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伊布替尼治疗套细胞淋巴瘤首次复发:211 例英国真实世界研究结果分析。

Ibrutinib for mantle cell lymphoma at first relapse: a United Kingdom real-world analysis of outcomes in 211 patients.

机构信息

University Hospitals Plymouth NHS Trust, Plymouth, United Kingdom.

Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.

出版信息

Br J Haematol. 2021 Apr;193(2):290-298. doi: 10.1111/bjh.17363. Epub 2021 Feb 23.

Abstract

Ibrutinib is an established treatment for relapsed/refractory (R/R) mantle cell lymphoma (MCL) and clinical trial data supports use at second line compared to later relapse. We aimed to investigate outcomes and tolerability for ibrutinib when given second line in a real-world setting. Our multicentre retrospective analysis included 211 R/R MCL patients, median age 73 years, receiving ibrutinib second-line within the United Kingdom's National Health Service. Overall response to ibrutinib was 69% (complete response 27%). The median progression-free survival (PFS) was 17·8 months (95% CI 13·1-22·2) and median overall survival (OS) 23·9 months (95% CI 15·0-32·8). Drug-related adverse event led to dose reduction in 10% of patients and discontinuation in 5%. In patients with progressive disease, accounting for 100 of 152 patients stopping ibrutinib, 43% received further systemic therapy. Post-ibrutinib rituximab, bendamustine and cytarabine (R-BAC) showed a trend toward improved survival compared to alternative systemic treatments (post-ibrutinib median OS 14·0 months, 95% CI 8·1-19·8, vs. 3·6 months, 95% CI 2·6-4·5, P = 0·06). Our study confirms the clinical benefit and good tolerability of ibrutinib at first relapse in a real-world population. Patients progressing on ibrutinib had limited survival but outcomes with R-BAC in select patients were promising.

摘要

伊布替尼是一种已被确立的复发/难治性(R/R)套细胞淋巴瘤(MCL)治疗药物,临床试验数据支持将其作为二线治疗药物,优于后线复发时使用。我们旨在研究在真实环境下,伊布替尼作为二线治疗药物的疗效和耐受性。我们的多中心回顾性分析纳入了 211 例 R/R MCL 患者,中位年龄 73 岁,在英国国家医疗服务体系中接受伊布替尼二线治疗。伊布替尼总体缓解率为 69%(完全缓解率 27%)。中位无进展生存期(PFS)为 17.8 个月(95%CI 13.1-22.2),中位总生存期(OS)为 23.9 个月(95%CI 15.0-32.8)。药物相关不良事件导致 10%的患者减少剂量,5%的患者停药。在疾病进展的 152 例患者中,有 100 例停止使用伊布替尼,其中 43%的患者接受了进一步的系统治疗。伊布替尼后继发利妥昔单抗、苯达莫司汀和阿糖胞苷(R-BAC)与其他系统治疗相比,生存趋势有所改善(伊布替尼后继发中位 OS 为 14.0 个月,95%CI 8.1-19.8,而其他系统治疗中位 OS 为 3.6 个月,95%CI 2.6-4.5,P=0.06)。本研究证实了伊布替尼在真实人群中首次复发时的临床获益和良好的耐受性。伊布替尼进展的患者生存时间有限,但在某些患者中 R-BAC 的疗效有希望。

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