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Cell Therapeutics: Xyotax and radiation produces major responses in 91% of cancer patients
By E. Janene Geiss
Philadelphia, Aug. 23 - Cell Therapeutics, Inc. said Wednesday that data from a phase 1 study of weekly Xyotax given in combination with radiation for patients with esophageal or gastric cancer showed major tumor responses in 91% of patients in the study.
Twenty-one patients were treated to evaluate the safety of the regimen and to determine the maximum-tolerated dose of Xyotax in combination with 50.4 Gy concurrent radiation, according to a company news release.
Of the 12 patients with loco-regional disease in whom tumor responses were evaluated, four patients, or 33%, achieved a complete response and seven patients, or 58%, achieved a partial response for an overall objective response rate of 91%.
"Xyotax may replace paclitaxel as the most important radiation sensitizer in solid tumors," Howard Safran of Brown University and principal investigator of the study, said in the release.
At the maximum-tolerated dose of 70 mg/m2/week given for six weeks, one patient had grade 3 esophagitis. There were no grade 3/ 4 toxicities at dose levels below 70 mg/m2/week. At the 80 mg/m2 dose level, three of four patients had dose-limiting toxicities including grade 3 esophagitis/gastritis (2 patients), grade 3 dehydration (1 patient), and grade 4 neutropenia (1 patient), officials said.
Except for the four patients who experienced dose-limiting toxicity, all patients completed the full six weeks of concurrent chemoradiation.
Results of the study were published in the August edition of the American Journal of Clinical Oncology.
Cell Therapeutics is a Seattle biopharmaceutical company.
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