New Kidney Cancer Guidelines Add First-Line Treatment Options

JENKINTOWN, Pa., Aug. 3 -- Temsirolimus (Torisel) and the combination of bevacizumab (Avastin) plus interferon are now first-line treatment options for relapsed or unresectable stage IV kidney cancer.

The National Comprehensive Cancer Network (NCCN) kidney cancer panel expanded its practice guidelines to include temsirolimus as a first-line option for predominant clear cell histology and non-clear cell histology. The bevacizumab-interferon combination was designated as a first-line therapeutic option for predominant clear cell histology.

The temsirolimus move came, in part, in response to the FDA's recent approval of the agent for treatment of renal cell carcinoma. Additionally, the panel was persuaded by "the safety and effectiveness of temsirolimus shown from the results of a large, multicenter, randomized clinical trial of 626 patients. The study showed that temsirolimus prolonged median overall survival."

The panel also designated temsirolimus as an option for subsequent therapy (second line and beyond) for patients with predominant clear cell histology.

The rationale for the bevacizumab-interferon decision came from results of the AVOREN trial, which was reported in June at the American Society of Clinical Oncology meeting. Results of the placebo-controlled trial showed statistically significant improvement in progression-free survival and tumor response and a trend toward improved overall survival in favor of the combination.

The kidney cancer guidelines update also included category 1 designation (highest quality of supporting evidence and uniform consensus) for sunitinib as first-line therapy for relapsed or unresectable stage IV disease.

Additionally, the panel clarified sorafenib's role as first-line therapy for selected patients with relapsed or stage IV unresectable cancer and removed the agent's category 2B designation (lower-quality evidence and non-uniform consensus).

The panel removed palliative radiation therapy and metastasectomy from the clinical pathway for recurrent and unresectable kidney cancer and added them to a footnote as examples of supportive care.

Finally, the kidney-cancer panel clarified predictors of short-term survival to identify poor-prognosis patients for temsirolimus use.

• Lactate dehydrogenase level >1.5 times upper limit of normal
• Hemoglobin level Corrected serum calcium level >10 mg/dl (2.5 mmol/l)
• Interval Karnofsky performance score ?70
• ?2 sites of organ metastasis