Response to 2 Induction Courses of Bacillus Calmette-Guèrin Therapy Among Patients With High-Risk Non-Muscle-Invasive Bladder Cancer: 5-year Follow-Up of a Phase 2 Clinical Trial.

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  • Additional Information
    • Source:
      Publisher: American Medical Association Country of Publication: United States NLM ID: 101652861 Publication Model: Print Cited Medium: Internet ISSN: 2374-2445 (Electronic) Linking ISSN: 23742437 NLM ISO Abbreviation: JAMA Oncol Subsets: MEDLINE
    • Publication Information:
      Original Publication: Chicago, Il : American Medical Association, [2015]-
    • Subject Terms:
      Non-Muscle Invasive Bladder Neoplasms* ; Urinary Bladder Neoplasms*/drug therapy; Male ; Humans ; Female ; Middle Aged ; Aged ; BCG Vaccine/therapeutic use ; Prospective Studies ; Follow-Up Studies
    • Abstract:
      Importance: With the ongoing bacillus Calmette-Guèrin (BCG) shortage, alternate therapeutic options for patients with high-risk non-muscle-invasive bladder cancer (NMIBC) are needed.
      Objective: 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.
      Design, Setting, and Participants: 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.
      Main Outcomes and Measures: 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.
      Results: 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.
      Conclusion and Relevance: 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.
    • Grant Information:
      P30 CA008748 United States CA NCI NIH HHS
    • Accession Number:
      0 (BCG Vaccine)
    • Publication Date:
      Date Created: 20240215 Date Completed: 20240419 Latest Revision: 20240523
    • Publication Date:
      20240523
    • Accession Number:
      PMC10870219
    • Accession Number:
      10.1001/jamaoncol.2023.6804
    • Accession Number:
      38358761