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Premenopausal Women with Non-Small Cell Lung Cancer Have


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Improved Survival with Xyotax™


Two large clinical trials, STELLAR 3 and STELLAR 4, suggest that premenopausal women with advanced non-small cell lung cancer have better survival after treatment with the chemotherapy drug Xyotax™ (paclitaxel poliglumex) than after treatment with other standard chemotherapy regimens. These results were presented at the 2005 annual Chemotherapy Foundation Symposium.

Lung cancer remains the leading cause of cancer deaths in the U.S. and Europe. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 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. Unfortunately, this chemotherapy regimen is associated with significant side effects, and some patients have a difficult time tolerating therapy. Research continues to evaluate ways to reduce side effects and improve survival of patients with NSCLC.

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 component of paclitaxel bound to water-soluble molecules. This formulation allows for the delivery of higher levels of the active drug to cancer cells, while sparing healthy cells from side effects.

Two clinical trials, referred to as the STELLAR 3 and STELLAR 4 trials, directly compared Xyotax to other chemotherapy regimens in the treatment of advanced non-small cell lung cancer. STELLAR3 compared Xyotax plus carboplatin to paclitaxel plus carboplatin, and STELLAR4 compared Xyotax as a single agent to gemcitabine plus vinorelbine. Neither of these trials reported overall differences in survival between treatment groups, but analyses of subgroups of patients suggested that some patients (such as women with high estrogen levels) may benefit from regimens that include Xyotax. To conduct additional subgroup analyses, researchers combined the data from the two trials.

The combined results suggest that premenopausal women may be most likely to benefit from treatment regimens that include Xyotax:

Among all women, median overall survival was longer among those treated with Xyotax (9.4 months) than among those treated with other chemotherapy regimens (7.7 months).

Women under the age of 55 years (considered premenopausal) had a more pronounced improvement in survival after treatment with Xyotax. Premenopausal women in the Xyotax treatment groups survived for a median of 10.0 months, compared to 5.2 months among women in the other treatment groups.

Among men, there was no difference in survival between treatment groups.

Xyotax produced fewer toxic effects than other chemotherapy regimens.

A clinical trial in underway to further explore the role of Xyotax among women with advanced NSCLC.

Reference: Socinski M, et al. Xyotax in NSCLC and Other Solid Tumors. Proceedings from the 2005 annual Chemotherapy Foundation Symposium. Presented November 4, 2005. New York, NY.

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