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Transforming the Perioperative Treatment Paradigm in Non-Metastatic RCC-A Possible Path Forward.

L C Harshman1, C G Drake2, N B Haas3

  • 1Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.

Kidney Cancer (Clifton, Va.)
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Summary
This summary is machine-generated.

Perioperative nivolumab offers a promising new treatment strategy for non-metastatic renal cell carcinoma (RCC). This approach aims to improve recurrence-free survival and overall survival in patients undergoing nephrectomy.

Keywords:
EA8143PD-1 blockadePROSPER RCCRenal cell carcinomaadjuvantneoadjuvantnephrectomynivolumabprimingrecurrence-free survival

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Area of Science:

  • Oncology
  • Immunotherapy
  • Renal Cell Carcinoma Research

Background:

  • No adjuvant systemic therapy currently improves overall survival for non-metastatic renal cell carcinoma (RCC).
  • Nivolumab, an anti-PD-1 antibody, has shown efficacy in metastatic RCC and is well-tolerated.
  • Preclinical models suggest neoadjuvant PD-1 blockade may be more beneficial than adjuvant therapy.

Purpose of the Study:

  • To evaluate the efficacy of perioperative nivolumab in improving clinical outcomes for patients with high-risk localized and locally advanced RCC.
  • To increase cure rates and recurrence-free survival (RFS) in non-metastatic RCC through a multidisciplinary approach.

Main Methods:

  • The PROSPER RCC trial is a global, randomized, phase 3 study enrolling 766 patients with clinical stage ≥T2 or node-positive M0 RCC.
  • The investigational arm receives neoadjuvant nivolumab before surgery followed by adjuvant nivolumab for 9 months.
  • The control arm receives standard surgical resection followed by observation.

Main Results:

  • The trial is powered to detect a 14.4% absolute benefit in RFS at 5 years (from 55.8% to 70.2%).
  • The study is also powered to demonstrate a significant overall survival benefit.
  • Key safety, feasibility, and quality of life endpoints are being assessed.

Conclusions:

  • Perioperative nivolumab is being investigated as a novel strategy to improve outcomes in non-metastatic RCC.
  • The PROSPER RCC trial aims to establish a new standard of care for high-risk localized and locally advanced RCC.
  • Correlative studies will explore the impact of the immune microenvironment on treatment response.