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

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.

The influence of operating room temperature and humidity on surgical site infection: A multisite ACS-NSQIP analysis.

BACKGROUND: Literature evaluating intraoperative temperature/humidity and risk of surgical site infection (SSI) is lacking. METHODS: All operations at three centers reported to the ACS-NSQIP were reviewed (2016-2020); ambient intraoperative temperature (°F) and relative humidity (RH) were recorded in 15-min intervals. The primary endpoint was superficial SSI, which was evaluated with multi-level logistic regression. RESULTS: 14,519 operations were analyzed with 179 SSIs (1.2%). The lower/upper 10th percentiles for temperature and RH were 64.4/71.4 °F and 33.5/55.5% respectively. Low or high temperature carried no significant increased risk for SSI (Low °F OR = 0.95, 95% CI 0.51-1.77, P = 0.86; High °F OR = 1.13, 95% CI = 0.69-1.86, P = 0.63). This was also true for low and high RH (Low RH OR = 0.96, 95% CI 0.58-1.61, p = 0.88; High RH OR = 0.61, 95% CI = 0.33-1.14, P = 0.12). Analysis of combined temperature/humidity showed no increased risk for SSI. CONCLUSION: Significant deviations in intraoperative temperature/humidity are not associated with increased risk of SSI.