Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: overall survival analysis and updated results from a randomised phase 3 trial

摘要: Summary Background In a phase 3 trial comparing the efficacy and safety of axitinib versus sorafenib as second-line treatment for metastatic renal cell carcinoma, patients given had longer progression-free survival (PFS). Here, we report overall updated efficacy, quality life, results. Methods Eligible clear progressive disease after one approved systemic treatment, an Eastern Cooperative Oncology Group performance status (ECOG PS) 0–1. 723 were stratified by ECOG PS previous randomly allocated (1:1) to receive (5 mg twice daily; n=361) or (400 n=362). The primary endpoint was PFS assessed masked, independent radiology review committee. We patient-reported outcomes using validated questionnaires. Baseline characteristics development hypertension on studied prognostic factors. Efficacy in intention-to-treat population, who received at least dose study drug. This ongoing is registered ClinicalTrials.gov, number NCT00678392. Findings Median 20·1 months (95% CI 16·7–23·4) with 19·2 (17·5–22·3) (hazard ratio [HR] 0·969, 95% 0·800–1·174; one-sided p=0·3744). investigator-assessed 8·3 6·7–9·2) 5·7 (4·7–6·5) (HR 0·656, 0·552–0·779; p Interpretation Although survival, secondary study, did not differ between two groups, remained group compared group. These results establish option carcinoma. Funding Pfizer Inc.