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Complete Study Results Comparing CTI's OPAXIO(TM) With Gemcitabine or Vinorelbine in Performance Status (PS 2) NSCLC Patients Published in Journal of Thoracic Oncology
Date:7/6/2008

atients 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 <0.001) and gastrointestinal (p = 0.004) adverse events. Neuropathy occurred more frequently in the OPAXIO arm compared
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SOURCE Cell Therapeutics, Inc.
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