Phase 2 study of intrathecal, long-acting liposomal cytarabine in the prophylaxis of lymphomatous meningitis in human immunodeficiency virus-related non-Hodgkin lymphoma

Cancer. 2010 Mar 15;116(6):1495-501. doi: 10.1002/cncr.24922.

Abstract

Background: Patients with aggressive non-Hodgkin lymphoma (NHL) develop central nervous system (CNS) progression or recurrence during the course of their disease. Patients with human immunodeficiency virus (HIV)-NHL often develop CNS progression despite the use of prophylaxis. Liposomal cytarabine (DepoCyte) has shown activity in lymphomatous meningitis, but there are limited data for prophylaxis.

Methods: Between May 2006 and December 2008, a phase 2 study of intrathecal liposomal cytarabine was performed at the dose of 50 mg in 30 patients with HIV-NHL, with the aim of evaluating feasibility and activity for prophylaxis.

Results: Liposomal cytarabine was well tolerated, with headache grade I to III being the most frequent side effect in 40% of patients. With a median follow-up of 10.5 months, only 1 (3%) patient developed a combined systemic and meningeal recurrence. The use of liposomal cytarabine allowed significant reduction of the number of lumbar injections in comparison to the standard schedules (around 50%), improving the quality of life of patients and reducing the professional exposure risk.

Conclusions: In this first study on prophylaxis of lymphomatous meningitis in HIV-NHL, liposomal cytarabine seems safe and active; it reduces by approximately 50% the number of lumbar punctures, and exposure risk for health staff as well.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adolescent
  • Adult
  • Cytarabine / administration & dosage*
  • Drug Evaluation
  • Female
  • HIV Infections / complications*
  • Humans
  • Injections, Spinal
  • Liposomes*
  • Lymphoma, AIDS-Related / drug therapy*
  • Lymphoma, Non-Hodgkin / complications*
  • Lymphoma, Non-Hodgkin / drug therapy*
  • Male
  • Meningeal Carcinomatosis / prevention & control*
  • Middle Aged

Substances

  • Liposomes
  • Cytarabine