Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): A randomised phase 3 trial
The Lancet - Early Online Publication, 11/04/2011
Clinical Article
Rini BI et al. – Axitinib resulted in significantly longer PFS compared with sorafenib. Axitinib is a treatment option for second-line therapy of advanced renal cell carcinoma.
Methods- Included patients coming from 175 sites (hospitals and outpatient clinics) in 22 countries aged 18 years or older with confirmed renal clear-cell carcinoma who progressed despite first-line therapy containing sunitinib, bevacizumab plus interferon-alfa, temsirolimus, or cytokines
- Patients were stratified according to Eastern Cooperative Oncology Group performance status and type of previous treatment and then randomly assigned (1:1) to either axitinib (5 mg twice daily) or sorafenib (400 mg twice daily)
- Axitinib dose increases to 7 mg and then to 10 mg, twice daily, were allowed for those patients without hypertension or adverse reactions above grade 2
- Participants were not masked to study treatment
- Primary endpoint was progression-free survival (PFS) and was assessed by a masked, independent radiology review and analysed by intention to treat
- 723 patients were enrolled and randomly assigned to receive axitinib (n=361) or sorafenib (n=362)
- Median PFS was 6·7 months with axitinib compared to 4·7 months with sorafenib (HR 0·665; 95% CI 0·544—0·812; one-sided p<0·0001)
- Treatment was discontinued because of toxic effects in 14 (4%) of 359 patients treated with axitinib and 29 (8%) of 355 patients treated with sorafenib
- Most common adverse events were diarrhea, hypertension, and fatigue in the axitinib arm, and diarrhoea, palmar-plantar erythrodysaesthesia, and alopecia in the sorafenib arm
