論文

査読有り 国際誌
2014年12月

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

Cancer science
  • Masatoshi Eto
  • ,
  • Hirotsugu Uemura
  • ,
  • Yoshihiko Tomita
  • ,
  • Hiroomi Kanayama
  • ,
  • Nobuo Shinohara
  • ,
  • Yoichi Kamei
  • ,
  • Yosuke Fujii
  • ,
  • Yoshiko Umeyama
  • ,
  • Seiichiro Ozono
  • ,
  • Seiji Naito
  • ,
  • Hideyuki Akaza

105
12
開始ページ
1576
終了ページ
83
記述言語
英語
掲載種別
DOI
10.1111/cas.12546

In an open-label, multicenter phase II study of Japanese patients with cytokine-refractory metastatic renal cell carcinoma, axitinib showed substantial antitumor activity with an acceptable safety profile. Here, we report overall survival and updated efficacy and safety results. Sixty-four Japanese patients with metastatic renal cell carcinoma following prior therapy with cytokines were treated with axitinib at a starting dose of 5 mg b.i.d. Following median treatment duration of 14.2 months, median overall survival was 37.3 months (95% CI, 28.6-49.9). The objective response rate, the primary endpoint of the study, was 51.6% (95% CI, 38.7-64.2); the median duration of response, 11.1 months (95% CI, 8.2-13.7); and the median progression-free survival was 11.0 months (95% CI, 9.2-12.0), assessed by the independent review committee. Common treatment-related all-grade adverse events were hypertension (88%), hand-foot syndrome (75%), diarrhea (66%), proteinuria (63%), fatigue (55%) and dysphonia (53%). 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. Some frequently reported adverse events warrant close monitoring and management. Changes in the plasma levels of soluble vascular endothelial growth factor receptor-2 may be used as a prognostic factor for overall survival in metastatic renal cell carcinoma following axitinib treatment. This study is registered at ClinicalTrial.gov (identifier NCT00569946).

リンク情報
DOI
https://doi.org/10.1111/cas.12546
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/25283266
PubMed Central
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4317969

エクスポート
BibTeX RIS