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
- Author:
Yoon Seok CHOI
1
;
Joonho SHIM
;
Ka-Won KANG
;
Sang Eun YOON
;
Jun Sik HONG
;
Sung Nam LIM
;
Ho-Young YHIM
;
Jung Hye KWON
;
Gyeong-Won LEE
;
Deok-Hwan YANG
;
Sung Yong OH
;
Ho-Jin SHIN
;
Hyeon-Seok EOM
;
Dok Hyun YOON
;
Hong Ghi LEE
;
Seong Hyun JEONG
;
Won Seog KIM
;
Seok Jin KIM
Author Information
- Publication Type:Original Article
- From:Cancer Research and Treatment 2025;57(1):267-279
- CountryRepublic of Korea
- Language:English
-
Abstract:
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.
Materials 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 of the 29 patients (44.8%) 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.
