A multicenter, open-label study for efficacy and safety evaluation of anagrelide in patients with treatment-naive, high-risk essential thrombocythemia as a primary treatment
- 주제(키워드) essential thrombocythemia , high risk , Anagrelide , phase IV clinical trial , myeloproliferative neoplasms
- 주제(기타) Oncology
- 설명문(일반) [Byun, Ja Min; Shin, Dong-Yeop; Yoon, Sung-Soo] Seoul Natl Univ Hosp, Dept Internal Med, Seoul, South Korea; [Kim, Ho Young] Hallym Univ, Dept Internal Med, Med Ctr, Anyang, South Korea; [Nam, Seung-Hyun] Kyung Hee Univ Gangdong, Dept Internal Med, Seoul, South Korea; [Shin, Ho-Jin] Pusan Natl Univ Hosp, Med Res Inst, Sch Med, Dept Internal Med,Div Haematol Oncol, Pusan, South Korea; [Song, Seulki] Seoul Natl Univ Hosp, Canc Res Inst, Seoul, South Korea; [Park, Jinny] Gachon Univ, Dept Internal Med, Div Hematol, Gil Med Ctr, Incheon, South Korea; [Han, Sang Hoon] Jeju Natl Univ, Jeju Natl Univ Hosp, Dept Internal Med, Sch Med, Jeju, South Korea; [Park, Yong] Korea Univ, Dept internal Med, Div Hematooncol, Sch Med, Seoul, South Korea; [Yuh, Young Jin] Inje Univ, Sanggye Paik Hosp, Dept Internal Med, Coll Med, Seoul, South Korea; [Mun, Yeung-Chul] Ewha Womans Univ, Coll Med, Dept Internal Med, Mokdong Hosp, Seoul, South Korea; [Do, Young Rok] Keimyung Univ, Sch Med, Dept Internal Med, Dongsan Hosp, Daegu, South Korea; [Sohn, Sang Kyun] Kyungpook Natl Univ, Kyungpook Natl Univ Hosp, Sch Med, Dept Internal Med, Daegu, South Korea; [Bae, Sung Hwa] Daegu Catholic Univ, Dept Internal Med, Sch Med, Daegu, South Korea
- 등재 SCIE, SCOPUS
- OA유형 Green Published, gold
- 발행기관 FRONTIERS MEDIA SA
- 발행년도 2022
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000203134
- 본문언어 영어
- Published As https://doi.org/10.3389/fonc.2022.989984
- PubMed https://pubmed.ncbi.nlm.nih.gov/36505839
초록/요약
As the discussion of first-line anagrelide treatment is ongoing, we aimed to prospectively examine the efficacy and safety of anagrelide in cytoreduction therapy-naive high risk essential thrombocythemia (ET) patients in Korea. Seventy patients from 12 centers were treated with anagrelide monotherapy for up to 8 weeks, followed up until 24 months. At week 8, 50.0% of the patients were able to achieve platelet < 600 x 10(9)/L, and by 12 months, 55/70 (78.6%) patients stayed on anagrelide, and 40.0% patients showed platelet normalization. 14 patients required additional hydroxyurea (HU) for cytoreduction. The median daily dose of needed HU was 500mg (range 250mg - 1500mg). The efficacy was independent of the somatic mutation status. There were 4 thromboembolic events and 7 bleeding events during the follow-up period. The most common adverse events associated with anagrelide use were headache, followed by palpitation/chest discomfort, edema and generalized weakness/fatigue. 7 patients wished to discontinue anagrelide treatment due to adverse events (3 due to headache; 2 due to edema; 1 due to palpitation and 1 due to skin eruption). All in all, first-line anagrelide treatment showed a favorable response with tolerable safety profiles regardless of somatic mutation status.
more