RENOIR phase 3 rituximab-lenalidomide vs rituximab as maintenance treatment in relapsed/refractory follicular lymphoma.

RENOIR was a multicenter, phase 3, open-label randomized trial conducted by the Fondazione Italiana Linfomi (FIL) in older patients with R/R FL after 1 or 2 previous therapies.

RENOIR是一项由意大利淋巴瘤基金会（FIL）进行的多中心、III期、开放标签的随机试验，针对接受过1次或2次治疗后的老年R/R FL患者。

Patients achieving partial response or complete response (CR) after 4 to 6 cycles of standard rituximab (R)-based chemotherapy were randomized 1:1 to maintenance with R alone (standard arm) or R plus lenalidomide (R2; experimental arm).

在4至6个周期的标准利妥昔单抗（R）为基础的化疗后，达到部分缓解或完全缓解（CR）的患者被随机分为1:1，分别接受R单独维持治疗（标准组）或R加雷尼替尼（R2；实验组）。

The primary end point was 2-year progression-free survival(PFS) from randomization, with an expected hazard ratio(HR) of 0.5.

主要终点是从随机分组开始的2年无进展生存（PFS），预期的风险比（HR）为0.5。

A total of 152 patients (median age, 71 years) were enrolled.

共有152名患者（中位年龄71岁）被纳入研究。

After induction, 129 (85%) achieved an overall response (CR, 58%) and were randomized to R (n = 65) or R2 (n = 64).

诱导治疗后，129名（85%）患者达到总体缓解（CR，58%），并被随机分配到R组（n=65）或R2组（n=64）。

At a median follow-up of 68 months, the 2-year PFS was 73% in the R2 arm and 64% in the R arm.

在中位随访68个月时，R2组的2年PFS为73%，而R组为64%。

An unplanned hypothesis-generating subgroup analysis showed a greater 2-year PFS benefit with R2 in patients aged <70 years: R2, 96% vs R, 69%.

一个未计划的假设生成的亚组分析显示，<70岁的患者使用R2的2年PFS获益更大：R2，96% vs R，69%。

Two-year overall survivalrates were similar (R2, 80% vs R, 89%).

两年总体生存率相似（R2，80% 对比 R，89%）。

Grade 3/4 adverse events were more frequent in R2, mainly neutropenia and gastrointestinal disorders.

3/4级不良事件在R2中更为频繁，主要是中性粒细胞减少症和胃肠道疾病。

In conclusion, the primary end point of the study was not met, and R2 maintenance did not significantly improve 2-year PFS in older patients with R/R FL, although a numerical benefit was observed.

总之，该研究的主要终点未达成，R2维持治疗并未显著改善复发/难治性滤泡性淋巴瘤老年患者的2年无进展生存期，尽管观察到数值上的益处。

R2 showed a more favorable benefit-risk profile in patients aged <70 years, whereas in older patients careful consideration of individual tolerability is warranted.

R2在70岁以下患者中显示出更有利的效益-风险比，而在老年患者中，需要仔细考虑个体的耐受性。

This trial was registered at www.clinicaltrials.gov as NCT02390869.

这项试验已在www.clinicaltrials.gov上注册，注册号为NCT02390869。