PMID- 34222013 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220424 IS - 2234-943X (Print) IS - 2234-943X (Electronic) IS - 2234-943X (Linking) VI - 11 DP - 2021 TI - 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. PG - 687374 LID - 10.3389/fonc.2021.687374 [doi] LID - 687374 AB - 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. CI - Copyright (c) 2021 Hu, Wang, Chen, Ding, Dong, Yang, Yin, Wu, Zhang, Fu, Sun, Li, Wang, Li, Guo, Zhang, Lu, Leng, Zhang, Zhu, Zhang and Chen. FAU - Hu, Junxia AU - Hu J AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Wang, Xin AU - Wang X AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Chen, Fei AU - Chen F AD - Medical School, Queen Mary School, Nanchang University, Nanchang, China. FAU - Ding, Mengjie AU - Ding M AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Dong, Meng AU - Dong M AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Yang, Wanqiu AU - Yang W AD - Department of Oncology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China. FAU - Yin, Meifeng AU - Yin M AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Wu, Jingjing AU - Wu J AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Zhang, Lei AU - Zhang L AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Fu, Xiaorui AU - Fu X AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Sun, Zhenchang AU - Sun Z AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Li, Ling AU - Li L AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Wang, Xinhua AU - Wang X AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Li, Xin AU - Li X AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Guo, Shuangshuang AU - Guo S AD - Department of Oncology, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China. FAU - Zhang, Dianbao AU - Zhang D AD - Department of Oncology, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China. FAU - Lu, Xiaohui AU - Lu X AD - Lymphoma Hematopoietic Stem Cell Transplantation Center of the People's Hospital of Jiaozuo City, Jiaozuo, China. FAU - Leng, Qing AU - Leng Q AD - Department of Hematology, Anshan Central Hospital, Anshan, China. FAU - Zhang, Mingzhi AU - Zhang M AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Zhu, Linan AU - Zhu L AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Zhang, Xudong AU - Zhang X AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Chen, Qingjiang AU - Chen Q AD - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. LA - eng SI - ClinicalTrials.gov/NCT03579082 PT - Journal Article DEP - 20210618 PL - Switzerland TA - Front Oncol JT - Frontiers in oncology JID - 101568867 PMC - PMC8253157 OTO - NOTNLM OT - chemotherapy OT - decitabine OT - diffuse large B cell lymphoma OT - modified DHAP regimen OT - safety COIS- 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. EDAT- 2021/07/06 06:00 MHDA- 2021/07/06 06:01 PMCR- 2021/01/01 CRDT- 2021/07/05 10:13 PHST- 2021/03/29 00:00 [received] PHST- 2021/05/31 00:00 [accepted] PHST- 2021/07/05 10:13 [entrez] PHST- 2021/07/06 06:00 [pubmed] PHST- 2021/07/06 06:01 [medline] PHST- 2021/01/01 00:00 [pmc-release] AID - 10.3389/fonc.2021.687374 [doi] PST - epublish SO - Front Oncol. 2021 Jun 18;11:687374. doi: 10.3389/fonc.2021.687374. eCollection 2021.