Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.
Leuk Lymphoma. 2021 May;62(5):1077-1087. doi: 10.1080/10428194.2020.1855344. Epub 2020 Dec 10.
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 ( = 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.
2018 年完成了伊德拉利昔单抗单药治疗惰性非霍奇金淋巴瘤（iNHL）的 2 期研究；报告了最长 6.7 年的随访的最终疗效和安全性数据。招募了对利妥昔单抗和烷化剂均耐药的 iNHL 患者，并接受 150mg 伊德拉利昔单抗，每日两次（ = 125）。伊德拉利昔单抗的总缓解率为 57.6%，34.4%的患者持续治疗≥12 个月。滤泡性淋巴瘤的无进展生存期和缓解持续时间中位数分别为 11.0 和 11.8 个月，淋巴浆细胞淋巴瘤/华氏巨球蛋白血症（LPL/WM）为 22.2 和 20.4 个月，边缘区淋巴瘤（MZL）为 6.6 和 18.4 个月。延长随访后的中位总生存期为 48.6（95%CI 33.9, 71.7）个月。长期随访未发现新的安全性问题。这些数据表明，伊德拉利昔单抗治疗 iNHL 的长期随访后，包括 LPL/WM 和 MZL 患者，有更好的获益。
