According to results from a recently conducted trial, the chemotherapy agent Xyotax™ results in reduced side effects and increased patient convenience in terms of administration compared to paclitaxel (Taxol®) in patients with advanced non-small cell lung cancer.
Lung cancer remains the leading cause of cancer deaths in the United States and Europe. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, comprising approximately 75%-80% of all lung cancers. Advanced NSCLC refers to cancer that has spread from its site of origin to distant and/or several sites in the body. The mainstay of treatment for advanced NSCLC is chemotherapy or targeted therapy. One of the most commonly used chemotherapy combinations includes paclitaxel and carboplatin (Paraplatin®). Unfortunately, this chemotherapy regimen is associated with significant side effects and patients who have concomitant health or medical problems, or those who are elderly may have a difficult time tolerating therapy. Research continues to evaluate ways to reduce side effects of agents and/or improve the duration of survival for patients with NSCLC.
One reason that paclitaxel is associated with side effects that make it difficult for many patients to tolerate is that its formulation includes agents that allow for the proper storage and administration of the drug. It is these agents that are responsible for the development of many side effects associated with paclitaxel. Often, administration of paclitaxel requires steroids and antihistamines to reduce side effects or allergic reactions to the agent. Xyotax™ is a new formulation of paclitaxel that is designed to reduce side effects while maintaining the effectiveness of the drug. Xyotax™ includes the active components of paclitaxel that are bound to water-soluble molecules, which are more easily tolerated by the body. In addition, the need for steroids or antihistamines are not necessary with Xyotax™, as they are with paclitaxel.
A recent multi-institutional clinical trial was conducted to directly compare Xyotax™ to paclitaxel in patients with NSCLC. The trial included 400 patients with NSCLC who had a poor performance status (a measure of the ability of a patient to perform daily activities). Patients were treated with either Xyotax™/carboplatin or paclitaxel/carboplatin. The Xyotax™ regimen was administered over just 10 minutes. Overall, preliminary data suggest that survival times were similar between the two treatment groups. However, patients treated with Xyotax™ had considerably reduced side effects compared to those treated with paclitaxel, including a reduction in hair loss, muscle and joint pain, heart symptoms, and side effects affecting the nervous system. Further results including survival and responses rates will be presented at the 2005 annual meeting of the American Society of Clinical Oncology (ASCO) in May 2005.
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The researchers concluded that the chemotherapy agent Xyotax™ is at least as effective as paclitaxel when used in combination with carboplatin, with a reduction in several side effects when used in the treatment of NSCLC. Furthermore, Xyotax™ only requires a 10-minute infusion and no pre-medication requirements. This trial was the last phase of clinical trials in the process prior to FDA review.
Reference: Cell Therapeutics Incorporated (CTI). STELLAR 3 Pivotal Trial Shows XYOTAX(TM) Reduces Side Effects of Paclitaxel With Equivalent Efficacy in the Treatment of Non-Small Cell Lung Cancer (NSCLC) Patients. Available at: http://www.cticseattle.com/investors_news.htm. Accessed March 2005.
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