Department of Hematology, Amsterdam UMC location VU, Amsterdam, The Netherlands.
HOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Blood Cancer J. 2023 May 22;13(1):85. doi: 10.1038/s41408-023-00854-2.
Patients with MYC rearranged (MYC-R) diffuse large B-cell lymphoma (DLBCL) have a poor prognosis. Previously, we demonstrated in a single-arm phase II trial (HOVON-130) that addition of lenalidomide to R-CHOP (R2CHOP) is well-tolerated and yields similar complete metabolic remission rates as more intensive chemotherapy regimens in literature. In parallel with this single-arm interventional trial, a prospective observational screening cohort (HOVON-900) was open in which we identified all newly diagnosed MYC-R DLBCL patients in the Netherlands. Eligible patients from the observational cohort that were not included in the interventional trial served as control group in the present risk-adjusted comparison. R2CHOP treated patients from the interventional trial (n = 77) were younger than patients in the R-CHOP control cohort (n = 56) (median age 63 versus 70 years, p = 0.018) and they were more likely to have a lower WHO performance score (p = 0.013). We adjusted for differences at baseline using 1:1 matching, multivariable analysis, and weighting using the propensity score to reduce treatment-selection bias. These analyses consistently showed improved outcome after R2CHOP with HRs of 0.53, 0.51, and 0.59, respectively, for OS, and 0.53, 0.59, and 0.60 for PFS. Thus, this non-randomized risk-adjusted comparison supports R2CHOP as an additional treatment option for MYC-R DLBCL patients.
具有 MYC 重排（MYC-R）的弥漫性大 B 细胞淋巴瘤（DLBCL）患者预后不良。此前，我们在一项单臂 II 期试验（HOVON-130）中证明，在 R-CHOP（R2CHOP）中添加来那度胺可耐受良好，并且与文献中更强化疗方案的完全代谢缓解率相似。在这项单臂干预性试验的同时，开放了一个前瞻性观察性筛选队列（HOVON-900），我们在荷兰确定了所有新诊断的 MYC-R DLBCL 患者。在观察性队列中未纳入干预性试验的合格患者作为本风险调整比较的对照组。干预试验中接受 R2CHOP 治疗的患者（n=77）比 R-CHOP 对照组的患者（n=56）年龄更小（中位年龄 63 岁与 70 岁，p=0.018），并且更有可能具有较低的世界卫生组织（WHO）表现评分（p=0.013）。我们通过 1:1 匹配、多变量分析以及使用倾向评分进行加权来调整基线差异，以减少治疗选择偏倚。这些分析一致表明，R2CHOP 后生存结果得到改善，OS 的 HR 分别为 0.53、0.51 和 0.59，PFS 的 HR 分别为 0.53、0.59 和 0.60。因此，这种非随机风险调整比较支持 R2CHOP 作为 MYC-R DLBCL 患者的附加治疗选择。
