High-dose intravenous (IV) methotrexate produces similar results as intrathecal (IT) methotrexate when used to prevent central nervous system (CNS) relapse in patients with high-risk diffuse large B-cell lymphoma (DLBCL), according to research presented at the EHA 2023 Hybrid Congress.

The 2-year incidence of CNS relapse was similar for patients who received IV methotrexate and those who received IT methotrexate in a phase 3 trial, said Seung-Ah Yahng, MD, of Incheon St. Mary’s Hospital in Seoul, South Korea, when presenting the trial’s results.

The trial (ClinicalTrials.gov Identifier: NCT03123718) included 151 patients with newly diagnosed DLBCL who had no evidence of CNS involvement at baseline but a high risk of CNS relapse.

The patients were randomly assigned to receive IT methotrexate (n=76) or IV methotrexate (n=75) along with standard chemoimmunotherapy (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone). Baseline characteristics were well balanced between the arms.

Continue Reading

The median follow-up was 24.6 months. The study’s primary endpoint was the cumulative incidence of CNS relapse at 2 years, which was 5.3% in the overall cohort. 

The incidence of CNS relapse at 2 years was 5.6% in the IT methotrexate arm and 5.0% in the IV methotrexate arm (P =.749). The median time to CNS relapse was 4.42 months in the IT methotrexate arm and 12.07 months in the IV methotrexate arm. 

The progression-free survival rate at 2 years was 68.1% overall. It was 70.2% in the IT methotrexate arm and 65.9% in the IV methotrexate arm (P =.607).

IV and IT methotrexate were both tolerable, according to Dr Yahng. 

Disclosures: Dr Yahng reported having no conflicts of interest. No other disclosures were provided.


Yahng S-A, Yhim H-Y, Kwak J-Y, et al. Prophylactic efficacy of intrathecal versus intravenous methotrexate for CNS relapse in high-risk diffuse large B cell lymphoma: A phase III randomized, controlled study. EHA 2023. June 8-11, 2023. Abstract S229.

This article originally appeared on Cancer Therapy Advisor