This phase 2 study evaluated the activity and safety of ibrutinib, a Bruton's tyrosine kinase inhibitor, plus rituximab in adults with previously untreated follicular lymphoma. Patients received once-daily ibrutinib 560 mg continuously plus once-weekly rituximab 375 mg/m2 for 4 weeks beginning Week 1 (Arm 1, n = 60) or Week 9 (following an 8-week ibrutinib lead-in) to explore biomarkers (Arm 2, n = 20). The primary endpoint was the best overall response rate (ORR). The median age was 58 years; most had an Eastern Cooperative Oncology Group Performance Status of 0 (74%) and Stage III/IV disease (84%). At a median study follow-up of 34 months in Arm 1 and 29 months in Arm 2, ORRs were 85% [95% confidence interval (CI) 73-93] and 75% (95% CI 51-91), respectively, with complete responses in 40% and 50%. The median duration of response was not reached in either arm; 30-month progression-free and overall survival rates were 67% and 97% (Arm 1) and 65% and 100% (Arm 2). The most common adverse events were fatigue, diarrhoea and nausea. Higher grade (Grade 3/4) haematological, haemorrhagic and cardiac events occurred infrequently. Ibrutinib plus rituximab was active and tolerable in first-line follicular lymphoma.

中文翻译：

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依鲁替尼和利妥昔单抗的组合在一线滤泡性淋巴瘤中显示出活性。

这项2期研究评估了Bruton酪氨酸激酶抑制剂ibrutinib和利妥昔单抗在先前未经治疗的滤泡性淋巴瘤成人中的活性和安全性。患者从第1周（Arm 1，n = 60）或第9周（连续8周ibrutinib引入）开始，连续4周每周接受每日一次ibrutinib 560 mg加rituximab每周一次375 mg / m2来探索生物标志物（第2组，n = 20）。主要终点是最佳总体缓解率（ORR）。中位年龄是58岁。多数患者的东部合作肿瘤小组表现状态为0（74％）和III / IV期疾病（84％）。在第1组中的34个月和第2组中的29个月的中位研究随访中，ORR分别为85％[95％置信区间（CI）73-93]和75％（95％CI 51-91），完整回应率分别为40％和50％。两组均未达到反应的中位数。30个月无进展生存率和总生存率分别为67％和97％（Arm 1）和65％和100％（Arm 2）。最常见的不良事件是疲劳，腹泻和恶心。较高级别（3/4级）的血液学，出血性和心脏事件很少发生。依鲁替尼加利妥昔单抗在一线滤泡性淋巴瘤中活跃且可耐受。