Efficacy and safety of axitinib in combination with gemcitabine in advanced pancreatic cancer: Subgroup analyses by region, including Japan, from the global randomized Phase III trial

Tatsuya Ioka, Takuji Okusaka, Shinichi Ohkawa, Narikazu Boku, Akira Sawaki, Yosuke Fujii, Yoichi Kamei, Satori Takahashi, Katsushi Namazu, Yoshiko Umeyama, Paul Bycott, Junji Furuse

研究成果: ジャーナルへの寄稿学術論文査読

33 被引用数 (Scopus)

抄録

Objective: Axitinib is a potent and selective inhibitor of vascular endothelial growth factor receptors 1-3. This analysis compared efficacy and safety of axitinib plus gemcitabine in patients with advanced pancreatic cancer from Japan, North America and the European Union, enrolled in a randomized Phase III study. Methods: Patients (n = 632), stratified by disease extent, were randomly assigned (1:1) to receive axitinib/gemcitabine or placebo/gemcitabine. Axitinib was administered at a starting dose of 5 mg orally twice daily and gemcitabine at 1000 mg/m2 once weekly for 3 weeks in 4 week cycles. Primary endpoint was overall survival. Results: Among Japanese patients, median overall survival was not estimable (95% confidence interval, 7.4 months-not estimable) with axitinib/gemcitabine (n = 58) and 9.9 months (95% confidence interval, 7.4-10.5) with placebo/gemcitabine (n = 56) (hazard ratio 1.093 [95% confidence interval, 0.525-2.274]). Median survival follow-up (range) was 5.1 months (0.02-12.3) with axitinib/gemcitabine vs. 5.4 months (1.8-10.5) with placebo/gemcitabine. Similarly, no difference was detected in overall survival between axitinib/gemcitabine and placebo/gemcitabine in patients from North America or the European Union. Common adverse events with axitinib/gemcitabine in Japanese patientswere fatigue, anorexia, dysphonia, nausea and decreased platelet count. Axitinib safety profile was generally similar in patients from the three regions, although there were differences in incidence of some adverse events. An exploratory analysis did not show any correlation between axitinib/gemcitabine-related hypertension and overall survival. Conclusions: Axitinib/gemcitabine, while tolerated, did not provide survival benefit over gemcitabine alone in patients with advanced pancreatic cancer from Japan or other regions.

本文言語英語
ページ(範囲)439-448
ページ数10
ジャーナルJapanese journal of clinical oncology
45
5
DOI
出版ステータス出版済み - 01-05-2015

All Science Journal Classification (ASJC) codes

  • 腫瘍学
  • 放射線学、核医学およびイメージング
  • 癌研究

フィンガープリント

「Efficacy and safety of axitinib in combination with gemcitabine in advanced pancreatic cancer: Subgroup analyses by region, including Japan, from the global randomized Phase III trial」の研究トピックを掘り下げます。これらがまとまってユニークなフィンガープリントを構成します。

引用スタイル