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Rituximab and high-dose cytarabine (HD-Ara-C) induction immunotherapy, followed by autologous stem cell transplantation (auto-SCT), has significantly improved the prognosis of patients with mantle cell lymphoma (MCL).1 Results from the HOVON 45 trial reported 4‐year progression‐free survival (PFS) rate of 44% and 4‐year overall survival (OS) rate of 66% for the three cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R‐CHOP) followed, in responding patients, by one cycle of HD‐Ara‐C and autoSCT.2 However, most patients with MCL relapse after auto-SCT. Bortezomib is a protease inhibitor approved for the treatment of relapsed/refractory MCL.3
Here, we present the results of HOVON 75 - a randomized phase II study, recently published in British Journal of Haematology. Jeanette Doorduijn and colleagues investigated the outcome of a modified chemo-immuno regimen and auto-SCT with or without maintenance therapy with bortezomib for treatment of patients with MCL.
Table 1. Patients characteristics
WHO, World Health Organization |
|||
All patients n = 135 |
Randomized patients after auto-SCT |
||
---|---|---|---|
No further treatment, n = 30 |
Bortezomib maintenance, n = 30 |
||
Age (median, range) |
57 (34–66) |
54 (36–65) |
56 (34–66) |
Male sex |
78% |
77% |
80% |
WHO performance |
|||
WHO 0 |
105 (78%) |
25 (83%) |
25 (83%) |
WHO 1 |
60 (19%) |
5 (17%) |
4 (13%) |
WHO 2 |
5 (4%) |
– |
1 (3%) |
Ann Arbor stage |
|||
II |
11 (8%) |
1 (3%) |
3 (10%) |
III |
8 (6%) |
2 (7%) |
2 (7%) |
IV |
116 (86%) |
27 (90%) |
25 (83%) |
This HOVON 75 trial was designed to improve the outcomes achieved in the earlier HOVON 45 trial,2 and to investigate if bortezomib maintenance after auto-SCT could improve outcomes.
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