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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.
Doorduijn, Jeanette K; Zijlstra, Josee M; Lugtenburg, Pieternella J; Kersten, Marie Josee; Böhmer, Lara H; Minnema, Monique C; MacKenzie, Marius A; van Marwijk Kooij, Rien; de Jongh, Eva; Snijders, Tjeerd J F; de Weerdt, Okke; van Gelder, Michel; Hoogendoorn, Mels; Leys, Rineke B L; Kibbelaar, Robby E; de Jong, Daphne; Chitu, Dana A; Van't Veer, Mars B; Kluin-Nelemans, Hanneke C.
Afiliación
  • Doorduijn JK; Haematology, Erasmus MC Cancer Centre, Rotterdam, Netherlands.
  • Zijlstra JM; Amsterdam UMC - Locatie VUMC, Amsterdam, Netherlands.
  • Lugtenburg PJ; Erasmus MC Cancer Centre, Rotterdam, Netherlands.
  • Kersten MJ; Haematology, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam and LYMMCARE (lymphoma and myeloma Center), Amsterdam, Netherlands.
  • Böhmer LH; Haematology, Haga Teaching Hospital, The Hague, USA.
  • Minnema MC; Haematology, UMC Utrecht Cancer Centre, Utrecht, Netherlands.
  • MacKenzie MA; UMCN, Nijmegen, Netherlands.
  • van Marwijk Kooij R; Internal Medicine, Isala Clinic, Zwolle, Netherlands.
  • de Jongh E; Albert Schweitzer Hospital Location Dordwijk, Dordrecht, Netherlands.
  • Snijders TJF; Medisch Spectrum Twente, Enschede, Netherlands.
  • de Weerdt O; Sint Antonius Hospital, Nieuwegein, Netherlands.
  • van Gelder M; Maastricht University Medical Centre+, Maastricht, Netherlands.
  • Hoogendoorn M; Medical Centre Leeuwarden, Leeuwarden, Netherlands.
  • Leys RBL; Maasstad Ziekenhuis, Rotterdam, Netherlands.
  • Kibbelaar RE; Department of Pathology, Pathology Friesland, Groningen, Netherlands.
  • de Jong D; Amsterdam UMC - Locatie VUMC, Amsterdam, Netherlands.
  • Chitu DA; Erasmus MC Cancer Center, Rotterdam, Netherlands.
  • Van't Veer MB; Erasmus MC Cancer Centre, Rotterdam, Netherlands.
  • Kluin-Nelemans HC; Haematology, University Medical Center Groningen, Groningen, Netherlands.
Br J Haematol ; 190(3): 385-393, 2020 08.
Article en En | MEDLINE | ID: mdl-32150297
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 (1·3 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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Trasplante de Células Madre Hematopoyéticas / Linfoma de Células del Manto / Bortezomib Tipo de estudio: Clinical_trials / Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: Br J Haematol Año: 2020 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Trasplante de Células Madre Hematopoyéticas / Linfoma de Células del Manto / Bortezomib Tipo de estudio: Clinical_trials / Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: Br J Haematol Año: 2020 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Reino Unido