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

Research output: Contribution to journalArticlepeer-review

25 Citations (Scopus)

Abstract

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.

Original languageEnglish
Article numberhyv011
Pages (from-to)439-448
Number of pages10
JournalJapanese journal of clinical oncology
Volume45
Issue number5
DOIs
Publication statusPublished - 01-05-2015
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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