To address shortages of bacillus Calmette-Guérin (BCG), urologists need to ration use of the drug and consider alternative intravesical treatments for nonmuscle-invasive bladder cancer (NMIBC), according to Sam S. Chang, MD, MBA, Patricia and Rodes Hart Professor of Urologic Surgery at Vanderbilt University Medical Center, and chief surgical officer at Vanderbilt Ingram Cancer Center in Nashville, Tennessee.
Speaking at the Large Urology Group Practice Association (LUGPA) virtual annual meeting, Dr Chang emphasized the importance of using BCG appropriately, noting that BCG should not be used for patients with low-risk NMIBC, in accordance with American Urological Association guidelines. Urologists should use intravesical chemotherapy as first-line treatment for intermediate-risk NMIBC. For cases in which BCG would be used as second-line therapy for intermediate-risk NMIBC, clinicians should use an alternative intravesical chemotherapy in light of the BCG shortage.
In addition, patients with high-risk disease, high-grade T1, and carcinoma in situ (CIS) receiving induction therapy should be prioritized for use of full-strength BCG. If BCG is in short supply, these patients and other high-risk patients should be given a one-half or one-third dose of BCG, if feasible, Dr Chang said.
He told attendees that optimized mitomycin C (MMC) should be used for low-grade, papillary, and intermediate-risk disease. For high-risk NMIBC, he noted, urologists can consider combination chemotherapy, such as gemcitabine and MMC and gemcitabine and docetaxel, which appear to show efficacy.
For example, in a study of 47 patients, of whom 76% had intermediate- or high-risk NMIBC and 55% had CIS, a combined regimen of gemcitabine (1 g per 50 mL water) plus MMC (40 mg/20 mL water) was associated with a 48% and 38% recurrence-free survival (RFS) rate at 12 and 24 months, respectively.2 Most of the patients (66%) had received 2 or more prior courses of BCG.
Similarly, improved RFS was observed in a study of gemcitabine (1 g per 50 mL water or normal saline) in combination with docetaxel (37.5 mg per 50 mL of water or normal saline). The study, by Michael O’Donnell, MD, of the University of Iowa in Iowa City, and colleagues, included 65 BCG-naïve patients, of whom 50 (75%) had high-risk NMIBC and 26 (40%) had pure CIS or papillary disease with concomitant CIS. The RFS rates were 82%, 76%, and 66% at 6, 12, and 24 months, respectively, according to Dr Chang. Study findings have been submitted for publication.
Dr Chang also reviewed statements from the AUA, EAU, and SUO, which recommend that maintenance therapy should not be prioritized during a BCG shortage and instead BCG-naïve patients with high-risk disease should be prioritized for induction BCG. If BCG shortages persist, BCG instillations should be limited to 1 year of BCG.
Careful surveillance is warranted when BCG maintenance therapy has to be avoided, he said.
- Au JL, Badalament RA, Wientjes MG, et al. Methods to improve efficacy of intravesical mitomycin C: results of a randomized phase III trial. J Natl Cancer Inst. 2001;93:597-604. doi:10.1093/jnci/93.8.597
- Lightfoot AJ, Breyer BN, Roseveare HM, et al. Multi-institutional analysis of sequential intravesical gemcitabine and mitomycin C chemotherapy for non-muscle invasive bladder cancer. Urol Oncol. 2014;32:35. doi:10.1016/j.urolonc.2013.01.009