Tests in patients with non-small cell lung cancer (NSCLC) have shown that treatment with Opaxio does not significantly improve overall survival rates compared with gemcitabine or vinorelbine.
The main objective of the randomised phase III trial was to determine whether Opaxio (paclitaxel poliglumex, CT-2103) would improve survival rates in performance status 2 (PS2) patients with advanced NSCLC who had not previously received chemotherapy.
However, patients treated with Opaxio did require less supportive care including fewer red blood cell transfusions, hematopoietic growth factors, and opioid analgesics than those patients receiving either gemcitabine or vinorelbine.
Additionally, patients receiving Opaxio in the trial, conducted at 83 centres in 10 countries, required fewer clinic visits and short infusion time compared with patients receiving either of the standard single-agent treatments.
A total of 190 patients with advanced NSCLC were randomised to the comparator arm; 191 were randomised to the Opaxio arm with a dosage of 175mg, and 96 were randomised to the Opaxio arm at a dosage of 235mg. The Opaxio dose was reduced to 175mg 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 235mg dosage.
The results of the trial were reported by Mary O’Brien of the Royal Marsden Hospital and the Kent Cancer Centre in Surrey.
Copyright PA Business 2008