As reported by Katims et al in JAMA Oncology, long-term follow-up of a single-center phase II study showed benefit with two induction courses of bacillus Calmette-Guérin (BCG) without maintenance in patients with high-risk non–muscle-invasive bladder cancer. The strategy markedly reduced the number of BCG vials required per patient.
As noted by the investigators, “With the ongoing BCG shortage, alternate therapeutic options for patients with high-risk non–muscle-invasive bladder cancer are needed.”
Study Details
The analysis involved 75 patients evaluable for long-term outcomes (out of 81 enrolled in study) who were treated at Memorial Sloan Kettering Cancer Center between November 2015 and June 2018. Patients had primary or recurrent disease (high-grade Ta,T1 tumors with or without carcinoma in situ). Treatment consisted of 12 intravesical instillations of BCG in two induction courses with no maintenance treatment. Recurrence was defined as pathologic high-grade disease.
Key Findings
Among the 75 patients included in the long-term analysis, 21 had high-grade recurrence. The 5-year recurrence-free survival rate was 69% (95% confidence interval [CI] = 58%–81%) with a median follow-up of 4.4 years (interquartile range [IQR] = 3.8–5.3 years) for patients without disease recurrence.
Three patients died of bladder cancer. The 5-year cancer-specific survival rate was 97% (95% CI = 93%–100%) with a median follow-up of 4.9 years (IQR = 4.2–5.7 years) among survivors.
As noted by the investigators, use of two induction courses without maintenance reduced the amount of BCG per patient from 27 vials to 12 vials.
The investigators concluded, “Twelve induction instillations of BCG without maintenance for patients with high-risk non–muscle-invasive bladder cancer 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.”
Harry W. Herr, MD, of Memorial Sloan Kettering Cancer Center, is the corresponding author for the JAMA Oncology article.
Disclosure: The study was supported by a grant from the National Cancer Institute. For full disclosures of the study authors, visit jamanetwork.com.
