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Updated Results Confirm Survival Benefit of Nexavar® in Renal Cell Carcinoma

According to results recently presented at the 2006 Kidney Cancer Symposium in Chicago, Illinois, Nexavar® (sorafenib) significantly improves progression-free and overall survival in patients with renal cell carcinoma.

Kidney Cancer CancerConnect Renal

The kidneys are each filled with tiny tubules that clean and filter the blood-the process that removes waste and makes urine. Renal cell cancer (RCC) is a malignancy involving these tubules of the kidney. Metastatic RCC refers to cancer that has spread from the kidney to distant sites in the body. Researchers continue to evaluate novel therapeutic strategies for the treatment of metastatic RCC. Targeted agents are becoming a strong focus for treatment of this disease.

Nexavar belongs to a group of drugs called targeted agents. Nexavar blocks the growth of cancer cells by inhibiting several biological pathways that are involved in cellular replication and spread.

The effect of Nexavar on survival with advanced kidney cancer is being evaluated in a phase III clinical trial known as TARGETs (Treatment Approaches in Renal cancer Global Evaluation Trial). Preliminary results from this study suggest that, compared to a placebo, treatment with Nexavar lengthens survival without cancer progression and does not compromise quality of life for patients. The TARGETs trial included approximately 900 patients, the majority of whom had received prior therapy. One group was treated with Nexavar and the other group received placebo (inactive substitute). Patients who initially received placebo were allowed to “cross over” and begin treatment with Nexavar once their cancer progressed.

  • Half of the patients initially treated with Nexavar were progression-free at six months, compared with only three months for those who initially received placebo.
  • Survival time for half of the patients initially treated with Nexavar has not yet been reached; for those initially received placebo, half were alive at 18 months.
  • Patients who initially received placebo and then crossed over to receive Nexavar had an improved overall survival by 30%.
  • Quality of life and respiratory function were improved among patients treated with Nexavar.

The most common adverse treatment effects reported by study participants were diarrhea, rash, fatigue, hand-foot skin reaction, hair loss, nausea, itching, high blood pressure, vomiting, and loss of appetite. Grade 3 adverse effects were reported by 31% of patients treated with Nexavar and 22% of patients treated with placebo. Grade 4 adverse effects were reported by 7% of patients treated with Nexavar and 6% of patients treated with placebo.

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Nexavar® Effective in Elderly Patients with Kidney Cancer

Nexavar (sorafenib) provides an effective and safe treatment option for elderly patients with renal cell carcinoma (RCC), or kidney cancer. These results were recently published in the Journal of the National Cancer Institute.

There is a long-held perception that older cancer patients may be at higher risk than younger patients of suffering from the toxic effects from cancer therapy and at the same time, they may actually obtain less clinical benefit from the therapy. However, this perception may result from the fact that the elderly are not a well-represented group in clinical trials. As a result, there is no data to show how the elderly respond to targeted therapy.

Researchers from Europe and the United States recently conducted a subgroup analysis of the Treatment Approach in Renal Cancer Global Evaluation Trial, a large clinical trial evaluating Nexavar in the treatment of advanced RCC. The researchers compared outcomes from elderly patients (over 70 years) to those of their younger counterparts in the trial to further assess Nexavar’s role in the treatment of RCC.

The results of the analysis indicated that overall clinical benefit derived from treatment with Nexavar was similar between older and younger patients. Side effects and self-reported health status were also similar between older and younger patients treated with Nexavar.

Genitourinary Cancer Newsletter 490 GU

Because the outcomes were similar for elderly and younger patients, the researchers concluded that Nexavar is an effective and safe treatment for elderly patients with RCC. Elderly patients with advanced RCC may wish to speak with their physician regarding their individual risks and benefits of treatment with Nexavar.

The researchers concluded that treatment with Nexavar improves overall survival, progression-free survival, and some aspects of quality of life among patients with advanced RCC. Finalized results from the TARGETs trial are eagerly awaited.


  1. Affiliates of the Treatment Approaches in Renal Cancer Global Evaluation (TARGETs) Trial. Proceedings from the 2006 Kidney Cancer Symposium. Chicago, Illinois. September 22, 2006.
  2. Eisen T, Oudard S, Szczylik C, et al. Sorafenib for Older Patients With Renal Cell Carcinoma: Subset Analysis From a Randomized Trial. Journal of the National Cancer Institute. 2008: 100;1454-1463