Hyperthermic Intravesical Chemotherapy for BCG Unresponsive Non-Muscle Invasive Bladder Cancer Patients

Jong, Joep J. de; Hendricksen, Kees; Rosier, Marloes; Mostafid, Hugh; Boormans, Joost L.

doi:10.3233/blc-180191

Cited by 62 publications

(41 citation statements)

References 32 publications

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“… 121 , 122 Chemothermotherapy is one such treatment option for patients with NMIBC who fail intravesical BCG and develop disease recurrence. 121 , 123 , 124 It involves the intravesical application of heated chemotherapy to the bladder through use of microwaves to heat the local bladder environment or through circulation of heated fluids (hyperthermic intravesical chemotherapy [HIVEC]). 121 , 122 , 125 , 126 In a meta-analysis of 12 studies, intravesical chemothermotherapy was associated with a significantly decreased risk of disease recurrence compared with normal-temperature chemotherapy after 2 years, with no difference in the rate of AEs.…”

Section: Discussionmentioning

confidence: 99%

<p>Humanistic and Economic Burden of Non-Muscle Invasive Bladder Cancer: Results of Two Systematic Literature Reviews</p>

Lee¹,

Kwon²,

Forsythe³

et al. 2020

CEOR

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Purpose: Non-muscle invasive bladder cancer (NMIBC) is a malignancy restricted to the inner lining of the bladder. Intravesical Bacillus Calmette-Guerin (BCG) following transurethral resection of the bladder tumor is the mainstay first-line treatment for high-risk NMIBC patients. Two systematic literature reviews (SLRs) were conducted to further assess the current evidence on BCG use in NMIBC and the humanistic and economic burden of disease. Methods: Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, Embase ® and MEDLINE ® were searched using the Ovid platform to identify interventional or real-world evidence studies on the health-related quality of life (HRQoL) and economic burden in NMIBC. Limited evidence was found from initial economic SLR searches in NMIBC, so additional targeted searches for bladder cancer were conducted to expand findings. Results: Fifty-nine publications were included in the HRQoL SLR, of which 23 reported HRQoL and symptoms in NMIBC. At diagnosis, HRQoL was comparable with population norms but worsened considerably 2 years following diagnosis. Maintenance therapy with intravesical BCG was associated with reduced HRQoL, and treatment-related adverse events (AEs) resembled typical NMIBC symptoms. Twenty-two studies reported decreasing BCG compliance over time. Common AEs with BCG were frequent urination, lower urinary tract symptoms, pain, and hematuria. Forty-two publications were included in the economic SLR, of which nine assessed healthcare costs and resource use in NMIBC or bladder cancer. Highrisk disease and high-intensity treatment were associated with increased healthcare costs. Conclusion: NMIBC has a considerable symptomatic, HRQoL, and economic burden. Symptoms persisted and HRQoL worsened despite intravesical BCG treatment. NMIBC is a costly disease, with higher healthcare costs associated with increased risk of disease progression and recurrence. There is a high unmet need for safe and effective treatments that reduce the risk of disease progression and recurrence, provide symptomatic relief, and improve HRQoL for patients.

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Section: Discussionmentioning

confidence: 99%

<p>Humanistic and Economic Burden of Non-Muscle Invasive Bladder Cancer: Results of Two Systematic Literature Reviews</p>

Lee¹,

Kwon²,

Forsythe³

et al. 2020

CEOR

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“…There is scarce literature available regarding the use of HIVEC in the setting of BCG failure. In a cohort of 52 BCG unresponsive patients, de Jong JJ et al [ 4 ] previously showed a median DSF of 17.7 months. A total of 26 out of 52 patients remained disease-free, 22 experienced a recurrence and 4 a progression to muscle-invasive or metastatic bladder cancer.…”

Section: Discussionmentioning

confidence: 99%

“…From March 2017 to February 2020, 103 BCG failure or intolerance patients with high-risk NMIBC underwent HIVEC adjuvant regimen. The inclusion criteria were as follows: 1) histological diagnosis of high-grade papillary Ta/T1 NMIBC alone or in combination with CIS [WHO 2014 grading system]; 2) the criteria of BCG-refractory, BCG-relapse, BCG-unresponsive or BCG intolerance disease were determined according to EAU guidelines criteria [ 2 ]; 3) adequate BCG treatment which is defined as having had BCG 6 weekly induction instillations followed by at least one 3 week maintenance course or a second induction course of 6 BCG instillations [ 4 ]. Patients who were unsuitable to undergo radical cystectomy were excluded.…”

Section: Methodsmentioning

confidence: 99%

“…Hyperthermic intravesical chemotherapy (HIVEC) is a feasible option in BCG-unresponsive NMIBC cases and the treatment is commonly associated with a low rate of adverse events. In a cohort of 52 BCG unresponsive NMIBC patients, including 30 patients with concomitant CIS, 50% of the patients remained disease free after a median follow-up of 14.0 months [ 4 ]. The most common complications described were urinary frequency, haematuria and bladder spasms.…”

