THE IMPACT OF BCG SHORTAGE ON DISEASE RECURRENCE FOR PATIENTS WITH NON-MUSCLE INVASIVE BLADDER CANCER: A SEER PATTERNS OF CARE ANALYSIS

Madison M. Wahlen; Vignesh T. Packiam; Sarah H. Nash; Ryan M. Carnahan; Knute D. Carter; Michael A. O'Rorke; Michael O'Donnell; Michael Halpern

doi:10.1016/j.urolonc.2024.12.117

The gold standard treatment for non-muscle invasive bladder cancer (NMIBC) involves adjuvant intravesical therapy with Bacillus Calmette-Guérin (BCG). Since 2012, ongoing national shortages of BCG have affected its use in many urologic practices. Retrospective single-institution studies from Europe and Asia have demonstrated an association between BCG shortages and increased recurrence among patients with intermediate- and high-risk NMIBC. However, the generalizability of these studies is limited, and the impact of these shortages on oncologic outcomes in the U.S. is unclear. The purpose of this study was to investigate the impact of BCG shortages on disease recurrence among patients with NMIBC using data from the National Cancer Institue Surveillance Epidemiology and End Results (SEER) Pattern of Care (POC) study. POC study is a large, population-based study which collects detailed patient-level information including demographic, tumor, and treatment characteristics via medical record abstraction. This analysis included patients diagnosed with NMIBC in 2019 who underwent transurethral resection of bladder tumor who had known information about experience of BCG shortages across 12 participating SEER registries. BCG shortage status (impacted versus not impacted) was classified by the POC study based on medical record documentation or from treating physicians’ office information. Patient follow-up for recurrence events was available through December 31, 2021. We used extended Cox proportional hazards regression adjusted for demographic, clinicopathologic, and hospital characteristics to model recurrence based on experience of BCG shortages. Observations were censored at the earliest date of either recurrence, metastasis, death, or end of the study period (December 31, 2021). We identified 587 patients diagnosed with NMIBC in 2019 with known information about BCG shortages and their impact. One-fifth (21%) experienced BCG shortages documented in medical records. Among those impacted by shortages, 62% received BCG before censoring, compared to 75% among those not impacted (p=0.06). Median follow-up was 27 months post-diagnosis. There were 196 recurrences, 36 among those impacted by shortages. Adjusting for covariates, patients impacted by BCG shortages did not have increased hazard of recurrence (HR:0.90; 95%CI:0.61-1.32) compared to patients not impacted by shortages; however, those who received BCG had a 51% decreased hazard of recurrence compared to those who did not receive BCG (HR:0.49; 95%CI:0.35-0.68, p=<0.0001). Patients impacted by shortage who received BCG had similar 36-month recurrence-free survival (RFS) to patients not impacted by shortages (73% versus 66%, p=0.67), while those impacted by shortages who did not receive BCG had marginally lower 36-month RFS (47%, p=0.20) (Figure 1). Our analysis of a population-based national dataset documenting BCG shortage revealed that receipt of BCG was associated with decreased hazard of recurrence. Interestingly, BCG shortages alone were not associated with increased hazard of recurrence among patients with NMIBC. These results suggest that the current risk-adapted use of BCG recommended by the American Urological Association to mitigate the impact of BCG shortages seem effective on a population level, although there is still detriment for patients who cannot receive BCG. As BCG shortages persist, this data supports efforts to develop effective alternative therapies to BCG.

THE IMPACT OF BCG SHORTAGE ON DISEASE RECURRENCE FOR PATIENTS WITH NON-MUSCLE INVASIVE BLADDER CANCER: A SEER PATTERNS OF CARE ANALYSIS

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