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Original Article
- Efficacy and Safety of Ropeginterferon Alfa-2b in Low-Risk Polycythemia Vera
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Ji Yun Lee1
, Sung-Soo Yoon2, Deok-Hwan Yang3, Sang Kyun Sohn4, Seug Yun Yoon5, Soo-Mee Bang1, Gyeong-Won Lee6, Chul Won Choi7, Eun-Ji Choi8, June-Won Cheong9, Young Hoon Park10, Sung-Eun Lee11
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DOI: https://doi.org/10.4143/crt.2025.552 [Accepted]
Published online: June 26, 2025
1Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
2Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
3Department of Internal Medicine, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwansun, Korea
4Department of Hematology/Oncology, Kyungpook National University Hospital, Daegu, Korea
5Division of Hematology & Medical Oncology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea
6Division of Hematology-Oncology, Department of Internal Medicine, Institute of Health Science, Gyeongsang National University Hospital, Gyeongsang National University College of Medicine, Jinju, Korea
7Division of Oncology and Hematology, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea
8Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
9Division of Hematology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
10Division of Hematology-Oncology, Department of Internal Medicine, Ewha Womans University Mokdong Hospital, Seoul, Korea
11Department of Hematology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
2Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
3Department of Internal Medicine, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwansun, Korea
4Department of Hematology/Oncology, Kyungpook National University Hospital, Daegu, Korea
5Division of Hematology & Medical Oncology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea
6Division of Hematology-Oncology, Department of Internal Medicine, Institute of Health Science, Gyeongsang National University Hospital, Gyeongsang National University College of Medicine, Jinju, Korea
7Division of Oncology and Hematology, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea
8Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
9Division of Hematology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
10Division of Hematology-Oncology, Department of Internal Medicine, Ewha Womans University Mokdong Hospital, Seoul, Korea
11Department of Hematology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
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Corresponding author:
Sung-Eun Lee
Tel: 82-2-2258-6058
Email: lee86@catholic.ac.kr
Received: 23 May 2025 • Accepted: 25 June 2025
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Abstract
Purpose
Conventional management of low-risk polycythemia vera (PV), consisting of phlebotomy and aspirin, often fails to adequately control symptoms and hematologic parameters. This study evaluated the efficacy and safety of ropeginterferon alfa-2b (Ropeg) in low-risk PV patients requiring cytoreductive therapy.
Materials and Methods
In this sub-analysis of an open-label, multicenter trial, 42 patients received Ropeg for 48 weeks. The primary endpoint was a reduction in phlebotomy frequency, while secondary endpoints included complete hematologic response (CHR), changes in JAK2V617F allele burden, and safety.
Results
Among 42 patients, Ropeg significantly reduced mean phlebotomy frequency per year from 3.0 to 0.5 (p < 0.05) and improved CHR rates (69.1% at 48 weeks). The JAK2V617F allele burden decreased, and hydroxyurea-naïve patients showed better responses. The most frequently reported treatment-related adverse events included elevated liver enzymes and alopecia. Most adverse events were mild or moderate, with no grade 4 or 5 events reported.
Conclusion
These findings suggest that Ropeg is a promising treatment option for low-risk PV by effectively reducing the need for phlebotomy and demonstrating efficacy and safety.
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