Mp73-06 chemo-Resection With Hyperthermic Intravesical Instillation (Hivec-R) vs Standard Treatment in Patients With Intermediate-High Risk Nmibc: Comparative, Prospective, Randomized, Controled Study of Efficacy and Tolerability: Preliminary Results

Sousa, Alejandro; Gonzalez-Valcárcel, Ignacio; Mata, Juan; Morena, J.M. De La; Martínez‐Piñeiro, Luis

doi:10.1097/ju.0000000000000959.06

Cited by 3 publications

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“…Sensitivity analysis after excluding BCG failure patients from the HYMN study shows CHT has a significantly lower recurrence rate when compared to BCG group (RR FE : 0.64, 95% CI 0.42–0.98, p = 0.04) ( Supplementary Material ). Of note, in the RCT by Sousa et al ( 26 ), the conductive CHT group had significantly lower rate of recurrence when compared to the BCG group (20.5% vs. 38.2%, p <0.02). However, a retrospective matched cohort study by Ekin et al ( 28 ) found a significantly higher recurrence rate in patients receiving conductive CHT compared to those who received BCG (35.9% vs. 20.5%, p <0.05).…”

Section: Resultsmentioning

confidence: 83%

“…A total of 2,277 articles were excluded upon initial screening, and 79 studies were further excluded upon full-text screening. Finally, four RCTs (24)(25)(26)(27) were included for metaanalysis, and one observational retrospective study (28) was retrieved and included for qualitative synthesis. Two studies included both intermediate-and high-risk NMIBC patients (24,25), and the other three studies included high-risk NMIBC patients only (26)(27)(28).…”

Section: Literature Search Resultsmentioning

confidence: 99%

“…Finally, four RCTs (24)(25)(26)(27) were included for metaanalysis, and one observational retrospective study (28) was retrieved and included for qualitative synthesis. Two studies included both intermediate-and high-risk NMIBC patients (24,25), and the other three studies included high-risk NMIBC patients only (26)(27)(28). All studies were non-inferiority trials and did not specifically focus on primary or recurrent cases.…”

Section: Literature Search Resultsmentioning

confidence: 99%

“…Four RCTs with 327 patients were included (24)(25)(26)(27). There was no significant difference between the two groups (RR FE 0.60, 95% CI 0.26-1.41, p = 0.24; low certainty of evidence) (Figure 3).…”

Section: Progression Rate At 24-36 Monthsmentioning

confidence: 99%

“…Four RCTs with 368 patients were included (24)(25)(26)(27). For Grade 1-2 AEs, there was no significant difference between the CHT group and the BCG group (RR FE 1.11, 95% CI 0.93-1.32, p = 0.26; moderate certainty of evidence), and no significant heterogeneity was detected (I 2 = 0%, p = 0.96) (Figure 4).…”

Section: Adverse Eventsmentioning

confidence: 99%

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Intravesical Chemohyperthermia vs. Bacillus Calmette-Guerin Instillation for Intermediate- and High-Risk Non-muscle Invasive Bladder Cancer: A Systematic Review and Meta-Analysis

et al. 2021

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Background: The efficacy of intravesical chemotherapy maintenance for patients with non-muscle invasive bladder cancer (NMIBC) is inferior compared to intravesical bacillus Calmette–Guerin (BCG). How intravesical chemohyperthermia (CHT) compares with BCG is under investigation.Objective: To compare the oncological outcomes and safety profile between intravesical CHT and BCG treatment for intermediate- and high-risk NMIBC.Methods: We performed a systematic review and meta-analysis of clinical studies comparing CHT with BCG for intermediate- and high-risk NMIBC patients. A comprehensive literature search on OVID MEDLINE, EMBASE, and Cochrane Library was conducted. Risk of bias was assessed by the Cochrane RoB tool and ROBINS-I. Certainty of evidence was rated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology.Results: A total of 2,375 articles were identified and five studies were finally included. Among them, four randomised trials comprising 327 patients (CHT group: 156 patients; BCG group: 171 patients) were included in the meta-analysis. There were no significant differences in the 24–36 months recurrence rates (CHT: 29.5%, BCG: 37.4%; RR: 0.83, 95% CI 0.61–1.13; moderate certainty of evidence) and the 24–36 months progression rates (CHT: 4.4%, BCG: 7.6%, RR = 0.62, 95% CI 0.26–1.49; low certainty of evidence). There were also no significant differences in grade 1–2 adverse events (CHT group: 59.9%, BCG group 54.5%; RR = 1.10, 95% CI 0.93–1.30; moderate certainty of evidence) and grade 3 or above adverse events (CHT group: 23.2%, BCG group 22.5%; RR = 0.99, 95% CI 0.69–1.43; low certainty of evidence).Conclusions: Intravesical CHT had equivalent oncological outcomes and similar safety profile when compared to BCG maintenance therapy for patients with intermediate- and high-risk NMIBC. CHT is a possible alternative treatment in the times of BCG shortage.

