The evidence for axitinib is based on a multicentre, randomised phase III study (AXIS).r A total of 723 patients with renal clear cell carcinoma who had progressed following first-line therapy with sunitinib, bevacizumab plus interferon-alpha, temsirolimus or cytokines were enrolled, and randomly assigned to axitinib (n=361) or sorafenib (n=362).
The primary-endpoint was progression free survival with secondary end-points being overall survival, objective response rate, duration of response and time to deterioration- a composite end-point consisting of time to death, disease progression or worsening of symptoms.
The median investigator assessed progression free survival was 8.3 months (95% CI 6.7 - 9.2 months) with axitinib and 5.7 months (95% CI 4.7 - 6.5 months) with sorafenib. The hazard ratio was 0.656, 95% CI was 0.552-0.779 with a one sided p<0.0001.r
The median overall survival was 20.1 months with axitinib and 19.2 months with sorafenib, which was not statistically significant. The objective overall response rate was 23% for axitinib and 12% for sorafenib.r There was no difference in patient reported outcomes.r
|Time to progression
Kaplan Meier curves for median PFS:r
© Lancet 2011
Toxicity related treatment discontinuation occurred in 14 (4%) of 359 patients treated with axitinib and 29 (8%) of 355 patients treated with sorafenib.r The most common grade 3 or higher treatment-related adverse events were hypertension, diarrhoea and fatigue in the axitinib group and hand-foot syndrome, hypertension, and diarrhoea in the sorafenib group.r
Treatment related adverse eventsr
© Lancet Oncol 2013