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 DoorduijnJosee M ZijlstraPieternella J LugtenburgMarie Josee KerstenLara H BöhmerMonique C MinnemaMarius A MacKenzieRien van Marwijk KooijEva de JonghTjeerd J F SnijdersOkke de WeerdtMichel van GelderMels HoogendoornRineke B L LeysRobby E KibbelaarDaphne de JongDana A ChituMars B Van't VeerHanneke C Kluin-NelemansPublished in: British journal of haematology (2020)
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.
Keyphrases
- newly diagnosed
- high dose
- end stage renal disease
- clinical trial
- stem cell transplantation
- ejection fraction
- chronic kidney disease
- peritoneal dialysis
- prognostic factors
- low dose
- squamous cell carcinoma
- phase ii
- acute myeloid leukemia
- study protocol
- radiation therapy
- drug delivery
- bone marrow
- photodynamic therapy
- mesenchymal stem cells
- high resolution
- locally advanced