XYOTAX in Combination with Carboplatin Produces Major Tumor Response in 98 Percent of First-line Ovarian Cancer Patients
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 preliminary data from a phase
II study of XYOTAX in combination with carboplatin for first-line induction
and single-agent maintenance therapy of advanced stage III/IV ovarian cancer.
Of the 82 patients studied, 80 patients (98 percent) achieved a major tumor
response (CR+PR based on reduction in CA-125 levels) during the induction
phase of the therapy, 85 percent complete response (CR) and 12 percent partial
response (PR). Grade 3/4 side effects at the 175mg/m2 dose in combination with
carboplatin (AUC=6) included neuropathy (23 percent), nausea (15 percent),
vomiting (7 percent), febrile neutropenia (19 percent), anemia (11 percent),
and thrombocytopenia (55 percent). Only three patients (5 percent) required
dose delay due to neutropenia. No grade 4 neuropathy was observed.
"The standard of care for patients with stage III or IV primary ovarian
cancer is tumor debulking surgery followed by a combination of a platinum and
a taxane, most usually paclitaxel/carboplatin therapy, which has been shown to
produce an objective response rate of 80 percent or more based on CA125,"
stated Thomas Herzog, M.D., of Columbia University and principal investigator
for the XYOTAX trial. "After the induction phase of the XYOTAX trial, 98
percent of the patients achieved an objective response based on CA125 levels,
which is quite remarkable. With the high response rate observed at the dose of
175 mg/m2, this study suggests that it may be possible to further dose reduce
to decrease the relatively high incidence of neuropathy without sacrificing
efficacy."
The study was designed to evaluate the toxicity and efficacy of XYOTAX in
combination with carboplatin as an induction therapy followed by single-agent
XYOTAX as monthly maintenance therapy in patients with newly diagnosed stage
III or IV ovarian cancer. XYOTAX was administered over a 10-minute infusion at
doses of 210mg/m2 in 20 patients and 175mg/m2 in 62 patients followed by
carboplatin (AUC6) on day one of each 21-day cycle for up to six cycles. After
six cycles, patients with stable disease or better continued on to receive
single-agent XYOTAX at a dose of 175mg/m2 for up to 12, four-week cycles. To
determine the true incidence of hematologic suppression, weekly blood counts
were drawn following each dose of the XYOTAX/carboplatin combination (day
8,15, 21). Similarly, patients underwent a rigorous examination to determine
and score potential neurosensory changes. Treatment was stopped if the
patient's disease progressed or if intolerable toxicity was observed. Data
presented at ASCO include only the induction phase of the trial. The
maintenance portion of the trial is ongoing.
CTI and the Gynecologic Oncology Group (GOG) are presently evaluating
XYOTAX (135mg/m2) as monthly maintenance in a phase III clinical trial in
ovarian cancer patients who have achieved a complete response following
standard first-line chemotherapy.
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