Short-changed during the bacillus Calmette–Guérin shortages?

2020 ◽  
pp. 205141582094178
Author(s):  
Kenneth R MacKenzie ◽  
Sidney D Parker ◽  
Dawn Watson ◽  
Joanne Cresswell
Keyword(s):  
High Risk ◽  
Treatment Strategies ◽  
Disease Free Survival ◽  
Disease Recurrence ◽  
Bacillus Calmette Guerin ◽  
Level Of Evidence ◽  
Significant Difference ◽  
Muscle Invasive ◽  
Long Term Impact

Objective: Intravesical bacillus Calmette–Guérin (BCG) is the first-line treatment of choice for high-risk non-muscle-invasive bladder cancer (NMIBC). Our aim was to evaluate the long-term impact of BCG shortages on oncological outcomes. Methods: All patients undertaking an initial course of intravesical BCG for intermediate or high risk NMIBC at a single UK cancer centre between August 2012 and August 2014 were evaluated. Compliance was defined as completing 12 doses of BCG within the first year following diagnosis. Results: Due to BCG shortages, 25/114 (22%) patients were compliant with planned maintenance treatment. Compared to the compliant cohort, the non-compliant due to BCG shortages cohort had a higher rate of disease recurrence (35.3% vs. 24%), required more additional intravesical treatments (14.7% vs. 12%) and had a higher rate of radical cystectomy (11.8% vs. 4%). Disease-free survival was superior in the compliant cohort at two years (88% vs. 79.5%) and at 4.5 years (72% vs. 56.1%). There was no statistically significant difference, likely due to the sample size. Conclusions: The consequences of undertreatment due to BCG shortages can impact long-term cancer outcomes. Increased vigilance, robust long-term surveillance and alternative treatment strategies are required for NMIBC patients affected by shortages in BCG supplies. Level of evidence: Level 2b

Robotic cystectomy histopathology outcomes in patients who have ‘failed’ Bacillus Calmette–Guérin: A case series

2021 ◽  
pp. 205141582097799
Author(s):  
Edward JM Hart ◽  
Liam E Kavanagh ◽  
Alexandra M Guy ◽  
Bronagh Lindsey ◽  
Jo Walters ◽  
...  
Keyword(s):  
Lymph Node ◽  
Case Series ◽  
Invasive Disease ◽  
Bacillus Calmette Guerin ◽  
Level Of Evidence ◽  
Number Of Patients ◽  
Significant Difference ◽  
Group A ◽  
Muscle Invasive ◽  
Group B

Objective: Robot-assisted radical cystectomy (RARC) is considered the gold-standard for patients who fail Bacillus Calmette–Guérin (BCG) treatment for high-grade non-muscle-invasive bladder cancer. We reviewed our histopathological outcomes to assess whether we are proceeding to cystectomy at an appropriate time. Methods: A retrospective analysis of the RARC database (2015–2020) was performed to identify patients who received intravesical BCG before cystectomy. Data regarding demographics, number of BCG instillations and staging were collected. Histopathological stage at cystectomy was compared between patients who received an induction course of BCG only (group A), and those who had continued maintenance doses (group B). Results: A total of 73 patients (57 males and 16 females) met the final inclusion criteria, with 24 patients in group A and 49 patients in group B. At cystectomy, 19 patients had ⩾T2 disease (group A: 7; group B: 12). There was no significant difference between groups ( p=0.78). Pelvic lymph node dissection was performed in 68 patients, with six patients found to have lymph node metastases. Conclusion: RARC plays a key role in managing BCG failure, considering the number of patients with muscle-invasive disease at final staging. However, prolonged BCG treatment was not associated with more advanced disease in our case series. Thus, persistence with intravesical treatment warrants consideration for selected patients. Level of evidence: Level 4.

Final 10-year analysis of prospective multicenter Chemo N0 trial for validation of ASCO-recommended biomarkers uPA/PAI-1 for therapy decision making in node-negative breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 511-511
Author(s):  
N. Harbeck ◽  
M. Schmitt ◽  
C. Meisner ◽  
C. Friedel ◽  
M. Untch ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Cox Regression ◽  
Final Analysis ◽  
Tumor Stage ◽  
Disease Recurrence ◽  
Level Of Evidence ◽  
Treatment Benefit ◽  
Pai 1

