Details

Autor(en) / Beteiligte

• GLANTZ, M. J
• JAECKLE, K. A
• HOWELL, S. B
• CHAMBERLAIN, M. C
• PHUPHANICH, S
• RECHT, L
• SWINNEN, L. J
• MARIA, B
• LAFOLLETTE, S
• SCHUMANN, G. B
• COLE, B. F

Titel

A Randomized Controlled Trial Comparing Intrathecal Sustained-release Cytarabine (DepoCyt) to Intrathecal Methotrexate in Patients with Neoplastic Meningitis from Solid Tumors

Ist Teil von

• Clinical cancer research, 1999-11, Vol.5 (11), p.3394-3402

Ort / Verlag

Philadelphia, PA: American Association for Cancer Research

Erscheinungsjahr

1999

Quelle

MEDLINE

Beschreibungen/Notizen

• Standard treatment for neoplastic meningitis requires frequent intrathecal (IT) injections of chemotherapy and is only modestly effective. DepoCyt is a sustained-release formulation of cytarabine that maintains cytotoxic concentrations of the drug in the cerebrospinal fluid (CSF) for more than 14 days after a single 50-mg injection. We conducted a randomized, controlled trial of DepoCyt versus methotrexate in patients with solid tumor neoplastic meningitis. Sixty-one patients with histologically proven cancer and positive CSF cytologies were randomized to receive IT DepoCyt (31 patients) or IT methotrexate (30 patients). Patients received up to six 50-mg doses of DepoCyt or up to sixteen 10-mg doses of methotrexate over 3 months. Treatment arms were well balanced with respect to demographic and disease-related characteristics. Responses occurred in 26% of DepoCyt-treated and 20% of methotrexate-treated patients ( P = 0.76). Median survival was 105 days in the DepoCyt arm and 78 days in the methotrexate arm (log-rank P = 0.15). The DepoCyt group experienced a greater median time to neurological progression (58 versus 30 days; log-rank P = 0.007) and longer neoplastic meningitis-specific survival (log-rank P = 0.074; median meningitis-specific survival, 343 versus 98 days). Factors predictive of longer progression-free survival included absence of visible central nervous system disease on neuroimaging studies ( P < 0.001), longer pretreatment duration of CSF disease ( P < 0.001), history of intraparenchymal tumor ( P < 0.001), and treatment with DepoCyt ( P = 0.002). The frequency and grade of adverse events were comparable between treatment arms. In patients with solid tumor neoplastic meningitis, DepoCyt produced a response rate comparable to that of methotrexate and significantly increased the time to neurological progression while offering the benefit of a less demanding dose schedule.