Retrospective, Non-Interventional, Multicenter Study on the Effectiveness and Safety of Intravesical Bacillus Calmette–Guerin in Patients with Non-Muscle-Invasive Bladder Cancer: Real-World Experience from Six Hospital Centers in Greece
Background: While the clinical application of SII-ONCO-Bacillus Calmette–Guerin (BCG) for non-muscle-invasive bladder cancer (NMIBC) is well established in Greece, there is a lack of real-world data on its effectiveness and safety. This retrospective, observational, multicenter, chart-review study a...
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2024-12-01
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| Series: | Current Oncology |
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| author | Panagiotis Angelopoulos Titos Markopoulos Lazaros Lazarou Andreas Skolarikos Panagiotis Stamatakos Georgios I. Papadopoulos Charalampos Fragkoulis Konstantinos Ntoumas Napoleon Moulavasilis Panagiotis Levis Dimitrios Papanikolaou Ioannis Sokolakis Konstantinos Hatzimouratidis Charalampos Tzanetakos Marina Psarra George Mavridoglou Konstantinos Skriapas Dimitra Akrivou Dimitrios Karagiannis Christos Noutsos Andreas Georgiou Konstantinos Hastazeris George Gourzoulidis Dionysios Mitropoulos |
| author_facet | Panagiotis Angelopoulos Titos Markopoulos Lazaros Lazarou Andreas Skolarikos Panagiotis Stamatakos Georgios I. Papadopoulos Charalampos Fragkoulis Konstantinos Ntoumas Napoleon Moulavasilis Panagiotis Levis Dimitrios Papanikolaou Ioannis Sokolakis Konstantinos Hatzimouratidis Charalampos Tzanetakos Marina Psarra George Mavridoglou Konstantinos Skriapas Dimitra Akrivou Dimitrios Karagiannis Christos Noutsos Andreas Georgiou Konstantinos Hastazeris George Gourzoulidis Dionysios Mitropoulos |
| author_sort | Panagiotis Angelopoulos |
| collection | DOAJ |
| description | Background: While the clinical application of SII-ONCO-Bacillus Calmette–Guerin (BCG) for non-muscle-invasive bladder cancer (NMIBC) is well established in Greece, there is a lack of real-world data on its effectiveness and safety. This retrospective, observational, multicenter, chart-review study aims to provide real-life data on the effectiveness and safety of SII-ONCO-BCG in patients with intermediate- and high-risk NMIBC. Methods: From January 2016 to December 2023, medical records from six hospital centers were reviewed for adult patients with histologically confirmed stage Ta or T1 NMIBC (with or without carcinoma in situ [CIS]) who received at least one maintenance course of SII-ONCO-BCG after induction. Tumor recurrence and progression were monitored at scheduled time intervals. Primary outcomes included recurrence-free survival (RFS) and progression-free survival (PFS), while adverse events (AEs) constituted secondary outcomes. Results: A total of 162 patients receiving SII-ONCO-BCG were enrolled. Among all patients, 145 (89.5%) patients were men, 88 (54.3%) aged 70 years or older, 103 (63.6%) had T1, 43 (26.5%) Ta, and 21 (12.9%) concurrent CIS. The median follow-up duration was 28.9 months (range, 5–36) and the mean BCG intravesical instillation courses were 13.7 (range, 9–27). After 3-, 2-, and 1-year follow-up, RFS rates of 85.2% (95% CI, 79.7–90.7%), 85.8% (80.4–91.2%), and 87.0% (81.8–92.3%) were observed, respectively. The corresponding 3-, 2-, and 1-year PFS rates were 96.9% (94.2–99.6%), 96.9% (94.2–99.6%), and 97.5% (95.1–99.9%), respectively. During the whole follow-up period, 24 (14.8%) patients experienced at least one AE. Conclusions: This real-world study demonstrates that SII-ONCO-BCG is an effective and safe treatment for patients with intermediate- and high-risk NMIBC. |
| format | Article |
| id | doaj-art-e4426ca41a3e4ddc83da982d9ecbab6f |
| institution | Kabale University |
| issn | 1198-0052 1718-7729 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Current Oncology |
