Illerhaus, Gerald, Kasenda, Benjamin ORCID: 0000-0003-0110-8585, Ihorst, Gabriele, Egerer, Gerlinde, Lamprecht, Monika, Keller, Ulrich, Wolf, Hans-Heinrich, Hirt, Carsten, Stilgenbauer, Stephan, Binder, Mascha ORCID: 0000-0003-0663-3004, Hau, Peter ORCID: 0000-0003-3894-5053, Edinger, Matthias ORCID: 0000-0003-2889-2533, Frickhofen, Norbert, Bentz, Martin, Moehle, Robert, Roeth, Alexander, Pfreundschuh, Michael, von Baumgarten, Louisa, Deckert, Martina, Hader, Claudia, Fricker, Heidi, Valk, Elke, Schorb, Elisabeth, Fritsch, Kristina and Finke, Juergen (2016). High-dose chemotherapy with autologous haemopoietic stem cell transplantation for newly diagnosed primary CNS lymphoma: a prospective, single-arm, phase 2 trial. Lancet Haematol., 3 (8). S. E388 - 10. OXFORD: ELSEVIER SCI LTD. ISSN 2352-3026

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Abstract

Background High-dose methotrexate-based chemotherapy is standard for primary CNS lymphoma, but most patients relapse. High-dose chemotherapy with autologous stem cell transplantation (HCT-ASCT) is supposed to overcome the blood-brain barrier and eliminate residual disease in the CNS. We aimed to investigate the safety and efficacy of HCT-ASCT in patients with newly diagnosed primary CNS lymphoma. Methods In this prospective, single-arm, phase 2 trial, we recruited patients aged 18-65 years with newly diagnosed primary CNS lymphoma and immunocompetence, with no limitation on clinical performance status, from 15 hospitals in Germany. Patients received five courses of intravenous rituximab 375 mg/m(2) (7 days before first high-dose methotrexate course and then every 10 days) and four courses of intravenous high-dose methotrexate 8000 mg/m(2) (every 10 days) and then two courses of intravenous rituximab 375 mg/m(2) (day 1), cytarabine 3 g/m(2) (days 2 and 3), and thiotepa 40 mg/m(2) (day 3). 3 weeks after the last course, patients commenced intravenous HCT-ASCT (rituximab 375 mg/m(2) [day 1], carmustine 400 mg/m(2) [day 2], thiotepa 2 x 5 mg/kg [days 3 and 4], and infusion of stem cells [day 7]), irrespective of response status after induction. We restricted radiotherapy to patients without complete response after HCT-ASCT. The primary endpoint was complete response at day 30 after HCT-ASCT in all registered eligible patients who received at least 1 day of study treatment. This trial is registered at ClinicalTrials. gov, number NCT00647049. Findings Between Jan 18, 2007, and May 23, 2011, we recruited 81 patients, of whom two (2%) were excluded, therefore we included 79 (98%) patients in the analysis. All patients started induction treatment; 73 (92%) commenced HCT-ASCT. 61 (77.2% [95% CI 66.1-86.6]) patients achieved a complete response. During induction treatment, the most common grade 3 toxicity was anaemia (37 [47%]) and the most common grade 4 toxicity was thrombocytopenia (50 [63%]). During HCT-ASCT, the most common grade 3 toxicity was fever (50 [68%] of 73) and the most common grade 4 toxicity was leucopenia (68 [93%] of 73). We recorded four (5%) treatment-related deaths (three [4%] during induction and one [1%] 4 weeks after HCT-ASCT). Interpretation HCT-ASCT with thiotepa and carmustine is an effective treatment option in young patients with newly diagnosed primary CNS lymphoma, but further comparative studies are needed.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Illerhaus, GeraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kasenda, BenjaminUNSPECIFIEDorcid.org/0000-0003-0110-8585UNSPECIFIED
Ihorst, GabrieleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Egerer, GerlindeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lamprecht, MonikaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Keller, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wolf, Hans-HeinrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hirt, CarstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stilgenbauer, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Binder, MaschaUNSPECIFIEDorcid.org/0000-0003-0663-3004UNSPECIFIED
Hau, PeterUNSPECIFIEDorcid.org/0000-0003-3894-5053UNSPECIFIED
Edinger, MatthiasUNSPECIFIEDorcid.org/0000-0003-2889-2533UNSPECIFIED
Frickhofen, NorbertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bentz, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moehle, RobertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roeth, AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pfreundschuh, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Baumgarten, LouisaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Deckert, MartinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hader, ClaudiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fricker, HeidiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Valk, ElkeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schorb, ElisabethUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fritsch, KristinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Finke, JuergenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-267167
DOI: 10.1016/S2352-3026(16)30050-3
Journal or Publication Title: Lancet Haematol.
Volume: 3
Number: 8
Page Range: S. E388 - 10
Date: 2016
Publisher: ELSEVIER SCI LTD
Place of Publication: OXFORD
ISSN: 2352-3026
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
CENTRAL-NERVOUS-SYSTEM; WHOLE-BRAIN RADIOTHERAPY; NON-HODGKIN-LYMPHOMA; 1ST-LINE TREATMENT; CENTER EXPERIENCE; RADIATION-THERAPY; RESPONSE CRITERIA; CLINICAL-TRIALS; PLUS RITUXIMAB; FOLLOW-UPMultiple languages
HematologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/26716

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