内容紹介
Summary
Objective: The clinical features(CF), laboratory data, disease transformation pattern and drug metabolism in essential thrombocythemia(ET)differ between Japan and Western countries. The CF of ET in clinical practice(CP)are more diverse than in prospective clinical studies. We should conduct retrospective analyses in CP. The present study was aimed at evaluating the efficacy, safety and tolerability of anagrelide(ANA)monotherapy and combined ANA plus hydroxycarbamide(HC)in Japanese ET. Patients and methods: We have a total of 35 cases. Sixteen patients received ANA monotherapy, 10 received ANA plus HC, and 9 received ANA plus other drugs. Results: Comparison among three groups revealed the absence of differences in response rate(platelet count ≤60×104/μL, platelet count ≤40×104/μL)(43.8%, 6.3% vs. 50.0%, 10.0% vs. 44.4%, 11.1%), treatment continuation rate(81.3% vs. 40.0% vs. 55.6%), median daily dose of ANA(1.00 mg in all three groups)or median treatment period(days)(259 vs. 198.5 vs. 161.0), the treatment continuation rate tended to be lower in the combined ANA plus HC. The incidence of all adverse events(AEs)was higher in the ANA monotherapy(45.7%)than ANA plus HC(28.6%)or ANA plus other drugs(25.7%), the AEs were mild in all groups. Conclusion: The tolerability of ANA monotherapy, ANA plus HC, and ANA plus other drugs were good.
要旨
目的: 日本と欧米では,essential thrombocythemia(ET)の臨床像や検査データ,disease transformation,薬剤の代謝が違う。また,前向き臨床試験に比較して実臨床での臨床像は多彩である。そのため実臨床での後方視的検討が必要であると考えられる。本報告の目的は,anagrelide(ANA)単剤およびANAとhydroxycarbamide(HC)の併用療法の有効性,安全性,認容性を日本人ET患者の実臨床で検討することである。患者と方法: 当施設においてANAが投与された35例。ANA単剤が16例(45.7%),ANAとHCの併用が10例(28.6%),ANAとその他の併用が9例(25.7%)であった。結果: 3群間での比較では,血小板60×10 4/μL以下と40×10 4/μL以下の奏効率(43.8%,6.3% vs 50.0%,10.0% vs 44.4%,11.1%),治療継続率(81.3% vs 40.0% vs 55.6%),ANA 1日投与量中央値(3群間すべてで1.00 mg),投与期間中央値(259日vs 198.5日vs 161.0日)に有意差を認めなかったが,HC併用で継続率が不良の傾向を示した。すべてのグレードの有害事象の頻度では,45.7%,28.6%,25.7%とANA単剤で多かったがすべて軽度であった。結論: ANA単剤,HC併用,その他の併用のすべてで認容性は良好であった。
目次
癌と化学療法 TOPへ
癌と化学療法 46巻7号 2019年7月号トップへ
【原著】
▶Clinical Evaluation of the Efficacy and Safety of Anagrelide Used with or without Hydroxycarbamide in Japanese Patients with Essential Thrombocythemia―A Retrospective Single-Center Study of 35 Cases 関口康宣ほか
Objective: The clinical features(CF), laboratory data, disease transformation pattern and drug metabolism in essential thrombocythemia(ET)differ between Japan and Western countries. The CF of ET in clinical practice(CP)are more diverse than in prospective clinical studies. We should conduct retrospective analyses in CP. The present study was aimed at evaluating the efficacy, safety and tolerability of anagrelide(ANA)monotherapy and combined ANA plus hydroxycarbamide(HC)in Japanese ET. Patients and methods: We have a total of 35 cases. Sixteen patients received ANA monotherapy, 10 received ANA plus HC, and 9 received ANA plus other drugs. Results: Comparison among three groups revealed the absence of differences in response rate(platelet count ≤60×104/μL, platelet count ≤40×104/μL)(43.8%, 6.3% vs. 50.0%, 10.0% vs. 44.4%, 11.1%), treatment continuation rate(81.3% vs. 40.0% vs. 55.6%), median daily dose of ANA(1.00 mg in all three groups)or median treatment period(days)(259 vs. 198.5 vs. 161.0), the treatment continuation rate tended to be lower in the combined ANA plus HC. The incidence of all adverse events(AEs)was higher in the ANA monotherapy(45.7%)than ANA plus HC(28.6%)or ANA plus other drugs(25.7%), the AEs were mild in all groups. Conclusion: The tolerability of ANA monotherapy, ANA plus HC, and ANA plus other drugs were good.
要旨
目的: 日本と欧米では,essential thrombocythemia(ET)の臨床像や検査データ,disease transformation,薬剤の代謝が違う。また,前向き臨床試験に比較して実臨床での臨床像は多彩である。そのため実臨床での後方視的検討が必要であると考えられる。本報告の目的は,anagrelide(ANA)単剤およびANAとhydroxycarbamide(HC)の併用療法の有効性,安全性,認容性を日本人ET患者の実臨床で検討することである。患者と方法: 当施設においてANAが投与された35例。ANA単剤が16例(45.7%),ANAとHCの併用が10例(28.6%),ANAとその他の併用が9例(25.7%)であった。結果: 3群間での比較では,血小板60×10 4/μL以下と40×10 4/μL以下の奏効率(43.8%,6.3% vs 50.0%,10.0% vs 44.4%,11.1%),治療継続率(81.3% vs 40.0% vs 55.6%),ANA 1日投与量中央値(3群間すべてで1.00 mg),投与期間中央値(259日vs 198.5日vs 161.0日)に有意差を認めなかったが,HC併用で継続率が不良の傾向を示した。すべてのグレードの有害事象の頻度では,45.7%,28.6%,25.7%とANA単剤で多かったがすべて軽度であった。結論: ANA単剤,HC併用,その他の併用のすべてで認容性は良好であった。