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.

与滤泡性淋巴瘤 (FL) 并发或转化而来的弥漫性大 B 细胞淋巴瘤 (DLBCL) 通常被排除在临床试验之外。来那度胺对复发性转化 DLBCL 的反应率为 45%。在此，我们对 MC078E 进行了分析，这是一项 II 期临床试验，测试来那度胺加 R-CHOP (R2CHOP) 用于未治疗的转化/并发 DLBCL (NCT00670358) 患者。包括转化或并发 DLBCL 的成年患者。患者接受了六个周期的利妥昔单抗、环磷酰胺、多柔比星、长春新碱、强的松 (R-CHOP) 和来那度胺 25 mg，每个周期的第 1-10 天。主要结果是 24 个月时的无进展生存期 (PFS)。次要结局是缓解率、无事件生存期 (EFS) 和总生存期 (OS)。2013 年 8 月 5 日至 7 月 28 日累计入组 39 例患者，2020 年和 33 名符合中央病理学审查的条件。中位年龄为 64 (24-80) 岁，18 人 (54%) 为男性，25 人 (76%) 并发，8 人 (24%) 被转化为 DLBCL。24 个月时的 PFS、EFS 和 OS 率为 84.4%（CI₉₅：67.2–94.7%）、84.5%（CI ₉₅：72.9–98%）和 97.0%（CI ₉₅：91.3–100%）。R2CHOP 在并发和转化的 DLBCL 中有效。该研究支持在新的免疫调节类似物的未来临床试验中纳入未经蒽环类药物转化和并发的 DLBCL。