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Xyotax STELLAR trial update

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Cell Therapeutics' Xyotax (paclitaxel poliglumex) showed a statistically significant, 40% improvement in survival compared to vinorelbine for first-line treatment of poor performance status (PS2) non-small cell lung cancer in the firm's STELLAR 4 trial (n=32, p=0.012, hazard ratio 0.6), the firm says. On-study deaths also were significantly reduced compared to vinorelbine or gemcitabine. CTI previously reported that the 381-patient trial showed a non-significant increase in median survival compared to controls receiving either gemcitabine or vinorelbine (1Pharmaceutical Approvals Monthly May 2005, p. 4)...
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