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Overall survival and final efficacy and safety results from a Japanese phase II study of axitinib in cytokine-refractory metastatic renal cell carcinoma.

Eto M, Uemura H, Tomita Y, Kanayama H, Shinohara N, Kamei Y, Fujii Y, Umeyama Y, Ozono S, Naito S, Akaza H, Japan Axitinib Phase II Study Gro - Cancer Sci. (2014)

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.

View Article: PubMed Central - PubMed

Affiliation: Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.

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Related in: MedlinePlus

Kaplan–Meier estimates of overall survival by (a) maximum diastolic blood pressure from initiation of treatment to cycle 2 day 1 and (b) percent change in sVEGFR-2 from baseline to cycle 2 day 1. *Median % change = −33.5. CI, confidence interval; HR, hazard ratio; NE, not estimable; OS, overall survival; sVEGFR, soluble vascular endothelial growth factor receptor.
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fig03: Kaplan–Meier estimates of overall survival by (a) maximum diastolic blood pressure from initiation of treatment to cycle 2 day 1 and (b) percent change in sVEGFR-2 from baseline to cycle 2 day 1. *Median % change = −33.5. CI, confidence interval; HR, hazard ratio; NE, not estimable; OS, overall survival; sVEGFR, soluble vascular endothelial growth factor receptor.

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).


Overall survival and final efficacy and safety results from a Japanese phase II study of axitinib in cytokine-refractory metastatic renal cell carcinoma.

Eto M, Uemura H, Tomita Y, Kanayama H, Shinohara N, Kamei Y, Fujii Y, Umeyama Y, Ozono S, Naito S, Akaza H, Japan Axitinib Phase II Study Gro - Cancer Sci. (2014)

Kaplan–Meier estimates of overall survival by (a) maximum diastolic blood pressure from initiation of treatment to cycle 2 day 1 and (b) percent change in sVEGFR-2 from baseline to cycle 2 day 1. *Median % change = −33.5. CI, confidence interval; HR, hazard ratio; NE, not estimable; OS, overall survival; sVEGFR, soluble vascular endothelial growth factor receptor.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4317969&req=5

fig03: Kaplan–Meier estimates of overall survival by (a) maximum diastolic blood pressure from initiation of treatment to cycle 2 day 1 and (b) percent change in sVEGFR-2 from baseline to cycle 2 day 1. *Median % change = −33.5. CI, confidence interval; HR, hazard ratio; NE, not estimable; OS, overall survival; sVEGFR, soluble vascular endothelial growth factor receptor.
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).

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.

View Article: PubMed Central - PubMed

Affiliation: Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.

Show MeSH
Related in: MedlinePlus