scholarly journals Intracutaneous and Intravesical Immunotherapy With Keyhole Limpet Hemocyanin Compared With Intravesical Mitomycin in Patients With Non–Muscle-Invasive Bladder Cancer: Results From a Prospective Randomized Phase III Trial

2012 ◽  
Vol 30 (18) ◽  
pp. 2273-2279 ◽  
Author(s):  
Rianne J.M. Lammers ◽  
Wim P.J. Witjes ◽  
Maria H.D. Janzing-Pastors ◽  
Christien T.M. Caris ◽  
J. Alfred Witjes
Keyword(s):  
Bladder Cancer ◽  
Cox Regression ◽  
Keyhole Limpet Hemocyanin ◽  
Phase Iii ◽  
Regression Analyses ◽  
Muscle Invasive Bladder Cancer ◽  
Phase Iii Trial ◽  
Free Survival ◽  
Muscle Invasive ◽  
Intravesical Instillations

Purpose Despite current treatment after transurethral resection of a bladder tumor, recurrences and progression remain a problem. Keyhole limpet hemocyanin (KLH) was beneficial in earlier studies. In this study, safety and efficacy of KLH were compared with that of mitomycin (MM). Patients and Methods Patients with intermediate- and high-risk non–muscle-invasive bladder cancer (NMIBC) without carcinoma in situ were enrolled in a randomized phase III trial. In all, 283 patients were randomly assigned for 16 adjuvant intravesical instillations with KLH after preimmunization, and 270 patients were randomly assigned for 11 adjuvant intravesical instillations with MM. Primary outcome measurement was recurrence-free survival (RFS). Secondary outcome measurements were progression-free survival, adverse events (AEs), and the effect of delayed-type hypersensitivity (DTH) response on clinical outcome. Results There were significantly more pT1 tumors in the MM group (P = .01). In a log-rank test, univariate and multivariate Cox regression analysis, KLH was less effective than MM regarding RFS (all P < .001). Progression was uncommon (n = 20). In univariate Cox regression analyses, KLH tended to prevent progression more effectively than MM, but in multivariate Cox regression analyses, this could not be shown. AEs were common but mild. Fever, flu-like symptoms, and fatigue occurred significantly more after KLH treatment. Allergic reactions and other skin disorders occurred significantly more after MM treatment. Significantly more DTH-positive patients developed a recurrence than DTH-negative patients. Conclusion KLH had a different safety profile and was inferior to MM in preventing NMIBC recurrences. KLH tended to be more effective than MM in preventing progression. More research is needed to clarify the immunologic effects of KLH and the effects of KLH on progression.

scholarly journals Intravesical Therapy for Non-Muscle-Invasive Bladder Cancer: What Is the Real Impact of Squamous Cell Carcinoma Variant on Oncological Outcomes?

Medicina ◽  
2022 ◽  
Vol 58 (1) ◽  
pp. 90
Author(s):  
Guglielmo Mantica ◽  
Francesco Chierigo ◽  
Rafaela Malinaric ◽  
Salvatore Smelzo ◽  
Francesca Ambrosini ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Bladder Cancer ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Cox Regression ◽  
Disease Recurrence ◽  
Intravesical Therapy ◽  
Regression Analyses ◽  
Muscle Invasive Bladder Cancer ◽  
Muscle Invasive

Background and Objectives: To evaluate the oncological impact of squamous cell carcinoma (SCC) variant in patients submitted to intravesical therapy for non-muscle-invasive bladder cancer (NMIBC). Materials and Methods: Between January 2015 and January 2020, patients with conventional urothelial NMIBC (TCC) or urothelial NMIBC with SCC variant (TCC + SCC) and submitted to adjuvant intravesical therapies were collected. Kaplan–Meier analyses targeted disease recurrence and progression. Uni- and multivariable Cox regression analyses were used to test the role of SCC on disease recurrence and/or progression. Results: A total of 32 patients out of 353 had SCC at diagnosis. Recurrence was observed in 42% of TCC and 44% of TCC + SCC patients (p = 0.88), while progression was observed in 12% of both TCC and TCC + SCC patients (p = 0.78). At multivariable Cox regression analyses, the presence of SCC variant was not associated with higher rates of neither recurrence (p = 0.663) nor progression (p = 0.582). Conclusions: We presented data from the largest series on patients with TCC and concomitant SCC histological variant managed with intravesical therapy (BCG or MMC). No significant differences were found in term of recurrence and progression between TCC and TCC + SCC. Despite the limited sample size, this study paves the way for a possible implementation of the use of intravesical BCG and MMC in NMIBC with histological variants.

scholarly journals Radical cystectomy (bladder removal) against intravesical BCG immunotherapy for high-risk non-muscle invasive bladder cancer (BRAVO): a protocol for a randomised controlled feasibility study

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e017913 ◽  
Author(s):  
Jamie B Oughton ◽  
Heather Poad ◽  
Maureen Twiddy ◽  
Michelle Collinson ◽  
Victoria Hiley ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Radical Cystectomy ◽  
Feasibility Study ◽  
Phase Iii ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Phase Iii Trial ◽  
Muscle Invasive ◽  
Randomised Controlled

IntroductionHigh-risk non-muscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease that can be difficult to predict. While around 25% of cancers progress to invasion and metastases, the remaining majority of tumours remain within the bladder. It is uncertain whether patients with HRNMIBC are better treated with intravesical maintenance BCG (mBCG) immunotherapy or primary radical cystectomy (RC). A definitive randomised controlled trial (RCT) is needed to compare these two different treatments but may be difficult to recruit to and has not been attempted to date. Before undertaking such an RCT, it is important to understand whether such a comparison is possible and how best to achieve it.Methods and analysisBRAVO is a multi-centre, parallel-group, mixed-methods, individually randomised, controlled, feasibility study for patients with HRNMIBC. Participants will be randomised to receive either mBCG immunotherapy or RC. The primary objective is to assess the feasibility and acceptability of performing the definitive phase III trial via estimation of eligibility and recruitment rates, assessing uptake of allocated treatment and compliance with mBCG, determining quality-of-life questionnaire completion rates and exploring reasons expressed by patients for declining recruitment into the study. We aim to recruit 60 participants from six centres in the UK. Surgical trials with disparate treatment options find recruitment challenging from both the patient and clinician perspective. By building on the experiences of other similar trials through implementing a comprehensive training package aimed at clinicians to address these challenges (qualitative substudy), we hope that we can demonstrate that a phase III trial is feasible.Ethics and disseminationThe study has ethical approval (16/YH/0268). Findings will be made available to patients, clinicians, the funders and the National Health Service through traditional publishing and social media.Trial registration numberISRCTN12509361; Pre results.

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