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Life sciences · Journal article
Cancer Urology · September 29, 2026
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The objective of the study was to demonstrate the non-inferiority of low-intensity BCG therapy regimens (BCG – Bacillus Calmette–Guérin) compared with the classical Southwest Oncology Group (SWOG) regimen in patients with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC) who underwent transurethral resection of the bladder tumor (TURBT). Materials and methods. A prospective, interventional, four-arm, open-label, randomized phase II clinical trial with a non-inferiority design is being conducted. The main inclusion criteria are histologically verified intermediate- or high-risk NMIBC in patients aged ≥18 years who have undergone TURBT. Patients were randomized into four treatment groups at a 1:1:1:1 ratio to receive intravesical BCG vaccine therapy: experimental groups 1 (50 mg, 1 year), 2 (50 mg, 3 years), and 3 (100 mg, 1 year), and control group 4 (100 mg, 3 years). The primary endpoint is the 1-year rate of local NMIBC recurrence after TURBT. To confirm the non-inferiority of the studied regimens compared with standard treatment, enrollment of 315 patients is required so that the upper limit of the 99 % one-sided confidence interval (CI) for the hazard ratio (HR) of the 1-year local recurrence rate does not exceed 1.35. Results. A second interim analysis was performed at a median follow-up of 16.7 (2.5–33.6) months. Data from 401 patients with a median age of 66.4 (31–95) years were included. According to the European Organization for Research and Treatment of Cancer (EORTC) risk classification, 93 (23.2 %) patients were classified as intermediate risk and 308 (76.8 %) as high risk. All patients received BCG therapy in the regimen corresponding to their randomization group (group 1 – 100 (24.9 %), group 2 – 92 (23.0 %), group 3 – 109 (27.2 %), group 4 – 100 (24.9 %)). The treatment groups were balanced with respect to the main characteristics. The 1-year local recurrence rate was 12.5 %. At a data maturity of 69.5 % by follow-up duration for the primary endpoint, per-protocol analysis demonstrated non-inferiority of the studied regimens in group 1 (HR 1.029; 99 % CI 0.916–1.156) and group 2 (HR 1.114; 99 % CI 0.850–1.125); the HR between groups 3 vs. 4 was 0.813 (99 % CI 0.349–1.893), in favor of the studied regimen. Conclusion. Short-term results support continuation of the randomized phase II clinical trial until the final analysis of the primary endpoint.