The following is a summary of “Assessment Of Surgical Complications In Patients With Metastatic Clear Cell Renal Cell Carcinoma (Mccrcc) Receiving Perioperative Cabozantinib And Nivolumab On Cyto-Kik Clinical Trial,” published in the April 2023 issue of Urology by Runcie et al.
The objective of this phase 2 trial was to assess the perioperative safety of cabozantinib and nivolumab in metastatic clear cell renal cell carcinoma (mccRCC) patients and determine the ideal timeframe for discontinuing cabozantinib before surgery. Patients were administered cabozantinib (40 mg daily) and nivolumab (480 mg q4 weeks) for 12 weeks before undergoing cytoreductive nephrectomy. The study utilized a 3+3 design to evaluate the safety of two different intervals (21 or 14 days) between discontinuation of cabozantinib and nephrectomy. Surgical complications were assessed using the Clavien-Dindo classification system as a secondary endpoint.
A total of 16 patients were enrolled, with 14 undergoing nephrectomy. Among them, 75% were male, with ages ranging from 44 to 77 years, with a median age at diagnosis of 58.5 years. The body mass index (BMI) ranged from 17.8 kg/m2 to 39.3 kg/m2, with a median of 28.7 kg/m2. The majority of patients (63%) were classified as intermediate-risk by the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC), while 37% were categorized as having poor-risk disease. Cabozantinib dose reductions were observed in 14% of patients who completed nephrectomy, and cabozantinib was temporarily withheld in 42% of nephrectomy patients during treatment. Three patients underwent nephrectomy within the 21-day interval and five within the 14-day interval after discontinuing cabozantinib. No treatment-related surgical complications occurred in patients who completed nephrectomy, and there were no post-surgery delays in resuming combination systemic therapy.
In conclusion, the combination of cabozantinib and nivolumab is safely administered up to 14 days before cytoreductive nephrectomy in mccRCC patients. This study suggests the feasibility of this treatment regimen without incurring surgical complications or hindering the resumption of systemic therapy after surgery.
Source: auajournals.org/doi/10.1097/JU.0000000000003302.06
