{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T08:38:10Z","timestamp":1788597490926,"version":"build-2803163510"},"reference-count":15,"publisher":"American Medical Association (AMA)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Oncol"],"published-print":{"date-parts":[[2024,4,1]]},"abstract":"Importance<\/jats:title>With the ongoing bacillus Calmette-Gu\u00e8rin (BCG) shortage, alternate therapeutic options for patients with high-risk non\u2013muscle-invasive bladder cancer (NMIBC) are needed.<\/jats:p><\/jats:sec>Objective<\/jats:title>To report the 5-year outcomes of a cohort from a prospective phase 2 trial of patients with high-risk NMIBC who underwent 12 instillations of induction BCG without maintenance.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>Between November 2015 and June 2018, patients at Memorial Sloan Kettering Cancer Center with primary or recurrent NMIBC (high-grade Ta, T1 tumors, with or without carcinoma in situ) were prospectively enrolled to receive 2 induction courses (12 intravesical instillations) of BCG without maintenance therapy. The analysis itself took place on July 28, 2023.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>Recurrence-free survival (RFS) and cancer-specific survival (CSS) was assessed by landmark analysis at 7.5 months. Recurrence was defined as pathologic high-grade disease.<\/jats:p><\/jats:sec>Results<\/jats:title>Among 81 patients (65 men [84%] and 12 women [16%] with a median [IQR] age of 72 [64-77] years) who consented to participate in the study, 75 remained evaluable for long-term follow-up analysis. Twenty-one patients experienced high-grade recurrence, yielding a 5-year RFS rate of 69% (95% CI, 58%-81%), with a median (IQR) follow-up of 4.4 (3.8-5.3) years for patients without recurrence. Three patients died of bladder cancer, corresponding to a CSS rate of 97% (95% CI, 93%-100%) with a median (IQR) follow-up of 4.9 (4.2-5.7) years for survivors. Using 2 induction courses reduced the amount of BCG per patient from 27 vials to 12 vials.<\/jats:p><\/jats:sec>Conclusion and Relevance<\/jats:title>Twelve induction instillations of BCG without maintenance for patients with high-risk NMIBC reduced the number of vials needed per patient while providing acceptable oncologic outcomes. Given the ongoing BCG shortage, this modified regimen may provide a suitable alternative in this setting.<\/jats:p><\/jats:sec>","DOI":"10.1001\/jamaoncol.2023.6804","type":"journal-article","created":{"date-parts":[[2024,2,15]],"date-time":"2024-02-15T16:01:08Z","timestamp":1708012868000},"page":"522","source":"Crossref","is-referenced-by-count":10,"title":["Response to 2 Induction Courses of Bacillus Calmette-Gu\u00e8rin Therapy Among Patients With High-Risk Non\u2013Muscle-Invasive Bladder Cancer"],"prefix":"10.1001","volume":"10","author":[{"given":"Andrew B.","family":"Katims","sequence":"first","affiliation":[{"name":"Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacob","family":"Tallman","sequence":"additional","affiliation":[{"name":"Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New 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