TY - JOUR
T1 - 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
AU - Doorduijn, Jeanette K.
AU - Zijlstra, Josee M.
AU - Lugtenburg, Pieternella J.
AU - Kersten, Marie Josee
AU - Böhmer, Lara H.
AU - Minnema, Monique C.
AU - MacKenzie, Marius A.
AU - van Marwijk Kooij, Rien
AU - de Jongh, Eva
AU - Snijders, Tjeerd J.F.
AU - de Weerdt, Okke
AU - van Gelder, Michel
AU - Hoogendoorn, Mels
AU - Leys, Rineke B.L.
AU - Kibbelaar, Robby E.
AU - de Jong, Daphne
AU - Chitu, Dana A.
AU - Van’t Veer, Mars B.
AU - Kluin-Nelemans, Hanneke C.
PY - 2020/8/1
Y1 - 2020/8/1
N2 - 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.
AB - 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.
KW - bortezomib
KW - cytarabine
KW - maintenance therapy
KW - Mantle cell lymphoma
KW - phase II trial
KW - randomised
UR - http://www.scopus.com/inward/record.url?scp=85081234775&partnerID=8YFLogxK
U2 - 10.1111/bjh.16567
DO - 10.1111/bjh.16567
M3 - Article
C2 - 32150297
AN - SCOPUS:85081234775
VL - 190
SP - 385
EP - 393
JO - British Journal of Haematology
JF - British Journal of Haematology
SN - 0007-1048
IS - 3
ER -