文章：

来那度胺联合R-CHOP方案在初治、由滤泡性淋巴瘤转化而来的弥漫大B细胞淋巴瘤中显示出高缓解率和无进展生存期：II期MC078E研究结果

Lenalidomide in combination with R-CHOP produces high response rates and progression-free survival in new, untreated diffuse large B-cell lymphoma transformed from follicular lymphoma: results from the Phase 2 MC078E study

原文发布日期：2021-09-25

DOI: 10.1038/s41408-021-00542-z

类型: Article

开放获取: 是

英文摘要：

Diffuse large B-cell lymphoma (DLBCL), either concurrent with or transformed from follicular lymphoma (FL) is often excluded from clinical trials. Lenalidomide has response rates of 45% in relapsed transformed DLBCL. Herein we present an analysis of MC078E, a phase II clinical trial testing lenalidomide plus R-CHOP (R2CHOP) for patients with untreated transformed/concurrent DLBCL (NCT00670358). Adult patients with transformed or concurrent DLBCL were included. Patients received six cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) with lenalidomide 25 mg days 1–10 of each cycle. The primary outcome was progression-free survival (PFS) at 24 months. Secondary outcomes were response rates, event-free survival (EFS), and overall survival (OS). Thirty-nine patients were accrued from August 5, 2013 to July 28, 2020 and 33 were eligible by central pathology review. The median age was 64 (24–80) years, 18 (54%) were male, 25 (76%) were concurrent and 8 (24%) were transformed DLBCL. The PFS, EFS, and OS rates at 24 months were 84.4% (CI95: 67.2–94.7%), 84.5% (CI95: 72.9–98%), and 97.0% (CI95: 91.3–100%), respectively. R2CHOP is effective in concurrent and transformed DLBCL. The study supports the inclusion of anthracycline-naive transformed and concurrent DLBCL in future clinical trials of novel immunomodulatory analogues.
 

摘要翻译： 

弥漫性大B细胞淋巴瘤（DLBCL）无论与滤泡性淋巴瘤（FL）共存还是由其转化而来，常被排除在临床试验之外。来那度胺在复发性转化型DLBCL中的缓解率为45%。本文介绍了MC078E试验的分析结果，这是一项针对未经治疗的转化型/共存型DLBCL患者进行的来那度胺联合R-CHOP（R2CHOP）的II期临床试验（NCT00670358）。研究纳入了转化型或共存型DLBCL成年患者。患者接受六个周期的利妥昔单抗、环磷酰胺、多柔比星、长春新碱、泼尼松（R-CHOP）治疗，并在每个周期的第1-10天加用来那度胺25毫克。主要终点为24个月无进展生存率（PFS），次要终点包括缓解率、无事件生存率（EFS）和总生存率（OS）。2013年8月5日至2020年7月28日期间共纳入39例患者，经中心病理学审核后33例符合条件。中位年龄64岁（范围24-80岁），男性18例（54%），其中25例（76%）为共存型DLBCL，8例（24%）为转化型DLBCL。24个月的PFS、EFS和OS率分别为84.4%（95%置信区间：67.2–94.7%）、84.5%（95%置信区间：72.9–98%）和97.0%（95%置信区间：91.3–100%）。R2CHOP方案对共存型和转化型DLBCL均有效。本研究支持将未使用过蒽环类药物的转化型及共存型DLBCL纳入未来新型免疫调节类似物的临床试验中。

原文链接：

Lenalidomide in combination with R-CHOP produces high response rates and progression-free survival in new, untreated diffuse large B-cell lymphoma transformed from follicular lymphoma: results from the Phase 2 MC078E study