A multicenter, open-label study for efficacy and safety evaluation of anagrelide in patients with treatment-naïve, high-risk essential thrombocythemia as a primary treatment
As the discussion of first-line anagrelide treatment is ongoing, we aimed to prospectively examine the efficacy and safety of anagrelide in cytoreduction therapy-naïve high risk essential thrombocythemia (ET) patients in Korea. Seventy patients from 12 centers were treated with anagrelide monotherap...
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| Format: | Article |
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Frontiers Media S.A.
2022-11-01
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| Series: | Frontiers in Oncology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2022.989984/full |
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| author | Ja Min Byun Ho Young Kim Seung-Hyun Nam Ho-Jin Shin Seulki Song Jinny Park Sang Hoon Han Yong Park Young Jin Yuh Yeung-Chul Mun Young Rok Do Sang Kyun Sohn Sung Hwa Bae Dong-Yeop Shin Sung-Soo Yoon |
| author_facet | Ja Min Byun Ho Young Kim Seung-Hyun Nam Ho-Jin Shin Seulki Song Jinny Park Sang Hoon Han Yong Park Young Jin Yuh Yeung-Chul Mun Young Rok Do Sang Kyun Sohn Sung Hwa Bae Dong-Yeop Shin Sung-Soo Yoon |
| author_sort | Ja Min Byun |
| collection | DOAJ |
| description | As the discussion of first-line anagrelide treatment is ongoing, we aimed to prospectively examine the efficacy and safety of anagrelide in cytoreduction therapy-naïve 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 109/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. |
| first_indexed | 2024-04-11T06:36:41Z |
| format | Article |
| id | doaj.art-053c6a7d2e1f40f3947f13cdf422dbf4 |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-04-11T06:36:41Z |
| publishDate | 2022-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj.art-053c6a7d2e1f40f3947f13cdf422dbf42022-12-22T04:39:41ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2022-11-011210.3389/fonc.2022.989984989984A multicenter, open-label study for efficacy and safety evaluation of anagrelide in patients with treatment-naïve, high-risk essential thrombocythemia as a primary treatmentJa Min Byun0Ho Young Kim1Seung-Hyun Nam2Ho-Jin Shin3Seulki Song4Jinny Park5Sang Hoon Han6Yong Park7Young Jin Yuh8Yeung-Chul Mun9Young Rok Do10Sang Kyun Sohn11Sung Hwa Bae12Dong-Yeop Shin13Sung-Soo Yoon14Department of Internal Medicine, Seoul National University Hospital, Seoul, South KoreaDepartment of Internal Medicine, Hallym University Medical Center, Anyang, South KoreaDepartment of Internal Medicine, Kyung Hee University at Gangdong, Seoul, South KoreaDivision of Haematology-Oncology, Department of Internal Medicine, School of Medicine, Medical Research Institute, Pusan National University Hospital, Busan, South KoreaCancer Research Institute, Seoul National University Hospital, Seoul, South KoreaDivision of Hematology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, South KoreaDepartment of Internal Medicine, Jeju National University Hospital, Jeju National University School of Medicine, Jeju, South KoreaDivision of Hemato-Oncology, Department of internal medicine, Korea University School of Medicine, Seoul, South KoreaDepartment of Internal Medicine, Inje University College of Medicine, Sanggye Paik Hospital, Seoul, South Korea0Department of Internal Medicine, Ewha Womans University Mokdong Hospital, Ewha Womans University College of Medicine, Seoul, South Korea1Department of Internal Medicine, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea2Department of Internal Medicine, Kyungpook National University Hospital, School of Medicine, Kyungpook National University, Daegu, South Korea3Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, South KoreaDepartment of Internal Medicine, Seoul National University Hospital, Seoul, South KoreaDepartment of Internal Medicine, Seoul National University Hospital, Seoul, South KoreaAs the discussion of first-line anagrelide treatment is ongoing, we aimed to prospectively examine the efficacy and safety of anagrelide in cytoreduction therapy-naïve 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 109/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.https://www.frontiersin.org/articles/10.3389/fonc.2022.989984/fullessential thrombocythemiahigh riskAnagrelidephase IV clinical trialmyeloproliferative neoplasms |
| spellingShingle | Ja Min Byun Ho Young Kim Seung-Hyun Nam Ho-Jin Shin Seulki Song Jinny Park Sang Hoon Han Yong Park Young Jin Yuh Yeung-Chul Mun Young Rok Do Sang Kyun Sohn Sung Hwa Bae Dong-Yeop Shin Sung-Soo Yoon A multicenter, open-label study for efficacy and safety evaluation of anagrelide in patients with treatment-naïve, high-risk essential thrombocythemia as a primary treatment Frontiers in Oncology essential thrombocythemia high risk Anagrelide phase IV clinical trial myeloproliferative neoplasms |
| title | A multicenter, open-label study for efficacy and safety evaluation of anagrelide in patients with treatment-naïve, high-risk essential thrombocythemia as a primary treatment |
| title_full | A multicenter, open-label study for efficacy and safety evaluation of anagrelide in patients with treatment-naïve, high-risk essential thrombocythemia as a primary treatment |
| title_fullStr | A multicenter, open-label study for efficacy and safety evaluation of anagrelide in patients with treatment-naïve, high-risk essential thrombocythemia as a primary treatment |
| title_full_unstemmed | A multicenter, open-label study for efficacy and safety evaluation of anagrelide in patients with treatment-naïve, high-risk essential thrombocythemia as a primary treatment |
| title_short | A multicenter, open-label study for efficacy and safety evaluation of anagrelide in patients with treatment-naïve, high-risk essential thrombocythemia as a primary treatment |
| title_sort | multicenter open label study for efficacy and safety evaluation of anagrelide in patients with treatment naive high risk essential thrombocythemia as a primary treatment |
| topic | essential thrombocythemia high risk Anagrelide phase IV clinical trial myeloproliferative neoplasms |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2022.989984/full |
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