| 李 聪,周昌明.不同分子亚型弥漫大B细胞淋巴瘤对硼替佐米联合R-CHOP（RB-CHOP）方案的疗效存在差异：REMoDL-B研究5年随访结果解读[J].肿瘤学杂志,2023,29(6):530-536. |
| 不同分子亚型弥漫大B细胞淋巴瘤对硼替佐米联合R-CHOP（RB-CHOP）方案的疗效存在差异：REMoDL-B研究5年随访结果解读 |
| Differential Efficacy from the Addition of Bortezomib to R-CHOP（RB-CHOP） in Diffuse Large B-Cell Lymphoma According to the Molecular Subgroup： Interpretation of the Results of 5-Year Follow-Up in the REMoDL-B Study |
| 投稿时间：2023-06-11 |
| DOI：10.11735/j.issn.1671-170X.2023.06.B013 |
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| 中文关键词: 弥漫大B细胞淋巴瘤 硼替佐米 R-CHOP 适应性设计 |
| 英文关键词:diffuse large B cell lymphoma bortezomib R-CHOP adaptive design |
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| 中文摘要: |
| 摘 要：REMoDL-B研究是一项开放标签、多中心、Ⅲ期适应性试验，在英国和瑞士的107家中心开展。研究对比了硼替佐米联合R-CHOP（RB-CHOP）方案与传统R-CHOP方案一线治疗弥漫大B细胞淋巴瘤（DLBCL）患者的疗效与安全性，同时进行了分子分型与基因检测，以进一步探索高危人群的治疗获益情况。2019年5月研究首先公布了随访30个月的研究结果：R-CHOP和RB-CHOP组的PFS和OS差异均无明显统计学意义［hazard ratio(HR)=0.86，95%CI：0.65~1.13］。研究后续对患者肿瘤组织进行了基因表达谱检测，并根据基因状态进行了再分类。共801例患者通过GEP检测被分入活化B细胞(activated B-cell ，ABC)组、生发中心B细胞组(germinal center B-cell，GCB）组和分子学高级别（molecular high-grade，MHG）组。2023年，研究公布了中位随访至64个月的最新结果，在所有成功分类的患者中，RB-CHOP组在无进展时间（progression-free survival，PFS）和总生存时间（overall survival，OS）方面均没有总体获益（5年PFS：HR=0.81，P=0.085；5年OS：HR=0.86，P=0.320），但ABC亚型的PFS和OS均有显著改善，MHG亚型的PFS也有获益。ABC亚型中，R-CHOP 组和 RB-CHOP 组的60个月PFS分别为54.4%和69.4%（HR=0.65，95%CI：0.43～0.98，P=0.041），60个月OS分别为67.4%和80.4%（HR=0.58，95%CI：0.35～0.95，P=0.032)；MHG亚型中，R-CHOP 组和 RB-CHOP 组60个月 PFS分别为29.3%和54.9%（HR=0.46，95%CI：0.26～0.84，P=0.011），60个月OS分别为47.5%和60.0%（HR=0.62，95%CI：0.32～1.20，P=0.160）。GCB亚组患者中，PFS和OS都没有显著改善。REMoDL-B研究提示，通过分子生物学检测进一步指导高危人群的筛选，并针对性给予R-CHOP+X的治疗模式在DLBCL患者一线治疗中具有一定的意义。 |
| 英文摘要: |
| Abstract： REMoDL-B study was an open-label， randomized， phase Ⅲ adaptive trial， which recruited from 107 cancer centers in the United Kingdom and Switzerland. The REMoDL-B study compared the efficacy and safety of Bortezomib combined with R-CHOP(tuximab， cyclophosphamide， doxorubicin， vincristine， and prednisolone)(RB-CHOP) regimen and the traditional R-CHOP regimen in the first-line treatment of patients with newly diagnosed diffuse large B-cell lymphoma(DLBCL). At the same time， molecular typing and genetic testing were carried out to further explore the treatment benefits of high-risk groups. In May 2019， the study first released the results of a 30 months follow-up： there was no statistically significant difference in progression-free survival(PFS) and overall survival(OS) between the R-CHOP and RB-CHOP groups ［hazard ratio(HR)=0.86， 95%CI： 0.65~1.13］. And the gene expression profiling(GEP) of the tumor tissues were detected and reclassified according to the gene status. Eight hundred and one patients were divided into activated B-cell(ABC) group， germinal center B-cell(GCB) group and molecular high grade(MHG). In 2023， REMoDL-B study released the updated results at a median follow-up of 64 months. Among all successfully classified patients， the RB-CHOP group did not have benefits on PFS and OS(5-year PFS： HR=0.81， P=0.085； 5-year OS： HR=0.86， P=0.320)， but there was a significant improvement in PFS and OS for the ABC group， as well as PFS for the MHG group.In the ABC group， the 5-year PFS in the R-CHOP group and RB-CHOP group was 54.4% and 69.4%， respectively(HR=0.65， 95%CI： 0.43～0.98， P=0.041)， and the 5-year OS was 67.4% and 80.4%， respectively(HR=0.58， 95%CI：0.35～0.95， P=0.032). In the MHG group， the 5-year PFS in the R-CHOP group and RB-CHOP group was 29.3% and 54.9%， respectively(HR=0.46， 95%CI： 0.26～0.84， P=0.011)， and the 5-year OS was 47.5% and 60.0%， respectively(HR=0.62， 95%CI： 0.32～1.20， P=0.160). In the GCB group， There was no significant improvement in PFS and OS. REMoDL-B study indicated that molecular biological tests might help to further guide the screening of high-risk groups， and chemotherapy regimens by the addition of novel drugs to R-CHOP had promising activity in DLBCL patients. |
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