(UroToday.com) In the on-demand poster session of the European Society for Medical Oncology (ESMO) Annual Congress, Dr. Guillermo De Velasco discussed the CABOPRE trial, a single-arm prospective multicentre phase II trial to assess the efficacy and safety of neoadjuvant cabozantinib in patients with clear cell metastatic renal cell carcinoma (mRCC) and potential candidates to cytoreductive nephrectomy (CN) (EudraCT Number: 2018-001201-93).
This trial is premised on the notion that a favorable response to systemic therapy may be a suitable approach to select ideal candidates for CN in mRCC. Cabozantinib is a guideline-recommended treatment approach with clinical benefit as first-line therapy in mRCC patients with intermediate- or poor-risk disease according to International Metastatic Renal Cell Carcinoma Database Consortium criteria (IMDC).
In the CABOPRE trial, patients with mRCC received three cycles of cabozantinib 60mg/daily followed by CN. Patients continued cabozantinib therapy after surgery. The primary endpoint was the objective response rate (ORR) at 12 weeks (prior to CN). Progression-free survival (PFS), overall survival (OS), safety, and exploratory biomarker analyses in paired tissue and blood samples were secondary endpoints.
The authors enrolled 18 patients between Dec 2018 and Dec 2020. Of 16 patients who were evaluable, at a median follow-up of 9.0 months, the 12-week ORR was 26.7% (partial response) with 66.7% of patients having stable disease and 6.7% having progressive disease. The median PFS was 12.7 months and median OS has not been reached.
No new or unexpected safety findings were observed with cabozantinib. No severe complications were reported postoperatively. A biomarker analysis utilizing sequential microRNA profiling from plasma as well as tumor-derived exosomes is being analyzed. The authors found 61 differentially expressed miRNAs that correctly classified samples based on hierarchical clustering analysis.
The authors conclude that, prior to cytoreductive nephrectomy, cabozantinib at 60 mg/day is feasible and active as a perioperative treatment in intermediate/poor-risk mRCC patients.