NEW YORK -- September 24, 2009 -- Combining cytarabine with conventional monochemotherapy (high-dose methotrexate) improves remission rates in patients with primary central nervous system (CNS) lymphoma, according to a study published online first and in an upcoming edition of The Lancet.
Andrés J. M. Ferreri, MD, San Raffaele H Scientific Institute, Milan, Italy, and colleagues from the International Extranodal Lymphoma Study Group (IELSG), assess the effect of adding high-dose cytarabine to methotrexate in patients with newly diagnosed primary CNS lymphoma.
The international, multicentre, phase 2 study included 79 patients aged 18 to 75 years with non-Hodgkin lymphoma exclusively localised into the CNS, cranial nerves, or eyes. Patients were given 4 courses of either methotrexate 3.5 g/m˛ on day 1 (n = 40) or methotrexate 3.5 g/m˛ on day 1 plus cytarabine 2 g/m˛ twice a day on days 2 and 3 (n = 39).
Both regimens were administered every 3 weeks and were followed by whole-brain irradiation. The primary endpoint was complete remission rate after chemotherapy.
The researchers found that, after chemotherapy, 7 patients given methotrexate and 18 given methotrexate plus cytarabine achieved a complete remission, with a complete remission rate of 18% and 46%, respectively.
Nine patients receiving methotrexate and 9 receiving methotrexate plus cytarabine achieved a partial response, with an overall response rate of 40% and 69%, respectively.
As expected, a higher, but manageable, blood toxicity rate was observed in the methotrexate plus cytarabine group than in the methotrexate group (92% vs 15%), and 4 patients died of toxic effects (3 vs 1).
Importantly, the drugs combination was associated with a significantly lower proportion of patients experiencing lymphoma relapse with respect to methotrexate alone, with a 20% improvement in the progression-free survival at 3 years.
"The addition of high-dose cytarabine to high-dose methotrexate is associated with a remarkable outcome benefit in patients with primary CNS lymphoma," the authors concluded. "This combination could be used as an upfront approach in patients aged 75 years and younger and with adequate liver and kidney function, with appropriate antimicrobial prophylaxis."
SOURCE: The Lancet
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