Interim results from a phase 2 clinical trial revealed that neoadjuvant axitinib significantly reduced renal tumor size and complexity, enabling partial nephrectomy (PN) in a cohort of highly complex renal masses, investigators reported during a late-breaking abstract session at the American Urological Association’s 2022 annual meeting in New Orleans, Louisiana.
The results are based on an analysis of 26 patients with complex biopsy-proven clear cell renal cell carcinoma tumors in the single-arm PADRES (Prior Axitinib as a Determinant of Outcome of Renal Surgery; NCT03438708). All had strong indications for PN and faced the risk of dialysis dependence if they underwent radical nephrectomy (RN).
Patients had a median age of 69 years and a median follow-up of 12 months. Axitinib 5 mg was administered orally twice daily for 8 weeks prior to surgery. The primary outcome was reduction in longest tumor diameter based on imaging criteria and achievement of PN. Secondary outcomes included preservation of renal function.
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With regard to the primary outcomes, axitinib resulted in significant reductions in median tumor size from 7.7 cm pre-axitinib to 6.3 cm post-axitinib and RENAL score (11 vs 10), lead author Kevin Hakimi, BS, a medical student at the UC San Diego School of Medicine in La Jolla, California, reported on behalf of his research team. Surgeons performed PN in 20 patients (76.9%), with a median ischemia time of 34 minutes, and RN in 5 patients. All RN patients had at least T3a tumors on final pathology.
Of the 26 patients, 25 (96.8%) had negative surgical margins. Most patients had adequate preservation of renal function. The median change in estimated glomerular filtration rate from before surgery to 1 month after surgery was 4.5 mL/min/1.72 m2. In addition, 2 out of 26 (7.8%) patients had 50% or greater reduction in renal function, with 1 patient (3.8%) becoming dialysis dependent following RN.
Accrual into the study is ongoing with a target of 50 patients.
Disclosures: The study is being funded by Pfizer, which markets axitinib.
Reference
Hakimi K, Campbell S, Nguyen M, et al. Interim analysis of PADRES (Prior Axitinib as a Determinant of Outcome of Renal Surgery NCT03438708) clinical trial. Presented at AUA 2022, May 13-16, 2022, New Orleans, Louisiana. Abstract LBA01-08.
