists, medical oncologists and radiation oncologists) reviewed the current guidelines and clinical evidence, discussed their experiences and formed a consensus regarding the optimal use of BCG in the management of patients with NIMBC. The experts concluded that continuing therapy with 3-week BCG maintenance is superior to induction treatment only and is the single most important factor in improving outcomes in patients with NMIBC. They also concluded that a reliable alternative to radical cystectomy in truly BCG-refractory disease remains the subject of clinical trials. In addition, definitions for common terms of BCG failure, such as BCG-refractory and BCG-intolerant, have been formulated.

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Intravesical Gemcitabine in BCG-Refractory T1G3 Transitional Cell Carcinoma of the Bladder: A Pilot Study

Cited by 29 publications

References 49 publications

Gemcitabine versus bacille Calmette‐Guérin after initial bacille Calmette‐Guérin failure in non‐muscle‐invasive bladder cancer

Gemcitabine versus bacille Calmette‐Guérin after initial bacille Calmette‐Guérin failure in non‐muscle‐invasive bladder cancer

1064 a Novel Simulation Model of Non-Muscle Invasive Bladder Cancer a Platform for a Virtual Randomized Trial of Conservative Therapy vs Cystectomy in BCG Refractory Patients

Consensus statement on best practice management regarding the use of intravesical immunotherapy with BCG for bladder cancer

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