NEW ORLEANS, LA USA (UroToday.com) - Adjuvant therapy for locally advanced or high-risk resected kidney cancer is under exploration in several randomized trials. The negative oncologic results of the ASSURE trial were presented previously at the ASCO GU Symposium, but Robert Uzzo pointed out that there is still a lot to learn from the trial patients.
The authors set to evaluate how soon after surgery it is safe to start TKIs and to describe the adverse events in a postoperative population. Importantly, although the drugs will not be given in an adjuvant setting as a result of the ASSURE trial, this type of information is relevant to cytoreductive patients who would be candidates for postoperative chemotherapy. Trial patients were randomized to sunitinib, sorafenib, or placebo. Intermediate- or high-risk disease was required for trial entry, and disease had to be fully resected. All patients received a prescription within 12 weeks. Baseline clinicopathologic and demographic characteristics were the same in all 3 groups. Patients mostly had clinical stage II and III disease. On average, day 1/cycle 1 (D1C1) of therapy occurred during the 10th week, with a range of the 4th-14th week. No differences in D1C1 were seen in patient groups when segregated by surgical approach, radical versus nephron-sparing surgery, demographic data, or complications. Renal dysfunction did delay D1C1 slightly.
The side effect profile in postoperative patients was similar to that seen in patients with metastatic disease. Importantly, hematologic complications occurred in 1% of nonplacebo patients, and there was no increase in wound dehiscence or infection as a result of earlier D1C1.
He closed by polling the audience to ask how many urologists start TKI therapy within 2-3 weeks of a cytoreductive nephrectomy; surprisingly few urologists admitted that this was their practice. Brad Leibovich pointed out that if he felt a patient needed to begin TKI therapy that promptly, then it would indicate he/she may have critical or bulky metastases that would likely preclude surgery in the first place. Dr. Leibovich did say that he will ask patients’ medical oncologists to start therapy in 3 weeks if they have sufficiently convalesced, or otherwise 4 weeks if they are slow to recover.
Presented by Robert Uzzo at the American Urological Association (AUA) Annual Meeting - May 15 - 19, 2015 - New Orleans, LA USA
Fox Chase Cancer Center, Philadelphia, PA USA
Reported by Phillip Abbosh, MD, PhD, medical writer for UroToday.com