Bacillus Calmette-Guérin therapy alters the progression of superficial bladder cancer.

1988 ◽  
Vol 6 (9) ◽  
pp. 1450-1455 ◽  
Author(s):  
H W Herr ◽  
V P Laudone ◽  
R A Badalament ◽  
H F Oettgen ◽  
P C Sogani ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Disease Progression ◽  
Superficial Bladder Cancer ◽  
Bladder Preservation ◽  
High Risk Patients ◽  
Bcg Therapy ◽  
Risk Patients ◽  
Muscle Invasive

The effectiveness of BCG in preventing disease progression in patients with superficial bladder cancer is evaluated. Long-term follow-up of high-risk patients treated in a previously reported randomized control trial of intravesical plus percutaneous BCG shows that progression occurred in 41/43 (95%) of control and 23/43 (53%) of BCG-treated patients. Muscle invasive and/or metastatic disease occurred with equal frequency in the two groups, but was significantly delayed by BCG treatment (P = .012). Cystectomies were required in 18/43 (42%) control and 11/43 (26%) BCG-treated patients. Median time to cystectomy was 8 months for control v 24 months for BCG-treated patients. Based on initial treatment, survival was improved by BCG therapy (P = .032) (median follow-up 6 years). These results suggest that in high-risk patients intravesical BCG can delay disease progression, prolong the period of bladder preservation, and increase overall survival.

Efficacy of chemohyperthermia (HIVEC) in patients with high-risk nonmuscle invasive bladder cancer (NMIBC) who fail BCG therapy.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 456-456
Author(s):  
Geraldine Pignot ◽  
Laure Doisy ◽  
Jochen Walz ◽  
Thibault Marquette ◽  
Thomas Maubon ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Invasive Disease ◽  
Invasive Bladder Cancer ◽  
Bladder Preservation ◽  
Bcg Therapy ◽  
Risk Of Progression ◽  
Muscle Invasive ◽  
Preservation Rate ◽  
Very High

456 Background: To evaluate Hyperthermic Intra-Vesical Chemotherapy (HIVEC) efficacy regarding 1-year disease-free survival (DFS) rate and bladder preservation rate in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who fail BCG therapy or are contraindicated to BCG. Methods: Between June 2016 and October 2019, patients treated with HIVEC for high-risk NMIBC who failed BCG (Fail-BCG) or BCG-naive if BCG contraindicated (N-BCG) have been included in our study. These patients had a theoretical indication for cystectomy but were ineligible for surgery or refused it. Results: Fifty-three patients, median age 72 [39-93] years, were included (n = 29 Fail-BCG and n = 24 N-BCG). The median follow-up was 18 months. The bladder preservation rate was 92.4%. The RFS rate at 12 months was 60.5%. The RFS rate at 12 months for N-BCG and Fail-BCG groups was respectively 70% and 52.2%. Three patients progressed to muscle-invasive disease, all in the Fail-BCG group and all in the very high-risk EORTC group. Two of them experienced metastatic progression and died from bladder cancer. Conclusions: Chemohyperthermia using HIVEC device achieved a RFS rate of 60% at 1 year and enabled a bladder preservation rate of 92%. Given the low risk of progression in the N-BCG group, HIVEC could be a good alternative. Conversely, for patients with very high-risk tumors that fail BCG, cystectomy should remain the standard of care and HIVEC may be discussed cautiously for patients who are not eligible for surgery and well informed of the risk of progression to muscle-invasive disease.

scholarly journals Radical cystectomy for high risk patients with superficial bladder cancer in the era of orthotopic urinary reconstruction

Cancer ◽  
1995 ◽  
Vol 76 (5) ◽  
pp. 833-839 ◽  
Author(s):  
John A. Freeman ◽  
David Esrig ◽  
John P. Stein ◽  
Anne R. Simoneau ◽  
Eila C. Skinner ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Radical Cystectomy ◽  
Superficial Bladder Cancer ◽  
High Risk Patients ◽  
Risk Patients ◽  
Urinary Reconstruction

