According to the results of a Phase III clinical trial published in The Lancet, the combination of Avastin® (bevacizumab) with interferon results in significantly better progression-free survival than interferon alone in the initial treatment of metastatic kidney cancer. These results were previously presented at the 2007 annual meeting of the American Society of Clinical Oncology.
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 cancer involving these tubules of the kidney. Metastatic RCC (MRCC) refers to cancer that has spread from the kidney to distant sites in the body.
For more than two decades the main treatment of MRCC has been interferon or interleukin, which are agents that stimulate the immune system to help fight cancer. These two agents are able to produce complete disappearance of cancer (remissions) in only a small fraction of patients. More recently, other biologic agents such as Sutent® (sunitinib) and Nexavar® (sorafenib) have demonstrated significant anticancer activity in the treatment of MRCC. Researchers continue to evaluate novel therapeutic strategies to improve outcomes for patients with MRCC, including the use of Avastin, an agent that starves cancer cells of blood and nutrients.
To evaluate the combination of Avastin and interferon alfa-2a for the initial treatment of MRCC, researchers in Europe conducted a Phase III clinical trial. The trial enrolled approximately 600 patients who had not received prior therapy; one group was treated with Avastin plus interferon while the other group was treated with interferon only.
- Patients treated with Avastin/interferon had a median progression-free survival of 10.2 months, compared with 5.4 months for those treated with interferon alone.
- Anticancer responses occurred in 31% of patients treated with Avastin/interferon, compared with only 13% for those treated with interferon alone.
- Serious adverse effects of treatment occurred among 29% of patients treated with Avastin/interferon and 16% of patients treated with interferon alone.
The researchers concluded that the addition of Avastin to interferon significantly improves progression-free survival compared with interferon alone in the treatment of metastatic RCC. Although Avastin is not currently approved for the treatment of RCC, Phase III trials, such as this one, are the last phases prior to FDA review.
Reference: Escudier B, Pluzanska A, Koralewski P et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind Phase III trial. Lancet. 2007;270:2103-11.