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55 例双重难治性滤泡性淋巴瘤患者中伊德拉利昔布的实际疗效和安全性。

Real-life efficacy and safety of idelalisib in 55 double-refractory follicular lymphoma patients.

机构信息

Hematology and Stem Cell Transplant Center, AORMN Hospital, Pesaro, Italy.

UOC di Ematologia San Giovanni Rotondo, San Giovanni Rotondo, Italy.

出版信息

Br J Haematol. 2022 Nov;199(3):339-343. doi: 10.1111/bjh.18426. Epub 2022 Aug 24.

Abstract

Idelalisib, a reversible inhibitor of PI3Kδ (phosphoinositide-3 kinase delta), showed remarkable activity in the phase II DELTA trial, leading to its approval by the European Medicines Agency (EMA) in patients with relapsed/refractory (R/R) follicular lymphoma (FL). However, real-life data on idelalisib are scarce. We treated 55 double-refractory FL patients with idelalisib in a real-life setting. With a median exposure to idelalisib of 10 months (range 1-43), overall response rate was 73%, the highest ever reported. Non-haematological toxicities were mild and manageable. At 12 months, 80% of patients were alive, and 72% disease-free. The efficacy and safety of idelalisib was confirmed in a real-life setting.

摘要

依鲁替尼,一种可逆的 PI3Kδ(磷酸肌醇-3 激酶 δ)抑制剂,在 II 期 DELTA 试验中表现出显著的活性,导致其在复发/难治性(R/R)滤泡性淋巴瘤(FL)患者中获得欧洲药品管理局(EMA)的批准。然而,依鲁替尼的真实世界数据很少。我们在真实环境中用依鲁替尼治疗了 55 例双难治性 FL 患者。依鲁替尼中位暴露时间为 10 个月(范围 1-43),总缓解率为 73%,是以往报道中最高的。非血液学毒性轻微且可管理。在 12 个月时,80%的患者存活,72%无疾病。依鲁替尼在真实环境中的疗效和安全性得到了证实。

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