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Abstract：
The phase 2 study of idelalisib monotherapy for indolent non-Hodgkin lymphomas (iNHLs) was completed in 2018; final efficacy and safety data with up to 6.7 years long-term follow-up are reported. Patients with iNHL refractory to both rituximab and an alkylating agent were enrolled and received 150 mg idelalisib twice daily (N = 125). Idelalisib resulted in an overall response rate of 57.6% with 34.4% continuing therapy for ≥12 months. The median progression-free survival and duration of response were 11.0 and 11.8 months for follicular lymphoma, 22.2 and 20.4 months for lymphoplasmacytic lymphoma/Waldenström\'s macroglobulinemia (LPL/WM), and 6.6 and 18.4 months for marginal zone lymphoma (MZL). Median overall survival after extended follow-up was 48.6 (95% CI 33.9, 71.7) months. Long-term follow-up did not reveal new safety concerns. These data indicate beneficial outcomes with longer follow-up after idelalisib for treatment of iNHL including in patients with LPL/WM and MZL.
摘要：
idelalisib单药治疗惰性非霍奇金淋巴瘤（iNHL）的2期研究于2018年完成；报告了长达6.7年长期随访的最终疗效和安全性数据。纳入对利妥昔单抗和烷化剂均无效的iNHL患者，每天两次接受150mgidelalisib（N=125）。Idelalisib的总体缓解率为57.6％，其中34.4％的患者继续治疗≥12个月。滤泡性淋巴瘤的中位无进展生存期和缓解持续时间分别为11.0和11.8个月，淋巴浆细胞性淋巴瘤/Waldenström巨球蛋白血症（LPL/WM）的22.2和20.4个月，边缘区淋巴瘤（MZL）为6.6个月和18.4个月。延长随访后的中位总生存期为48.6个月(95%CI33.9,71.7)。长期随访没有发现新的安全问题。这些数据表明，在idelalisib治疗iNHL后，包括LPL/WM和MZL患者的随访时间更长，具有有益的结果。