Section: Introductionmentioning

confidence: 99%

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Outcomes and complications of Hyperthermic IntraVesical Chemotherapy using Mitomycin-C or Epirubicin for patients with non-muscle invasive bladder cancer after Bacillus Calmette-Guérin treatment failure

2020

Cent european J Urol

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Introduction Chemohyperthermia is a feasible option in BCG (bacillus Calmette-Guérin) failure patients who desire bladder preservation. We aimed to assess outcomes and complications of chemohyperthermia using mitomycin C (MMC) or epirubicin (EPI). Material and methods From March 2017 to February 2020, 103 BCG failure or intolerance patients with high-risk NMIBC (non-muscle invasive bladder cancer) underwent a hyperthermic intravesical chemotherapy (HIVEC) regimen. Five patients did not complete at least 5 instillations and were excluded from analysis. MMC was used in 72 out of 98 patients (Group A) while EPI was used in 26 patients (Group B). Response to HIVEC, predictive factors for treatment outcome and the disease-free survival (DFS) were defined as primary endpoints. The complications of chemohyperthermia were assessed as a secondary endpoint. Results No significant differences were found in recurrence and progression after induction course between Groups A and B. Kaplan-Meier disease-free survival was 22.61 months in Group A and 21.93 in Group B. The log-rank test showed no statistically significant difference between the two curves (p = .627). In the multivariate analysis, patients with tumor size ≥3 cm (p = .029), recurrence rate >1/year (p = .034), concomitant carcinoma in situ (CIS) during transurethral resection of bladder (TURB) (p = .039) and BCG-unresponsive status (p = .048) were associated with a worse response to chemohyperthermia. The use of MMC or EPI did not influence the response to treatment (p = .157). A slightly significant higher rate of overall complications (p = .0488) was observed in Group B. A significantly higher rate of Grade 3 frequency/urgency (p = .0064) contributed to this difference. The use of EPI was the only independent factor associated with severe urinary frequency/urgency (p = .017). No patients experienced Grade 4/5 adverse events. Conclusions HIVEC can be considered a feasible option in BCG failure/intolerant NMIBC patients, avoiding or postponing radical cystectomy in some particular subclasses of patients.

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“…These data may boost the evidence synthesis for future guidelines. In a recent study by de Jong et al , 52 BCG-unresponsive, high-risk NMIBC patients received CHT ( 13 ). The overall recurrence rate was 50%, with median duration of follow-up of 14 months.…”

Section: Hyperthermic Intravesical Chemotherapymentioning

confidence: 99%

Device-assisted intravesical therapy for non-muscle invasive bladder cancer

Hendricksen

2019

Transl. Androl. Urol

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Non-muscle invasive bladder cancer (NMIBC) is a challenging disease, with a high risk of recurrence and even progression to muscle invasive disease. The present standard treatment is suboptimal, and consists of a complete transurethral resection of the visible bladder tumour(s), followed by prophylactic intravesical instillations mitomycin-C (MMC) or bacillus Calmette-Guérin (BCG). In search for higher efficacy, several adjuvant device-assisted intravesical therapies are developed. Chemohyperthermia may be based on microwave-/radiofrequency-induced (RF) hyperthermia systems, for which most evidence exists, or on hyperthermic intravesical chemotherapy, which is applied by conductive or loco-regional heating systems. RF-induced CHT has shown superiority over MMC alone, and in one prospective study superiority over BCG in per-protocol analysis, which has led to the ‘weak’ recommendation in the EAU guidelines to consider RF-based CHT as a bladder preservation strategy in patients with BCG-refractory tumours, who are not candidates for radical cystectomy due to comorbidities. Prospective studies on hyperthermic intravesical chemotherapy for patients with intermediate-risk NMIBC are awaited next year. The combination of electromotive drug administration (EMDA) with MMC has shown superiority over MMC as well, and seems promising when combined with BCG in sequential treatment. Photodynamic therapy should still be considered experimental, in which a study with the intravenous photosensitizer Radachlorin® has shown promising results.

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Hyperthermic Intravesical Chemotherapy for BCG Unresponsive Non-Muscle Invasive Bladder Cancer Patients

Cited by 62 publications

References 32 publications

<p>Humanistic and Economic Burden of Non-Muscle Invasive Bladder Cancer: Results of Two Systematic Literature Reviews</p>

<p>Humanistic and Economic Burden of Non-Muscle Invasive Bladder Cancer: Results of Two Systematic Literature Reviews</p>

Outcomes and complications of Hyperthermic IntraVesical Chemotherapy using Mitomycin-C or Epirubicin for patients with non-muscle invasive bladder cancer after Bacillus Calmette-Guérin treatment failure

Device-assisted intravesical therapy for non-muscle invasive bladder cancer

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