Quality of Life in Patients with High-grade Non-muscle-invasive Bladder Cancer Undergoing Standard Versus Reduced Frequency of Bacillus Calmette-Guérin Instillations : The EAU-RF NIMBUS Trial
van Straten, Christine G.J.I. (Radboud University Medical Center)
Caris, Christien (EAU Research Foundation)
Grimm, Marc-Oliver (Jena University Hospital (Alemania))
Colombel, Marc (Hospital Edouard Herriot)
Muilwijk, Tim (University Hospitals Leuven (Bèlgica))
Martínez-Piñeiro, Luis (Hospital Universitario La Paz (Madrid))
Babjuk, Marek (Charles University)
Türkeri, Levent N. (Acıbadem University)
Palou, Juan (Institut d'Investigació Biomèdica Sant Pau)
Patel, Anup
Bjartell, Anders S. (Skåne University Hospital (Suècia))
Witjes, Wim P.J. (EAU Research Foundation)
van der Heijden, Antoine G. (Radboud University Medical Center)
Kiemeney, Lambertus A.L.M. (Radboud University Medical Center)
Universitat Autònoma de Barcelona

Data:	2023
Resum:	Adverse events induced by intravesical bacillus Calmette-Guérin (BCG) to treat high-grade non-muscle-invasive bladder cancer (NMIBC) often lead to treatment discontinuation. The EAU-RF NIMBUS trial found a reduced number of standard-dose BCG instillations to be inferior with the standard regimen. Nonetheless, it remains important to evaluate whether patients in the reduced BCG treatment arm had better quality of life (QoL) due to a possible reduction in toxicity or burden. To evaluate whether patients in the EAU-RF NIMBUS trial experienced better QoL after a reduced BCG instillation frequency. Design, setting, and participants: A total of 359 patients from 51 European sites were randomized to one of two treatment arms between December 2013 and July 2019. The standard frequency arm (n = 182) was 6 weeks of BCG induction followed by 3 weeks of maintenance at months 3, 6, and 12. The reduced frequency arm (n = 177) was BCG induction at weeks 1, 2, and 6, followed by maintenance instillations at weeks 1 and 3 of months 3, 6, and 12. Outcome measurements and statistical analysis: Analyses were performed using an intention-to-treat analysis and a per-protocol analysis. QoL was measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 version 3. 0 (QLQ-C30 v. 03) prior to the first and last instillations of each BCG cycle. Group differences were determined using linear regression corrected for QoL at baseline. Differences in QoL over time were tested for significance using a linear mixed model. Side effects were recorded by the treating physician using a standardized form. Chi-square tests were used to compare the side-effect frequency between the arms. There were no significant differences in the means of each QoL scale between the two arms. There were also no significant changes over time in all QoL domains for both arms. However, differences in the incidence of general malaise at T1 (before the last induction instillation), frequency, urgency, and dysuria at T7 (before the last maintenance instillation) were detected in favor of the reduced frequency arm. Reducing the BCG instillation frequency does not improve the QoL in NMIBC patients despite lower storage symptoms. In this study, we evaluated whether a reduction in the number of received bacillus Calmette-Guérin instillations led to better quality of life in patients with high-grade non-muscle-invasive bladder cancer. We found no difference in the quality of life between the standard and the reduced bacillus Calmette-Guérin instillation frequency. We conclude that reducing the number of instillations does not lead to better quality of life in patients with high-grade non-muscle-invasive bladder cancer.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Bacillus Calmette-Guérin ; Bladder cancer ; High-grade non-muscle-invasive bladder cancer ; Quality of life
Publicat a:	European Urology Open Science, Vol. 56 (october 2023) , p. 15-24, ISSN 2666-1683

DOI: 10.1016/j.euros.2023.08.004
PMID: 37822514

10 p, 1.1 MB

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