Introduction:

BCG is the standard intravesical therapy for the treatment of intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC). However, given recent financial and manufacturing constraints on the companies that produce BCG, a shortage has developed. As a result, we developed a comprehensive algorithm for managing patients with NMIBC in the BCG shortage era. After implementing this algorithm, we monitored patient access and treatment compliance to intravesical therapy to compare to those patients treated prior to implementation.

Methods:

Figure 1 illustrates the protocol utilized during the BCG shortage era. There is continual monitoring of BCG supplies with a focus on administering Gemcitabine/Docetaxel in high-risk patients when BCG is unavailable. In this study, we evaluated patients diagnosed with high-risk NMIBC requiring induction therapy in the year prior to the BCG shortage protocol, and compared them to patients diagnosed after the protocol was initiated. Overall patient access to intravesical therapy was evaluated based on time to initiation of therapy (delays diagnosed as receiving induction 6 weeks or more from TURBT) . Of those who received induction BCG, we evaluated time to initiation of BCG and associated delays. Given the increasing reliance on Gemcitabine/Docetaxel, we evaluated 1 year recurrence rates between groups, including only those patients who either recurred in the first year or who had at least 1 year of follow-up, to determine if this protocol has maintained oncologic efficacy.

Results:

Overall, there were 34 patients with high-risk NMIBC between August 2019 and August 2020. Delays to induction intravesical therapy were seen in 47.1% of patients. Average time to induction BCG therapy was 54.5 days. 63.6% of patients experienced a delay in BCG therapy.  After initiating our protocol in August 2020, we identified 128 patients with high-risk NMIBC. Delays to induction intravesical therapy were significantly less, seen in only 26.5% of patients (p=0.02). Average time to induction BCG was less at 38.6 days. Only 26.5% of patients experienced a delay, representing a significant improvement as compared to pre-protocol (p<0.001). 1 year recurrence rates were compared and found not to be significantly different between the groups. Results are displayed in Table 1.

Conclusion:

Implementation of this protocol allows for prioritization of BCG to the high-risk NMIBC patients and optimization of resources while maintaining flexibility and short-term oncologic efficacy. This study has demonstrated that by utilizing this protocol, patients are receiving induction intravesical therapy with fewer delays. In addition, despite a greater reliance on Gemcitabine/Docetaxel to threat these high-risk patients, short-term oncologic efficacy is maintained. 

Funding: N/A