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      High-dose methotrexate-based immuno-chemotherapy for elderly primary CNS lymphoma patients (PRIMAIN study)

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          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/m 2, days 1, 15, 29), high-dose methotrexate (3 g/m 2 days 2, 16, 30), procarbazine (60 mg/m 2 days 2–11) and lomustine (110 mg/m 2, 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.

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          Estimation of failure probabilities in the presence of competing risks: new representations of old estimators.

          A topic that has received attention in both the statistical and medical literature is the estimation of the probability of failure for endpoints that are subject to competing risks. Despite this, it is not uncommon to see the complement of the Kaplan-Meier estimate used in this setting and interpreted as the probability of failure. If one desires an estimate that can be interpreted in this way, however, the cumulative incidence estimate is the appropriate tool to use in such situations. We believe the more commonly seen representations of the Kaplan-Meier estimate and the cumulative incidence estimate do not lend themselves to easy explanation and understanding of this interpretation. We present, therefore, a representation of each estimate in a manner not ordinarily seen, each representation utilizing the concept of censored observations being 'redistributed to the right.' We feel these allow a more intuitive understanding of each estimate and therefore an appreciation of why the Kaplan-Meier method is inappropriate for estimation purposes in the presence of competing risks, while the cumulative incidence estimate is appropriate.
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            Report of an international workshop to standardize baseline evaluation and response criteria for primary CNS lymphoma.

            Standardized guidelines for the baseline evaluation and response assessment of primary CNS lymphoma (PCNSL) are critical to ensure comparability among clinical trials for newly diagnosed patients. The relative rarity of this tumor precludes rapid completion of large-scale phase III trials and, therefore, our reliance on the results of well-designed phase II trials is critical. To formulate this recommendation, an international group of experts representing hematologic oncology, medical oncology, neuro-oncology, neurology, radiation oncology, neurosurgery, and ophthalmology met to review current standards of reporting and to formulate a consensus opinion regarding minimum baseline evaluation and common standards for assessing response to therapy. The response guidelines were based on the results of neuroimaging, corticosteroid use, ophthalmologic examination, and CSF cytology. A critical issue that requires additional study is the optimal method to assess the neurocognitive impact of therapy and address the quality of life of PCNSL survivors. We hope that these guidelines will improve communication among investigators and comparability among clinical trials in a way that will allow us to develop better therapies for patients.
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              Chemoimmunotherapy with methotrexate, cytarabine, thiotepa, and rituximab (MATRix regimen) in patients with primary CNS lymphoma: results of the first randomisation of the International Extranodal Lymphoma Study Group-32 (IELSG32) phase 2 trial

              Standard treatment for patients with primary CNS lymphoma remains to be defined. Active therapies are often associated with increased risk of haematological or neurological toxicity. In this trial, we addressed the tolerability and efficacy of adding rituximab with or without thiotepa to methotrexate-cytarabine combination therapy (the MATRix regimen), followed by a second randomisation comparing consolidation with whole-brain radiotherapy or autologous stem cell transplantation in patients with primary CNS lymphoma. We report the results of the first randomisation in this Article.
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                Author and article information

                Journal
                Leukemia
                Leukemia
                Leukemia
                Nature Publishing Group
                0887-6924
                1476-5551
                April 2017
                15 November 2016
                09 December 2016
                : 31
                : 4
                : 846-852
                Affiliations
                [1 ]Department of Haematology, Oncology and Stem Cell Transplantation, University Hospital Freiburg , Freiburg, Germany
                [2 ]Department of Haematology/Oncology, Klinikum Stuttgart , Stuttgart, Germany
                [3 ]Department of Medicine, Royal Marsden Hospital , London, UK
                [4 ]Department of Neurology and Wilhelm Sander-NeuroOncology Unit, University Hospital Regensburg , Regensburg, Germany
                [5 ]Department of Internal Medicine III, University of Ulm , Ulm, Germany
                [6 ]Department of Medicine II, Hematology and Oncology, University of Tübingen , Tübingen, Germany
                [7 ]Department of Neurology, University Hospital Heidelberg , Heidelberg, Germany
                [8 ]Department of Internal Medicine II, Oncology/Hematology/Bone Marrow Transplantation with the Section Pneumology, University Medical Center Hamburg-Eppendorf , Hamburg, Germany
                [9 ]Department of Internal Medicine II, Center of Internal Medicine, Johann Wolfgang Goethe-University , Frankfurt, Germany
                [10 ]III Medical Department, Technische Universität München , Munich, Germany
                [11 ]Department of Haematology and Oncology, University Hospital Halle , Halle, Germany
                [12 ]Department of Internal Medicine 5, Universitätsklinik Erlangen , Erlangen, Germany
                [13 ]Department of Hematology/Oncology, Johannes Gutenberg University , Mainz, Germany
                [14 ]Department of Internal Medicine, Gemeinschaftsklinikum Mittelrhein , Koblenz, Germany
                [15 ]Department of Internal Medicine I, University Hospital of Cologne , Cologne, Germany
                [16 ]Department of Internal Medicine C (Haematology and Oncology, Marrow Transplantation), Ernst-Moritz-Arndt-University Greifswald , Greifswald, Germany
                [17 ]Department of Internal Medicine II, University Hospital of Schleswig-Holstein , Kiel, Germany
                [18 ]Department of Hematology/Oncology, Cancer Center Heilbronn-Franken , Heilbronn, Germany
                [19 ]Department of Internal Medicine III, Klinikum Chemnitz GmbH , Chemnitz, Germany
                [20 ]Department of Hematology, Oncology and Stem Cell Transplantation, Medical Faculty, RWTH Aachen University , Aachen, Germany
                [21 ]Department of Hematology and Oncology, HELIOS Dr-Horst-Schmidt-Kliniken , Wiesbaden, Germany
                [22 ]Department of Haematology, West German Cancer Centre, University Hospital Essen , Essen, Germany
                [23 ]Department of Neuro-Radiology, University Hospital Freiburg , Freiburg, Germany
                [24 ]Institute of Neuropathology, University Hospital of Cologne , Cologne, Germany
                [25 ]Clinical Trials Unit, Medical Centre - University of Freiburg , Freiburg, Germany
                Author notes
                [* ]Department of Haematology/Oncology, Klinikum Stuttgart , Kriegsbergstrasse 60, Stuttgart 70174, Germany. E-mail: g.illerhaus@ 123456klinikum-stuttgart.de
                [26]

                These authors contributed equally to this work.

                Article
                leu2016334
                10.1038/leu.2016.334
                5383936
                27843136
                065b5bf5-8b18-40c3-ab6b-9edff21a3058
                Copyright © 2017 The Author(s)

                This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License. The images or other third party material in this article are included in the article's Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/

                History
                : 25 August 2016
                : 10 October 2016
                : 21 October 2016
                Categories
                Original Article

                Oncology & Radiotherapy
                Oncology & Radiotherapy

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