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Section: Resultsmentioning

confidence: 83%

Section: Literature Search Resultsmentioning

confidence: 99%

Section: Literature Search Resultsmentioning

confidence: 99%

Section: Progression Rate At 24-36 Monthsmentioning

confidence: 99%

Section: Adverse Eventsmentioning

confidence: 99%

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Intravesical Chemohyperthermia vs. Bacillus Calmette-Guerin Instillation for Intermediate- and High-Risk Non-muscle Invasive Bladder Cancer: A Systematic Review and Meta-Analysis

et al. 2021

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The Efficacy and Safety of Hyperthermia Intravesical Chemotherapy in the Treatment of Non-Muscle-Invasive Bladder Cancer: A Meta-Analysis

Duan,

Deng,

Zou

et al. 2024

Urol Int

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Background：The current treatment of non-muscle-invasive bladder cancer is suboptimal. However, in recent years, hyperthermia intravesical chemotherapy has emerged as a more effective alternative to conventional bladder perfusion. This novel treatment approach appears to have a similar therapeutic effect as BCG perfusion. Objective: This study aims to evaluate the safety and effectiveness of hyperthermia intravesical chemotherapy compared to conventional bladder perfusion chemotherapy for non-muscle-invasive bladder cancer. Additionally, it aims to evaluate the safety and effectiveness of hyperthermia intravesical chemotherapy in comparison to BCG perfusion therapy for non-muscle-invasive bladder cancer. Methods：We conducted a comprehensive search of PubMed, Embase, Cochrane Library, and Web of Science databases to gather relevant studies on hyperthermia intravesical chemotherapy for non-muscle-invasive bladder cancer. The analysis of the collected data was carried out using RevMan 5.3 software. Results：A total of 8 randomized controlled trials (RCTs) were included in this meta-analysis, involving 1203 patients. Among them, 629 cases received hyperthermia intravesical chemotherapy (HIVEC), 419 cases received conventional bladder perfusion chemotherapy with mitomycin C (MMC), and 155 cases received Bacillus Calmette-Guérin (BCG). The combined analysis revealed that the recurrence rate of bladder hyperthermic perfusion was significantly lower than that of conventional perfusion chemotherapy (RR=0.65, 95%CI 0.52-0.82, P=0.0003). However, there was no significant difference in recurrence rate between hyperthermia intravesical chemotherapy and BCG perfusion (RR=0.78, 95%CI 0.56-1.09, P=0.14). Furthermore, no significant difference was found in the progression rate between the hyperthermia intravesical chemotherapy group and either the conventional bladder chemotherapy group (RR=1.08, 95%CI 0.52-2.26, P=0.83) and the BCG perfusion group (RR=0.48, 95%CI 0.19-1.25, P=0.13). However, Compared with the conventional bladder perfusion chemotherapy group, there was no significant statistical difference in adverse events between the bladder hyperthermia chemotherapy group and the conventional bladder perfusion chemotherapy group (RR1.08, 95% CI 0.80,1.45, p=0.63). No significant difference in the incidence of adverse events was observed between hyperthermia intravesical chemotherapy and BCG perfusion (RR1.03, 95% CI 0.83,1.29, p=0.79).

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The clinical efficacy and safety of equipment-assisted intravesical instillation of mitomycin C after transurethral resection of bladder tumour in patients with nonmuscular invasive bladder cancer: A meta-analysis

Zhou

Liu²,

Mao³

et al. 2022

PLoS ONE

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Background This review and meta-analysis aimed to systematically evaluate the clinical efficacy and safety of equipment-assisted intravesical instillation of mitomycin C (MMC) in patients with nonmuscular invasive bladder cancer (NMIBC) after transurethral resection of bladder tumour (TURBT). Methods The Embase, PubMed, CNKI, CBM, WANGFANG, VIP, Cochrane Library, and Clinicaltrial.com databases were searched for articles published before April 2022. The experimental group was treated with intravesical instillation of MMC assisted by equipment, including radiofrequency-induced thermochemotherapy, conductive thermochemical therapy, electromotive drug administration, or locoregional hyperthermia. The control group was treated with simple MMC perfusion. The outcomes of interest in the meta-analysis were recurrence, progression, side-effects, gross haematuria, and bladder irritation. Results A total of 15 studies that enrolled 1,190 patients were included in the meta-analysis. Compared to that of the control group, device-assisted intravesical instillation of MMC significantly reduced both tumour recurrence (odds ratio [OR] = 0.32, 95% confidence interval [CI] [0.24, 0.42], P <0.00001) and progression (OR = 0.29, 95% CI [0.12, 0.67], P = 0.004). There were no significant differences between the two groups in terms of safety (OR = 1.21, 95% CI [0.66,2.21], P = 0.54), bladder irritation (OR = 1.06, 95% CI [0.72,1.55], P = 0.78), or gross haematuria (OR = 1.11, 95% CI [0.64,1.94], P = 0.72). Conclusions Equipment-assisted intravesical instillation of MMC significantly reduced the recurrence and progression of patients with NMIBC who underwent TURBT and improved their quality of life. Given the significant heterogeneity in research quality and sample size among earlier studies, more prospective, multicentre, large sample randomized controlled trials are needed to supplement and verify this in the future.

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Mp73-06 chemo-Resection With Hyperthermic Intravesical Instillation (Hivec-R) vs Standard Treatment in Patients With Intermediate-High Risk Nmibc: Comparative, Prospective, Randomized, Controled Study of Efficacy and Tolerability: Preliminary Results

Cited by 3 publications

References 0 publications

Intravesical Chemohyperthermia vs. Bacillus Calmette-Guerin Instillation for Intermediate- and High-Risk Non-muscle Invasive Bladder Cancer: A Systematic Review and Meta-Analysis

Intravesical Chemohyperthermia vs. Bacillus Calmette-Guerin Instillation for Intermediate- and High-Risk Non-muscle Invasive Bladder Cancer: A Systematic Review and Meta-Analysis

The Efficacy and Safety of Hyperthermia Intravesical Chemotherapy in the Treatment of Non-Muscle-Invasive Bladder Cancer: A Meta-Analysis

The clinical efficacy and safety of equipment-assisted intravesical instillation of mitomycin C after transurethral resection of bladder tumour in patients with nonmuscular invasive bladder cancer: A meta-analysis

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