Adjuvant treatment for operable intermediate-high or high-risk clear-cell renal cell carcinoma after nephrectomy
This protocol addresses the post-surgical management of patients with clear-cell renal cell carcinoma (ccRCC) who have undergone nephrectomy and whose disease is classified as intermediate-high- or high-risk according to the KEYNOTE-564 trial criteria. In this population, surgery alone carries a meaningful risk of recurrence, and adjuvant systemic therapy is an established evidence-based consideration.
Clinical scenario
Histologically confirmed clear-cell RCC, successfully resected, meeting intermediate-high- or high-risk criteria as defined by the KEYNOTE-564 protocol. Patient counselling regarding the potential for long-term adverse effects is an integral part of the shared treatment decision in this setting.
Adjuvant approach
The evidence-based strategy in this setting involves adjuvant immunotherapy with pembrolizumab, initiated in the post-operative period. The full regimen details, eligibility thresholds, and clinical algorithm are available in the complete protocol.
References
DOI: 10.1016/j.annonc.2024.05.537
- Adjuvant pembrolizumab should be considered for patients with intermediate-high- or high-risk operable ccRCC (as defined by the KEYNOTE-564 criteria) after careful patient counselling regarding potential long-term AEs.
- The phase III KEYNOTE-564 trial evaluated pembrolizumab (17 cycles of 200 mg three times weekly) versus placebo as adjuvant therapy in 994 patients with ccRCC with intermediate-high- or high-risk disease (as defined by the trial protocol), or M1 and no evidence of disease (NED).
- Treatment should start within 12 weeks of surgery and continue for up to 1 year.