The Side Effects of Bacillus Calmette-Guerin in the Treatment of Ta T1 Bladder Cancer Do Not Predict its Efficacy: Results from a European Organisation for Research and Treatment of Cancer Genito-Urinary Group Phase III Trial

Sylvester, Richard; Meijden, A.P.M. van der; Oosterlinck, W; Hoeltl, Wolfgang; Bono, Aldo

doi:10.1016/s0302-2838(03)00371-3

Cited by 72 publications

(40 citation statements)

References 18 publications

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“…Neither local nor systemic BCG toxicity before 6 months was found to be a prognostic factor for subsequent recurrence. Thus, it is not possible to confirm that BCG toxicity is actually responsible for an improved outcome and a causal effect cannot be inferred from the data [29]. …”

Section: Resultsmentioning

confidence: 99%

Could Hyaluronic acid (HA) reduce Bacillus Calmette-Guérin (BCG) local side effects? Results of a pilot study

et al. 2014

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BackgroundBacillus Calmette-Guérin (BCG) is considered the most effective treatment to reduce recurrence and progression of non-muscle invasive bladder cancer (NMIBC) but can induce local side effects leading to treatment discontinuation or interruption. Aim of this exploratory study is to investigate if the sequential administration of Hyaluronic acid (HA) may reduce local side effects of BCG.Methods30 consecutive subjects undergoing BCG intravesical administration for high risk NMIBC were randomized to receive BCG only (Group A) or BCG and HA (Group B). A 1 to 10 Visual Analog Scale (VAS) for bladder pain, International Prostate Symptom Score (IPSS) and number of micturitions per day were evaluated in the two groups before and after six weekly BCG instillations. Patients were also evaluated at 3 and 6 months by means of cystostopy and urine cytology.ResultsOne out of 30 (3,3%) patients in group A dropped out from the protocol, for local side effects. Mean VAS for pain was significantly lower in group B after BCG treatment (4.2 vs. 5.8, p = 0.04). Post vs. pre treatment differences in VAS for pain, IPSS and number of daily micturitions were all significantly lower in group B. Three patients in group A and 4 in group B presented with recurrent pathology at 6 month follow up.ConclusionsThese preliminary data suggest a possible role of HA in reducing BCG local side effects and could be used to design larger randomized controlled trials, assessing safety and efficacy of sequential BCG and HA administration.Trial registrationNCT02207608 (ClinicalTrials.gov) 01/08/2014Policlinico Tor Vergata Ethics Committee, resolution n 69–2011.

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Section: Resultsmentioning

confidence: 99%

Could Hyaluronic acid (HA) reduce Bacillus Calmette-Guérin (BCG) local side effects? Results of a pilot study

et al. 2014

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“…The completion rate of maintenance therapy in the SWOG trial was 16%, whereas another study reported that only one of 111 patients completed seven cycles of maintenance therapy (13). However, Sylvester et al (19) reported that local side effects of BCG do not increase during maintenance therapy and that systemic side effects are more frequent during the first 6 months of treatment, after which time they decrease. In a European Organisation for Research and Treatment of Cancer (EORTC) prospective study, the majority of discontinuations resulting from adverse events occurred during induction therapy and the first 6 months of maintenance therapy, suggesting that BCG maintenance does not necessarily increase adverse events (11).…”

Section: Discussionmentioning

confidence: 99%

A 2-week Maintenance Regimen of Intravesical Instillation of Bacillus Calmette-Guerin is Safe, Adherent and Effective in Patients with Non-muscle-invasive Bladder Cancer: A Prospective, Multicenter Phase II Clinical Trial