| spelling | doaj-art-e4426ca41a3e4ddc83da982d9ecbab6f2025-01-24T13:28:22ZengMDPI AGCurrent Oncology1198-00521718-77292024-12-013211810.3390/curroncol32010018Retrospective, Non-Interventional, Multicenter Study on the Effectiveness and Safety of Intravesical Bacillus Calmette–Guerin in Patients with Non-Muscle-Invasive Bladder Cancer: Real-World Experience from Six Hospital Centers in GreecePanagiotis Angelopoulos0Titos Markopoulos1Lazaros Lazarou2Andreas Skolarikos3Panagiotis Stamatakos4Georgios I. Papadopoulos5Charalampos Fragkoulis6Konstantinos Ntoumas7Napoleon Moulavasilis8Panagiotis Levis9Dimitrios Papanikolaou10Ioannis Sokolakis11Konstantinos Hatzimouratidis12Charalampos Tzanetakos13Marina Psarra14George Mavridoglou15Konstantinos Skriapas16Dimitra Akrivou17Dimitrios Karagiannis18Christos Noutsos19Andreas Georgiou20Konstantinos Hastazeris21George Gourzoulidis22Dionysios Mitropoulos232nd Department of Urology, Sismanogleio Hospital, Medical School, National and Kapodistrian University of Athens, 15126 Athens, Greece2nd Department of Urology, Sismanogleio Hospital, Medical School, National and Kapodistrian University of Athens, 15126 Athens, Greece2nd Department of Urology, Sismanogleio Hospital, Medical School, National and Kapodistrian University of Athens, 15126 Athens, Greece2nd Department of Urology, Sismanogleio Hospital, Medical School, National and Kapodistrian University of Athens, 15126 Athens, GreeceDepartment of Urology, General Hospital of Athens G. Gennimatas, 11527 Athens, GreeceDepartment of Urology, General Hospital of Athens G. Gennimatas, 11527 Athens, GreeceDepartment of Urology, General Hospital of Athens G. Gennimatas, 11527 Athens, GreeceDepartment of Urology, General Hospital of Athens G. Gennimatas, 11527 Athens, Greece1st Department of Urology, “Laiko” Gen. Hospital, Medical School, National and Kapodistrian University of Athens, 11527 Athens, Greece1st Department of Urology, “Laiko” Gen. Hospital, Medical School, National and Kapodistrian University of Athens, 11527 Athens, Greece2nd Urology Department of Medical School, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece2nd Urology Department of Medical School, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece2nd Urology Department of Medical School, Aristotle University of Thessaloniki, 54124 Thessaloniki, GreeceHealth Through Evidence, 17456 Athens, GreeceHealth Through Evidence, 17456 Athens, GreeceDepartment of Accounting and Finance, School of Management, University of the Peloponnese, 24150 Kalamata, GreeceDepartment of Urology, General Hospital of Larissa, 41334 Larissa, GreeceDepartment of Urology, General Hospital of Larissa, 41334 Larissa, GreeceDepartment of Urology, General Hospital of Larissa, 41334 Larissa, GreeceDepartment of Urology, General Hospital G. Hatzikosta, 45445 Ioannina, GreeceDepartment of Urology, General Hospital G. Hatzikosta, 45445 Ioannina, GreeceDepartment of Urology, General Hospital G. Hatzikosta, 45445 Ioannina, GreeceHealth Through Evidence, 17456 Athens, Greece1st Department of Urology, “Laiko” Gen. Hospital, Medical School, National and Kapodistrian University of Athens, 11527 Athens, GreeceBackground: While the clinical application of SII-ONCO-Bacillus Calmette–Guerin (BCG) for non-muscle-invasive bladder cancer (NMIBC) is well established in Greece, there is a lack of real-world data on its effectiveness and safety. This retrospective, observational, multicenter, chart-review study aims to provide real-life data on the effectiveness and safety of SII-ONCO-BCG in patients with intermediate- and high-risk NMIBC. Methods: From January 2016 to December 2023, medical records from six hospital centers were reviewed for adult patients with histologically confirmed stage Ta or T1 NMIBC (with or without carcinoma in situ [CIS]) who received