Decitabine combined with RDHAP regimen in relapsed/refractory diffuse large B cell lymphoma

• Published in: Cancer medicine (Malden, MA) MA), 2023-04, Vol.12 (7), p.8134-8143
• Main Authors: Kong, Xiaoshuang, Zhang, Xudong, Ding, Mengjie, Feng, Xiaoyan, Dong, Meng, Zhang, Lei, Fu, Xiaorui, Li, Ling, Li, Xin, Sun, Zhenchang, Yan, Jiaqin, Wang, Xinhua, Wu, Xiaolong, Chen, Qingjiang, Zhang, Mingzhi, Zhu, Linan
• Format: Article
• Language: English
• Subjects: 5-aza-2'-deoxycytidine; Antineoplastic Combined Chemotherapy Protocols - adverse effects; B-cell lymphoma; Bone marrow; Chemotherapy; Cisplatin; Clinical trials; Cytarabine; decitabine; Decitabine - adverse effects; Dexamethasone; diffuse large B‐cell lymphoma; Disease; DNA methylation; Humans; Lymphocytes B; Lymphoma; Lymphoma, Large B-Cell, Diffuse - drug therapy; Lymphoma, Non-Hodgkin - drug therapy; Medical prognosis; Patients; Remission; Rituximab; Rituximab - therapeutic use; Stem cell transplantation; Survival analysis; Tomography; Toxicity; Treatment Outcome
• ISSN: 2045-7634; 2045-7634
• DOI: 10.1002/cam4.5615

Background There is an urgent need for effective treatment of patients with relapsed/refractory diffuse large B‐cell lymphoma (R/R‐DLBCL). This trial investigated the efficacy of decitabine in combination with rituximab, cisplatin, cytarabine, dexamethasone (RDHAP) in R/R‐DLBCL. Methods 56 patients were divided into two groups (decitabine‐RDHAP group. n = 35; RDHAP group, n = 21). The primary endpoints were the overall response rate (ORR) and duration of remission (DOR). Secondary objectives were toxicity, progression‐free survival (PFS), and overall survival (OS). Results The ORR was 40% and 33% for decitabine‐RDHAP and RDHAP groups, respectively, with no difference between the groups. The DOR for the decitabine‐RDHAP regimen was higher than that for the RDHAP regimen (p = 0.044). After a median follow‐up of 12.0 months, the median PFS and OS were 7.0 and 17.0 months for in the decitabine‐RDHAP group and 5.0 and 9.0 months in the RDHAP group with no significant differences between the two groups (p = 0.47, 0.17). The incidence of adverse events was not significantly different between groups. Conclusion The decitabine‐RDHAP regimen is effective and well tolerated, and is a promising salvage regimen for R/R‐DLBCL. A randomized phase II study of decitabine in combination withrituximab, cisplatin, cytarabine, dexamethasone (RDHAP) in relapsed/refractory diffuse large B cell lymphoma.