A phase 2 study of ibrutinib maintenance following first-line high-dose methotrexate-based chemotherapy for elderly patients with primary central nervous system lymphoma

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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Background: 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. Methods: 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. Results: 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%. Conclusions: 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.

Original languageEnglish
Pages (from-to)3905-3914
Number of pages10
JournalCancer
Volume129
Issue number24
DOIs
StatePublished - 15 Dec 2023

Keywords

  • elderly
  • ibrutinib
  • maintenance treatment
  • primary central nervous system lymphoma

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