at least one maintenance course of SII-ONCO-BCG after induction. Tumor recurrence and progression were monitored at scheduled time intervals. Primary outcomes included recurrence-free survival (RFS) and progression-free survival (PFS), while adverse events (AEs) constituted secondary outcomes. Results: A total of 162 patients receiving SII-ONCO-BCG were enrolled. Among all patients, 145 (89.5%) patients were men, 88 (54.3%) aged 70 years or older, 103 (63.6%) had T1, 43 (26.5%) Ta, and 21 (12.9%) concurrent CIS. The median follow-up duration was 28.9 months (range, 5–36) and the mean BCG intravesical instillation courses were 13.7 (range, 9–27). After 3-, 2-, and 1-year follow-up, RFS rates of 85.2% (95% CI, 79.7–90.7%), 85.8% (80.4–91.2%), and 87.0% (81.8–92.3%) were observed, respectively. The corresponding 3-, 2-, and 1-year PFS rates were 96.9% (94.2–99.6%), 96.9% (94.2–99.6%), and 97.5% (95.1–99.9%), respectively. During the whole follow-up period, 24 (14.8%) patients experienced at least one AE. Conclusions: This real-world study demonstrates that SII-ONCO-BCG is an effective and safe treatment for patients with intermediate- and high-risk NMIBC.https://www.mdpi.com/1718-7729/32/1/18Bacillus Calmette–Guerinnon-muscle-invasive bladdermulticenter studyGreece |
| spellingShingle | Panagiotis Angelopoulos Titos Markopoulos Lazaros Lazarou Andreas Skolarikos Panagiotis Stamatakos Georgios I. Papadopoulos Charalampos Fragkoulis Konstantinos Ntoumas Napoleon Moulavasilis Panagiotis Levis Dimitrios Papanikolaou Ioannis Sokolakis Konstantinos Hatzimouratidis Charalampos Tzanetakos Marina Psarra George Mavridoglou Konstantinos Skriapas Dimitra Akrivou Dimitrios Karagiannis Christos Noutsos Andreas Georgiou Konstantinos Hastazeris George Gourzoulidis Dionysios Mitropoulos Retrospective, Non-Interventional, Multicenter Study on the Effectiveness and Safety of Intravesical Bacillus Calmette–Guerin in Patients with Non-Muscle-Invasive Bladder Cancer: Real-World Experience from Six Hospital Centers in Greece Current Oncology Bacillus Calmette–Guerin non-muscle-invasive bladder multicenter study Greece |
| title | Retrospective, Non-Interventional, Multicenter Study on the Effectiveness and Safety of Intravesical Bacillus Calmette–Guerin in Patients with Non-Muscle-Invasive Bladder Cancer: Real-World Experience from Six Hospital Centers in Greece |
| title_full | Retrospective, Non-Interventional, Multicenter Study on the Effectiveness and Safety of Intravesical Bacillus Calmette–Guerin in Patients with Non-Muscle-Invasive Bladder Cancer: Real-World Experience from Six Hospital Centers in Greece |
| title_fullStr | Retrospective, Non-Interventional, Multicenter Study on the Effectiveness and Safety of Intravesical Bacillus Calmette–Guerin in Patients with Non-Muscle-Invasive Bladder Cancer: Real-World Experience from Six Hospital Centers in Greece |
| title_full_unstemmed | Retrospective, Non-Interventional, Multicenter Study on the Effectiveness and Safety of Intravesical Bacillus Calmette–Guerin in Patients with Non-Muscle-Invasive Bladder Cancer: Real-World Experience from Six Hospital Centers in Greece |
| title_short | Retrospective, Non-Interventional, Multicenter Study on the Effectiveness and Safety of Intravesical Bacillus Calmette–Guerin in Patients with Non-Muscle-Invasive Bladder Cancer: Real-World Experience from Six Hospital Centers in Greece |
| title_sort | retrospective non interventional multicenter study on the effectiveness and safety of intravesical bacillus calmette guerin in patients with non muscle invasive bladder cancer real world experience from six hospital centers in greece |
| topic | Bacillus Calmette–Guerin non-muscle-invasive bladder multicenter study Greece |
| url | https://www.mdpi.com/1718-7729/32/1/18 |
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