文章：

来那度胺联合R-CHOP21方案治疗初诊弥漫大B细胞淋巴瘤（DLBCL）：两项II期试验汇总分析的长期随访结果

Lenalidomide plus R-CHOP21 in newly diagnosed diffuse large B-cell lymphoma (DLBCL): long-term follow-up results from a combined analysis from two phase 2 trials

原文发布日期：2018-11-08

DOI: 10.1038/s41408-018-0145-9

类型: Article

开放获取: 是

英文摘要：

Lenalidomide-RCHOP (R2-CHOP21) has been shown to be safe and effective in patients with untreated diffuse large B-cell lymphoma (DLBCL). The aim of this analysis is to report long-term outcome and toxicities in newly diagnosed DLBCL patients who received R2-CHOP21 in two independent phase 2 trials, conducted by Mayo Clinic (MC) and Fondazione Italiana Linfomi (FIL). All patients received R-CHOP21 plus lenalidomide. Long-term progression-free survival (PFS), time to progression (TTP), overall survival (OS) and late toxicities and second tumors were analyzed. Hundred and twelve patients (63 MC, 49 FIL) were included. Median age was 69 years, 88% were stage III–IV. At a median follow-up of 5.1 years, 5y-PFS was 63.5%, 5y-TTP 70.1% and 5y-OS 75.4%; according to cell of origin (COO): 5y-PFS 52.8% vs 64.5%, 5y-TTP 61.6% vs 69.6% and 5y-OS 68.6% vs 74.1% in germinal center (GCB) vs non-GCB respectively. Four patients experienced grade 4–5 late toxicities. Grade ≤ 3 toxicities were infections (N = 4), thrombosis (N = 1) and neuropathy (N = 3). Seven seconds tumors were observed. Long-term follow-up demonstrates that R2-CHOP21 efficacy was maintained with high rates of PFS, TTP, and OS. Lenalidomide appears to mitigate the negative prognosis of non-GCB phenotype. Incidence of therapy-related secondary malignancies and late toxicities were low.

摘要翻译： 

来那度胺-RCHOP（R2-CHOP21）方案已被证明在未经治疗的弥漫性大B细胞淋巴瘤（DLBCL）患者中安全有效。本次分析旨在报告由梅奥诊所（MC）和意大利淋巴瘤基金会（FIL）开展的两项独立二期试验中，接受R2-CHOP21治疗的新诊断DLBCL患者的长期结局及毒性反应。所有患者均接受R-CHOP21联合来那度胺治疗，并对长期无进展生存期（PFS）、至疾病进展时间（TTP）、总生存期（OS）以及远期毒性和第二肿瘤进行分析。共纳入112例患者（MC63例，FIL49例），中位年龄69岁，88%为III–IV期。中位随访5.1年时，5年PFS为63.5%，5年TTP为70.1%，5年OS为75.4%；根据细胞起源（COO）分层：生发中心型（GCB）与非GCB型的5年PFS分别为52.8%对64.5%，5年TTP为61.6%对69.6%，5年OS为68.6%对74.1%。4例患者出现4-5级远期毒性反应。≤3级毒性包括感染（4例）、血栓形成（1例）和神经病变（3例）。观察到7例第二肿瘤。长期随访证实R2-CHOP21能持续维持较高的PFS、TTP和OS率。来那度胺似乎可缓解非GCB表型的不良预后，且治疗相关继发性恶性肿瘤与远期毒性发生率较低。

原文链接：

Lenalidomide plus R-CHOP21 in newly diagnosed diffuse large B-cell lymphoma (DLBCL): long-term follow-up results from a combined analysis from two phase 2 trials