Combination of Decitabine and a Modified Regimen of Cisplatin, Cytarabine and Dexamethasone: A Potential Salvage Regimen for Relapsed or Refractory Diffuse Large B-Cell Lymphoma After Second-Line Treatment Failure

Junxia Hu, Xin Wang, Fei Chen, Mengjie Ding, Meng Dong, Wanqiu Yang, Meifeng Yin, Jingjing Wu, Lei Zhang, Xiaorui Fu, Zhenchang Sun, Ling Li, Xinhua Wang, Xin Li, Shuangshuang Guo, Dianbao Zhang, Xiaohui Lu, Qing Leng, Mingzhi Zhang, Linan Zhu, Xudong Zhang, Qingjiang Chen, Junxia Hu, Xin Wang, Fei Chen, Mengjie Ding, Meng Dong, Wanqiu Yang, Meifeng Yin, Jingjing Wu, Lei Zhang, Xiaorui Fu, Zhenchang Sun, Ling Li, Xinhua Wang, Xin Li, Shuangshuang Guo, Dianbao Zhang, Xiaohui Lu, Qing Leng, Mingzhi Zhang, Linan Zhu, Xudong Zhang, Qingjiang Chen

Abstract

Objective: The prognosis for patients with relapsed or refractory diffuse large B-cell lymphoma (R/R-DLBCL) after second-line treatment failure is extremely poor. This study prospectively observed the efficacy and safety of decitabine with a modified cisplatin, cytarabine, and dexamethasone (DHAP) regimen in R/R-DLBCL patients who failed second-line treatment.

Methods: Twenty-one R/R-DLBCL patients were enrolled and treated with decitabine and a modified DHAP regimen. The primary endpoints were overall response rate (ORR) and safety. The secondary endpoints were progression-free survival (PFS) and overall survival (OS).

Results: ORR reached 50% (complete response rate, 35%), five patients (25%) had stable disease (SD) with disease control rate (DCR) of 75%. Subgroup analysis revealed patients over fifty years old had a higher complete response rate compared to younger patients (P = 0.005), and relapsed patients had a better complete response rate than refractory patients (P = 0.031). Median PFS was 7 months (95% confidence interval, 5.1-8.9 months). Median OS was not achieved. One-year OS was 59.0% (95% CI, 35.5%-82.5%), and two-year OS was 51.6% (95% confidence interval, 26.9%-76.3%). The main adverse events (AEs) were grade 3/4 hematologic toxicities such as neutropenia (90%), anemia (50%), and thrombocytopenia (70%). Other main non-hematologic AEs were grade 1/2 nausea/vomiting (40%) and infection (50%). No renal toxicity or treatment-related death occurred.

Conclusion: Decitabine with a modified DHAP regimen can improve the treatment response and prognosis of R/R-DLBCL patients with good tolerance to AEs, suggesting this regimen has potential as a possible new treatment option for R/R-DLBCL patients after second-line treatment failure.

Clinical trial registration: ClinicalTrials.gov, identifier: NCT03579082.

Keywords: chemotherapy; decitabine; diffuse large B cell lymphoma; modified DHAP regimen; safety.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Hu, Wang, Chen, Ding, Dong, Yang, Yin, Wu, Zhang, Fu, Sun, Li, Wang, Li, Guo, Zhang, Lu, Leng, Zhang, Zhu, Zhang and Chen.

Figures

Figure 1
Figure 1
Kaplan–Meier survival curves for twenty patients with relapsed or refractory diffuse large B cell lymphoma (R/R-DLBCL) after second-line treatment failure treated with a treatment of decitabine and a modified cisplatin, cytarabine, and dexamethasone (DHAP) regimen. (A) Progression-free survival (PFS) is shown for twenty patients, showing that the median PFS is 7 months. (B) Overall survival (OS) is shown for twenty patients, showing that the one-year OS is 59.0% and two-year OS is 51.6%.

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