Efficacy and Safety of a 5-Alpha Reductase Inhibitor, Dutasteride, Added to Bacillus Calmette-Guérin Immunotherapy for Prevention of Recurrence and Progression of Intermediate- and High-Risk Non- Muscle Invasive Bladder Cancer: A Single-Arm, Phase 2 Clinical Trial
Objective:To assess the efficacy and safety of 5α-R inhibitor dutasteride added to standard Bacillus Calmette-Guérin (BCG) immunotherapy for preventing recurrence and progression in intermediate- and high-risk non-muscle invasive bladder cancer (NMIBC).Materials and Methods:Patients received BCG imm...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Galenos Yayinevi
2023-03-01
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| Series: | Journal of Urological Surgery |
| Subjects: | |
| Online Access: |
http://jurolsurgery.org/archives/archive-detail/article-preview/efficacy-and-safety-of-a-5-alpha-reductase-nhibito/58883
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| _version_ | 1797884315723366400 |
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| author | Müslim Doğan Değer Hüseyin Alperen Yıldız Canet İncir Selçuk Özer Alper Ege Sarıkaya Gül Ergör Yeşim Tunçok Volkan Şen Ozan Bozkurt Ahmet Adil Esen |
| author_facet | Müslim Doğan Değer Hüseyin Alperen Yıldız Canet İncir Selçuk Özer Alper Ege Sarıkaya Gül Ergör Yeşim Tunçok Volkan Şen Ozan Bozkurt Ahmet Adil Esen |
| author_sort | Müslim Doğan Değer |
| collection | DOAJ |
| description | Objective:To assess the efficacy and safety of 5α-R inhibitor dutasteride added to standard Bacillus Calmette-Guérin (BCG) immunotherapy for preventing recurrence and progression in intermediate- and high-risk non-muscle invasive bladder cancer (NMIBC).Materials and Methods:Patients received BCG immunotherapy in accordance with the European Association of Urology guidelines and dutasteride (0.5 mg) tablet were orally administered once a day. The participants were monitored for recurrence or progression for 24 months. Androgen receptor expression assay was performed on cystoscopic biopsy materials. According to the data from retrospective studies of patients with bladder cancer, the recurrence rate was 50% in patients with BCG immunotherapy without dutasteride, and 25% in those given dutasteride, with 23 patients included in the study.Results:A total of 14 (60.9%) patients could finish the follow-up. Ten patients completed the 24 months follow-up without recurrence and 4 patients had recurrence. Nine (39.1%) patients failed to complete the follow-up. Of these patients, 28.5% had recurrence. No patient progressed to MIBC and no low-grade tumor progressed to high grade. There was no statistical significance between recurrence and non-recurrence groups for AR mRNA, ARV7 mRNA, AR protein and ARV7 protein expression. But all expressions were higher in the non-recurrence group.Conclusion:Dutasteride failed to show predicted efficacy in recurrence in this prospective study, most likely due to the limited number of patients, however the decrease in recurrences after the 6th month of dutasteride treatment and the fact that the lack of progression during the treatment is promising for future studies. |
| first_indexed | 2024-04-10T04:04:34Z |
| format | Article |
| id | doaj.art-0f80b750d96545879166fce18a3c2503 |
| institution | Directory Open Access Journal |
| issn | 2148-9580 |
| language | English |
| last_indexed | 2024-04-10T04:04:34Z |
| publishDate | 2023-03-01 |
| publisher | Galenos Yayinevi |
| record_format | Article |
| series | Journal of Urological Surgery |
| spelling | doaj.art-0f80b750d96545879166fce18a3c25032023-03-13T06:27:27ZengGalenos YayineviJournal of Urological Surgery2148-95802023-03-01101364210.4274/jus.galenos.2022.2022.003713049054Efficacy and Safety of a 5-Alpha Reductase Inhibitor, Dutasteride, Added to Bacillus Calmette-Guérin Immunotherapy for Prevention of Recurrence and Progression of Intermediate- and High-Risk Non- Muscle Invasive Bladder Cancer: A Single-Arm, Phase 2 Clinical TrialMüslim Doğan Değer0Hüseyin Alperen Yıldız1Canet İncir2Selçuk Özer3Alper Ege Sarıkaya4Gül Ergör5Yeşim Tunçok6Volkan Şen7Ozan Bozkurt8Ahmet Adil Esen9 Trakya University Faculty of Medicine, Department of Urology, Edirne, Turkiye Abant İzzet Baysal University Faculty of Medicine, Department of Urology, Bolu, Turkiye Dokuz Eylül University Faculty of Medicine, Department of Pharmacology, İzmir, Turkiye Dokuz Eylül University Faculty of Medicine, Department of Urology, İzmir, Turkiye Dokuz Eylül University Faculty of Medicine, Department of Urology, İzmir, Turkiye Dokuz Eylül University Faculty of Medicine, Department of Public Health, İzmir, Turkiye