High-dose chemotherapy with autologous haemopoietic stem cell transplantation for newly diagnosed primary CNS lymphoma: a prospective, single-arm, phase 2 trial

Standard

High-dose chemotherapy with autologous haemopoietic stem cell transplantation for newly diagnosed primary CNS lymphoma: a prospective, single-arm, phase 2 trial. / Illerhaus, Gerald; Kasenda, Benjamin; Ihorst, Gabriele; Egerer, Gerlinde; Lamprecht, Monika; Keller, Ulrich; Wolf, Hans-Heinrich; Hirt, Carsten; Stilgenbauer, Stephan; Binder, Mascha; Hau, Peter; Edinger, Matthias; Frickhofen, Norbert; Bentz, Martin; Möhle, Robert; Röth, Alexander; Pfreundschuh, Michael; von Baumgarten, Louisa; Deckert, Martina; Hader, Claudia; Fricker, Heidi; Valk, Elke; Schorb, Elisabeth; Fritsch, Kristina; Finke, Jürgen.

in: LANCET HAEMATOL, Jahrgang 3, Nr. 8, 08.2016, S. e388-97.

Publikationen: SCORING: Beitrag in Fachzeitschrift/ZeitungSCORING: ZeitschriftenaufsatzForschungBegutachtung

Harvard

Illerhaus, G, Kasenda, B, Ihorst, G, Egerer, G, Lamprecht, M, Keller, U, Wolf, H-H, Hirt, C, Stilgenbauer, S, Binder, M, Hau, P, Edinger, M, Frickhofen, N, Bentz, M, Möhle, R, Röth, A, Pfreundschuh, M, von Baumgarten, L, Deckert, M, Hader, C, Fricker, H, Valk, E, Schorb, E, Fritsch, K & Finke, J 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, Jg. 3, Nr. 8, S. e388-97. https://doi.org/10.1016/S2352-3026(16)30050-3

APA

Illerhaus, G., Kasenda, B., Ihorst, G., Egerer, G., Lamprecht, M., Keller, U., Wolf, H-H., Hirt, C., Stilgenbauer, S., Binder, M., Hau, P., Edinger, M., Frickhofen, N., Bentz, M., Möhle, R., Röth, A., Pfreundschuh, M., von Baumgarten, L., Deckert, M., ... Finke, J. (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), e388-97. https://doi.org/10.1016/S2352-3026(16)30050-3

Vancouver

Bibtex

@article{85c260cf6a0243e1baf2a8b661017819,
title = "High-dose chemotherapy with autologous haemopoietic stem cell transplantation for newly diagnosed primary CNS lymphoma: a prospective, single-arm, phase 2 trial",
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 × 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.FUNDING: University Hospital Freiburg and Amgen.",
keywords = "Journal Article",
author = "Gerald Illerhaus and Benjamin Kasenda and Gabriele Ihorst and Gerlinde Egerer and Monika Lamprecht and Ulrich Keller and Hans-Heinrich Wolf and Carsten Hirt and Stephan Stilgenbauer and Mascha Binder and Peter Hau and Matthias Edinger and Norbert Frickhofen and Martin Bentz and Robert M{\"o}hle and Alexander R{\"o}th and Michael Pfreundschuh and {von Baumgarten}, Louisa and Martina Deckert and Claudia Hader and Heidi Fricker and Elke Valk and Elisabeth Schorb and Kristina Fritsch and J{\"u}rgen Finke",
note = "Copyright {\textcopyright} 2016 Elsevier Ltd. All rights reserved.",
year = "2016",
month = aug,
doi = "10.1016/S2352-3026(16)30050-3",
language = "English",
volume = "3",
pages = "e388--97",
journal = "LANCET HAEMATOL",
issn = "2352-3026",
publisher = "Lancet Publishing Group",
number = "8",

}

RIS

TY - JOUR

T1 - High-dose chemotherapy with autologous haemopoietic stem cell transplantation for newly diagnosed primary CNS lymphoma: a prospective, single-arm, phase 2 trial

AU - Illerhaus, Gerald

AU - Kasenda, Benjamin

AU - Ihorst, Gabriele

AU - Egerer, Gerlinde

AU - Lamprecht, Monika

AU - Keller, Ulrich

AU - Wolf, Hans-Heinrich

AU - Hirt, Carsten

AU - Stilgenbauer, Stephan

AU - Binder, Mascha

AU - Hau, Peter

AU - Edinger, Matthias

AU - Frickhofen, Norbert

AU - Bentz, Martin

AU - Möhle, Robert

AU - Röth, Alexander

AU - Pfreundschuh, Michael

AU - von Baumgarten, Louisa

AU - Deckert, Martina

AU - Hader, Claudia

AU - Fricker, Heidi

AU - Valk, Elke

AU - Schorb, Elisabeth

AU - Fritsch, Kristina

AU - Finke, Jürgen

N1 - Copyright © 2016 Elsevier Ltd. All rights reserved.

PY - 2016/8

Y1 - 2016/8

N2 - 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 × 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.FUNDING: University Hospital Freiburg and Amgen.

AB - 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 × 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.FUNDING: University Hospital Freiburg and Amgen.

KW - Journal Article

U2 - 10.1016/S2352-3026(16)30050-3

DO - 10.1016/S2352-3026(16)30050-3

M3 - SCORING: Journal article

C2 - 27476790

VL - 3

SP - e388-97

JO - LANCET HAEMATOL

JF - LANCET HAEMATOL

SN - 2352-3026

IS - 8

ER -