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The New England Journal of MedicineAdjuvant Pembrolizumab after Nephrectomy in Renal Cell Carcinoma

Advancing Renal Cell Carcinoma Care: Pembrolizumab’s Role in Enhancing Post-Surgical Outcomes

The KEYNOTE-564 trial marked a pivotal shift in the treatment paradigm for patients with renal cell carcinoma at high risk of recurrence post-nephrectomy. This comprehensive study evaluates the efficacy and safety of adjuvant pembrolizumab, offering new hope for extending disease-free and overall survival rates. Through meticulous research and robust statistical analysis, the findings underscore the potential of immunotherapy in changing the landscape of renal cell carcinoma management, particularly for those with locoregional clear-cell renal cell carcinoma and surgically resected metastatic sites.

Key Points:

  • Partial or radical nephrectomy is the standard treatment for locoregional clear-cell renal-cell carcinoma, yet nearly half of the patients face disease recurrence, often with distant metastases.
  • The KEYNOTE-564 trial explored the use of adjuvant pembrolizumab versus placebo in patients post-nephrectomy, showing a significant improvement in disease-free survival for those treated with pembrolizumab.
  • Eligibility for the trial included adults with histologically confirmed locoregional renal-cell carcinoma at high risk of recurrence, who had not received prior systemic therapy and underwent surgery with negative margins within 12 weeks before randomization.
  • The primary endpoint, disease-free survival, significantly favored pembrolizumab over placebo, with a 32% lower risk of disease recurrence or death (hazard ratio, 0.68; P=0.002).
  • Median overall survival was not reached in either group, but pembrolizumab showed a promising trend towards improved survival (hazard ratio for death, 0.54).
  • Adverse events were more common in the pembrolizumab group, with 96.3% experiencing any-grade events, but were consistent with the known safety profile of PD-1 inhibitors.
  • The trial included a diverse patient population across 21 countries, emphasizing the global relevance of the findings to the treatment of renal-cell carcinoma.
  • Patient-reported outcomes indicated that quality of life remained stable in the pembrolizumab group, affirming the treatment’s manageable side effect profile.

HCN Medical Memo
The benefit with regard to disease-free survival was generally consistent across subgroups, although the numbers of patients and events were small in some subgroups and therefore should be interpreted with caution.

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