TY - JOUR T1 - Incidence, Risk Factors, and Clinical Outcomes of BCG-Related Complications TT - BCG ile İlgili Komplikasyonların Görülme Sıklığı, Risk Faktörleri ve Klinik Sonuçları AU - Gürcüoğlu, Emel AU - Oner, Sedat AU - Ekıcı, Ozgur AU - Benli, Müzeyyen Tuğçe AU - Bulut, Tülay PY - 2025 DA - August Y2 - 2025 DO - 10.29058/mjwbs.1651962 JF - Medical Journal of Western Black Sea JO - Med J West Black Sea PB - Zonguldak Bulent Ecevit University WT - DergiPark SN - 2822-4302 SP - 222 EP - 230 VL - 9 IS - 2 LA - en AB - Aim: While intravesical Bacillus Calmette-Guérin (BCG) therapy provides successful outcomes in the treatment of non-muscle-invasivebladder cancer (NMIBC) due to its immunomodulatory effects, it can also lead to serious complications that may pose a life-threateningrisk, albeit rarely. This study aimed to analyze the frequency, types, and clinical course of complications arising in patients who underwentintravesical BCG therapy in a tertiary healthcare center between 2019 and 2024. Additionally, findings that may contribute to the earlyrecognition of these complications were examined. The obtained data are expected to aid in the effective management of BCG instillationrelatedcomplications and enhance patient safety Material and Methods: A total of 400 patients who underwent intravesical BCG therapy were evaluated for complications using the hospitalinformation management system. One hundred forty-six patients were excluded due to missing clinical/laboratory data or follow-upsconducted outside the center. The remaining 254 patients were assessed for demographic characteristics, comorbidities, smoking habits,Systemic Immune-Inflammation Index (SII), COVID-19 infection status, and complications related to BCG instillation.Results: The mean age of the patients was 66.2±9.7 years, and 225 (90%) were male. BCG-related complications were observed in 15patients (6.0%). Primary disease relapse occurred in 87 patients (34.8%), and 30 patients (12.0%) died. The incidence of BCG-relatedcomplications was significantly higher in patients under 65 years of age compared to those aged 65 and older (12.0% vs. 2.5%; p=0.002).Patients without any comorbidities (p=0.022) and those without diabetes (p=0.005) had a statistically significant higher risk of developingBCG-related complications.Conclusion: This study highlights the challenges in managing complications associated with intravesical BCG therapy and underscores theimportance of comprehensive patient monitoring to prevent adverse outcomes KW - Bacillus Calmette-Guérin KW - Bladder Neoplasms KW - Complications KW - Systemic Immune-Inflammation Index N2 - Amaç: Kasa invaze olmayan mesane kanseri (KİOMK) tedavisinde intravezikal BCG (Bacillus Calmette-Guérin) uygulaması immünmodülatöretkileri sayesinde başarılı sonuçlar sağlarken, nadir de olsa hasta hayatını tehlikeye atabilecek ciddi komplikasyonlara yol açabilmektedir.Bu çalışmada 2019-2024 yılları arasında üçüncü basamak bir sağlık kuruluşunda intravezikal BCG uygulanan hastalarda ortaya çıkankomplikasyonların sıklığı, türleri ve klinik seyirleri irdelenerek, komplikasyonların erken tanınmasına yararı olabilecek bulgular incelendi. Eldeedilen verilerin, BCG instilasyonuna bağlı gelişen komplikasyonların etkin yönetimine ve hasta güvenliğinin artırılmasına katkı sağlamasıamaçlandı.Gereç ve Yöntemler: Hastane bilgi yönetim sisteminden, intravezikal BCG uygulanan toplam 400 hasta komplikasyonları açısındanincelendi. Eksik klinik/laboratuvar verisi olan ya da takipleri merkez dışında sürdülen 146 hasta çalışma dışı bırakıldı. İkiyüzellidört hasta,demografik özellikler, yandaş hastalıklar, sigara alışkanlıkları, sistemik İmmün-İnflamatuvar İndeks (Systemic Immune-Inflammation Index,SII), COVID-19 enfeksiyon durumları ve BCG instilasyonu ile ilişkili gelişen komplikasyonlar incelendi.Bulgular: Hastaların yaş ortalaması 66,2±9,7 idi ve 225’i (%90) erkekti. Hastaların 15’inde (%6,0) BCG işlemi ile ilişkili komplikasyongelişmişti. Hastaların 87’sinde (%34,8) primer hastalık relapsı görülmüştü. Genel mortalite %12,0 olarak saptanırken, KİOMK veya BCG ilişkilikomplikasyonlara bağlı mortalite yalnızca bir hastada (%0,4) görülmüştür. 65 yaş altındaki hastalarda BCG işlemi ile ilişkili komplikasyongelişme oranı 65 yaş ve üzeri olanlara göre anlamlı yüksek bulundu (%12,0 vs. %2,5; p=0,002). Herhangi bir komorbiditesi olmayanlarda(p=0,022), diyabeti olmayanlarda (p=0,005) BCG işlemi ile ilişkili komplikasyon gelişme riski istatistiksel olarak anlamlı yüksekti.Sonuç: Bu çalışma, intravesikal BCG tedavisiyle ilişkili komplikasyonların yönetimindeki zorlukları vurgulamakta ve olumsuz sonuçlarınönlenmesi için kapsamlı hasta takibinin önemine dikkat çekmektedir. CR - 1. Decaestecker K, Oosterlinck W. Managing the adverse events of intravesical bacillus Calmette-Guérin therapy. Res Rep Urol. 2015;7:157-163. https://doi.org/10.2147/RRU.S63448 CR - 2. Brausi M, Oddens J, Sylvester R, Bono A, Van De Beek C, Van Andel G, et al. 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