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Original Article
Assessing the Efficacy of Bortezomib and Dexamethasone for Induction and Maintenance Therapy in Relapsed/Refractory Cutaneous T-Cell Lymphoma: A Phase II CISL1701/BIC Study
Yoon Seok Choi1orcid , Joonho Shim2orcid , Ka-Won Kang1, Sang Eun Yoon3, Jun Sik Hong4, Sung Nam Lim5, Ho-Young Yhim6, Jung Hye Kwon7, Gyeong-Won Lee8, Deok-Hwan Yang9, Sung Yong Oh10, Ho-Jin Shin11, Hyeon-Seok Eom12, Dok Hyun Yoon13, Hong Ghi Lee14, Seong Hyun Jeong15, Won Seog Kim3, Seok Jin Kim3orcid

DOI: https://doi.org/10.4143/crt.2024.479 [Accepted]
Published online: July 16, 2024
1Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea
2Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
3Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
4Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea
5Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, Korea
6Department of Internal Medicine, Jeonbuk National University Medical School, Research Institute of Clinical Medicine of Jeonbuk National University-Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, Korea
7Department of Internal Medicine, Chungnam National University School of Medicine, Daejeon, Korea
8Division of Hematology and Oncology, Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University College of Medicine, Changwon, Korea
9Department of Internal Medicine, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Korea
10Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea
11Department of Internal Medicine, Pusan National University College of Medicine, Busan, Korea
12Department of Hematology-Oncology, Center for Hematologic Malignancy, National Cancer Center, Goyang, Korea
13Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
14Department of Internal Medicine, Konkuk University Hospital, Seoul, Korea
15Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, Korea
Corresponding author:  Seok Jin Kim, Tel: 82-2-3410-1766, Fax: 82-2-3410-1754, 
Email: kstwoh@skku.edu
Yoon Seok Choi and Joonho Shim contributed equally to this study as co-first authors.
Received: 21 May 2024   • Accepted: 15 July 2024
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Purpose
This multicenter, open-label, phase II trial evaluated the efficacy and safety of bortezomib combined with dexamethasone for the treatment of relapsed/refractory cutaneous T-cell lymphoma (CTCL) in previously treated patients across 14 institutions in South Korea. Patients and Methods Between September 2017 and July 2020, 29 patients with histologically confirmed CTCL received treatment, consisting of eight 4-week cycles of induction therapy followed by maintenance therapy, contingent upon response, for up to one year. The primary endpoint was the proportion of patients achieving an objective global response.
Results
Thirteen (44.8%) of the 29 patients achieved an objective global response, including two complete responses. The median progression-free survival (PFS) was 5.8 months, with responders showing a median PFS of 14.0 months. Treatment-emergent adverse events were generally mild, with a low incidence of peripheral neuropathy and hematologic toxicities. Despite the trend toward shorter PFS in patients with higher mutation burdens, genomic profiling before and after treatment showed no significant emergence of new mutations indicative of disease progression.
Conclusion
This study supports the use of bortezomib and dexamethasone as a viable and safe treatment option for previously treated CTCL, demonstrating substantial efficacy and manageability in adverse effects. Further research with a larger cohort is suggested to validate these findings and explore the prognostic value of mutation profiles.


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