XYOTAX in Combination with Radiation Produces Major Tumor Responses in 81 Percent of Patients with Esophageal or Gastric Cancer
ORLANDO, Fla., May 14 /PRNewswire-FirstCall/ -- At the 2005 Annual Meeting
of the American Society of Clinical Oncology (ASCO), Cell Therapeutics, Inc.
(CTI) (Nasdaq and Nuovo Mercato: CTIC) reported initial data from a phase I
study of weekly XYOTAX given in combination with radiation for patients with
esophageal and gastric cancer. Of the 11 patients with loco-regional disease
evaluable for tumor response, four patients (36 percent) achieved a complete
disappearance of their tumor or complete response and five patients (45
percent) achieved a 50 percent or greater shrinkage of their cancer, a partial
response, for an overall objective response rate of 81 percent.
No grade 3/4 toxicities were observed at the maximum tolerated dose of 70
mg/m2/week given for six weeks. At the 80mg/m2 dose level two patients had
grade 3 esophagitis and one patient had grade 4 neutropenia.
"Preclinical data suggest that XYOTAX is a more effective radiation
sensitizer than paclitaxel. XYOTAX has a radiation enhancement factor of 4 to
8 versus 1.5 to 2 for paclitaxel. This study has defined the optimal dose of
XYOTAX with radiation and shown that XYOTAX is an important radiation
sensitizer for esophageal and gastric cancer with impressive anti-tumor
activity," stated Howard Safran, M.D., of Brown University and principal
investigator on the study. "The side effect profile, the 10-minute infusion
time, and the lack of hair loss along with these encouraging response rates
make us eager to broaden our clinical experience with this novel agent."
The objective of the study was to determine the maximum tolerated dose of
weekly XYOTAX in combination with 50.4 Gy concurrent radiation in patients
with esophageal or gastric cancer. Twenty patients were treated with five dose
levels of XYOTAX of 40 mg/m2 (three patients), 50 mg/m2 (four patients), 60
mg/m2 (four patients), 70 mg/m2 (five patients) and 80 mg/m2 (four patients).
Sixteen patients had esophageal cancer and four had gastric cancer. |
