Bortezomib maintenance after R-CHOP, cytarabine and autologous stem cell transplantation in newly diagnosed patients with mantle cell lymphoma, results of a randomised phase II HOVON trial

J.K. Doorduijn*, J.M. Zijlstra, P.J. Lugtenburg, M.J. Kersten, L.H. Bohmer, M.C. Minnema, M.A. MacKenzie, R.V. Kooij, E. de Jongh, T.J.F. Snijders, O. de Weerdt, M. van Gelder, M. Hoogendoorn, R.B.L. Leys, R.E. Kibbelaar, D. de Jong, D.A. Chitu, M.B. Van't Veer, H.C. Kluin-Nelemans

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Rituximab-containing induction followed by autologous stem cell transplantation (ASCT) is the standard first-line treatment for young mantle cell lymphoma patients. However, most patients relapse after ASCT. We investigated in a randomised phase II study the outcome of a chemo-immuno regimen and ASCT with or without maintenance therapy with bortezomib. Induction consisted of three cycles R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone), two cycles high-dose cytarabine, BEAM (carmustine, etoposide, cytarabine, melphalan) and ASCT. Patients responding were randomised between bortezomib maintenance (1 center dot 3 mg/m(2)intravenously once every 2 weeks, for 2 years) and observation. Of 135 eligible patients, 115 (85%) proceeded to ASCT, 60 (44%) were randomised. With a median follow-up of 77 center dot 5 months for patients still alive, 5-year event-free survival (EFS) was 51% (95% CI 42-59%); 5-year overall survival (OS) was 73% (95% CI 65-80%). The median follow-up of randomised patients still alive was 71 center dot 5 months. Patients with bortezomib maintenance had a 5-year EFS of 63% (95% CI 44-78%) and 5-year OS of 90% (95% CI 72-97%). The patients randomised to observation had 5-year PFS of 60% (95% CI, 40-75%) and OS of 90% (95% CI 72-97%). In conclusion, in this phase II study we found no indication of a positive effect of bortezomib maintenance after ASCT.
Original languageEnglish
Pages (from-to)385-393
Number of pages9
JournalBritish Journal of Haematology
Issue number3
Publication statusPublished - 1 Aug 2020


  • beam
  • bortezomib
  • cytarabine
  • high-dose cytarabine
  • immunochemotherapy
  • maintenance therapy
  • mantle cell lymphoma
  • mcl younger
  • multicenter
  • nordic mcl2
  • phase ii trial
  • randomised
  • rescue
  • rituximab
  • survival
  • BEAM
  • Mantle cell lymphoma
  • phase II trial

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