Efficacy of four regimens of intravesical BCG therapy in patients with non-muscle-invasive bladder cancer: second interim analysis of a randomized phase II trial

Mariya I. Volkova; Волкова Мария Игоревна; Ya. V. Gridneva; Гриднева Я. В.; A. Sh. Baymashev; Баймашев А. Ш.; O. R. Sinitsyna; Синицына О. Р.; A. V. Oskarev; Оскарев А. В.; O. A. Stativko; Стативко О. А.; I. A. Pokataev; Покатаев И. А.; E. M. Koldakova; Колдакова Е. М.; T. R. Umyarov; Умяров Т. Р.; M. T. Ayvazov; Айвазов М. Т.; O. N. Abuduev; Абудуев О. Н.; A. A. Vorontsova; Воронцова А. А.; K. O. Tsedenova; Цеденова К. О.; K. S. Nemtseva; Немцева К. С.; E. V. Chernenko; Черненко Е. В.; A. A. Bystrov; Быстров А. А.; L. A. Nekrasova; Некрасова Л. А.; I. N. Naumova; Наумова И. Н.; V. N. Galkin; Галкин В. Н.

doi:10.17650/1726-9776-2026-22-2-66-76

Efficacy of four regimens of intravesical BCG therapy in patients with non-muscle-invasive bladder cancer: second interim analysis of a randomized phase II trial

Authors: Volkova M.I.¹^,2, Gridneva Y.V.¹^,2^,3, Baymashev A.S.², Sinitsyna O.R.¹, Oskarev A.V.¹, Stativko O.A.¹, Pokataev I.A.¹, Koldakova E.M.¹, Umyarov T.R.⁴, Ayvazov M.T.⁴, Abuduev O.N.⁴, Vorontsova A.A.⁴, Tsedenova K.O.⁵, Nemtseva K.S.⁵, Chernenko E.V.⁵, Bystrov A.A.⁶, Nekrasova L.A.⁶, Naumova I.N.⁶, Galkin V.N.¹
Affiliations:
1. S.S. Yudin City Clinical Hospital, Moscow Healthcare Department
2. Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia
3. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
4. Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
5. S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center, Moscow Healthcare Department
6. Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
Issue: Vol 22, No 2 (2026)
Pages: 66-76
Section: DIAGNOSIS AND TREATMENT OF URINARY SYSTEM TUMORS. URINARY BLADDER CANCER
Published: 29.09.2026
URL: https://oncourology.abvpress.ru/oncur/article/view/2049
DOI: https://doi.org/10.17650/1726-9776-2026-22-2-66-76
ID: 2049

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Abstract
About the authors
References
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Abstract

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.

Keywords

non-muscle-invasive bladder cancer, BCG therapy, randomized trial

About the authors

Mariya I. Volkova

S.S. Yudin City Clinical Hospital, Moscow Healthcare Department; Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia

Author for correspondence.
Email: VolkovaMI1@zdrav.mos.ru
ORCID iD: 0000-0001-7754-6624
Russian Federation, 18A Zagorodnoye Shosse, Moscow 117152; Build. 1, 2 / 1 Barrikadnaya St., Moscow 125993

Ya. V. Gridneva

S.S. Yudin City Clinical Hospital, Moscow Healthcare Department; Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia; Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)

Email: VolkovaMI1@zdrav.mos.ru
ORCID iD: 0000-0002-9015-2002
Russian Federation, 18A Zagorodnoye Shosse, Moscow 117152; Build. 1, 2 / 1 Barrikadnaya St., Moscow 125993; Build. 2, 8 Trubetskaya St., Moscow 119048

References

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