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Home » Xyotax Produces Equivalent Survival, Reduces Side Effects in Lung Cancer
Xyotax Produces Equivalent Survival, Reduces Side Effects in Lung Cancer
Cell Therapeutics announced the results of its Phase III clinical studies of Xyotax in non-small cell lung cancer (NSCLC), known as STELLAR 2 and 4.
The studies were designed to determine if Xyotax could increase the overall survival of patients while reducing serious side effects associated with the treatment of first-line or second-line NSCLC. Both trials demonstrated equivalent survival with significant reductions in serious side effects when compared to either docetaxel or gemcitabine/vinorelbine; although they missed their primary endpoints of superior overall survival.
Xyotax was administered in a convenient 10-minute infusion without the requirement for steroids and other premedications. STELLAR 4, a Phase III clinical trial of Xyotax versus either gemcitabine or vinorelbine for the first-line treatment of poor performance status patients with NSCLC, resulted in a median survival of 7.3 months and two-year survival of 15 percent for patients on the Xyotax arm compared to 6.6 months and 10 percent for the control arm.
Significantly more patients completed a full six courses of therapy on the Xyotax arm compared to the control arm. Side effects were comparable on both arms, except for a significant reduction in all cardiac toxicities, gastrointestinal side effects, nausea and vomiting. Xyotax patients also had a significant reduction in severe hematologic toxicities including anemia, neutropenia and thrombocytopenia. Hair loss was uncommon on both arms. Grade 3/4 neuropathy was observed more frequently on the Xyotax arm.
KEYWORDS Drug Pipeline Alert
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