Evaluate the efficacy and safety of Vedolizumab combined with immunotherapy in bladder cancer bladder-sparing treatment.

A retrospective analysis of the clinical data of 21 bladder cancer patients who received Vadastuximab combined with immunotherapy at the First Affiliated Hospital of Fujian Medical University from March 2023 to January 2024. There were 16 males and 5 females, with an average age of (65.0±10.1) years. Pre-treatment imaging assessments showed tumor clinical staging of cT1 in 5 cases, cT2 in 8 cases, and cT3 in 8 cases; biopsy pathology revealed low-grade urothelial carcinoma in 12 cases and high-grade urothelial carcinoma in 9 cases; immunohistochemical staining of biopsy pathology showed HER-2 (0), (+), (++) and (+++), with 0, 5, 10, and 6 cases respectively. Treatment regimen: Vadastuximab 120mg every 3 weeks for a total of 3 cycles; Toripalimab 240mg every 3 weeks for a total of 3 cycles. Post-treatment imaging examinations and secondary radical transurethral bladder tumor resection were performed to assess changes in target lesions. The efficacy and adverse reactions of Vadastuximab combined with immunotherapy for bladder preservation treatment were analyzed.

All 21 cases completed treatment with Vadastuximab in combination with immunotherapy. 14 cases (66.67%) achieved complete remission, 4 cases (19.05%) had partial remission, 1 case (4.76%) had stable disease, and 2 cases (9.52%) experienced disease progression. 18 cases (85.71%) had objective responses, and 19 cases (90.48%) had disease control. Among the 16 HER-2 positive and 5 HER-2 negative patients, 11 cases (68.75%) and 3 cases (60.00%) achieved complete remission, respectively, while 14 cases (87.50%) and 4 cases (80.00%) achieved objective responses. Among them, 11 cases achieved pathological complete response (pCR) with imaging assessments also showing complete remission; 5 cases had pathological T1 tumors with imaging assessments showing objective responses. 2 cases underwent cystoscopy, and imaging assessments showed complete remission. The bladder preservation rate was 76.19% (16/21), and the patients who successfully preserved their bladders continued to receive 3 cycles of Vadastuximab combined with immunotherapy as a follow-up treatment plan. The incidence of grade 3-4 adverse reactions with Vadastuximab combined immunotherapy was relatively low.

The objective response rate and disease control rate of bladder cancer in the combination therapy model of Vidisicimab and immunotherapy are high, with a high bladder preservation rate, low incidence of severe adverse reactions, and significant improvement after treatment, showing good efficacy even in HER-2 negative patients.