Researchers affiliated with the international study, AVOREN, have reported that the addition of Avastin® (bevacizumab) to interferon improves progression-free survival when used as initial therapy among patients with metastatic renal cell carcinoma(mRCC). The details of this randomized trial were presented at a plenary session of the 2007 annual meeting of the American Society of Clinical Oncology (ASCO) in June.

For more than two decades the main treatment of mRCC has been interferon or interleukin. These two agents are able to produce complete remissions in only a small fraction of patients. More recently, other biologic agents such as Sutent® (sunitinib), Nexavar® (sorafenib), Torisel™ (temsirolimus) and laptinib 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 which has shown some activity in early studies.

Researchers from France recently conducted a Phase III clinical trial in which Avastin plus interferon was compared with interferon alone in the treatment of metastatic RCC. This trial included approximately 600 patients who had not received prior therapy.

• 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.
• Responses occurred in 31% of patients treated with Avastin/interferon, compared with only 13% for those treated with interferon alone.
• The most common side effects associated with treatment with Avastin were bleeding, high blood pressure, and protein in the urine.
• There was a trend for improved survival (0.06) in the Avastin group.

Comments: These authors concluded that Avastin improves progression-free survival and may improve overall survival in newly treated patients with mRCC. However, the relative role of Avastin in relation to recently approved drugs such as Torisel and Sutent is not clear. The apparent increased efficacy of Avastin plus Tarceva would lead to study of other combinations of biologic agents.

Reference: Escudier B, Koralewski P, Piuzanska A, et al. A randomized, controlled, double-blind Phase III study (AVOREN) of bevacizumab/interferon/a2a vs placebo/interferon-a2a as first-line therapy in metastatic renal cell carcinoma. Proceedings from the American Society of Clinical Onclology. Chicago, IL. 2007 Abstract # 3.

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