{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T21:17:41Z","timestamp":1792703861526,"version":"4.5.0"},"reference-count":13,"publisher":"American Medical Association (AMA)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n Bacillus Calmette-Gu\u00e9rin (BCG) therapy is the standard of care for non\u2013muscle-invasive bladder cancer (NMIBC), yet many patients experience recurrence and progression, and clinical adherence to recommended regimens is low.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To examine the clinical burden, treatment patterns, and outcomes of patients with BCG-exposed NMIBC in the US.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This retrospective cohort study examined Optum\u2019s deidentified Market Clarity Data (Optum Market Clarity), linking US electronic health records and insurance claims from January 1, 2007, to June 30, 2024. Eligible patients were identified by diagnostic codes consistent with bladder cancer and were required to have received at least 1 full course of BCG. Subgroups were defined by adequacy of induction and maintenance therapy.<\/jats:p>\n <\/jats:sec>\n \n Exposure<\/jats:title>\n Bacillus Calmette-Gu\u00e9rin therapy classified as adequate or inadequate induction and maintenance according to regulatory definitions.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary outcome was recurrence within 24 months. Secondary outcomes were progression and cystectomy, and survival was an exploratory outcome. Rates of recurrence, progression, and radical cystectomy were compared between patients with BCG-exposed and BCG-unresponsive NMIBC.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n The study included 26\u202f876 patients with NMIBC (median [IQR] age at BCG initiation, 73 [65-77] years; 79.5% male), including 9639 patients with carcinoma in situ; baseline demographic and clinical characteristics were similar across induction and maintenance subgroups. Adequate BCG maintenance therapy was uncommon; only 24.9% (4951 of 19 889) of patients across all risk groups received maintenance therapy. Of 5271 patients with carcinoma in situ\u2013containing tumors and sufficient follow-up, 3134 (59.3%) experienced recurrence within 24 months, of whom 2604 (83.1%) were BCG exposed and 530 (16.9%) were BCG unresponsive. Among patients with recurrence, those who were BCG exposed accounted for 83.0% (366 of 441) of disease progression and 87.8% (337 of 384) of cystectomy cases. Most patients with BCG-exposed NMIBC (2442 [93.8%]) had received inadequate maintenance therapy, and progression and cystectomy outcomes were disproportionately concentrated among those with incomplete BCG exposure (330 of 366 [90.2%] and 327 of 337 [97.0%], respectively).<\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n This retrospective cohort study found that patients with BCG-exposed NMIBC represented a large, underserved population and the majority of those who experienced progression and cystectomy. These findings highlight an urgent need for new therapeutic strategies and clinical trial designs targeting this group.<\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2026.7470","type":"journal-article","created":{"date-parts":[[2026,4,16]],"date-time":"2026-04-16T15:30:34Z","timestamp":1776353434000},"page":"e267470","source":"Crossref","is-referenced-by-count":2,"title":["Clinical Outcomes in Bacillus Calmette-Gu\u00e9rin\u2013Exposed Non\u2013Muscle-Invasive Bladder Cancer"],"prefix":"10.1001","volume":"9","author":[{"given":"Maria","family":"Giatsoglou","sequence":"first","affiliation":[{"name":"Pfizer Artificial Intelligence, Data and Analytics Research and Development AI and Data Science, Thessaloniki, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimitrios","family":"Chatzistavrou","sequence":"additional","affiliation":[{"name":"Pfizer Artificial Intelligence, Data and Analytics Research and Development AI and Data Science, Thessaloniki, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joan Mazzarelli","family":"Sopczynski","sequence":"additional","affiliation":[{"name":"Pfizer Artificial Intelligence, Data, and Analytics Research and Development AI and Data Science, Collegeville, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gang","family":"Feng","sequence":"additional","affiliation":[{"name":"Pfizer Oncology, Cambridge, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Genitourinary Oncology, H. Lee Moffitt Cancer Center, Tampa, Florida"},{"name":"Department of Immunology, H. Lee Moffitt Cancer Center, Tampa, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2026,4,16]]},"reference":[{"issue":"4","key":"zoi260245r1","first-page":"308","article-title":"Cancer