title: High-dose methotrexate-based immuno-chemotherapy for elderly primary CNS lymphoma patients (PRIMAIN study).
abstract: To investigate immuno-chemotherapy for elderly immuno-competent patients (⩾65 years) with newly diagnosed primary central nervous system lymphoma, we conducted a multicentre single-arm trial. One cycle consisted of rituximab (375 mg/m2, days 1, 15, 29), high-dose methotrexate (3 g/m2days 2, 16, 30), procarbazine (60 mg/m2days 2-11) and lomustine (110 mg/m2, day 2)-R-MPL protocol. Owing to infectious complications, we omitted lomustine during the study and consecutive patients were treated with the R-MP protocol. Three cycles were scheduled and repeated on day 43. Subsequently, patients commenced 4 weekly maintenance treatment with procarbazine (100 mg for 5 days). Primary end point was complete remission (CR) after 3 cycles. We included 107 patients (69 treated with R-MPL and 38 with R-MP). In all, 38/107 patients achieved CR (35.5%) and 15 (14.0%) achieved partial remission. R-MP was associated with a lower CR rate (31.6%) compared with R-MPL (37.7%), but respective 2-year progression-free survival (All 37.3%; R-MP 34.9%; R-MPL 38.8%) and overall survival (All 47.0%; R-MP 47.7%; R-MPL 46.0%) rates were similar. R-MP was associated with less ⩾grade 3 toxicities compared with R-MPL (71.1% vs 87.0%). R-MP is more feasible while still associated with similar efficacy compared with R-MPL and warrants further improvement in future studies.
authors.affiliation: Department of Haematology, Oncology and Stem Cell Transplantation, University Hospital Freiburg, Freiburg, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Fritsch
authors.affiliation: Department of Haematology/Oncology, Klinikum Stuttgart, Stuttgart, Germany.|Department of Medicine, Royal Marsden Hospital, London, UK.
authors.forename: B
authors.initials: B
authors.lastname: Kasenda
authors.affiliation: Department of Haematology, Oncology and Stem Cell Transplantation, University Hospital Freiburg, Freiburg, Germany.
authors.forename: E
authors.initials: E
authors.lastname: Schorb
authors.affiliation: Department of Neurology and Wilhelm Sander-NeuroOncology Unit, University Hospital Regensburg, Regensburg, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Hau
authors.affiliation: Department of Internal Medicine III, University of Ulm, Ulm, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Bloehdorn
authors.affiliation: Department of Medicine II, Hematology and Oncology, University of Tübingen, Tübingen, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Möhle
authors.affiliation: Department of Neurology, University Hospital Heidelberg, Heidelberg, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Löw
authors.affiliation: Department of Internal Medicine II, Oncology/Hematology/Bone Marrow Transplantation with the Section Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Binder
authors.affiliation: Department of Internal Medicine II, Center of Internal Medicine, Johann Wolfgang Goethe-University, Frankfurt, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Atta
authors.affiliation: III Medical Department, Technische Universität München, Munich, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Keller
authors.affiliation: Department of Haematology and Oncology, University Hospital Halle, Halle, Germany.
authors.forename: H-H
authors.initials: HH
authors.lastname: Wolf
authors.affiliation: Department of Internal Medicine 5, Universitätsklinik Erlangen, Erlangen, Germany.
authors.forename: S W
authors.initials: SW
authors.lastname: Krause
authors.affiliation: Department of Hematology/Oncology, Johannes Gutenberg University, Mainz, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Heß
authors.affiliation: Department of Internal Medicine, Gemeinschaftsklinikum Mittelrhein, Koblenz, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Naumann
authors.affiliation: Department of Internal Medicine I, University Hospital of Cologne, Cologne, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Sasse
authors.affiliation: Department of Internal Medicine C (Haematology and Oncology, Marrow Transplantation), Ernst-Moritz-Arndt-University Greifswald, Greifswald, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Hirt
authors.affiliation: Department of Internal Medicine II, University Hospital of Schleswig-Holstein, Kiel, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Lamprecht
authors.affiliation: Department of Hematology/Oncology, Cancer Center Heilbronn-Franken, Heilbronn, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Martens
authors.affiliation: Department of Internal Medicine III, Klinikum Chemnitz GmbH, Chemnitz, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Morgner
authors.affiliation: Department of Hematology, Oncology and Stem Cell Transplantation, Medical Faculty, RWTH Aachen University, Aachen, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Panse
authors.affiliation: Department of Hematology and Oncology, HELIOS Dr-Horst-Schmidt-Kliniken, Wiesbaden, Germany.
authors.forename: N
authors.initials: N
authors.lastname: Frickhofen
authors.affiliation: Department of Haematology, West German Cancer Centre, University Hospital Essen, Essen, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Röth
authors.affiliation: Department of Neuro-Radiology, University Hospital Freiburg, Freiburg, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Hader
authors.affiliation: Institute of Neuropathology, University Hospital of Cologne, Cologne, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Deckert
authors.affiliation: Department of Haematology, Oncology and Stem Cell Transplantation, University Hospital Freiburg, Freiburg, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Fricker
authors.affiliation: Clinical Trials Unit, Medical Centre - University of Freiburg, Freiburg, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Ihorst
authors.affiliation: Department of Haematology, Oncology and Stem Cell Transplantation, University Hospital Freiburg, Freiburg, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Finke
authors.affiliation: Department of Haematology, Oncology and Stem Cell Transplantation, University Hospital Freiburg, Freiburg, Germany.|Department of Haematology/Oncology, Klinikum Stuttgart, Stuttgart, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Illerhaus
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016543:Central Nervous System Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage; D008223:Lymphoma / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D011788:Quality of Life; D012074:Remission Induction; D016896:Treatment Outcome; D047368:Tumor Burden
chemical_list: D007155:Immunologic Factors; D008727:Methotrexate