Tarceva™ Plus Avastin® Highly Active in Advanced Kidney Cancer

Tarceva™ Plus Avastin® Highly Active in Advanced Kidney Cancer

According to results presented at the 40th annual meeting of the American Society of Clinical Oncology, the treatment combination consisting of two targeted therapeutic agents, Tarceva™ plus Avastin® provides some of the highest ever reported anti-cancer activity in the treatment of advanced kidney cancer.

The kidneys are a pair of bean-shaped organs located on each side of the spine. The kidneys filter the blood and eliminate waste in the urine through a complex system of filtration tubules. All of the blood in the body passes through the kidneys approximately 20 times an hour. Renal cell cancer (RCC) is an uncommon form of cancer that is most often characterized by the presence of cancer cells in the lining of the filtration tubules of the kidney. Metastatic RCC refers to cancer that has spread outside the kidney to several and/or distant sites in the body. Proleukin® is a biologic agent that enhances the immune system to help fight cancer, and is the only agent approved for the treatment of metastatic RCC.

Targeted therapy, or treatment that has been designed to target a specific component of a cell, is becoming part of standard therapeutic approaches for some types of cancer. Recently, the FDA has approved targeted therapeutic agents such as Iressa®, Gleevec®, Herceptin®, Avastin® and Erbitux® which have demonstrated a therapeutic benefit with relatively mild side effects in patients. Newer targeted agents are progressing through clinical trials and researchers continue to evaluate these agents in various types of cancers, either alone or in combination with other drugs or treatment modalities. One such promising agent that has recently completed the last phase of clinical trials prior to FDA approval is Tarceva™ (erlotinib). Results presented at the 40th annual ASCO meeting indicated that Tarceva™ improves survival compared to placebo (inactive substitute) in patients with recurrent non-small cell lung cancer. Tarceva™ is targeted against the epidermal growth factor receptor (EGFR) pathway, which is involved in the replication of cells. By blocking the action of the EGFR, Tarceva™ reduces or prevents the replication of cancer cells. An additional targeted agent that was recently approved for the treatment of colorectal cancer, Avastin® (bevacizumab), is targeted against the vascular endothelial growth factor (VEGF), which is involved in the spread of cancer. Researchers have been evaluating the effectiveness of the combination of Tarceva™ and Avastin® in several types of cancer, in the hopes of preventing growth or spread through different mechanisms of action.

Researchers from the Sarah Cannon Center in Tennesse recently conducted a clinical trial to evaluate Tarceva™ and Avastin® in the treatment of advanced RCC. This trial included 58 patients with recurrent RCC; all patients had surgery to remove their kidney (nephrectomy). Following treatment with Tarceva™/Avastin®, 87% of patients achieved a clinical benefit, with 21% of patients achieving at least a 50% reduction in their cancer size and 66% achieving either a disease stabilization of a minor anti-cancer response. Only 13% of patients had a progression of their cancer while on treatment. At one year, 81% of patients were still alive. Side effects caused by treatment were generally mild, with the most common side effects being high blood pressure, diarrhea, rash, nausea and vomiting.

The researchers concluded that the combination of Tarceva™ and Avastin® achieves high rates of disease responses or stabilization, resulting in high levels of survival at one year in recurrent RCC with manageable side effects. The researchers added that these rates are some of the highest rates ever achieved in patients with this stage of RCC. Further evaluation of Tarceva™ and Avastin® are warranted, including a comparison against standard therapy. Patients with recurrent RCC may wish to speak with their physician about the risks and benefits of participating in a clinical trial further evaluating Tarceva™/Avastin® or other promising therapeutic approaches.

Reference: Hainsworth, J, Sosman J, Spigel D , et al. Phase II trial of bevacizumab and erlotinib in patients with metastatic renal carcinoma (RCC). Proceedings from the 40th annual meeting of the American Society of Clinical Oncology. New Orleans, LA. June 2004. Abstract #4502.

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