The Management of Newly-Diagnosed Non-muscle Invasive Bladder Cancer in Veterans Integrated Services Network 02 of the Veterans Health Administration

2019 ◽  
Author(s):  
Joseph M Caputo ◽  
George Moran ◽  
Benjamin Muller ◽  
Alison T Keller ◽  
Gen Li ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Veterans Health Administration ◽  
Veterans Health ◽  
Newly Diagnosed ◽  
Health Administration ◽  
Muscle Invasive Bladder Cancer ◽  
High Risk Patients ◽  
Risk Patients ◽  
Muscle Invasive

Abstract Introduction Over 1,500 bladder cancers were diagnosed among US Veterans in 2010, the majority of which were non-muscle invasive bladder cancer (NMIBC). Little is known about NMIBC treatment within the Veterans Health Administration. The objective of the study was to assess the quality of care for Veterans with newly-diagnosed NMIBC within Veterans Integrated Service Network (VISN) 02. Materials and Methods We used ICD-9 and ICD-10 codes to identify patients with newly-diagnosed bladder cancer from 1/2016–8/2017. We risk-stratified the patients into low, intermediate, and high-risk based on the 2016 American Urological Association Guidelines on NMIBC. Our primary objectives were percentages of transurethral resection of bladder tumors (TURBTs) with detrusor, repeat TURBT in high-risk and T1 disease, high-risk NMIBC treated with induction intravesical therapy (IVT), and responders treated with maintenance IVT. We performed logistic regression for association between distance to diagnosing hospital and receipt of induction IVT in high-risk patients. Results There were 121 newly-diagnosed NMIBC patients; 16% low-risk, 28% intermediate-risk, and 56% high-risk. Detrusor was present in 80% of all initial TURBTs and 84% of high-risk patients. Repeat TURBT was performed in 56% of high-risk NMIBC and 60% of T1. Induction IVT was given to 66% of high-risk patients and maintenance IVT was given to 59% of responders. On multivariate logistic regression, distance to medical center was not associated with receipt of induction IVT (OR = 0.99, 95% CI [0.97,1.01], p = 0.52). Conclusions We observed high rates of sampling of detrusor in the first TURBT specimen, utilization of repeat TURBT, and administration of induction and maintenance intravesical BCG for high-risk patients among a regional cohort of US Veterans with NMIBC. While not a comparative study, our findings suggest high quality NMIBC care in VA VISN 02.

scholarly journals Recognition and Treatment of BCG Failure in Bladder Cancer

2011 ◽  
Vol 11 ◽  
pp. 602-613 ◽  
Author(s):  
Andrew J. Lightfoot ◽  
Henry M. Rosevear ◽  
Michael A. O'Donnell
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Treatment Options ◽  
Standard Of Care ◽  
Complete Response ◽  
Bcg Therapy ◽  
Risk Patients ◽  
Bcg Failure ◽  
Muscle Invasive ◽  
American Urological Association

Patients with high-grade Ta, T1, or carcinomain situnon–muscle-invasive bladder cancer (NMIBC) are at high risk for recurrence and, more importantly, progression. Thus, both the American Urological Association and European Association of Urology recommend initial intravesical treatment with bacillus Calmette-Guerin(BCG) followed by maintenance therapy for a minimum of 1 year. The complete response rate to BCG therapy in patients with high-risk NMIBC can be as high as ∼80%; however, most patients with high-risk disease suffer from recurrence. BCG failure can be further characterized into BCG refractory, BCG resistant, BCG relapsing, and BCG intolerant. Current recommendations include one further course of BCG or cystectomy. In patients who continue to fail conservative treatment and who refuse surgical therapy or are not surgical candidates, treatment options become even more complicated. In this setting, treatment options are limited and include repeat BCG treatment, an alternate immunotherapy regimen, chemotherapy, or device-assisted therapy. To date, however, further research is necessary for all secondary treatment options in order to determine which might be the most efficacious. All conservative treatments should be considered investigational. Currently, cystectomy remains the standard of care for high-risk patients who have failed BCG therapy.

