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
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Mentions: At the data cutoff date, 43 patients had died due to disease progression and 21 were censored (20 alive and 1 lost to follow up). Median OS was 37.3 months (95% CI, 28.6–49.9; Fig. 1b). When stratified by baseline MSKCC risk factors, median OS was 33.8 months (95% CI, 14.6–45.3) for the favorable group, 41.3 months (95% CI, 31.8–57.9) for the intermediate group and 17.4 months (95% CI, 14.4 to not estimable) for the poor group (Fig. 2a). The HR for the intermediate νersus the favorable risk group was 0.723 (95% CI, 0.330–1.583; P = 0.3365) in favor of the intermediate risk group, and that for the poor νersus the favorable risk group was 1.320 (95% CI, 0.347–5.016; P = 0.8670) in favor of the favorable risk group. When stratified by baseline ECOG PS, median OS was 41.3 months (95% CI, 31.8–57.9) for PS 0 and 19.4 months (95% CI, 2.8–37.0) for PS 1 (HR: PS 1 vs 0, 3.402 [95% CI, 1.479–7.828; P = 0.0022]; Fig. 2b).
Affiliation: Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.