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| |  New Guidelines Prefer Clinical Trial for Advanced Kidney Cancer Therapy: Presented at NCCN By Ed Susman HOLLYWOOD, Fla -- March 10, 2008 -- The preferred treatment for advanced and metastatic renal cell carcinoma is entry into a well-designed clinical trial, according to a presentation of new guidelines for the treatment of kidney cancer made here on March 7 at the National Comprehensive Cancer Network (NCCN) 13th Annual Conference: Clinical Practice Guidelines and Quality Cancer Care. While long-term survival appears promising for patients diagnosed with primary kidney cancer, renal cell carcinoma is the third most common genitourinary cancer after prostate and bladder cancer, said Timothy M. Kuzel, MD, Professor of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois. "About 51,190 new cases were estimated in the United States in 2007, and 12,890 deaths from the disease are expected," he added. Dr. Kuzel, who headed the guideline committee, noted that surgery remains the treatment of choice for localised kidney cancer, although what type of treatment should follow surgery remains controversial. In his presentation, Dr. Kuzel noted that "no data thus far demonstrate [that] adjuvant systemic therapy is effective in reducing the risk of relapse." Approximately 20% to 30% of kidney cancer patients who have undergone surgical resection suffer relapse, and the treatment of those patients is also controversial, he said. The guideline committee stated that, in cases of relapse or patients who present with stage IV and medically or surgically unresectable kidney cancer, entry into a clinical trial is one treatment possibility. The guidelines also note that therapy with sunitinib has demonstrated category 1 evidence of effectiveness in treating the disease, although the ability to produce cures is rare. Category 1 evidence is supported by results from well-designed clinical trials. Other clinical trial results demonstrated that treatment with temsirolimus also produces some clinical benefit among poor-prognosis patients -- those with 3 or more predictors of short survival. Those predictors include a lactate dehydrogenase level greater than 1.5 times the upper limit of normal; haemoglobin levels less than the lower limit of normal; corrected serum calcium level greater than 10 mg/dl; an interval of less than a year from original diagnosis to the start of systemic therapy; a Karnoksky performance score greater than or equal to 70; and 2 or more sites of organ metastases. The guidelines also suggest that the combination of bevacizumab plus interferon, the use of high-dose interleukin-2 for selected patients, sorafenib, and best supportive care are also acceptable therapies. In the case of progression after first-line treatment in patients with renal cell carcinoma, a clinical trial is the preferred treatment option, Dr. Kuzel said, but crossover regimens used sorafenib, sunitinib, temsirolimus, interferon, IL-2 (both high dose and low dose), bevacizumab, and best supportive care. In most of these cases, however, Dr. Kuzel reported that the committee lacks the best quality evidence for recommending the treatments. Dr. Kuzel said that for treatment of non-clear-cell renal cell carcinoma, entry into a clinical trial is also preferred. Treatment with temsirolimus, sorafenib, and sunitinib could also be considered. There was disagreement among the guideline-committee members as to the usefulness of chemotherapeutic agents such as gemcitabine, capecitabine, floxuridine, or doxorubicin. There are several ongoing clinical trials in renal cell carcinoma, as well as many others being planned to determine which of the current drugs and which new therapeutic entities might be able to effectively fight these advanced cancers.
[Presentation title: Update: Kidney Cancer Guidelines.]
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