49-year-old male was diagnosed with renal cell carcinoma and underwent left radical nephrectomy. The expert recommended either close observation every few months or participating in an adjuvant vaccine trial or monoclonal antibody therapy trial.
The patient pursuing a another opinion with regard to the benefit of any additional therapy and with questions as to how he should be followed
Diagnosis: Stage ill, T3aNOMO clear cell carcinoma of the kidney (conventional nuclear grade III)
Prior oncologic history: Left radical nephrectomy 09/05 with ipsilateral para-aortic lymph node dissection, 9 cm conventional renal cell carcinoma, nuclear grade Fubnnan 3, with tumor infiltrating renal capsule and focally penetrating perinephric fat tissue (pT3aNOMO).
History of present illness: This is a 49-year-old Caucasian male who complained of right flank discomfort in the spring of 2005 and was found on abdominal CT workup to have a solid lesion of the kidney, measuring 9x6.5 cm. Patient underwent a radical nephrectomy of the left kidney on 09/05, at which time a T3aNOMO conventional carcinoma of the kidney was noted. Patient has apparently recovered without any incidence since his surgery but it is pursuing a second opinion with regard to the benefit of any additional therapy and with questions as to how he should be followed.
There is no information provided as to how the patient is doing since the completion of his nephrectomy and I will assume that he is in good physical condition. Therefore, one could include as part of his staging. The UCLA Integrated Staging System. which was developed from a retrospective analysis of 661 patients undergoing nephrectomy. According to this staging classification, which is based on stage Fuhrman grade, because performance status and additional prognostic factors, the patient has a UISS Stage of 2. This is assuming that he has Stage III disease with high-grade Fuhrman 3, and an ECOG performance status of O. Based on this data, his two-year percentage of survival would be 89%, however if he had any debilitation or pain and his ECOG performance status was 1 or more, he would have only a 66% two-year survival. A five-year survival rate for UISS survival stage is 64%. He therefore, is at some risk for recurrence from his renal cell carcinoma, however there is no evidence that adjuvant therapy is helpful in this setting at the present time. Three Phase III trials have been conducted using either adjuvant interferon of interIeukin-2 versus observation in patients with local resection of advanced renal cell carcinoma. None of these patients demonstrated a survival benefit and toxicities expected with these agents were seen in patients assigned to the treatment arms. Adjuvant vaccine trials are currently an ongoing area of investigation. There is a Phase II study of vaccine comprising HLA*A2 and HLA-A3 binding peptides from FOP factor 5 in patients with Stage ill or IV renal cell carcinoma that is currently being offered at the National Cancer Institute by Dr. James Yang. Additionally there is a study of monoclonal antibody therapy, CG250 versus placebo antibody for patients with clear cell cancer after nephrectomy sponsored by Wilex Pharmaceuticals that is also recruiting patients in the United States for which the lead investigator is in California but additional sites throughout the United States are open. My understanding is that there was some exploratory vaccine therapy being done directed against the Vell protein. however I do not see that on our current clinical trials database.
My recommendation, therefore, is that the patient consider either standard of care which would be close observation every four months for two years and then every six months for three years, and then annually, which would include a history and physical, chest x-ray, comprehensive metabolic panel, and an abdominal CT scan. Alternatively, the patient could consider participating in an adjuvant vaccine trial or monoclonal antibody therapy trial such as the ones I mentioned above.