一项针对老年原发性中枢神经系统淋巴瘤患者的一线高剂量甲氨蝶呤化疗后伊布替尼维持治疗的2期研究。
A phase 2 study of ibrutinib maintenance following first-line high-dose methotrexate-based chemotherapy for elderly patients with primary central nervous system lymphoma.
发表日期:2023 Aug 12
作者:
Osnat Bairey, Alisa Taliansky, Amir Glik, Alexandra Amiel, Shlomit Yust-Katz, Ronit Gurion, Miri Zektser, Tzvika Porges, Nadav Sarid, Netanel A Horowitz, Tzahala Tzuk Shina, Eyal Lebel, Amos Cohen, Karyn Revital Geiger, Pia Raanani, Ofir Wolach, Tali Siegal
来源:
CANCER
摘要:
老年患者占所有初次发病中枢神经系统淋巴瘤(PCNSL)病例的近70%。他们无法耐受侵袭性治疗,预后较差,中位总生存期(OS)不足2年,无进展生存期(PFS)为6-16个月。伊布替尼能穿透血脑屏障,并在PCNSL中显示出活性。该前瞻性研究调查了伊布替尼维持治疗的可行性,并研究了其对老年PCNSL患者预期2年PFS的益处。此为开放标签、2期研究,针对60-85岁初次诊断的PCNSL患者,采用首线高剂量甲氨蝶呤(HDMTX)为基础的治疗,对其出现部分或完全缓解。伊布替尼维持治疗(560 mg/d)持续至疾病进展或耐受性不良。共招募20名患者,中位年龄72岁(范围61-80岁)。伊布替尼维持治疗的中位时间为12.5个月(范围2-46个月)。共有12名患者停止治疗:5例由于中枢神经系统复发,7例由于主要为2级的不良事件。总共有5名患者死亡(25%),均因复发。1年和2年的PFS分别为90%和72.6%,2年的OS为89%。该研究达到了主要终点,并显示出伊布替尼维持治疗在老年患者中耐受度较好。因此,该研究支持将伊布替尼维持治疗作为老年患者的可选择巩固措施进一步评估的概念。© 2023美国癌症协会。(Note: I have made slight changes to the translation for clarity and adherence to the academic paper pattern)
Elderly patients account for nearly 70% of all primary central nervous system lymphoma (PCNSL) cases. They cannot tolerate aggressive treatment and have poor prognosis with a median overall survival (OS) of less than 2 years and progression-free survival (PFS) of 6-16 months. Ibrutinib penetrates the blood-brain barrier and has shown activity in PCNSL.This prospective study investigated whether ibrutinib maintenance is feasible, and whether it can benefit elderly PCNSL patients in terms of expected 2-year PFS. It is an open label, phase 2 study in newly diagnosed PCNSL patients 60-85 years old who responded to first-line high-dose methotrexate (HDMTX)-based treatment with partial or complete response. Ibrutinib maintenance (560 mg/d) was continued until disease progression or intolerable toxicity.Twenty patients were enrolled, with a median age of 72 years (range, 61-80). Median time on ibrutinib maintenance was 12.5 (range, 2-46) months. Twelve patients stopped treatment: five due to central nervous system relapse and seven due to adverse events that were mainly grade 2. Five patients died (25%) all due to relapse. The 1- and 2-year PFS are 90% and 72.6%, respectively, and the 2-year OS is 89%.The study reached its primary end points and also showed that ibrutinib maintenance is tolerated reasonably well by the elderly. Therefore, this study supports the concept that ibrutinib maintenance should be further evaluated as an optional consolidation measure in the elderly.© 2023 American Cancer Society.