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Tissue based biomarkers in non-clear cell RCC: Correlative analysis from the ASPEN clinical trial.

Susan Halabi1, Qian Yang1, Andrea Carmack1

  • 1Department of Biostatistics and Bioinformatics, Duke University, Durham NC.

Kidney Cancer Journal : Official Journal of the Kidney Cancer Association
|November 12, 2021
PubMed
Summary

Biomarkers like S6/Akt and c-kit show prognostic value in non-clear cell renal cell carcinoma (NC-RCC). While S6/Akt activation correlates with poorer outcomes, c-kit expression is linked to better survival, guiding future treatment strategies.

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Area of Science:

  • Oncology
  • Translational Research
  • Biomarker Discovery

Background:

  • Non-clear cell renal cell carcinoma (NC-RCC) lacks established biomarkers for treatment selection.
  • Identifying novel therapeutic targets is crucial for improving patient outcomes in NC-RCC.

Purpose of the Study:

  • To explore potential tissue biomarkers in NC-RCC patients treated with everolimus or sunitinib.
  • To associate biomarkers of mTOR and VEGF pathway activation with clinical outcomes.

Main Methods:

  • An international randomized phase 2 trial (ASPEN) enrolled 108 patients with metastatic NC-RCC.
  • Tissue biomarkers (phospho-S6, -Akt, c-kit, HIF-1α, c-MET) were analyzed by immunohistochemistry.
  • Exploratory analysis correlated biomarkers with overall survival (OS) and radiographic progression-free survival (rPFS).

Main Results:

  • S6/Akt activation was more frequent in poor-risk tumors and associated with worse OS and rPFS for both treatments.
  • C-kit expression was common in chromophobe tumors and linked to improved outcomes.
  • C-MET expression in papillary tumors correlated with lower response rates but not PFS.
  • Multivariable analysis identified pAkt and c-kit as significant prognostic OS biomarkers.

Conclusions:

  • pAkt and c-kit are significant prognostic biomarkers for OS in NC-RCC.
  • No predictive biomarkers for treatment response were identified.
  • Sunitinib demonstrated improved outcomes compared to everolimus across most biomarker subgroups.