Complete Study Results Comparing CTI's OPAXIO(TM) With Gemcitabine or Vinorelbine in Performance Status (PS 2) NSCLC Patients Pu
07 7월 2008 - 3:30PM
PR Newswire (US)
Results are basis for CTI's Marketing Authorization Application
currently under review by the EMEA SEATTLE, July 7
/PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq:
CTIC; MTA) today announced the publication of results from its
randomized phase III trial comparing OPAXIO(TM) (paclitaxel
poliglumex, CT-2103) with gemcitabine or vinorelbine for the
treatment of PS 2 (performance status 2) patients with previously
untreated non-small cell lung cancer (NSCLC) in the Journal of
Thoracic Oncology (Volume 3, Number 7, July 2008). Results showed
that overall survival was similar between the two arms (hazard
ratio of 0.95; OPAXIO to control). Patients treated with OPAXIO
required less supportive care including fewer red blood cell
transfusions, hematopoietic growth factors, and opioid analgesics
than those patients receiving either gemcitabine or vinorelbine.
There were relatively few non-hematopoietic grade 3 or 4 toxicities
in either arm. Additionally, patients receiving OPAXIO required
fewer clinic visits due to its administration schedule, once every
three weeks, and short infusion time, compared to patients
receiving either gemcitabine or vinorelbine. The objective of the
study, known as STELLAR 4, was to determine if OPAXIO would improve
overall survival when compared with the standard single-agent
treatments of gemcitabine or vinorelbine in PS 2 patients with
advanced NSCLC who had not previously received chemotherapy. The
trial did not meet the primary endpoint. Secondary objectives of
the study included measuring the efficacy and safety of the
treatments. OPAXIO did demonstrate similar overall survival and a
reduction in the supportive care required by patients. A total of
190 patients with advanced NSCLC were randomized to the comparator
arm; 191 were randomized to the OPAXIO arm with a dosage of 175
mg/m^2, and 96 were randomized to the OPAXIO arm at a dosage of 235
mg/m^2. The OPAXIO dose was reduced to 175 mg/m^2 after 96 patients
had been treated, because the Data Monitoring Committee noted an
increase in deaths associated with neutropenia in patients who had
received the 235 mg/m^2 dosage. The following data refers to those
patients treated at the OPAXIO dose of 175 mg/m^2. The median
number of cycles administered was 4, with a median of 3.5 in the
control arm. A total of 754 cycles of OPAXIO were administered, and
652 cycles were administered in the comparator arm. More patients
in the OPAXIO arm received 6 cycles of treatment (38 percent versus
23 percent; p = 0.002). Progressive disease was the most common
reason for not completing 6 cycles (55 percent in the OPAXIO arm
and 59 percent in the comparator arm). Fewer OPAXIO patients (12
percent) discontinued treatment as a result of adverse events,
compared to 17 percent of patients in the control arm. Survival,
time to progression (TTP), and response rates were similar in both
arms. Median overall survival was 7.3 months in the OPAXIO arm and
6.6 months in the control arm. The estimated 1-year survival rate
was the same in both arms (26 percent), and the approximate 2-year
survival rate was numerically higher in the OPAXIO arm (15 percent)
than the comparator arm (10 percent). There was a lower requirement
for red blood cell transfusions (p = 0.001), erythropoietin use (p
= 0.014), myeloid growth factors (p = 0.032), and new narcotic
analgesics (p = 0.034) in the OPAXIO arm when compared to the
control arm. No significant differences were evident in quality of
life based on FACT-LCS evaluations between the two arms. OPAXIO
patients experienced fewer hematologic (p