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
Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Medical School, Queen Mary School, Nanchang University, Nanchang, China.
Front Oncol. 2021 Jun 18;11:687374. doi: 10.3389/fonc.2021.687374. eCollection 2021.
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.
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).
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 ( = 0.005), and relapsed patients had a better complete response rate than refractory patients ( = 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.
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.
ClinicalTrials.gov, identifier: NCT03579082.
二线治疗失败后的复发或难治性弥漫性大B细胞淋巴瘤（R/R-DLBCL）患者预后极差。本研究前瞻性观察了地西他滨联合改良顺铂、阿糖胞苷和地塞米松（DHAP）方案治疗二线治疗失败的R/R-DLBCL患者的疗效和安全性。
纳入21例R/R-DLBCL患者，用地西他滨和改良DHAP方案进行治疗。主要终点为总缓解率（ORR）和安全性。次要终点为无进展生存期（PFS）和总生存期（OS）。
ORR达到50%（完全缓解率为35%），5例患者（25%）疾病稳定（SD），疾病控制率（DCR）为75%。亚组分析显示，50岁以上患者的完全缓解率高于年轻患者（P = 0.005），复发患者的完全缓解率优于难治性患者（P = 0.031）。中位PFS为7个月（95%置信区间为5.1 - 8.9个月）。未达到中位OS。1年总生存率为59.0%（95%CI，35.5% - 82.5%），2年总生存率为51.6%（95%置信区间，26.9% - 76.3%）。主要不良事件（AE）为3/4级血液学毒性，如中性粒细胞减少（90%）、贫血（50%）和血小板减少（70%）。其他主要非血液学AE为1/2级恶心/呕吐（40%）和感染（50%）。未发生肾毒性或治疗相关死亡。
地西他滨联合改良DHAP方案可改善R/R-DLBCL患者的治疗反应和预后，且对AE耐受性良好，提示该方案有可能成为二线治疗失败的R/R-DLBCL患者新的治疗选择。
ClinicalTrials.gov，标识符：NCT03579082。
