Department of Oncology, Lymphoma Diagnosis and Treatment Centre of Henan Province, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
Cancer Med. 2023 Apr;12(7):8134-8143. doi: 10.1002/cam4.5615. Epub 2023 Jan 25.
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.
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).
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.
The decitabine-RDHAP regimen is effective and well tolerated, and is a promising salvage regimen for R/R-DLBCL.
目前迫切需要有效的治疗方案来治疗复发/难治性弥漫大 B 细胞淋巴瘤（R/R-DLBCL）患者。本试验研究了地西他滨联合利妥昔单抗、顺铂、阿糖胞苷、地塞米松（RDHAP）方案治疗 R/R-DLBCL 的疗效。
56 例患者分为两组（地西他滨-RDHAP 组，n=35；RDHAP 组，n=21）。主要终点为总缓解率（ORR）和缓解持续时间（DOR）。次要目标为毒性、无进展生存期（PFS）和总生存期（OS）。
地西他滨-RDHAP 组和 RDHAP 组的 ORR 分别为 40%和 33%，两组间无差异。地西他滨-RDHAP 方案的 DOR 高于 RDHAP 方案（p=0.044）。中位随访 12.0 个月后，地西他滨-RDHAP 组的中位 PFS 和 OS 分别为 7.0 和 17.0 个月，RDHAP 组分别为 5.0 和 9.0 个月，两组间无显著差异（p=0.47，0.17）。两组不良反应发生率无显著差异。
地西他滨-RDHAP 方案有效且耐受性良好，是 R/R-DLBCL 有前途的挽救治疗方案。
