title: German Cancer Society Neuro-Oncology Working Group NOA-03 multicenter trial of single-agent high-dose methotrexate for primary central nervous system lymphoma.
abstract: The prospective multicenter NOA-03 trial, conducted by the Neuro-Oncology Working Group (NOA) of the German Cancer Society, was initiated to define the feasibility and efficacy of single-agent high-dose methotrexate therapy without concomitant radiotherapy in immunocompetent patients with primary central nervous system lymphoma. Thirty-seven patients (median age, 60 years) received 179 biweekly courses of 8 g/m2 methotrexate. Response was assessed after 3 and 6 courses. We had planned to enter 105 patients into the trial. Since fewer than the projected 18 of 37 patients achieved a complete response after an intermediate analysis, the trial was closed. In intention-to-treat analysis, 11 of 37 patients (29.7%) achieved complete response, whereas 14 of 37 patients (37.8%) were found to have progressive disease. The median relapse-free survival among complete response patients was 13.7 months. Multivariate logistic regression analysis revealed that corticosteroid application during the first methotrexate course was associated with complete response. The regimen was well tolerated, but, unlike previously reported results, the activity of high-dose methotrexate was only moderate.
authors.affiliation: Department of Neurology, University of Tübingen, Tübingen, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Herrlinger
authors.forename: Martin
authors.initials: M
authors.lastname: Schabet
authors.forename: Wolfram
authors.initials: W
authors.lastname: Brugger
authors.forename: Rolf-Dieter
authors.initials: RD
authors.lastname: Kortmann
authors.forename: Wilhelm
authors.initials: W
authors.lastname: Küker
authors.forename: Martina
authors.initials: M
authors.lastname: Deckert
authors.forename: Corinna
authors.initials: C
authors.lastname: Engel
authors.forename: Hans-Jürgen
authors.initials: HJ
authors.lastname: Schmeck-Lindenau
authors.forename: Hans-Günther
authors.initials: HG
authors.lastname: Mergenthaler
authors.forename: Peter
authors.initials: P
authors.lastname: Krauseneck
authors.forename: Christian
authors.initials: C
authors.lastname: Benöhr
authors.forename: Christoph
authors.initials: C
authors.lastname: Meisner
authors.forename: Otmar D
authors.initials: OD
authors.lastname: Wiestler
authors.forename: Johannes
authors.initials: J
authors.lastname: Dichgans
authors.forename: Lothar
authors.initials: L
authors.lastname: Kanz
authors.forename: Michael
authors.initials: M
authors.lastname: Bamberg
authors.forename: Michael
authors.initials: M
authors.lastname: Weller
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D016543:Central Nervous System Neoplasms / Q000188:drug therapy* / Q000453:epidemiology; D018572:Disease-Free Survival; D006801:Humans; D008223:Lymphoma / Q000188:drug therapy* / Q000453:epidemiology; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D015999:Multivariate Analysis; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D008727:Methotrexate