多中心、前瞻性 II 期澳大利亚白血病和淋巴瘤组 (ALLG) NHL29 试验 (ACTRN12615000551594) 旨在评估在 R-mini-CHOP (IRiC) 中添加依鲁替尼治疗年龄 ≥75 岁的新诊断弥漫性大 B 细胞患者淋巴瘤（DLBCL）。治疗包括六个为期 21 天的依鲁替尼-R-mini-CHOP 周期，随后是两个为期 21 天的利妥昔单抗-依鲁替尼周期。共同主要终点是分娩率和 2 年总生存期 (OS)。 63/79 名患者 (80%) 完成了所有六个周期的 R-mini-CHOP，整个方案的平均相对总剂量和平均相对剂量强度中位数均为 97% (IQR 82, 100; 88, 100)。中位随访时间为 35.5 个月，2 年 OS 为 68%（95% CI，55.6 - 77.4），2 年 PFS 为 60.0%（95% CI，47.7 - 70.3）。中位 OS 和 PFS 分别为 72 个月（95% CI，35 - 未达到）和 40 个月（95% CI，20.4 - 未达到）。总缓解率 (ORR) 为 76%（61/79 名患者），完全缓解 (CR) 率为 71%（56/79 名患者）。 34/79 例患者死亡（43%），其中 17 例死于疾病进展，5 例与治疗相关。 67% 的患者经历过至少一种严重不良事件。最常见的不良事件是感染和腹泻（大多数为 1-2 级）。在这两项与健康相关的生活质量指标中，随着时间的推移，反应者的功能和症状量表、中位健康状态分类评分和中位视觉模拟量表都有所改善。总之，这项研究表明，在 R-mini-CHOP 中添加依鲁替尼对于老年 DLBCL 患者既可递送又有效。版权所有 © 2024 美国血液学会。

The multicenter, prospective phase II Australasian Leukaemia and Lymphoma Group (ALLG) NHL29 trial (ACTRN12615000551594) was conducted to assess the addition of ibrutinib to R-mini-CHOP (IRiC) in patients aged ≥75 years with newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL). Treatment consisted of six 21-day cycles of ibrutinib-R-mini-CHOP followed by two 21-day cycles of rituximab-ibrutinib. Co-primary endpoints were deliverability and 2-year overall survival (OS). All six cycles of R-mini-CHOP were completed in 63/79 patients (80%) with the median Average Relative Total Dose and Average Relative Dose Intensity for the entire regimen both 97% (IQR 82, 100; 88, 100). With a median follow-up of 35.5 months, the 2-year OS was 68% (95% CI, 55.6 - 77.4) with a 2-year PFS of 60.0% (95% CI, 47.7- 70.3). Median OS and PFS were 72 months (95% CI, 35 - not reached) and 40 months (95% CI, 20.4 - not reached) respectively. The overall response rate (ORR) was 76% (61/79 patients), with a complete response (CR) rate of 71% (56/79 patients). Deaths occurred in 34/79 patients (43%), including 17 from progressive disease and 5 treatment related. 67% patients experienced at least one serious adverse event. Most common adverse events were infections and diarrhea (majority grade 1-2). In both health-related quality of life measures, there was an improvement in functional and symptom scales, median health state classification score and median visual analogue scale in responders over time. In conclusion, this study showed that the addition of ibrutinib to R-mini-CHOP was both deliverable and efficacious in elderly DLBCL patients.Copyright © 2024 American Society of Hematology.