Phase 2 study of intrathecal, long-acting liposomal cytarabine in the prophylaxis of lymphomatous meningitis in human immunodeficiency virus-related non-Hodgkin lymphoma.
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.
Spina
Michele
M
Division of Medical Oncology A, National Cancer Institute, Via Franco Gallini 2, 33081-Aviano (PN) Italy. mspina@cro.it
Chimienti
Emanuela
E
Martellotta
Ferdinando
F
Vaccher
Emanuela
E
Berretta
Massimiliano
M
Zanet
Ernesto
E
Lleshi
Arben
A
Canzonieri
Vincenzo
V
Bulian
Pietro
P
Tirelli
Umberto
U
D000293:Adolescent; D000328:Adult; D003561:Cytarabine / Q000008:administration & dosage*; D004341:Drug Evaluation; D005260:Female; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D007278:Injections, Spinal; D008081:Liposomes; D016483:Lymphoma, AIDS-Related / Q000188:drug therapy*; D008228:Lymphoma, Non-Hodgkin / Q000150:complications* / Q000188:drug therapy*; D008297:Male; D055756:Meningeal Carcinomatosis / Q000517:prevention & control*; D008875:Middle Aged
D008081:Liposomes; D003561:Cytarabine