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

• Published in: Cancer research and treatment Vol. 57; no. 1; pp. 267 - 279
• Main Authors: Choi, Yoon Seok, Shim, Joonho, Kang, Ka-Won, Yoon, Sang Eun, Hong, Jun Sik, Lim, Sung Nam, Yhim, Ho-Young, Kwon, Jung Hye, Lee, Gyeong-Won, Yang, Deok-Hwan, Oh, Sung Yong, Shin, Ho-Jin, Eom, Hyeon-Seok, Yoon, Dok Hyun, Lee, Hong Ghi, Jeong, Seong Hyun, Kim, Won Seog, Kim, Seok Jin
• Format: Journal Article
• Language: English
• Published: Korea (South) Korean Cancer Association 01.01.2025; 대한암학회
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Bortezomib - administration & dosage; Bortezomib - adverse effects; Bortezomib - therapeutic use; Dexamethasone - administration & dosage; Dexamethasone - adverse effects; Dexamethasone - therapeutic use; Drug Resistance, Neoplasm; Female; Humans; Induction Chemotherapy; Lymphoma, T-Cell, Cutaneous - drug therapy; Lymphoma, T-Cell, Cutaneous - mortality; Lymphoma, T-Cell, Cutaneous - pathology; Maintenance Chemotherapy; Male; Middle Aged; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - pathology; Original; Skin Neoplasms - drug therapy; Skin Neoplasms - pathology; Treatment Outcome; 의학일반; Treatment efficacy; Bortezomib; Dexamethasone; Relapsed/refractory; Cutaneous T-cell lymphoma; Safety profile
• ISSN: 1598-2998; 2005-9256; 2005-9256
• DOI: 10.4143/crt.2024.479

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.