The combination of rituximab and lenalidomide (R-len) stands as an established treatment for relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL). However, the reproducibility of clinical trial results in routine clinical practice is unknown. To address this gap in knowledge, we reviewed our experience with patients diagnosed with R/R follicular lymphoma (FL) or marginal zone lymphoma (MZL) treated with this combination. Eighty-four patients underwent treatment with R-len, 69 (82%) affected by FL and 15 (18%) by MZL. The median age at the time of treatment initiation was 65 years (range, 39-94), 38 patients (45%) had a pre-treatment FLIPI score of 3-5, 19 (23%) had a bulky disease, 29 (37%) had a lymphoma refractory to the last treatment line, while in 20 (24%) cases the disease was refractory to rituximab. The best overall response rate (ORR) was 82%, and 52% achieved a complete response (CR). The best CR rates for FL and MZL patients were 55% and 40%, respectively. With a median follow-up of 22 months, the median progression-free survival (mPFS) was 22 months (95% CI 19-36) and the 2-year overall survival (OS) was 83% (95% CI 74-93). The median duration of CR (DoCR) was 46 months (95% CI 22-NR). Factors associated with shorter PFS in multivariate analysis were bulky disease and rituximab refractoriness. The most common adverse events (AE) included hematologic toxicity, fatigue and gastrointestinal disorders, such as diarrhea and constipation. Neutropenia and thrombocytopenia were the most common severe toxicities (grade ≥3 in 25% and 4%, respectively). No new safety signals were reported. Real-life results of R-len in patients with R/R iNHL appear consistent with those reported in prospective studies, and further support its use as comparator arm in controlled clinical trials.

中文翻译：

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利妥昔单抗和来那度胺治疗复发或难治性惰性非霍奇金淋巴瘤：现实生活经验。


利妥昔单抗和来那度胺 (R-len) 的组合是治疗复发/难治性 (R/R) 惰性非霍奇金淋巴瘤 (iNHL) 的既定疗法。然而，临床试验结果在常规临床实践中的可重复性尚不清楚。为了解决这一知识差距，我们回顾了诊断为 R/R 滤泡性淋巴瘤 (FL) 或边缘区淋巴瘤 (MZL) 的患者接受该联合治疗的经验。 84 名患者接受了 R-len 治疗，其中 69 名患者 (82%) 受到 FL 的影响，15 名患者 (18%) 受到 MZL 的影响。开始治疗时的中位年龄为 65 岁（范围为 39-94），38 名患者（45%）治疗前 FLIPI 评分为 3-5，19 名患者（23%）患有大块疾病，29 名患者（23%）患有大块疾病。 37%）的淋巴瘤对最后一个治疗线耐药，而 20 例（24%）的病例对利妥昔单抗耐药。最佳总体缓解率 (ORR) 为 82%，52% 达到完全缓解 (CR)。 FL 和 MZL 患者的最佳 CR 率分别为 55% 和 40%。中位随访时间为 22 个月，中位无进展生存期 (mPFS) 为 22 个月 (95% CI 19-36)，2 年总生存率 (OS) 为 83% (95% CI 74-93) ）。 CR (DoCR) 的中位持续时间为 46 个月 (95% CI 22-NR)。多变量分析中与较短 PFS 相关的因素是大体积疾病和利妥昔单抗无效。最常见的不良事件（AE）包括血液毒性、疲劳和胃肠道疾病，例如腹泻和便秘。中性粒细胞减少症和血小板减少症是最常见的严重毒性（≥3 级的发生率分别为 25% 和 4%）。没有报告新的安全信号。 R-len 在 R/R iNHL 患者中的实际结果似乎与前瞻性研究中报告的结果一致，并进一步支持其在对照临床试验中用作比较臂。