The AMBASSADOR trial is a phase 3 randomized clinical trial aimed at evaluating whether pembrolizumab as adjuvant therapy is more effective than observation in patients with high-risk muscle-invasive urothelial carcinoma after radical surgery.
Study Details:
- Objective: Assess the effectiveness of pembrolizumab as adjuvant therapy for patients with high-risk muscle-invasive urothelial carcinoma post-radical cystectomy.
- Patients Enrolled:
- Total: 702
- Pembrolizumab Group: 354 patients
- Observation Group: 348 patients
Inclusion Criteria:
- Age ≥ 18 years
- Muscle-invasive urothelial carcinoma
- Received neoadjuvant chemotherapy (≥ pT2 or N+)
- Radical cystectomy performed 4-16 weeks before registration
- ECOG performance status ≤ 2
- Adequate blood counts, kidney function (CrCl ≥ 30 mL/min), liver function, and albumin ≥ 2.8 g/dL
Primary Outcome:
- Median Disease-Free Survival (DFS):
- Pembrolizumab Group: 29.6 months
- Observation Group: 14.2 months
- Hazard Ratio (HR) for disease progression or death: 0.73 (95% CI: 0.59-0.90, p = 0.003)
- Conclusion: Pembrolizumab significantly improved disease-free survival compared to observation.
Secondary Outcome:
- Grade 3 or Higher Adverse Events:
- Pembrolizumab Group: 50.7%
- Observation Group: 31.6%
- Conclusion: While pembrolizumab improved DFS, it was associated with a higher incidence of severe adverse events.
Final Conclusion:
For patients with high-risk muscle-invasive urothelial carcinoma, adjuvant pembrolizumab after surgery significantly extends disease-free survival. However, there is an elevated risk of adverse events that must be considered when opting for this treatment.
For further reading, you might find this study on immune checkpoint inhibitors in cancer therapy and their evolving role in adjuvant settings helpful: Source