Efficacy and safety of febuxostat for prevention of tumor lysis syndrome in patients with malignant tumors receiving chemotherapy: a phase III, randomized, multi-center trial comparing febuxostat and allopurinol

Kazuo Tamura, Yasukazu Kawai, Toru Kiguchi, Masataka Okamoto, Masahiko Kaneko, Makoto Maemondo, Kenichi Gemba, Katsumichi Fujimaki, Keita Kirito, Tetsuya Goto, Tomoaki Fujisaki, Kenji Takeda, Akihiro Nakajima, Takanori Ueda

研究成果: Article査読

30 被引用数 (Scopus)

抄録

Background: Control of serum uric acid (sUA) levels is very important during chemotherapy in patients with malignant tumors, as the risks of tumor lysis syndrome (TLS) and renal events are increased with increasing levels of sUA. We investigated the efficacy and safety of febuxostat, a potent non-purine xanthine oxidase inhibitor, compared with allopurinol for prevention of hyperuricemia in patients with malignant tumors, including solid tumors, receiving chemotherapy in Japan. Methods: An allopurinol-controlled multicenter, open-label, randomized, parallel-group comparative study was carried out. Patients with malignant tumors receiving chemotherapy, who had an intermediate risk of TLS or a high risk of TLS and were not scheduled to be treated with rasburicase, were enrolled and then randomized to febuxostat (60 mg/day) or allopurinol (300 or 200 mg/day). All patients started to take the study drug 24 h before chemotherapy. The primary objective was to confirm the non-inferiority of febuxostat to allopurinol based on the area under the curve (AUC) of sUA for a 6-day treatment period. Results: Forty-nine and 51 patients took febuxostat and allopurinol, respectively. sUA decreased over time after initiation of study treatment. The least squares mean difference of the AUC of sUA between the treatment groups was −33.61 mg h/dL, and the 95 % confidence interval was −70.67 to 3.45, demonstrating the non-inferiority of febuxostat to allopurinol. No differences were noted in safety outcomes between the treatment groups. Conclusion: Febuxostat demonstrated an efficacy and safety similar to allopurinol in patients with malignant tumors receiving chemotherapy. Trial registry: http://www.clinicaltrials.jp; Identifier: JapicCTI-132398.

本文言語English
ページ(範囲)996-1003
ページ数8
ジャーナルInternational Journal of Clinical Oncology
21
5
DOI
出版ステータスPublished - 01-10-2016

All Science Journal Classification (ASJC) codes

  • 外科
  • 血液学
  • 腫瘍学

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