Phase II trial of atezolizumab in BCG-unresponsive non-muscle invasive bladder cancer: SWOG S1605 (NCT #02844816).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5022-5022 ◽  
Author(s):  
Peter C. Black ◽  
Catherine Tangen ◽  
Parminder Singh ◽  
David James McConkey ◽  
Scott Lucia ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Phase Ii ◽  
Complete Response ◽  
Median Number ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Bladder Preservation ◽  
Bcg Therapy ◽  
Muscle Invasive

5022 Background: Radical cystectomy (RC) is the standard of care for patients with BCG-unresponsive high risk non-muscle invasive bladder cancer (NMIBC), but many patients are unfit for surgery or elect bladder preservation. Based on the reported efficacy of atezolizumab in metastatic urothelial carcinoma and the known expression of PD-L1 in NMIBC after BCG therapy, this trial was designed to evaluate the activity of atezolizumab in BCG-unresponsive high risk NMIBC. Methods: This single arm phase II registration trial testing systemic atezolizumab (1200 mg IV) every 3 weeks for one year aimed to enroll 135 (70 CIS and 65 non-CIS) eligible patients with histologically proven BCG-unresponsive high risk NMIBC who were unfit for or declined RC. Here we report on the subset with CIS (with or without concomitant Ta/T1) among patients who received at least one protocol treatment. The primary endpoint was pathological complete response (CR) rate at 6 months as defined by mandatory biopsy with a null hypothesis of 30% and alternative of 50% with a 1-sided alpha = 0.05 and 96% power. The 3 month CR rate, defined by cytology, cystoscopy and for-cause biopsy, is reported here as a secondary endpoint, in addition to safety. Results: Seventy-five eligible CIS patients were enrolled. Two received no treatment and are not evaluable. Of 73, median patient age was 73.4 years and median number of prior BCG doses was 12. Concomitant Ta/T1 tumor was found in 30 (41.1%) patients, including T1 disease in 16 (21.9%). A CR was observed in 30 (41.1%; 95% CI 29.7%, 53.2%) patients at 3 months and 19 (26.0%; 95% CI 16.5%, 37.6%) at 6 months. Any possibly or probably treatment-related adverse event (AE) was observed in 61 (83.6%) patients. The most frequent AEs were fatigue 36 (49.3%), pruritis 8 (11.0%), hypothyroidism 8 (11.0%), and nausea 8 (11.0%). Grade 3-5 AEs occurred in 9 (12.3%) patients and there was one treatment-related death (myasthenia gravis with respiratory failure and sepsis). Conclusion: The observed response to atezolizumab at 3 and 6 months in patients with BCG-unresponsive CIS was similar to that reported in recent similar trials and meets the benchmark for initial CR defined by the FDA guidance. This trial provided no new safety concerns. The duration of response will determine if this is a suitable treatment option for patients with BCG-unresponsive high risk CIS. Clinical trial information: 02844816 .

Disease progression among patients who receive available bladder preservation therapies after failure of BCG therapy in the SEER-Medicare data.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 453-453
Author(s):  
Ashish M. Kamat ◽  
Mihaela V. Georgieva ◽  
Jinlin Song ◽  
Iryna Bocharova ◽  
Kun Qian ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Disease Progression ◽  
Mitomycin C ◽  
Radical Cystectomy ◽  
Interferon Alpha ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Bladder Preservation ◽  
Bcg Therapy ◽  
Muscle Invasive