511 Background: Based on interim results of the prospective, randomized, multicenter Chemo N0 trial and an EORTC pooled analysis (n = 8,377), ASCO and AGO guidelines recommend invasion markers uPA/PAI-1 for risk assessment in N0 breast cancer. Methods: We present final analysis of the Chemo N0 trial (recruitment 1993–1998; n = 647; 12 centers) with 113 (5–167) months median follow-up. Patients (pts) with low tumor levels of uPA and PAI-1 (n = 283) were observed. Of 364 patients with high uPA and/or PAI-1, 242 were randomized to CMF chemotherapy (n = 117) vs. observation (n =125); 122 pts decided for or against CMF on their own. External quality assurance provided good ELISA standardization in 5 participating laboratories. Results: The actuarial 10-year recurrence rate (without any adjuvant systemic therapy) for high uPA/PAI-1 pts in the combined (randomized and not randomized) observation group was 23.0%, in contrast to only 12.9% in those with low uPA/PAI-1 (p = 0.011, log rank). High-risk pts randomized for CMF had a 26.0% lower estimated probability of disease recurrence than high-risk pts randomized for observation (intention-to-treat analysis: HR 0.74 (0.44–1.27); p = 0.28, log rank). In per-protocol analysis, the treatment benefit was significant: HR 0.48 (0.25–0.88), p = 0.019, adjusted for tumor stage and grading in Cox regression for DFS; for OS, HR was 0.64 (0.35–1.19); p = 0.162, adjusted for tumor stage and grading in Cox regression. Conclusions: Chemo N0 is the first prospective biomarker-based therapy trial in early breast cancer defining a patient group achieving good long-term DFS without any adjuvant therapy. This trial demonstrates that, using a standardized uPA/PAI-1 ELISA, about half of N0 pts, classified as low-risk, could be spared chemotherapy, while high-risk pts benefit from adjuvant chemotherapy. These 10-year results validate the long-term prognostic and predictive impact of uPA/PAI-1 at highest level of evidence (LOE I) and support their guideline-based routine use for risk-adapted individualized therapy decisions in N0 breast cancer. The ongoing NNBC-3 trial is evaluating optimal chemotherapy for uPA/PAI-1 high-risk patients. [Table: see text]

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

2015 ◽  
Vol 9 (5-6) ◽  
pp. 278 ◽  
Author(s):  
Rahmi Gokhan Ekin ◽  
Ilker Akarken ◽  
Ferruh Zorlu ◽  
Huseyin Tarhan ◽  
Ulku Kucuk ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Propensity Score ◽  
Cox Regression ◽  
Invasive Bladder Cancer ◽  
Bacillus Calmette Guerin ◽  
Muscle Invasive Bladder Cancer ◽  
Free Interval ◽  
Significant Difference ◽  
Muscle Invasive

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.

Effectiveness of the Moreau strain of Bacillus Calmette-Guerin (BCG) for nonmuscle invasive bladder cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4539-4539 ◽  
Author(s):  
Daher Cezar Chade ◽  
Andre Machado ◽  
Ricardo Waksman ◽  
Guilherme Garcia ◽  
Paulo Esteves ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Disease Progression ◽  
Disease Recurrence ◽  
Intravesical Instillation ◽  
Bacillus Calmette Guerin ◽  
Free Survival ◽  
Instillation Therapy ◽  
Bcg Therapy ◽  
Muscle Invasive

4539 Background: Intravesical instillation therapy of Bacillus Calmette-Guerin (BCG) for intermediate and high-risk non-muscle invasive bladder cancer (NMIBC) after complete transurethral resection has been widely shown to be more effective than any other adjuvant treatment. However, there are several different BCG strains not appropriately evaluated in clinical setting, but in current use. BCG Moreau is by far the most utilized strain in Brazil and has been recently introduced to the European market to cover the issue of BCG shortage, but there is insufficient data regarding its oncologic efficacy. Methods: We retrospectively analyzed 336 consecutive patients, who received adjuvant intravesical instillation therapy with BCG Moreau for intermediate- and high-risk NMIBC between January 2005 and February 2015 at a single institution. The end points of this study were time to first recurrence and progression to muscle-invasive disease. Results: Median age was 62 years (interquartile range 54-76, mean 64.3 years). In addition to induction BCG therapy, 228 (67.9%) patients received maintenance BCG. However, 35 (15.4%) patients interrupted maintenance BCG due to toxicity. Overall, after at least a complete induction BCG therapy, 87 (25.9%) patients presented with disease recurrence and 33 (9.8%) patients had disease progression. When analyzing on patients who received BCG maintenance in addition to induction therapy, 31 (13.6%) patients had disease recurrence and 10 (4.4%) had disease progression. The 5-year recurrence-free survival and progression-free survival rate was 69.8% (95% CI 52.8-77.2) and 86.2% (95% CI 69.9-93.2), respectively. Conclusions: BCG Moreau has shown to be safe and effective as adjuvant intravesical treatment in intermediate and high-risk NMIBC patients. Since results are comparable to other strains, wider use of BCG Moreau may be encouraged and prospective clinical trials stimulated for higher level of evidence.

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