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: Although there was no CR, 33 patients treated with axitinib achieved PR and an additional 28 patients had stable disease ≥8 weeks. The final IRC-assessed ORR was 51.6% (95% CI, 38.7–64.2) (Table 3) and the median duration of response was 11.1 months (95% CI, 8.2–13.7). The investigator-assessed ORR (56.3% [95% CI, 43.3–68.6]) and median duration of response (12.8 months [95% CI, 7.7–17.5]) were generally in agreement with those determined by the IRC. Median PFS per the IRC assessment was 11.0 months (95% CI, 9.2–12.0) (Fig. 1a). Forty-eight patients had objective progression and 16 patients were censored due to treatment discontinuation (n = 8) or administration of new anti-cancer treatment (n = 6) prior to tumor progression, or lack of on-study disease assessments (n = 2). Median PFS per the investigator assessment (12.0 months [95% CI, 9.2–14.8]) was similar to that assessed by the IRC.
Affiliation: Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.