Dokuz Eylül University Faculty of Medicine, Department of Pharmacology, İzmir, Turkiye Dokuz Eylül University Faculty of Medicine, Department of Urology, İzmir, Turkiye Dokuz Eylül University Faculty of Medicine, Department of Urology, İzmir, Turkiye Dokuz Eylül University Faculty of Medicine, Department of Urology, İzmir, Turkiye Objective:To assess the efficacy and safety of 5α-R inhibitor dutasteride added to standard Bacillus Calmette-Guérin (BCG) immunotherapy for preventing recurrence and progression in intermediate- and high-risk non-muscle invasive bladder cancer (NMIBC).Materials and Methods:Patients received BCG immunotherapy in accordance with the European Association of Urology guidelines and dutasteride (0.5 mg) tablet were orally administered once a day. The participants were monitored for recurrence or progression for 24 months. Androgen receptor expression assay was performed on cystoscopic biopsy materials. According to the data from retrospective studies of patients with bladder cancer, the recurrence rate was 50% in patients with BCG immunotherapy without dutasteride, and 25% in those given dutasteride, with 23 patients included in the study.Results:A total of 14 (60.9%) patients could finish the follow-up. Ten patients completed the 24 months follow-up without recurrence and 4 patients had recurrence. Nine (39.1%) patients failed to complete the follow-up. Of these patients, 28.5% had recurrence. No patient progressed to MIBC and no low-grade tumor progressed to high grade. There was no statistical significance between recurrence and non-recurrence groups for AR mRNA, ARV7 mRNA, AR protein and ARV7 protein expression. But all expressions were higher in the non-recurrence group.Conclusion:Dutasteride failed to show predicted efficacy in recurrence in this prospective study, most likely due to the limited number of patients, however the decrease in recurrences after the 6th month of dutasteride treatment and the fact that the lack of progression during the treatment is promising for future studies. http://jurolsurgery.org/archives/archive-detail/article-preview/efficacy-and-safety-of-a-5-alpha-reductase-nhibito/58883 bladder cancerdutasteriderecurrence |
| spellingShingle | Müslim Doğan Değer Hüseyin Alperen Yıldız Canet İncir Selçuk Özer Alper Ege Sarıkaya Gül Ergör Yeşim Tunçok Volkan Şen Ozan Bozkurt Ahmet Adil Esen Efficacy and Safety of a 5-Alpha Reductase Inhibitor, Dutasteride, Added to Bacillus Calmette-Guérin Immunotherapy for Prevention of Recurrence and Progression of Intermediate- and High-Risk Non- Muscle Invasive Bladder Cancer: A Single-Arm, Phase 2 Clinical Trial Journal of Urological Surgery bladder cancer dutasteride recurrence |
| title | Efficacy and Safety of a 5-Alpha Reductase Inhibitor, Dutasteride, Added to Bacillus Calmette-Guérin Immunotherapy for Prevention of Recurrence and Progression of Intermediate- and High-Risk Non- Muscle Invasive Bladder Cancer: A Single-Arm, Phase 2 Clinical Trial |
| title_full | Efficacy and Safety of a 5-Alpha Reductase Inhibitor, Dutasteride, Added to Bacillus Calmette-Guérin Immunotherapy for Prevention of Recurrence and Progression of Intermediate- and High-Risk Non- Muscle Invasive Bladder Cancer: A Single-Arm, Phase 2 Clinical Trial |
| title_fullStr | Efficacy and Safety of a 5-Alpha Reductase Inhibitor, Dutasteride, Added to Bacillus Calmette-Guérin Immunotherapy for Prevention of Recurrence and Progression of Intermediate- and High-Risk Non- Muscle Invasive Bladder Cancer: A Single-Arm, Phase 2 Clinical Trial |
| title_full_unstemmed | Efficacy and Safety of a 5-Alpha Reductase Inhibitor, Dutasteride, Added to Bacillus Calmette-Guérin Immunotherapy for Prevention of Recurrence and Progression of Intermediate- and High-Risk Non- Muscle Invasive Bladder Cancer: A Single-Arm, Phase 2 Clinical Trial |
| title_short | Efficacy and Safety of a 5-Alpha Reductase Inhibitor, Dutasteride, Added to Bacillus Calmette-Guérin Immunotherapy for Prevention of Recurrence and Progression of Intermediate- and High-Risk Non- Muscle Invasive Bladder Cancer: A Single-Arm, Phase 2 Clinical Trial |
| title_sort | efficacy and safety of a 5 alpha reductase inhibitor dutasteride added to bacillus calmette guerin immunotherapy for prevention of recurrence and progression of intermediate and high risk non muscle invasive bladder cancer a single arm phase 2 clinical trial |
| topic | bladder cancer dutasteride recurrence |
| url |
http://jurolsurgery.org/archives/archive-detail/article-preview/efficacy-and-safety-of-a-5-alpha-reductase-nhibito/58883
|
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