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Kasenda, Benjamin; Ihorst, Gabriele; Schroers, Roland; Korfel, Agnieszka; Schmidt-Wolf, Ingo GH; Egerer, Gerlinde; von Baumgarten, Louisa; Röth, Alexander; Stilgenbauer, Stephan; Möhle, Robert; Binder, Mascha; Keller, Ulrich; Lamprecht, Monika; Wolf, Hans-Heinrich; Pfreundschuh, Michael; Valk, Elke; Fricker, Heidi; Elisabeth, Schorb; Kristina, Fritsch; Finke, Jürgen; Illerhaus, Gerald

High-Dose Chemotherapy with Autologous Hematopoietic Stem Cell Support for Relapsed or Refractory Primary CNS Lymphoma - a Prospective Multicentre Trial By the German Cooperative PCNSL Study Group

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  • Medientyp: E-Artikel
  • Titel: High-Dose Chemotherapy with Autologous Hematopoietic Stem Cell Support for Relapsed or Refractory Primary CNS Lymphoma - a Prospective Multicentre Trial By the German Cooperative PCNSL Study Group
  • Beteiligte: Kasenda, Benjamin; Ihorst, Gabriele; Schroers, Roland; Korfel, Agnieszka; Schmidt-Wolf, Ingo GH; Egerer, Gerlinde; von Baumgarten, Louisa; Röth, Alexander; Stilgenbauer, Stephan; Möhle, Robert; Binder, Mascha; Keller, Ulrich; Lamprecht, Monika; Wolf, Hans-Heinrich; Pfreundschuh, Michael; Valk, Elke; Fricker, Heidi; Elisabeth, Schorb; Kristina, Fritsch; Finke, Jürgen; Illerhaus, Gerald
  • Erschienen: American Society of Hematology, 2016
  • Erschienen in: Blood
  • Sprache: Englisch
  • DOI: 10.1182/blood.v128.22.781.781
  • ISSN: 0006-4971; 1528-0020
  • Schlagwörter: Cell Biology ; Hematology ; Immunology ; Biochemistry
  • Entstehung:
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  • Beschreibung: <jats:title>Abstract</jats:title> <jats:p /> <jats:p>Purpose</jats:p> <jats:p>To investigate safety and efficacy of high-dose chemotherapy followed by autologous stem cell transplantation (HCT-ASCT) in patients with relapsed or refractory primary CNS lymphoma (PCNSL).</jats:p> <jats:p>Patients and methods</jats:p> <jats:p>We conducted a single-arm multicentre phase 2 study for immunocompetent patients (&lt;66 years of age) with PCNSL failing prior HD-MTX based chemotherapy. Induction treatment consisted of 2 courses of rituximab (rituximab 375mg/m2), high-dose cytarabine (2 x 3g/m2) and thiotepa (40mg/m2) with collection of autologous stem cells in between. Conditioning treatment for HCT-ASCT consisted of rituximab 375mg/m2, carmustine 400mg/m2 and thiotepa (4 x 5mg/kg). Patients commenced HCT-ASCT irrespective of response status after induction. Only patients not achieving complete remission (CR) after HCT-ASCT received whole brain radiotherapy (WBRT). The primary endpoint was CR after HCT-ASCT by intention-to-treat (ITT). Secondary endpoints included safety, progression free survival (PFS, time to progression or death) and overall survival (OS, time to death due to any cause).</jats:p> <jats:p>Results</jats:p> <jats:p>Between May 2007 and July 2012, we enrolled 39 patients from 12 German centres. The median age and Karnofsky performance score was 57 years (range 37 to 65) and 90% (range 60% to 100%), respectively. 28 (71.8%) patients had relapsed and 8 (28.2%) refractory disease. 22 (56.4%) patients responded to induction (4 CR, 18 partial remissions [PR]) and 32 (82.1%) patients commenced HCT-ASCT. 22 patients (56.4%, 95% CI 39.6% to 72.2%) achieved CR after HCT-ASCT, 6 (15.4%) achieved PR, and 1 (2.6%) had stable disease. In 9 (17.8%) patients the final scan was not done, because 7 (18.0%) did not undergo HCT-ASCT and 2 died (5.1%) during HCT-ASCT procedure. After a median follow-up of 45.2 months, the respective 2-year PFS and OS rates were 46.0% (95% CI 30.3% to 61.7%, median PFS 12.4 months, Figure 1) and 56.4% (95% CI 40.8% to 72.0%); median OS not reached (Figure 2). The non-relapse mortality rate was 10.3% (95% CI 4.1% to 26.0%) at 1 year without any further increase afterwards. In the subset of 32 patients who received HCT-ASCT, 14 (56.3%) experienced progression or died translating into 1 and 2-year PFS rates (calculated from date of HCT-ASCT) of 62.5% (95% CI 45.7% to 79.3%) and 56.1% (95% CI 38.8% to 73.3%) with no further decrease afterwards. Main grade 3 or higher toxicities were hematological as expected. We recorded four (10.3%) treatment-related deaths, 2 during induction and 2 during HCT-ASCT.</jats:p> <jats:p>Conclusions</jats:p> <jats:p>In eligible PCNSL patients failing HD-MTX based chemotherapy, a short induction with high-dose cytarabine and thiotepa followed by HCT-ASCT is an effective treatment option. Our data provide a reliable benchmark for future comparative studies needed to further scrutinize the role of HCT-ASCT in the salvage setting for PCNSL.</jats:p> <jats:p>Figure 1. Progression free survival Figure 1. Progression free survival Figure 2. Overall survival Figure 2. Overall survival</jats:p> <jats:sec> <jats:title>Disclosures</jats:title> <jats:p>Kasenda: Riemser: Other: Travel Support. Schmidt-Wolf:Janssen: Research Funding; Novartis: Research Funding. Röth:Alexion Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Honoraria. Stilgenbauer:Amgen: Consultancy, Honoraria, Other: Travel grants, Research Funding; Genentech: Consultancy, Honoraria, Other: Travel grants , Research Funding; Boehringer Ingelheim: Consultancy, Honoraria, Other: Travel grants , Research Funding; Janssen: Consultancy, Honoraria, Other: Travel grants , Research Funding; Hoffmann-La Roche: Consultancy, Honoraria, Other: Travel grants , Research Funding; Pharmacyclics: Consultancy, Honoraria, Other: Travel grants , Research Funding; Novartis: Consultancy, Honoraria, Other: Travel grants , Research Funding; Sanofi: Consultancy, Honoraria, Other: Travel grants , Research Funding; Gilead: Consultancy, Honoraria, Other: Travel grants , Research Funding; AbbVie: Consultancy, Honoraria, Other: Travel grants, Research Funding; Mundipharma: Consultancy, Honoraria, Other: Travel grants , Research Funding; Genzyme: Consultancy, Honoraria, Other: Travel grants , Research Funding; GSK: Consultancy, Honoraria, Other: Travel grants , Research Funding; Celgene: Consultancy, Honoraria, Other: Travel grants , Research Funding. Illerhaus:Riemser: Honoraria; Amgen: Honoraria.</jats:p> </jats:sec>
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