treatment and survivorship statistics, 2025.","volume":"75","author":"Wagle","year":"2025","journal-title":"CA Cancer J Clin"},{"issue":"5","key":"zoi260245r2","doi-asserted-by":"crossref","first-page":"1375","DOI":"10.1016\/j.euo.2025.03.007","article-title":"Oncological outcomes in Bacillus Calmette-Guerin-na\u00efve high-risk non-muscle-invasive bladder cancer patients: a systematic review on current treatment strategies and future perspectives.","volume":"8","author":"Longoni","year":"2025","journal-title":"Eur Urol Oncol"},{"issue":"1","key":"zoi260245r4","doi-asserted-by":"publisher","first-page":"34","DOI":"10.1016\/j.eururo.2021.12.005","article-title":"International Bladder Cancer Group consensus statement on clinical trial design for patients with Bacillus Calmette-Gu\u00e9rin-exposed high-risk non-muscle-invasive bladder cancer.","volume":"82","author":"Roumigui\u00e9","year":"2022","journal-title":"Eur Urol"},{"issue":"4","key":"zoi260245r5","doi-asserted-by":"publisher","first-page":"533","DOI":"10.1097\/JU.0000000000003846","article-title":"Diagnosis and treatment of non-muscle invasive bladder cancer: AUA\/SUO guideline: 2024 amendment.","volume":"211","author":"Holzbeierlein","year":"2024","journal-title":"J Urol"},{"issue":"2","key":"zoi260245r6","doi-asserted-by":"publisher","first-page":"109","DOI":"10.36469\/jheor.2024.124208","article-title":"Adherence to first-line intravesical Bacillus Calmette-Gu\u00e9rin therapy in the context of guideline recommendations for US patients with high-risk non-muscle invasive bladder cancer.","volume":"11","author":"Gaylis","year":"2024","journal-title":"J Health Econ Outcomes Res"},{"issue":"4","key":"zoi260245r7","doi-asserted-by":"publisher","first-page":"1124","DOI":"10.1016\/S0022-5347(05)67707-5","article-title":"Maintenance Bacillus Calmette-Guerin immunotherapy for recurrent TA, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group Study.","volume":"163","author":"Lamm","year":"2000","journal-title":"J Urol"},{"key":"zoi260245r8","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2025.43.17_suppl.LBA4504","article-title":"Mitomycin plus BCG as adjuvant intravesical therapy for high-risk, non\u2013muscle-invasive bladder cancer: a randomized phase 3 trial (ANZUP 1301).","volume":"43","author":"Hayne","year":"2025","journal-title":"J Clin Oncol"},{"issue":"3","key":"zoi260245r9","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2021.3800","article-title":"Estimated costs and long-term outcomes of patients with high-risk non-muscle-invasive bladder cancer treated with Bacillus Calmette-Gu\u00e9rin in the Veterans Affairs health system.","volume":"4","author":"Williams","year":"2021","journal-title":"JAMA Netw Open"},{"issue":"3","key":"zoi260245r11","doi-asserted-by":"publisher","first-page":"147","DOI":"10.3233\/BLC-179020","article-title":"Letter to the editor: Bacillus Calmette-Guerin (BCG) treatment failures with non-muscle invasive bladder cancer: a data-driven definition for BCG unresponsive disease.","volume":"3","author":"Li","year":"2017","journal-title":"Bladder Cancer"},{"issue":"6","key":"zoi260245r12","doi-asserted-by":"publisher","first-page":"516","DOI":"10.1016\/j.eururo.2024.08.001","article-title":"Bladder-sparing therapy for Bacillus Calmette-Gu\u00e9rin-unresponsive non-muscle-invasive bladder cancer: International Bladder Cancer Group recommendations for optimal sequencing and patient selection.","volume":"86","author":"Li","year":"2024","journal-title":"Eur Urol"},{"issue":"35","key":"zoi260245r13","doi-asserted-by":"publisher","first-page":"5437","DOI":"10.1200\/JCO.23.00307","article-title":"Definitions, end points, and clinical trial designs for bladder cancer: recommendations from the Society for Immunotherapy of Cancer and the International Bladder Cancer Group.","volume":"41","author":"Kamat","year":"2023","journal-title":"J Clin Oncol"},{"key":"zoi260245r3","unstructured":"Bacillus Calmette-Gu\u00e9rin-unresponsive nonmuscle invasive bladder cancer: developing drugs and biological products for treatment. US Food and Drug Administration. August 2024. Accessed September 19, 2025. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/bacillus-calmette-guerin-unresponsive-nonmuscle-invasive-bladder-cancer-developing-drugs-and"},{"key":"zoi260245r10","doi-asserted-by":"crossref","unstructured":"Doobaree? I, Quignot? N, Jiang? H, Lehmann? J, Khachatryan? A, Ghatnekar? O. Treatment patterns and outcomes of BCG-treated non-muscle invasive bladder cancer patients in Germany.? Research Square. Preprint posted online July 6, 2023. 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