Overall survival and final efficacy and safety results from a Japanese phase II study of axitinib in cytokine-refractory metastatic renal cell carcinoma.
Bottom Line: Here, we report overall survival and updated efficacy and safety results.In an exploratory analysis, median overall survival was found to be significantly longer in patients who had greater decreases in plasma levels of soluble vascular endothelial growth factor receptor-2 during the first cycle of treatment.In conclusion, the present study showed axitinib to be effective, and toxicities with long-term treatment were generally controllable with axitinib dose modification and/or standard medications in these Japanese patients.
Affiliation: Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.Show MeSH
Related in: MedlinePlus
Mentions: Patients were grouped into two categories according to whether or not they had observed maximum DBP ≥90 mmHg during the first cycle of axitinib treatment. Median OS in patients who had maximum DBP ≥90 mmHg (n = 48) was 41.3 months (95% CI, 28.6 to not estimable) compared with 30.8 months (95% CI, 15.1–43.4) in those who had DBP <90 mmHg (n = 16) (HR: DBP <90 vs ≥90 mmHg, 1.864 [95% CI, 0.978–3.553]; P = 0.0542; Fig. 3a). A potential association between OS and change in sVEGFR-2 levels from baseline to cycle 2 day 1 was also investigated. The median OS in patients who had percent change in sVEGFR-2 <median of −33.5% (greater decrease) (n = 31) was 47.0 months (95% CI, 29.5 to not estimable), which was significantly longer than the 34.6 months (95% CI, 15.7–49.9) in those who had ≥median percent change (lesser decrease) (n = 32) (HR: sVEGFR-2 ≥median vs <median % change, 1.994 [95% CI, 1.061–3.748]; P = 0.0289; Fig. 3b).
Affiliation: Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.