Professor Olivier Rixe of the University of Paris, France, and colleagues assessed the activity and safety of axitinib in a group of patients with metastatic renal-cell cancer who had failed to respond to cytokine-based treatments.
The researchers enrolled 52 patients between October 2003 and April 2004. Each patient had at least one measurable lesion that could be targeted and was given an oral dose of axitinib starting at 5 mg twice a day.
Rixe and colleagues assessed the percentage of patients who responded either completely or partially using the Response Evaluation Criteria In Solid Tumors (RECIST) method, as well as how long they took to respond, the time to progression, overall survival, safety and other measures.
In an intention to treat analysis, the study produced the following results:
Of the 52 patients, 2 responded completely and 21 partially.
This equated to an objective response rate of 44.2 per cent.
The median response rate was 23.0 months (range 4.2 to 29.8 months).
But 12 of 23 initial responders progressed with response durations of 4.2 to 26.5 months.
Also, 22 patients showed stable disease for more than 8 weeks, with 13 of them for 24 weeks or more.
4 patients had early disease progression, 3 had missing response data.
Median time to progression was 15.7 months (range 0.03 to 31.5 months).
Median overall survival was 29