دورية أكاديمية
أعرض في EDS

Bacillus Calmette-Guerin (BCG) therapy is safe and effective in non-muscle invasive bladder cancer (NMIBC) patients with immunomodulating conditions.

التفاصيل البيبلوغرافية
العنوان: Bacillus Calmette-Guerin (BCG) therapy is safe and effective in non-muscle invasive bladder cancer (NMIBC) patients with immunomodulating conditions.
المؤلفون: Durant AM; Department of Urology, Mayo Clinic Arizona, Phoenix, AZ. Electronic address: durant.adri@mayo.edu., Choudry MM; Department of Urology, Mayo Clinic Arizona, Phoenix, AZ., Madura G; Mayo Clinic College of Medicine and Science, Scottsdale, AZ., Mi L; Department of Quantitative Health Sciences, Mayo Clinic Arizona, Scottsdale, AZ., Faraj KS; Department of Urology, University of Michigan, Ann Arbor, MI., Tyson MD; Department of Urology, Mayo Clinic Arizona, Phoenix, AZ.
المصدر: Urologic oncology [Urol Oncol] 2024 Jan; Vol. 42 (1), pp. 21.e21-21.e28. Date of Electronic Publication: 2023 Oct 16.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Elsevier Country of Publication: United States NLM ID: 9805460 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2496 (Electronic) Linking ISSN: 10781439 NLM ISO Abbreviation: Urol Oncol Subsets: MEDLINE
أسماء مطبوعة: Publication: 2003- : Philadelphia, PA : Elsevier
Original Publication: New York, NY : Elsevier Science,
مواضيع طبية MeSH: Non-Muscle Invasive Bladder Neoplasms* , Urinary Bladder Neoplasms*/drug therapy , Urinary Bladder Neoplasms*/pathology, United States ; Humans ; Aged ; Female ; Male ; BCG Vaccine/therapeutic use ; Adjuvants, Immunologic/therapeutic use ; Medicare ; Neoplasm Recurrence, Local/pathology ; Neoplasm Invasiveness/pathology ; Administration, Intravesical
مستخلص: Introduction: Bacillus Calmette-Guerin (BCG) is the most effective therapy available to treat high-risk nonmuscle invasive bladder cancer (NMIBC) patients. However, for patients with immunomodulating conditions BCG is a relative contraindication due to efficacy and safety concerns. To our knowledge, no population-level study evaluating the efficacy and safety profile of BCG for immunomodulated patients exists.
Methods: NMIBC patients aged 66 years or older were identified in the Surveillance, Epidemiology, and End Results (SEER) - Medicare database from 1975-2013. All patients completed adequate BCG (at least 5 plus 2 treatments completed within 12 months of diagnosis). Two groups were defined: an immunomodulated population identified by immunomodulating conditions such as solid-organ transplantation, HIV, and autoimmune conditions, and an immunocompetent group. The primary endpoint was 5-year progression-free survival defined as progression to systemic chemotherapy, checkpoint inhibitors, radical or partial cystectomy, metastasis, or cancer-specific death. A safety analysis was performed as a secondary outcome.
Results: In a total of 4,277 patients with NMIBC who completed adequate BCG, 606 (14.2%) were immunomodulated. The immunomodulated group was older at diagnosis (P < 0.001), more likely to be female (P < 0.001), more likely to live in a metropolitan area (P < 0.001), and had higher Charlson comorbidity scores (P < 0.001). There were no differences in progression to chemotherapy (P = 0.17), checkpoint inhibitors (P > 0.99), radical cystectomy (P = 0.40), partial cystectomy (P = 0.93), metastasis (P = 0.19), cancer-specific death (P = 0.18) or 5-year total bladder cancer progression (P = 0.30) between the groups. For the safety analysis, rates of disseminated BCG were similar between immunomodulated and immunocompetent patients (0.7% vs. <1.8%, P = 0.51). On multivariable analysis 5-year total bladder cancer progression (HR 1.07 [CI 0.88-1.30]) was similar between the groups.
Conclusion: Rates of bladder cancer progression and disseminated BCG complications 5-years after BCG therapy were similar regardless of immunomodulation status. These findings suggest that BCG intravesical therapy can be offered to immunomodulated patients with high-risk NMIBC although theoretical infectious complication risks remain.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 Elsevier Inc. All rights reserved.)
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معلومات مُعتمدة: P30 CA015083 United States CA NCI NIH HHS
فهرسة مساهمة: Keywords: Bladder cancer; Immunotherapy; Outcomes studies
المشرفين على المادة: 0 (BCG Vaccine)
0 (Adjuvants, Immunologic)
تواريخ الأحداث: Date Created: 20231018 Date Completed: 20231225 Latest Revision: 20240610
رمز التحديث: 20240610
مُعرف محوري في PubMed: PMC10842448
DOI: 10.1016/j.urolonc.2023.09.010
PMID: 37852817
قاعدة البيانات: MEDLINE
الوصف
تدمد:1873-2496
DOI:10.1016/j.urolonc.2023.09.010