Randomized trial of a slow-release versus a standard formulation of cytarabine for the intrathecal treatment of lymphomatous meningitis

Michael J. Glantz, Suzanne LaFollette, Kurt A. Jaeckle, William Shapiro, Lode Swinnen, Jack R. Rozental, Surasak Phuphanich, Lisa R. Rogers, John C. Gutheil, Tracy Batchelor, David Lyter, Marc Chamberlain, Bernard L. Maria, Charles Schiffer, Rifaat Bashir, David Thomas, Wayne Cowens, Stephen B. Howell*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

366 Scopus citations


Purpose: To evaluate the efficacy and safety of a slow-release formulation of cytarabine (DepoCyt; Chiron Corp, Emeryville, CA, and Skye Pharma, Inc, San Diego, CA) that maintains cytotoxic concentrations of cytarabine (ara-C) in the CSF of most patients for more than 14 days. Patients and Methods: Twenty-eight patients with lymphoma and a positive CSF cytology were randomized to receive DepoCyt 50 mg once every 2 weeks or free ara-C 50 mg twice a week for 1 month. Patients whose CSF cytology converted to negative and who did not have neurologic progression received an additional 3 months of consolidation therapy and then 4 months of maintenance therapy. All patients received dexamethasone 4 mg orally bid on days 1 through 5 of each 2-week cycle. Results: The response rate was 71% for DepoCyt and 15% for ara-C on an intent-to-treat basis (P = .006). All of the patients on the DepoCyt arm but only 53% of those on the ara-C arm were able to complete the planned 1-month induction therapy regimen. Time to neurologic progression and survival trended in favor of DepoCyt (median, 78.5 v 42 days and 99.5 v 63 days, respectively; P > .05). DepoCyt treatment was associated with an improved mean change in Karnofsky performance score at the end of induction (P = .041). The major adverse events on both arms were headache and arachnoiditis, which were often caused by the underlying disease. Conclusion: DepoCyt injected once every 2 weeks produced a high response rate and a better quality of life as measured by Karnofsky score relative to that produced by free ara-C injected twice a week.

Original languageEnglish (US)
Pages (from-to)3110-3116
Number of pages7
JournalJournal of Clinical Oncology
Issue number10
StatePublished - Oct 1999

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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