According to results recently presented at the 2005 annual meeting of the American Society of Clinical Oncology, an new drug called Xinlay (atrasentan) that is not yet FDA approved delays cancer progression and bone pain in patients diagnosed with hormone-refractory prostate cancer. Xinlay represents a novel therapeutic approach to patients with this stage of prostate cancer.

The prostate is a gland of the male reproductive system that is responsible for producing some of the fluid that transports the sperm during male ejaculation. Prostate cancer is a disease in which cancer cells form in the tissues of the prostate. It is the most common form of cancer diagnosed in men, after skin cancer. The outlook is good for men diagnosed with prostate cancer as over the past 20 years overall survival rates for all stages of prostate cancer have improved dramatically. Current treatment options for prostate cancer include watchful waiting, surgery, chemotherapy, radiation, or hormonal therapy. Hormonal therapy is designed to lower the presence or block the effects of testosterone that can stimulate the growth of hormone dependent types of prostate cancer. Some types of prostate cancers can become resistant to hormonal therapy, requiring a different approach. This is known as hormone refractory or resistant prostate cancer.

Previous trials have indicated positive results with Xinlay in terms of delaying cancer progression and improving quality of life in men with hormone resistant prostate cancer. Xinlay is an agent that can be taken orally, and disrupts pathways that are involved in replication of cancer cells. Xinlay tends to be much easier tolerated than chemotherapy agents.

Researchers in this recent study reviewed previous studies that evaluated the effects of Xinlay in terms of time to disease progression. These studies included over 1,000 men with hormone resistant prostate cancer who were randomized to receive either Xinlay or a placebo (inactive substitute). Overall, Xinlay provided significant improvements in time to disease progression and bone pain over placebo. After 3 months, the probability of remaining progression free was improved by 10% among the patients treated with Xinlay. After 6 months, the probability of remaining progression free had improved to 22% among the patients treated with Xinlay, when compared with the placebo treatment group. Additionally, patients treated with Xinlay were 18% less likely to experience bone pain than those patients who were treated with a placebo.

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Researchers concluded that Xinlay is a promising new drug for the treatment of metastatic hormone refractory prostate cancer, as it significantly delayed the time to cancer progression, as well as decreased the frequency of bone pain. The Food and Drug Administration will be reviewing these study results for possible approval of Xinlay for the treatment of prostate cancer.

Reference: Vogelzang N, Nelson J, Schulman C, et al. Meta-analysis of clinical trials of atrasentan 10 mg in metastatic hormone refractory prostate cancer. Proceedings from the 2005 annual meeting of the American Society of Clinical Oncology. Orlando FL. 2005; Abstract #4563.

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