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
Por:
van Straten C.G.J.I., Caris C., Grimm M.-O., Colombel M., Muilwijk T., Martínez-Piñeiro L., Babjuk M.M., Türkeri L.N., Palou J., Patel A., Bjartell A.S., Witjes W.P.J., van der Heijden A.G., Kiemeney L.A.L.M.
Publicada:
1 ene 2023
Ahead of Print:
1 sep 2023
Resumen:
Background: Adverse events induced by intravesical bacillus Calmette-Guerin (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.Objective: 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.Results and limitations: 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.Conclusions: Reducing the BCG instillation frequency does not improve the QoL in NMIBC patients despite lower storage symptoms. Patient summary: In this study, we evaluated whether a reduction in the number of received bacillus Calmette-Guerin 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-Guerin 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.(c) 2023 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4.0/).
Filiaciones:
van Straten C.G.J.I.:
Department of Urology, Radboud University Medical Center, Nijmegen, Netherlands
Caris C.:
EAU Research Foundation, Arnhem, Netherlands
Grimm M.-O.:
Department of Urology, Jena University Hospital, Jena, Germany
Colombel M.:
Department of Urology, Hospital Edouard Herriot, Lyon, France
Muilwijk T.:
Department of Urology, University Hospitals Leuven, Leuven, Belgium
Martínez-Piñeiro L.:
Department of Urology, Hospital Universitario La Paz, Madrid, Spain
Babjuk M.M.:
Department of Urology, Hospital Motol, 2nd Faculty of Medicine, Charles University, Prague, Czech Republic
Türkeri L.N.:
Department of Urology, Acibadem University, Istanbul, Turkey
Palou J.:
Urology Department, Fundació Puigvert, Universitat Autònoma de Barcelona, Barcelona, Spain
Patel A.:
London, United Kingdom
Bjartell A.S.:
Skåne University Hospital, Lund University, Lund, Sweden
Witjes W.P.J.:
EAU Research Foundation, Arnhem, Netherlands
van der Heijden A.G.:
Department of Urology, Radboud University Medical Center, Nijmegen, Netherlands
Kiemeney L.A.L.M.:
Department of Urology, Radboud University Medical Center, Nijmegen, Netherlands
hybrid, All Open Access; Gold
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