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

TITLE=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

JOURNAL=Frontiers in Oncology

VOLUME=11

YEAR=2021

URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.687374

DOI=10.3389/fonc.2021.687374

ISSN=2234-943X

ABSTRACT=<sec><title>Objective</title><p>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.</p></sec><sec><title>Methods</title><p>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).</p></sec><sec><title>Results</title><p>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 (<italic>P</italic> = 0.005), and relapsed patients had a better complete response rate than refractory patients (<italic>P</italic> = 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.</p></sec><sec><title>Conclusion</title><p>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.</p></sec><sec><title>Clinical Trial Registration</title><p><uri xlink:href="https://clinicaltrials.gov/" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</uri>, identifier: NCT03579082.</p></sec>