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Physicians who conducted a pilot study at University of North Carolina ( UNC ) Lineberger Comprehensive Cancer Center found that therapy before surgery with the drug Sorafenib ( Nexavar ) can reduce the size of large kidney tumors and could be safely undertaken administered without adding significantly to the risks of surgery.

The findngs are published in the Journal of Clinical Oncology.

At present, removal of the primary tumor ( often with the kidney as well ) is the standard treatment for patients with kidney cancer, whether the disease is localized to the kidney or has spread to distant sites. This broad spectrum includes patients with very large tumors that may not be ideal for surgical removal as well as patients who may benefit from early systemic interventions, but who would also benefit from removing the kidney later.

The study addressed the question of whether systemic therapy, and in particular, therapy that targets the process by which tumors seek and find new blood vessels to fuel their growth, can benefit patients before they undergo surgery to remove tumors.

The study was conducted to evaluate the safety and feasibility of preoperative treatment using Sorafenib in 30 patients with stage two or higher kidney cancer including metastatic disease. Patients received their treatment at UNC Lineberger Comprehensive Cancer Center and at Rex Cancer Center in Raleigh. They took two daily oral doses of the drug for between four to eight weeks prior to surgery.

Sorafenib is a targeted drug used to treat advanced kidney cancer and a type of liver cancer; it prevents the growth of new blood vessels that fuel tumor growth. Sorafenib is one among the class of new targeted agents approved by the FDA in 2005 for evidence of benefit for patients with metastatic kidney carcinoma.

Two previous studies had been conducted using similar targeted therapy drugs, Sunitinib ( Sutent ) and Bevacizumab ( Avastin ), but UNC study is the largest to evaluate the use of Sorafenib alone, and the first to explore the possibility that pre-operative treatment might benefit patients who do not have metastatic disease.

The study has demonstrated that Sorafenib is well-tolerated for pre-surgery use, with no increase in the rates of complications or difficulties recovering from surgical removal of the kidney.

Another important aspect of this study is the successful integration of systemic therapy with what is traditionally a surgical stage of the disease.

In conclusion, it has been seen a significant reduction in the size of tumors using Sorafenib, reducing the extent of surgery and making patient recovery less challenging. A larger study needs to be conducted to determine if preoperative systemic therapy improves outcomes in patients undergoing surgery for kidney tumor.

Source: University of North Carolina School of Medicine, 2010

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