Department of Neurosurgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
Genexine, Inc., Seongnam-si, Gyeonggi-do, South Korea.
Cancer Med. 2023 Mar;12(6):6778-6787. doi: 10.1002/cam4.5467. Epub 2022 Dec 30.
Addressing lymphopenia in cancer patients has been suggested as a novel immunotherapeutic strategy. As interleukin-7 (IL-7) is necessary for proliferation of lymphocytes and to increase total lymphocyte count (TLC), IL-7 therapy has been attempted in various cancers. Here, we describe the clinical results of treatment of recurrent glioblastoma (GBM) with a long-acting engineered version of recombinant human IL-7 (rhIL-7-hyFc).
This prospective case series based on compassionate use was approved by the Ministry of Food and Drug Safety in South Korea. Primary outcomes were safety profile and TLC. Secondary outcomes were overall survival (OS) and progression-free survival (PFS).
Among the 18 patients enrolled, 10 received rhIL-7-hyFc with temozolomide, 5 received rhIL-7-hyFc with bevacizumab, 1 received rhIL-7-hyFc with PCV chemotherapy, and 2 received rhIL-7-hyFc alone. Mean TLC of the enrolled patients after the first rhIL-7-hyFc treatment increased significantly from 1131 cells/mm (330-2989) at baseline to 4356 cells/mm (661-22,661). Higher TLCs were maintained while rhIL-7-hyFc was repeatedly administered. Median OS and PFS were 378 days (107-864 days) and 231 days (55-726 days), respectively.
Our study reports that IL-7 immunotherapy can restore and maintain TLC during treatment with various salvage chemotherapies in recurrent GBM patients without serious toxicity.
有研究提出，治疗癌症患者的淋巴细胞减少症可能是一种新的免疫治疗策略。由于白细胞介素 7（IL-7）对于淋巴细胞的增殖和总淋巴细胞计数（TLC）的增加是必需的，因此已尝试在各种癌症中使用 IL-7 治疗。在此，我们描述了使用长效工程化重组人白细胞介素 7（rhIL-7-hyFc）治疗复发性胶质母细胞瘤（GBM）的临床结果。
本前瞻性基于同情使用的病例系列研究得到了韩国食品和药物安全部的批准。主要结局为安全性概况和 TLC。次要结局为总生存期（OS）和无进展生存期（PFS）。
在纳入的 18 名患者中，10 名接受 rhIL-7-hyFc 联合替莫唑胺治疗，5 名接受 rhIL-7-hyFc 联合贝伐单抗治疗，1 名接受 rhIL-7-hyFc 联合 PCV 化疗治疗，2 名单独接受 rhIL-7-hyFc 治疗。接受首次 rhIL-7-hyFc 治疗后，纳入患者的平均 TLC 从基线时的 1131 个细胞/mm³（330-2989 个细胞/mm³）显著增加到 4356 个细胞/mm³（661-22661 个细胞/mm³）。重复给予 rhIL-7-hyFc 时，可维持较高的 TLC。中位 OS 和 PFS 分别为 378 天（107-864 天）和 231 天（55-726 天）。
我们的研究报告称，IL-7 免疫疗法可在复发性 GBM 患者接受各种挽救性化疗时恢复和维持 TLC，且无严重毒性。
