RECENT studies have shown promising results in the treatment of muscle-invasive bladder cancer (MIBC) using a combination of radiation therapy and immunotherapy. The objective of this study was to assess the feasibility, safety, and efficacy of a bladder-preserving treatment approach that combines dual immune checkpoint blockade and radiotherapy in patients with MIBC.
The trial involved patients with localized MIBC who underwent transurethral resection, followed by a regimen of durvalumab (1,500 mg) and tremelimumab (75 mg) every four weeks for three doses, alongside concurrent radiotherapy (64–66 Gy to the bladder). Patients with residual or relapsed MIBC were subjected to salvage cystectomy. The primary endpoint of the study was complete response, defined as the absence of MIBC at post-treatment biopsy. Secondary endpoints included bladder-intact disease-free survival, distant metastasis-free survival, and overall survival.
A total of 32 patients were enrolled across six centres. Remarkably, a complete response was observed in 26 (81%) of the participants. Only two patients had residual MIBC, while four were not evaluated. After a median follow-up period of 27 months, two patients required salvage cystectomy. The 2-year survival rates were 65% for bladder-intact disease-free survival, 83% for distant metastasis-free survival, and 84% for overall survival. Furthermore, the 2-year estimates for non-muscle-invasive bladder relapse, MIBC recurrence, and distant metastasis were 3%, 19%, and 16%, respectively.
While the treatment was generally well tolerated, 31% of patients experienced grade 3 to 4 toxicities. The most common adverse events included diarrhoea (6%) and acute kidney failure (6%).
In conclusion, the combination of durvalumab and tremelimumab with concurrent radiotherapy is a feasible and safe treatment strategy that shows high efficacy in preserving the bladder in a significant number of patients. Further research is essential to evaluate this approach as a potential alternative to cystectomy in the management of MIBC.
Katie Wright, EMJ
Reference
Garcia-Del-Muro X et al. Bladder preservation with durvalumab plus tremelimumab and concurrent radiotherapy in patients with localized muscle-invasive bladder cancer (IMMUNOPRESERVE): a Phase II spanish oncology genitourinary group trial. Clin Cancer Res. 2025;31(4):659-66.
