Commentary on “Efficacy and safety of photodynamic therapy for recurrent, high grade nonmuscle invasive bladder cancer refractory or intolerant to bacille Calmette-Guérin immunotherapy.” Lee JY, Diaz RR, Cho KS, Lim MS, Chung JS, Kim WT, Ham WS, Choi YD, Department of Urology, Yonsei University College of Medicine, Seoul, Republic of Korea; Severance Hospital and Urological Science Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.

2015 ◽  
Vol 33 (1) ◽  
pp. 46
Author(s):  
Ashish Kamat
Keyword(s):  
Bladder Cancer ◽  
Photodynamic Therapy ◽  
Republic Of Korea ◽  
High Grade ◽  
Efficacy And Safety ◽  
Bacille Calmette Guerin ◽  
Science Institute ◽  
Severance Hospital ◽  
University College ◽  
Nonmuscle Invasive Bladder Cancer

scholarly journals A multicentre, prospective, randomised controlled trial to evaluate hexaminolevulinate photodynamic therapy (Cevira®) as a novel treatment in patients with high grade squamous intraepithelial lesion: APRICITY Phase 3 study protocol

2021 ◽  
Author(s):  
Fei Chen ◽  
Zoltán Novák ◽  
Christian Dannecker ◽  
Long Sui ◽  
Youzhong Zhang ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Low Grade ◽  
High Grade ◽  
Efficacy And Safety ◽  
Squamous Intraepithelial Lesion ◽  
Phase 3 ◽  
Link Type ◽  
Surgical Methods ◽  
Intraepithelial Lesion ◽  
Randomised Controlled

AbstractIntroductionHigh-risk human papilloma virus (HPV)-associated cervical cancer is the fourth most common cancer in women worldwide. Current treatments of high grade squamous intraepithelial lesion (HSIL) of the cervix are based on invasive surgical interventions, compromising cervical competence and functionality.ObjectiveAPRICITY is a multicentre, prospective, double-blind, randomised controlled Phase 3 study further evaluating the efficacy and safety of Cevira®, an integrated drug- and light-delivery device for hexaminolevulinate photodynamic therapy, which shows promise as a novel, non-invasive therapy for women with HSIL.Methods and analysisPatients with biopsy-confirmed HSIL histology are invited to participate in the study currently being conducted at 47 sites in China and 25 sites in Ukraine, Russia and European Union. The aim is to include at least 384 patients which will be randomised to either Cevira® or placebo group (2:1). All patients will be assessed 3 months after first treatment and a second treatment will be administered in patients who are HPV positive or have at least low grade squamous intraepithelial lesion (LSIL). Primary endpoint is the proportion of the responders at 6 months after first treatment. Secondary efficacy endpoints and safety endpoints will be assessed at 6 months, and data for secondary performance endpoints for Cevira® device will be collected at 3 months and 6 months, in case second treatment was administered. All patients in the Cevira® group will be enrolled in an open, long-term extension study following patients for further 6 months to collect additional efficacy and safety data (study extension endpoints).ConclusionDue to its non-invasiveness and convenient application, Cevira® may be a favourable alternative to surgical methods in treatment of patients with HSIL.Ethics and disseminationThe study was approved by the ethics committee of the Peking Union Medical College Hospital and Hannover Medical University, Germany. Findings will be disseminated through peer review publications and conference presentations.Trial registration numberclinicaltrials.govNCT04484415

Restaging transurethral resection in ta high-grade nonmuscle invasive bladder cancer

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Sophie Regnier ◽  
Gianluigi Califano ◽  
Vincent Elalouf ◽  
Simone Albisinni ◽  
Atiqullah Aziz ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Transurethral Resection ◽  
Invasive Bladder Cancer ◽  
High Grade ◽  
Nonmuscle Invasive Bladder Cancer

scholarly journals Radical Cystectomy Against Intravesical BCG for High-Risk High-Grade Nonmuscle Invasive Bladder Cancer: Results From the Randomized Controlled BRAVO-Feasibility Study

2020 ◽  
pp. JCO.20.01665
Author(s):  
James W. F. Catto ◽  
Kathryn Gordon ◽  
Michelle Collinson ◽  
Heather Poad ◽  
Maureen Twiddy ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Radical Cystectomy ◽  
Controlled Trial ◽  
Invasive Bladder Cancer ◽  
High Grade ◽  
Bacillus Calmette Guerin ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Nonmuscle Invasive Bladder Cancer

