Around the Practice is a monthly urologic virtual live event featuring case reviews from multidisciplinary experts, presented by Urology Times[R] in partnership with the Large Urology Group Practice Association. On April 21, 2021, a panel convened to discuss cases involving high-risk renal cell carcinoma (RCC) and metastatic castrate-resistant prostate cancer. What follows is an edited portion of the panel's conversation regarding the RCC case. The panelists for this case included moderator Raoul S. Concepcion, MD, FACS; Vahan Kassabian, MD; Paul J. Kim, MD; and Abhishek Tripathi, MD.
CONCEPCION: This patient is a 51-year-old man who presents with left flank pain and gross hematuria. His medical history is significant for type 2 diabetes, hypertension, elevated cholesterol, hypogonadism, and depression. He's had a right inguinal herniorrhaphy. He has allergies to aspirin, iodine contrast, walnuts, and cats. He's taking a number of medications, including glyburide, statins, and lisinopril. His review of systems is noncontributory. He is married, has significant occupational exposure, and has a significant family history of esophageal cancer in his father. On exam, he has no abdominal masses and doesn't exhibit any cutaneous lesions. For lab evaluations, his complete blood count, basic metabolic panel, and liver function test are all normal. His alkaline phosphatase is slightly elevated. On CAT scan imaging, he has a large enhancing left renal mass of about 11 cm, no lymphadenopathy, and no evidence of metastatic disease. There is no evidence of metastases on his chest x-ray or bone scan.
After shared decision-making, the patient opted for a left robotically assisted radical nephrectomy. The final pathology showed mixed clear and granular cell type. The tumor itself was 10 by 7 cm. It was Fuhrman [nuclear] grade 3, with invasion into the renal vein, but negative margin at the renal vein resection site. He also had extension of the tumor into the perirenal fat and renal sinus adipose tissue, but Gerota fascia was not involved and it is intact. He has a pathologic T3N0M0 lesion. Dr Tripathi, tell us a little bit about how you would manage this patient, especially in light of some of the existing therapies that are now approved for the high-risk patient.
TRIPATHI: High-risk RCC has been an area of active research for the past decade, if not longer, with several trials aimed at investigating different adjuvant therapies. These trials resulted in the approval of sunitinib [Sutent] in the adjuvant setting for high-risk RCC, which this patient meets the criteria for. However, this happens to be one of those situations where even though there is an FDA approval, there is not widespread consensus on whether we should be offering or strongly recommending these therapies for patients with high-risk disease.
The reason for that is the discordance between the results of the ASSURE [NCT00326898] and S-TRAC [NCT00375674] trials, and the lack of an overall survival benefit to date and high rate of grade 3 adverse events.
Considering these factors, our practice is to try to enroll patients in a clinical trial if possible, and if...