Transurethral resection of the bladder tumor (TURBT) followed by intravesical Bacillus Calmette-Guérin (BCG) immunotherapy is a standard treatment for high-risk non muscle-invasive bladder cancer (NMIBC).
However, due to potential risk of dissemination, current guidelines recommend caution when proposing BCG treatment in immunocompromised patients. Our aim was to assess the efficacy and safety of BCG treatment in immunocompromised patients.
Patients aged ≥18 with a diagnosis of bladder cancer (BC) who underwent BCG therapy in 2007-2021, were identified in the MerativeTM Marketscan® Research Commercial and Medicare databases. Multivariable Cox proportion hazard regressions adjusted by relevant confounders were performed to investigate the influence of immunosuppression on the events associated with progression and recurrence of BC, both in the unmatched cohort and after 1:2 propensity score matching (PSM). Also, subgroup analysis on progression in patients without cancer other than BC was conducted.
Immunocompromised and immunocompetent patients had similar rates of disseminated BCG infection after intravesical immunotherapy. However, immunocompromised patients had shorter progression-free survival and higher probability of progression (aHR: 1.23, 95% CI: 1.11-1.38), as well as shorter recurrence-free survival and a higher probability of recurrence (aHR: 1.13, 95% CI: 1.05-1.20). Similar significant associations were observed in the PSM cohort. A subgroup analysis of patients without any additional oncological diagnoses beyond BC confirmed a higher likelihood of progression in the immunocompromised group (aHR: 1.34, 95% CI: 1.15-1.56).
BCG immunotherapy is safe in immunocompromised patients. Nevertheless, the efficacy of intravesical BCG in these patients might be suboptimal thus advocating the need for appropriate counselling and a possible lower threshold to consider radical treatment.
Urologic oncology. 2025 Sep 19 [Epub ahead of print]
Francesco Del Giudice, Valerio Santarelli, Jan Łaszkiewicz, Shufeng Li, Wojciech Krajewski, Łukasz Nowak, Tomasz Szydełko, Matteo Ferro, Bernardo Rocco, Felice Crocetto, Biagio Barone, Carlo Buonerba, Roberto Contieri, Renate Pichler, José Daniel Subiela, Benjamin Pradere, Marco Moschini, Andrea Mari, Keiichiro Mori, Francesco Soria, Roman Mayr, Jung Ki Jo, Mohamed Gad, Ben Challacombe, Yasmin Abu-Ghanem, Elsie Mensah, Rajesh Nair, Ramesh Thurairaja, Muhammad Shamim Khan, Benjamin I Chung, Young Academic Urology (YAU) Urothelial Working Gourp
Department of Maternal Infant and Urologic Sciences, "Sapienza" University of Rome, Policlinico Umberto I Hospital, Rome, Italy; Department of Urology, Stanford University School of Medicine, Stanford, CA; Guy's and St. Thomas' NHS Foundation Trust, Guys and St Thomas' Hospital, London, UK. Electronic address: ., Department of Maternal Infant and Urologic Sciences, "Sapienza" University of Rome, Policlinico Umberto I Hospital, Rome, Italy., Department of Minimally Invasive and Robotic Urology, University Center of Excellence in Urology, Wroclaw Medical University, Wroclaw, Poland., Department of Urology, Stanford University School of Medicine, Stanford, CA; Department of Dermatology, Stanford University School of Medicine, Stanford, CA., Department of Life Sciences, University of Milan, Milan, Italy, Urologic Unit, ASST Santi Paolo and Carlo, Milan, Italy., Department of Urology, IRCCS A. Gemelli University Polyclinic Foundation, Sacred Heart Catholic University, Rome, Italy., Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II, Naples, Italy., Oncology Unit, "Andrea Tortora" Hospital, ASL Salerno, Pagani, Italy., Department of Urology, Humanitas Clinical and Research Institute IRCCS, Milan, Italy., Department of Urology, Comprehensive Cancer Center Innsbruck, Medical University of Innsbruck, Innsbruck, Austria., Department of Urology, Hospital Universitario Ramón y Cajal, IRYCIS, Universidad de Alcala, Madrid, Spain., Department of Urology, La Croix Du Sud Hospital, Quint Fonsegrives, France., Division of Experimental Oncology, Unit of Urology, IRCCS Ospedale San Raffaele, Milan, Italy., Urological Robotic Surgery and Renal Transplantation Unit, Careggi Hospital, University of Florence, Firenze, Italy., Department of Urology, Jikei University School of Medicine, Tokyo, Japan., Division of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, Turin, Italy., Department of Urology, St. Josef Medical Center, University of Regensburg, Regensburg, Germany., Department of Urology, College of Medicine, Hanyang University, Seoul , Republic of Korea., Guy's and St. Thomas' NHS Foundation Trust, Guys and St Thomas' Hospital, London, UK., Department of Urology, Stanford University School of Medicine, Stanford, CA.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/40975643