Hematology and Stem Cell Transplant Center, AORMN Hospital, Pesaro, Italy.
UOC di Ematologia San Giovanni Rotondo, San Giovanni Rotondo, Italy.
Br J Haematol. 2022 Nov;199(3):339-343. doi: 10.1111/bjh.18426. Epub 2022 Aug 24.
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.
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。