PURPOSE High-grade nonmuscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease. Treatments include intravesical maintenance Bacillus Calmette-Guerin (mBCG) and radical cystectomy (RC). We wanted to understand whether a randomized trial comparing these options was possible. MATERIALS AND METHODS We conducted a two-arm, prospective multicenter randomized study to determine the feasibility in Bacillus Calmette-Guerin-naive patients. Participants had new high-risk HRNMIBC suitable for both treatments. Random assignment was stratified by age, sex, center, stage, presence of carcinoma in situ, and prior low-risk bladder cancer. Qualitative work investigated how to maintain equipoise. The primary outcome was the number of patients screened, eligible, recruited, and randomly assigned. RESULTS We screened 407 patients, approached 185, and obtained consent from 51 (27.6%) patients. Of these, one did not proceed and therefore 50 were randomly assigned (1:1). In the mBCG arm, 23/25 (92.0%) patients received mBCG, four had nonmuscle invasive bladder cancer (NMIBC) after induction, three had NMIBC at 4 months, and four received RC. At closure, two patients had metastatic BC. In the RC arm, 20 (80.0%) participants received cystectomy, including five (25.0%) with no tumor, 13 (65.0%) with HRNMIBC, and two (10.0%) with muscle invasion in their specimen. At follow-up, all patients in the RC arm were free of disease. Adverse events were mostly mild and equally distributed (15/23 [65.2%] patients with mBCG and 13/20 [65.0%] patients with RC). The quality of life (QOL) of both arms was broadly similar at 12 months. CONCLUSION A randomized controlled trial comparing mBCG and RC will be challenging to recruit into. Around 10% of patients with high-risk HRNMIBC have a lethal disease and may be better treated by primary radical treatment. Conversely, many are suitable for bladder preservation and may maintain their prediagnosis QOL.

scholarly journals The impact of age on intravesical instillation of Bacille Calmette–Guerin treatment in patients with high-grade T1 bladder cancer

Medicine ◽  
2019 ◽  
Vol 98 (31) ◽  
pp. e16223 ◽  
Author(s):  
B. Calò ◽  
F. Sanguedolce ◽  
F. Fortunato ◽  
G. Stallone ◽  
N. d’Altilia ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Intravesical Instillation ◽  
High Grade ◽  
Bacille Calmette Guerin ◽  
The Impact

scholarly journals Impact of maintenance therapy using a half dose of the bacillus Calmette–Guérin Tokyo strain on recurrence of intermediate and high-risk nonmuscle invasive bladder cancer: a retrospective single-center study

BMC Urology ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Dai Koguchi ◽  
Kazumasa Matsumoto ◽  
Takahiro Hirayama ◽  
Shigetaka Moroo ◽  
Momoko Kobayashi ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Maintenance Therapy ◽  
Cancer Recurrence ◽  
Invasive Bladder Cancer ◽  
Bacillus Calmette Guerin ◽  
Efficacy And Safety ◽  
Kaplan Meier ◽  
Half Dose ◽  
Nonmuscle Invasive Bladder Cancer

Abstract Background Data are scarce regarding intravesical maintenance therapy (MT) with the low-dose bacillus Calmette–Guérin (BCG) Tokyo strain. We investigated the efficacy and safety of MT with a half dose of the Tokyo strain for patients following transurethral resection of nonmuscle invasive bladder cancer (NMIBC). Methods This study retrospectively reviewed clinical data on 78 patients diagnosed with intermediate or high-risk NMIBC followed by either MT (n = 38) or IT alone (n = 40) between January 2012 and March 2018. Statistical analysis was performed to compare recurrence-free survival (RFS) and adverse effects between the two groups. BCG was instilled once weekly for 6 weeks as IT, then once weekly in 2-week for a total of 20 instillations over 3 years. Results Kaplan–Meier analyses showed that patients undergoing MT had significantly better RFS than did those undergoing IT alone (hazard ratio (HR):0.32, 95% confidence interval (CI):0.12–0.89, P = 0.02). The 3-year RFS was 65.0% in the IT group and 89.5% in the MT group. Multivariate analysis showed that MT was associated with a reduced risk of recurrence (HR: 0.32, 95% CI:0.11–0.93, P = 0.03). One MT patient (2.6%) exhibited progression. Conclusions The BCG Tokyo strain showed acceptable efficacy and safety in patients undergoing MT; thus, it is a potential treatment for preventing bladder cancer recurrence.

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