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Updated results from NABTT
CNS consortium studies in primary CNS lymphoma
T. Batchelor, S. Grossman, K. Carson, J. Fisher
Massachusetts General Hospital, Boston, MA; Johns Hopkins
Oncology Center, Baltimore, MD
Background.
Optimal therapy for patients with newly diagnosed PCNSL has
not been defined.
Methods.
From 6/98-12/99, The New Approaches to Brain Tumor Therapy
(NABTT) CNS consortium conducted a phase 2 trial of high dose methotrexate (MTX)
without radiation (J Clin Oncol 2003; 21:1044-1049).
We now report longer-term follow-up data from this study
as well as preliminary results from our ongoing phase 2 study.
Results.
In the initial study, 25 patients with a median age of 60 and
median KPS of 80 were treated with MTX at an intravenous (i.v.) dose of 8 g/m2
for up to 8 induction cycles every 14 days, 2 consolidation cycles every 14 days
and 11 maintenance cycles every 28 days.
There were 12/23 (52%) complete responses (CR); 5/23 (22%)
partial responses; 1/23 (4%) stable disease and 5/23 (22%) progressions during
treatment.
In the 12 patients who achieved CR the median number of
cycles to CR was 6.
The median progression free survival was 12.8 months and
median overall survival has not been reached at 47.6 months.
Based on these promising results a second study was
initiated combining MTX (8 g/m2 i.v. every 14 days) with thio-TEPA (2
mg/kg i.v. every 14 days).
The first 3 patients treated with this regimen each
achieved a CR after a median of 4 cycles of chemotherapy and remain in CR at
280, 313, and 340 days.
Myelosuppression was prohibitive and the thio-TEPA dose
was reduced to 2 mg/kg every 28 days for subsequent patients.
Conclusions.
Overall survival with high dose MTX monotherapy compares
favorably with results reported with more toxic, chemotherapy plus radiation
strategies.
Early results from the NABTT protocol using MTX and
thio-TEPA suggest that this combination might reduce the time to CR and increase
the percentage of patients achieving CR.
Copyright 2004 American Society of Clinical Oncology All rights
reserved worldwide.
Source: http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-003691,00.asp
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