From the Guidelines
Durvalumab is recommended as adjuvant therapy for high-risk muscle-invasive bladder cancer patients who have undergone radical surgery and have received neoadjuvant cisplatin-based chemotherapy or are ineligible for cisplatin-based therapy. The standard regimen is 1500 mg administered intravenously every 4 weeks for up to 1 year (maximum of 13 doses). This recommendation is based on the most recent and highest quality study available, which demonstrated that durvalumab significantly improved disease-free survival compared to observation alone 1. Durvalumab works as an immune checkpoint inhibitor by blocking PD-L1, allowing the immune system to better recognize and attack cancer cells. Common side effects include fatigue, rash, diarrhea, and potential immune-related adverse events such as pneumonitis, colitis, hepatitis, and endocrinopathies. Patients should be monitored regularly with laboratory tests and imaging during treatment. Durvalumab is contraindicated in patients with severe active autoimmune disorders.
Some key points to consider when using durvalumab as adjuvant therapy for bladder cancer include:
- The importance of proper patient selection, including those with high-risk muscle-invasive bladder cancer who have undergone radical surgery and have received neoadjuvant cisplatin-based chemotherapy or are ineligible for cisplatin-based therapy
- The need for regular monitoring of patients during treatment, including laboratory tests and imaging
- The potential for immune-related adverse events, which can be severe and require prompt treatment
- The importance of considering the patient's overall health and medical history when deciding whether to use durvalumab as adjuvant therapy.
It's also important to note that while the evidence for adjuvant chemotherapy is not as strong as for neoadjuvant therapy, the growing body of data supports the administration of adjuvant chemotherapy for patients with a high risk for relapse who did not receive neoadjuvant therapy 1. However, the use of durvalumab as adjuvant therapy is a more recent development, and the evidence for its use is based on the most recent and highest quality studies available 1.
From the Research
Durvalumab in Adjuvant Bladder Cancer Treatment
- Durvalumab has been studied as an adjuvant treatment for bladder cancer in several clinical trials 2, 3, 4.
- A phase 3 trial published in The New England Journal of Medicine found that perioperative durvalumab plus neoadjuvant chemotherapy improved event-free survival and overall survival compared to neoadjuvant chemotherapy alone in patients with muscle-invasive bladder cancer 2.
- The trial reported an estimated event-free survival at 24 months of 67.8% in the durvalumab group and 59.8% in the comparison group, with a hazard ratio of 0.68 (95% CI, 0.56 to 0.82; P<0.001) 2.
- A phase II study published in the Journal for Immunotherapy of Cancer found that concurrent durvalumab and radiation therapy followed by adjuvant durvalumab was safe and effective in patients with localized urothelial cancer of the bladder, with a disease control rate of 72.7% and a complete response rate of 54.5% 3.
- Another study published in Archivos Espanoles de Urologia found that durvalumab combined with radiotherapy as a second-line treatment for advanced bladder cancer improved overall clinical objective response rate, two-year survival rate, and progression-free survival compared to durvalumab monotherapy 4.
Efficacy and Safety of Durvalumab
- The studies suggest that durvalumab is effective in improving outcomes in patients with bladder cancer, including event-free survival, overall survival, and disease control rate 2, 3, 4.
- The safety profile of durvalumab was generally manageable, with treatment-related adverse events of grade 3 or 4 occurring in 40.6% of patients in the durvalumab group in the phase 3 trial 2.
- The phase II study found that durvalumab and radiation therapy was well tolerated, with grade ≥3 treatment-related adverse events occurring in a minority of patients 3.