Phase 2 trial of neoadjuvant axitinib in patients with locally advanced nonmetastatic clear cell renal cell carcinoma.

ABSTRACT:

Background

Previous studies have shown a modest impact of tyrosine kinase inhibitors on primary renal tumors. Those studies were mostly retrospective or heterogeneous in their eligibility criteria with regard to histology, disease stage, duration of therapy, and time off therapy prior to surgery.

Objective

To prospectively investigate the safety and efficacy of axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma (ccRCC).

Design, setting, and participants

This was a single-institution, single-arm phase 2 clinical trial. Patients with locally advanced nonmetastatic biopsy-proven ccRCC were eligible.

Intervention

Patients received axitinib 5mg for up to 12 wk. Axitinib was continued until 36h prior to surgery.

SUBMITTER: Karam JA 

PROVIDER: S-EPMC4396847 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature