Long-term efficacy, safety and neurotolerability of MATRix regimen followed by autologous transplant in primary CNS lymphoma: 7-year results of the IELSG32 randomized trial.


Journal

Leukemia
ISSN: 1476-5551
Titre abrégé: Leukemia
Pays: England
ID NLM: 8704895

Informations de publication

Date de publication:
07 2022
Historique:
received: 12 01 2022
accepted: 20 04 2022
revised: 16 04 2022
pubmed: 14 5 2022
medline: 7 7 2022
entrez: 13 5 2022
Statut: ppublish

Résumé

219 HIV-negative adults ≤70 years with primary CNS lymphoma (PCNSL) were enrolled in the randomized IELSG32 trial. Enrolled patients were randomly assigned to receive methotrexate-cytarabine (arm A), or methotrexate-cytarabine-rituximab (B), or methotrexate-cytarabine-thiotepa-rituximab (MATRix; arm C). A second randomization allocated patients with responsive/stable disease to whole-brain irradiation (WBRT) or carmustine-thiotepa-conditioned autologous transplantation (ASCT). First results, after a median follow-up of 30 months, showed that MATRix significantly improves outcome, with both WBRT and ASCT being similarly effective. However, sound assessment of overall survival (OS), efficacy of salvage therapy, late complications, secondary tumors, and cognitive impairment requires longer follow-up. Herein, we report the results of this trial at a median follow-up of 88 months. As main findings, MATRix was associated with excellent long-lasting outcome, with a 7-year OS of 21%, 37%, and 56% respectively for arms A, B, and C. Notably, patients treated with MATRix and consolidation had a 7-year OS of 70%. The superiority of arm B on arm A suggests a benefit from the addition of rituximab. Comparable efficacy of WBRT and ASCT was confirmed. Salvage therapy was ineffective; benefit was recorded only in patients with late relapse re-treated with methotrexate. Eight (4%) patients developed a second cancer. Importantly, MATRix and ASCT did not result in higher non-relapse mortality or second tumors incidence. Patients who received WBRT experienced impairment in attentiveness and executive functions, whereas patients undergoing ASCT experienced improvement in these functions as well as in memory and quality of life.

Identifiants

pubmed: 35562406
doi: 10.1038/s41375-022-01582-5
pii: 10.1038/s41375-022-01582-5
doi:

Substances chimiques

Cytarabine 04079A1RDZ
Rituximab 4F4X42SYQ6
Thiotepa 905Z5W3GKH
Methotrexate YL5FZ2Y5U1

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1870-1878

Subventions

Organisme : Cancer Research UK
ID : 12115
Pays : United Kingdom
Organisme : Cancer Research UK
ID : CRUK/10/023
Pays : United Kingdom
Organisme : Cancer Research UK
ID : C36711/A12115
Pays : United Kingdom

Informations de copyright

© 2022. The Author(s), under exclusive licence to Springer Nature Limited.

Références

Ferreri AJ, Cwynarski K, Pulczynski E, Ponzoni M, Deckert M, Politi LS, et al. 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. Lancet Haematol. 2016;3:e217–27.
doi: 10.1016/S2352-3026(16)00036-3
Ferreri AJM, Cwynarski K, Pulczynski E, Fox CP, Schorb E, La Rosee P, et al. Whole-brain radiotherapy or autologous stem-cell transplantation as consolidation strategies after high-dose methotrexate-based chemoimmunotherapy in patients with primary CNS lymphoma: results of the second randomisation of the International Extranodal Lymphoma Study Group-32 phase 2 trial. Lancet Haematol. 2017;4:e510–23.
doi: 10.1016/S2352-3026(17)30174-6
Scordo M, Wang TP, Ahn KW, Chen Y, Ahmed S, Awan FT, et al. Outcomes associated with thiotepa-based conditioning in patients with primary central nervous system lymphoma after autologous hematopoietic cell transplant. JAMA Oncol. 2021;7:993–1003.
doi: 10.1001/jamaoncol.2021.1074
Ferreri AJ, Illerhaus G. The role of autologous stem cell transplantation in primary central nervous system lymphoma. Blood. 2016;127:1642–9.
doi: 10.1182/blood-2015-10-636340
Illerhaus G, Kasenda B, Ihorst G, Egerer G, Lamprecht M, Keller U, et al. High-dose chemotherapy with autologous haemopoietic stem cell transplantation for newly diagnosed primary CNS lymphoma: a prospective, single-arm, phase 2 trial. Lancet Haematol. 2016;3:e388–97.
doi: 10.1016/S2352-3026(16)30050-3
Kasenda B, Loeffler J, Illerhaus G, Ferreri AJ, Rubenstein J, Batchelor TT. The role of whole brain radiation in primary CNS lymphoma. Blood. 2016;128:32–6.
doi: 10.1182/blood-2016-01-650101
Houillier C, Taillandier L, Dureau S, Lamy T, Laadhari M, Chinot O, et al. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients 60 Years of Age and Younger: Results of the Intergroup ANOCEF-GOELAMS Randomized Phase II PRECIS Study. J Clin Oncol. 2019;37:823–33.
doi: 10.1200/JCO.18.00306
Correa DD, Braun E, Kryza-Lacombe M, Ho KW, Reiner AS, Panageas KS, et al. Longitudinal cognitive assessment in patients with primary CNS lymphoma treated with induction chemotherapy followed by reduced-dose whole-brain radiotherapy or autologous stem cell transplantation. J Neurooncol. 2019;144:553–62.
doi: 10.1007/s11060-019-03257-1
Correa DD, Maron L, Harder H, Klein M, Armstrong CL, Calabrese P, et al. Cognitive functions in primary central nervous system lymphoma: literature review and assessment guidelines. Ann Oncol. 2007;18:1145–51.
doi: 10.1093/annonc/mdl464
Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25:579–86.
doi: 10.1200/JCO.2006.09.2403
Yin X, Xu A, Huang Z, Fan F, Wang Y, Chen L, et al. The relationship among primary anatomic subsite and risk and distribution of second malignant neoplasms in patients with stage I/II diffuse large B-cell lymphoma: An analysis of the surveillance, epidemiology, and end results database. Transl Oncol. 2021;14:101106.
doi: 10.1016/j.tranon.2021.101106
Frontzek F, Ziepert M, Nickelsen M, Altmann B, Glass B, Haenel M, et al. Rituximab plus high-dose chemotherapy (MegaCHOEP) or conventional chemotherapy (CHOEP-14) in young, high-risk patients with aggressive B-cell lymphoma: 10-year follow-up of a randomised, open-label, phase 3 trial. Lancet Haematol. 2021;8:e267–77.
doi: 10.1016/S2352-3026(21)00022-3
Correa DD, Shi W, Abrey LE, Deangelis LM, Omuro AM, Deutsch MB, et al. Cognitive functions in primary CNS lymphoma after single or combined modality regimens. Neuro Oncol. 2012;14:101–8.
doi: 10.1093/neuonc/nor186
Doolittle ND, Korfel A, Lubow MA, Schorb E, Schlegel U, Rogowski S, et al. Long-term cognitive function, neuroimaging, and quality of life in primary CNS lymphoma. Neurology. 2013;81:84–92.
doi: 10.1212/WNL.0b013e318297eeba
Schorb E, Fox CP, Kasenda B, Linton K, Martinez-Calle N, Calimeri T, et al. Induction therapy with the MATRix regimen in patients with newly diagnosed primary diffuse large B-cell lymphoma of the central nervous system—an international study of feasibility and efficacy in routine clinical practice. Br J Haematol. 2020;189(5):879–887.
doi: 10.1111/bjh.16451
Omuro AMP, DeAngelis LM, Karrison T, Bovi JA, Rosenblum M, Corn BW, et al. Randomized phase II study of rituximab, methotrexate (MTX), procarbazine, vincristine, and cytarabine (R-MPV-A) with and without low-dose whole-brain radiotherapy (LD-WBRT) for newly diagnosed primary CNS lymphoma (PCNSL). J Clin Oncol. 2020; 38: (suppl): abstr 2501.
Batchelor T, Giri S, Ruppert AS, Bartlett NL, Hsi ED, Cheson BD, et al. Myeloablative versus non-myeloablative consolidative chemotherapy for newly diagnosed primary central nervous system lymphoma: Results of CALGB 51101 (Alliance). J Clin Oncol. 2021; 39 (suppl 15); abstr 7506.
Schorb E, Finke J, Ferreri AJ, Ihorst G, Mikesch K, Kasenda B, et al. High-dose chemotherapy and autologous stem cell transplant compared with conventional chemotherapy for consolidation in newly diagnosed primary CNS lymphoma-a randomized phase III trial (MATRix). BMC Cancer. 2016;16:016–2311-4.
doi: 10.1186/s12885-016-2311-4
Bromberg JEC, Issa S, Bakunina K, Minnema MC, Seute T, Durian M, et al. Rituximab in patients with primary CNS lymphoma (HOVON 105/ALLG NHL 24): a randomised, open-label, phase 3 intergroup study. Lancet Oncol. 2019;20:216–228.
doi: 10.1016/S1470-2045(18)30747-2
Schmitt AM, Herbrand AK, Fox CP, Bakunina K, Bromberg JEC, Cwynarski K, et al. Rituximab in primary central nervous system lymphoma-A systematic review and meta-analysis. Hematol Oncol. 2019;37:548–557.
doi: 10.1002/hon.2666
Houillier C, Soussain C, Ghesquieres H, Soubeyran P, Chinot O, Taillandier L, et al. Management and outcome of primary CNS lymphoma in the modern era: An LOC network study. Neurology. 2020;94:e1027–39.
doi: 10.1212/WNL.0000000000008900
Langner-Lemercier S, Houillier C, Soussain C, Ghesquieres H, Chinot O, Taillandier L, et al. Primary CNS lymphoma at first relapse/progression: characteristics, management, and outcome of 256 patients from the French LOC network. Neuro Oncol. 2016;18:1297–303.
doi: 10.1093/neuonc/now033
Nguyen PL, Chakravarti A, Finkelstein DM, Hochberg FH, Batchelor TT, Loeffler JS. Results of whole-brain radiation as salvage of methotrexate failure for immunocompetent patients with primary CNS lymphoma. J Clin Oncol. 2005;23:1507–13.
doi: 10.1200/JCO.2005.01.161
Plotkin SR, Betensky RA, Hochberg FH, Grossman SA, Lesser GJ, Nabors LB, et al. Treatment of relapsed central nervous system lymphoma with high-dose methotrexate. Clin Cancer Res. 2004;10:5643–6.
doi: 10.1158/1078-0432.CCR-04-0159

Auteurs

Andrés J M Ferreri (AJM)

Lymphoma Unit, Department of Onco-Hematology, IRCCS San Raffaele Scientific Institute, Milano, Italy. ferreri.andres@hsr.it.

Kate Cwynarski (K)

University College Hospital, London, UK.

Elisa Pulczynski (E)

Aarhus University Hospital, Aarhus, Denmark.

Christopher P Fox (CP)

Nottingham University Hospitals NHS Trust, Nottingham, UK.

Elisabeth Schorb (E)

Uniklinik Freiburg, Freiburg, Germany.

Claudia Celico (C)

Dept. of Neurology, Milano, Italy.

Monica Falautano (M)

Dept. of Neurology, Milano, Italy.

Alessandro Nonis (A)

Ateneo Vita-Salute San Raffaele University, Pathology Unit, Milano, Italy.

Paul La Rosée (P)

Schwarzwald-Baar-Klinikum, Villingen-Schwenningen, Germany.

Mascia Binder (M)

Universitätsklinikum Hamburg- Eppendorf, Hamburg, Germany.

Alberto Fabbri (A)

Azienda Ospedaliera Università Senese, Siena, Italy.

Fiorella Ilariucci (F)

Azienda Ospedaliera Arcispedale Santa Maria Nuova IRCCS, Reggio Emilia, Italy.

Mauro Krampera (M)

Dipartimento di Medicina, Sezione di Ematologia, Università di Verona, Verona, Italy.

Alexander Roth (A)

Universitatsklinikum Essen, Essen, Germany.

Claire Hemmaway (C)

Queen's Hospital, Romford, UK.

Peter W Johnson (PW)

Medical Oncology Unit, Southampton General Hospital, Southampton, UK.

Kim M Linton (KM)

The Christie Hospital NHS Foundation Trust, Manchester, UK.

Tobias Pukrop (T)

Georg-August-Universität, Göttingen, Germany.

Jettes Sønderskov Gørløv (JS)

Rigshospitalet, Copenhagen, Denmark.

Monica Balzarotti (M)

Istituto Clinico Humanitas, Milano Rozzano, Italy.

Georg Hess (G)

J. Gutenberg Universität, Mainz, Germany.

Ulrich Keller (U)

Technische Universität München, München, Germany.

Stephan Stilgenbauer (S)

Department of Internal Medicine III, Ulm University, Ulm, Germany.

Jense Panse (J)

Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital Aachen, Aachen, Germany.

Alessandra Tucci (A)

Spedali Civili, Brescia, Italy.

Lorella Orsucci (L)

AOU Città Della Salute e Della Scienza di Torino, Turin, Italy.

Francesco Pisani (F)

Hematology and Stem Cell Transplantation Unit, IRCCS Istituto Nazionale dei Tumori Regina Elena, Roma, Italy.

Manuela Zanni (M)

A.O. Santi Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.

Stefan W Krause (SW)

Universitätsklinikum Erlangen, Erlangen, Germany.

Hans J Schmoll (HJ)

Martin-Luther Universität, Halle/Saale, Germany.

Bernd Hertenstein (B)

Klinikum Bremen-Mitte, Bremen, Germany.

Mathias Rummel (M)

Klinikum Der Justus-Liebig-Universität, Giessen, Germany.

Jeffery Smith (J)

University Hospital Aintree, Liverpool, UK.

Lorenz Thurner (L)

Universitätsklinik des Saarlandes, Homburg, Germany.

Giuseppina Cabras (G)

Division of Hematology, Ospedale Oncologico, Cagliari, Italy.

Elsa Pennese (E)

Ospedale Civile S. Spirito, Pescara, Italy.

Maurilio Ponzoni (M)

Ateneo Vita-Salute San Raffaele University, Pathology Unit, Milano, Italy.

Martina Deckert (M)

Institute of Neuropathology, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.

Letterio S Politi (LS)

Istituto Clinico Humanitas, Milano Rozzano, Italy.
Unit of Neuroradiology, IRCCS San Raffaele Scientific Institute, Milano, Italy.

Jurgen Finke (J)

Uniklinik Freiburg, Freiburg, Germany.

Antonella Ferranti (A)

Fondazione Italiana Linfomi, Alessandria, Italy.

Kelly Cozens (K)

Clinical Trials Unit, University of Southampton, Southampton, UK.

Elvira Burger (E)

Zentrum Klinische Studien, Universitätsklinikum Freiburg, Freiburg, Germany.

Nicoletta Ielmini (N)

International Extranodal Lymphoma Study Group, Foundation for the Institute of Oncology Research, Bellinzona, Switzerland.

Franco Cavalli (F)

International Extranodal Lymphoma Study Group, Foundation for the Institute of Oncology Research, Bellinzona, Switzerland.
Istituto Oncologico della Svizzera Italiana, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.

Emanuele Zucca (E)

International Extranodal Lymphoma Study Group, Foundation for the Institute of Oncology Research, Bellinzona, Switzerland.
Istituto Oncologico della Svizzera Italiana, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.

Gerald Illerhaus (G)

Klinikum Stuttgart, Stuttgart, Germany.

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