KEY TAKEAWAYS
- The phase (Cyto-KIK) 2 study aimed to assess the safety of cabozantinib and nivolumab during the perioperative period for mccRCC, and the ideal period to discontinue cabozantinib before surgery remains uncertain.
- The trial demonstrated that it’s safe to administer a combination of cabozantinib and nivolumab for up to 14 days before performing a cytoreductive nephrectomy.
In this phase 2 study, mccRCC patients (pts) received cabozantinib (40 mg daily) and nivolumab (480 mg every 4 weeks) for a duration of 12 weeks before undergoing cytoreductive nephrectomy. After surgery, the treatments continued until the disease advanced further. The study employed a 3+3 design to determine the safety of either a 21-day or 14-day gap between stopping cabozantinib and the surgery. To be considered evaluable, pts had to take at least 10 out of the 14 scheduled doses of cabozantinib before its pre-decided discontinuation. The secondary objective was to gauge surgical complications using the Clavien-Dindo classification system.
Out of the 16 pts that participated, 14 underwent nephrectomy. The patient breakdown included 12 (75%) males and 4 (25%) females, with ages ranging from 44-77 years and a median age of 58.5 years at diagnosis. BMI values varied between 17.8 kg/m2 and 39.3 kg/m2, averaging at a median of 28.7 kg/m2. According to the IMDC classification, 63% of the participants were categorized as intermediate-risk, while 37% were labeled as poor-risk. 14% of those who underwent nephrectomy had their cabozantinib dosage reduced, and 42% paused their cabozantinib intake during their treatment phase. Three participants had their nephrectomy within 21 days of stopping cabozantinib, and five did so within a 14-day interval. Notably, no surgery-related complications due to the treatments were recorded. Furthermore, there were no delays in starting the combined systemic treatment after the surgery.
Administering a combination of cabozantinib and nivolumab up to 14 days before a cytoreductive nephrectomy is deemed safe.
Source: https://www.auajournals.org/doi/10.1097/JU.0000000000003302.06
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04322955
Runcie, Karie; Ornstein, Moshe; Saraiya, Biren; Krishnamurthi, Venkatesh; Lee, Byron; Anderson, Christopher; DeCastro, Guarionex; McKiernan, James; Mayer, Tina; Dallos, Matthew; Stein, Mark; Singer, Eric PD24-06 ASSESSMENT OF SURGICAL COMPLICATIONS IN PATIENTS WITH METASTATIC CLEAR CELL RENAL CELL CARCINOMA (MCCRCC) RECEIVING PERIOPERATIVE CABOZANTINIB AND NIVOLUMAB ON CYTO-KIK CLINICAL TRIAL, Journal of Urology: April 2023 – Volume 209 – Issue Supplement 4 doi: 10.1097/JU.0000000000003302.06