2012

Japanese Journal of Clinical Oncology

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Objective: To investigate the safety and efficacy of a maintenance regimen of bacillus Calmette -Gué rin therapy including 6-week induction and 2-week maintenance instillation for patients with recurrent or multiple Ta, T1 tumors or carcinoma in situ of the urinary bladder. Methods: This study was performed as single-arm multi-institutional study. The enrolled patients had been diagnosed with urothelial carcinoma of the bladder, including the presence of at least two bladder tumors, single tumors recurring within 12 months of follow-up, any Grade 3 Stage Ta or T1 tumor, and primary or recurrent biopsy proven carcinoma in situ. Patients received 81 mg intravesical bacillus Calmette -Gué rin (Connaught strain). The instillation was repeated once a week for another 5 weeks, followed by once a week for 2 weeks at months 3, 6, 12, 18, 24, 30 and 36, for a total of 20 instillations in 3 years. Results: From 28 hospitals, 202 patients were registered. A total of 186 patients matched the inclusion criteria: 139 patients in the Ta/T1group and 47 patients in the carcinoma in situ group. At the 4-year median point of follow-up, recurrence-free survival rates in the Ta/T1 group and the carcinoma in situ group were 76.7 and 77.7%, respectively. Completion rates for maintenance therapy in both groups at months 3, 6, 12, 24 and 36 were 81.7, 68.9, 58.1, 42.5 and 35.0%, respectively. Common toxicities were pain on urination, urinary frequency and gross hematuria. There was no treatment-related death. Conclusions: This regimen may be feasible in patients with Ta/T1 tumor or carcinoma in situ; however, future Phase III randomized study is needed to determine whether this regimen would be truly safe and effective compared with 3-week maintenance regimen.

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“…Less than one third of the 169 patients complaining grade-I local side effects received medical treatment. Mild BCG cystitis is sometimes considered an expected and positive effect, rather than a side effect worthy of therapy, although it has been demonstrated that there is no statistically significant correlation between BCG-related toxicity and clinical efficacy [12]. …”

Section: Discussionmentioning

confidence: 99%

Does the Compliance to Intravesical BCG Differ between Common Clinical Practice and International Multicentric Trials?

Serretta¹,

Gesolfo²,

Alonge³

et al. 2015

Urol Int

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Introduction: The aim of this study was to analyze the reasons for intravesical BCG interruption in clinical practice. BCG for at least one year is advocated as the best regimen to treat high-risk non-muscle invasive bladder cancer (NMIBC). However, almost 50% of patients don't complete it. Toxicity accounts for 10% of dropouts in international trials. Materials and Methods: Patients with T1HG NMIBC undergoing 1-year BCG were enrolled in this study. BCG was administered for one year. Toxicity and causes of treatment interruption were recorded. Results: A total of 411 patients were enrolled in the study. Out of these total number of patients, 380 (92.5%) completed the induction cycle and 215 (52.3%) completed one year. Toxicity requiring interruption or postponement was recorded in 25 (6.1%) and 60 (14.6%) patients. Ninety-three patients (30.2%) stopped BCG, 9 (9.7%) for recurrence and 14 (15.1%) for grade-3 toxicity. Intriguingly, 55 (59.1%) patients refused BCG due to mild discomfort and deterioration in quality of social life. Conclusions: Grades 2-3 toxicity causes BCG interruption in a few cases. Almost 60% of interruptions are attributable to persistent grade-1 toxicity, which is inadequately treated.

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The Side Effects of Bacillus Calmette-Guerin in the Treatment of Ta T1 Bladder Cancer Do Not Predict its Efficacy: Results from a European Organisation for Research and Treatment of Cancer Genito-Urinary Group Phase III Trial

Cited by 72 publications

References 18 publications

Could Hyaluronic acid (HA) reduce Bacillus Calmette-Guérin (BCG) local side effects? Results of a pilot study

Could Hyaluronic acid (HA) reduce Bacillus Calmette-Guérin (BCG) local side effects? Results of a pilot study

A 2-week Maintenance Regimen of Intravesical Instillation of Bacillus Calmette-Guerin is Safe, Adherent and Effective in Patients with Non-muscle-invasive Bladder Cancer: A Prospective, Multicenter Phase II Clinical Trial

Does the Compliance to Intravesical BCG Differ between Common Clinical Practice and International Multicentric Trials?

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