演題詳細

一般口演 / Oral Session

一般口演 8 (Oral Session 8) :MDS:臨床 2

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日程
2013年10月11日(金)
時間
10:30 - 11:30
会場
第6会場 / Room No.6 (ロイトン札幌 2F エンプレス)
座長・司会
前田 嘉信 (Yoshinobu Maeda):1
1:岡山大学病院 血液・腫瘍・呼吸器・アレルギー内科
 
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Anagrelide as second-line therapy in high-risk Japanese patients with essential thrombocythemia(ET)

演題番号 : OS-1-36

Yoshitake Miyakawa:1、Yoshitaka Miyakawa:1、Wilde Paul:2、Jonathan Smith:2、Heinrich Achenbach:3、金倉 譲 (Yuzuru Kanakura):4

1:Division of Hematology, Keio University School of Medicine、2:Shire Pharmaceutical Development Ltd, United Kingdom、3:Shire AG, Switzerland、4:Osaka University, Graduate School of Medicine, Osaka University Hospital, Suita, Osaka, Japan

 

Objective: The study assessed the safety and efficacy of 12 month anagrelide (ANA) therapy in Japanese patients with ET who were at high risk of developing thromboembolic events (>60 years of age; history of thrombosis; platelet count >1000x109/L) and were intolerant/refractory to their previous cytoreductive treatment (CRT). Patients and methods: Fifty-three patients (56.6% female), characterized as intolerant (64.2%) or refractory (35.8%) to their previous CRT, were enrolled into this study, SPD422-308 (NCT01214915). ANA was started at 1 mg/day and titrated to achieve a response in platelet count. A response was defined as a platelet count <600x109/L across consecutive visits for ≥4 weeks, following ≥3 months of ANA therapy. Results: The median average daily dose of ANA was 1.90 mg/day (range 0.58–5.48). A response was obtained in 36 patients (67.9%), with a median time to response of 98.5 days. Among these, the platelet count was normalized (<400x109/L) in 24 patients (45.3%). Half of all patients (50.9%) achieved a ≥50% reduction in platelet count from baseline. The majority of patients experienced a mild (39.6%) or moderate (47.2%) adverse event (AE), most of which were considered drug related. Nine patients (17%) discontinued ANA due to an AE, of which headache (5.7%) was the most frequent followed by palpitations (3.8%). Conclusions: ANA therapy as second-line treatment in high-risk Japanese patients with ET demonstrated a similar efficacy and safety profile to that seen previously in non-Japanese patients. No new safety concerns were identified in this population.

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