453 Background: For patients with high-grade (HG) non-muscle invasive bladder cancer (NMIBC) who recur after Bacillus Calmette-Guérin (BCG) therapy, treatment options other than radical cystectomy have been limited. This study examined real-world utilization and outcomes of current bladder preservation therapies (BPT) after BCG treatment. Methods: We analyzed the SEER-Medicare database and identified patients diagnosed with HG NMIBC between 2008 and 2015 who received at least one BCG induction course (defined as ≥5 weekly instillations). Use of BPT within six months of the last consecutive BCG instillation was identified and included BCG + interferon alpha, docetaxel, doxorubicin, epirubicin, gemcitabine, mitomycin C, nab-paclitaxel, thiotepa, valrubicin, or their combinations. Progression was identified as initiation of treatment for muscle-invasive bladder cancer, radical cystectomy, or presence of metastases. Time to progression (TTP) was defined as time from BPT initiation to progression event. Progression-free survival (PFS) was assessed from BPT initiation and defined as the absence of progression or death due to bladder cancer. TTP and PFS were assessed using Kaplan-Meier analysis. Results: A total of 7,074 patients were diagnosed with HG NMIBC and received ≥ 5 BCG weekly induction instillations. Of these, 8.8% (620 patients) initiated BPT. The most commonly used agents were mitomycin C (66.0%), followed by BCG + interferon alpha (22.9%), valrubicin (4.0%), doxorubicin (2.9%), and gemcitabine (2.1%). Disease progression occurred in 18.7% of patients within 1 year of treatment initiation (40.5% due to metastases), 36.4% within 3 years (50.0% due to metastases), and 45.4% within 5 years (50.2% due to metastases). The rate of PFS was 80.9%, 61.8%, and 52.3% at 1, 3, and 5 years, respectively. Conclusions: High rates of metastatic disease are noted in HG NMIBC following available BPT treatments after failure of BCG therapy. A high unmet need remains for novel bladder-sparing therapies to improve outcomes in this difficult-to-treat population.

scholarly journals The LACE Score as a Tool to Identify Radical Cystectomy Patients at Increased Risk of 90-Day Readmission and Mortality

2018 ◽  
Vol 12 (1) ◽  
pp. 20-26 ◽  
Author(s):  
Jennifer L. Saluk ◽  
Robert H. Blackwell ◽  
William S. Gange ◽  
Matthew A. C. Zapf ◽  
Anai N. Kothari ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Radical Cystectomy ◽  
Multivariable Analysis ◽  
Emergency Department Visits ◽  
High Risk Patients ◽  
Increased Risk ◽  
Patients At Risk ◽  
Risk Patients

Introduction: Radical cystectomy for bladder cancer is associated with high rates of readmission. We investigated the LACE score, a validated prediction tool for readmission and mortality, in the radical cystectomy population. Materials &amp; Methods: Patients who underwent radical cystectomy for bladder cancer were identified by ICD-9 codes from the Healthcare Cost and Utilization Project State Inpatient Database for California years 2007-2010. The LACE score was calculated as previously described, with components of L: length of stay, A: acuity of admission, C: comorbidity, and E: number of emergency department visits within 6 months preceding surgery. Results: Of 3,470 radical cystectomy patients, 638 (18.4%) experienced 90-day readmission, and 160 (4.6%) 90-day mortality. At a previously validated “high-risk” LACE score ≥ 10, patients experienced an increased risk of 90-day readmission (22.8 vs. 17.7%, p = 0.002) and mortality (9.1 vs. 3.5%, p < 0.001). On adjusted multivariable analysis, “high risk” patients by LACE score had increased 90-day odds of readmission (adjusted OR = 1.24, 95% CI: 0.99-1.54, p = 0.050) and mortality (adjusted OR = 2.09, 95% CI: 1.47-2.99, p < 0.001). Conclusion: The LACE score reasonably identifies patients at risk for 90-day mortality following radical cystectomy, but only poorly predicts readmission. Providers may use the LACE score to target high-risk patients for closer follow-up or intervention.

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