• Br. J. Haematol. · Aug 2020

    Randomized Controlled Trial Multicenter Study Comparative Study

    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.

    • Jeanette K Doorduijn, Josee M Zijlstra, Pieternella J Lugtenburg, Marie Josee Kersten, Lara H Böhmer, Monique C Minnema, Marius A MacKenzie, Rien van Marwijk Kooij, Eva de Jongh, Tjeerd J F Snijders, Okke de Weerdt, Michel van Gelder, Mels Hoogendoorn, Rineke B L Leys, Robby E Kibbelaar, Daphne de Jong, Dana A Chitu, Mars B Van't Veer, and Hanneke C Kluin-Nelemans.
    • Haematology, Erasmus MC Cancer Centre, Rotterdam, Netherlands.
    • Br. J. Haematol. 2020 Aug 1; 190 (3): 385-393.

    AbstractRituximab-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 (1·3 mg/m2 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 77·5 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 71·5 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.© 2020 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.

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