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Immunochemotherapy followed by autologous hematopoietic stem cell transplant (auto-HSCT) improves the median progression-free survival (PFS) of patients with mantle cell lymphoma (MCL). However, all regimens evaluated so far have been associated with late disease recurrences. In the randomized, phase II trial CALGB (Alliance) 50403, Lawrence D. Kaplan and colleagues investigated whether the addition of bortezomib following high-dose cytarabine-etoposide-rituximab (EAR) stem cell mobilization, high-dose cyclophosphamide-carmustine-etoposide (CBV) autografting, and post-transplant rituximab, could further improve outcomes in patients with MCL. The efficacy and safety results of the study were published in the American Journal of Hematology.1
Table 1. Adverse events
AEs, adverse events; BC, bortezomib consolidation; BM, bortezomib maintenance; NE, not established |
||||
AEs |
BC group (n= 50) |
BM group (n= 52) |
P value |
|
---|---|---|---|---|
Grade 4 hematologic events, % |
42 |
31 |
NE |
|
Non-hematologic events, % Grade 3 Grade 4 Grade 5 |
42 6 2 |
38.5 8 0 |
NE NE NE |
|
Common adverse events, % Neutropenia (Grade ≥ 3) Thrombocytopenia (Grade ≥ 3) Peripheral sensory neuropathy (Grade ≥ 2) Fatigue (Grade ≥ 2) |
54 32 44 40 |
42 17 25 31 |
0.32 0.11 0.06 0.41 |
|
Withdrawal due to AEs, % |
28 |
13 |
0.09 |
|
Table 2. Best response to bortezomib consolidation and maintenance before and after randomization
BC, bortezomib consolidation; BM, bortezomib maintenance; CR, complete response; CRu, complete response unconfirmed; NA, not assessed; PR, partial response; SD, stable disease |
||||
|
BC (n= 50) |
BM (n= 52) |
||
---|---|---|---|---|
Randomization |
Before |
After |
Before |
After |
Best response, % CR CRu PR SD NA |
38 10 48 2 2 |
70 8 20 0 2 |
38.5 21.2 34.6 5.8 0 |
59.6 21.2 17.3 1.9 0 |
Outcome comparison between CALGB 50403 and 59909
The study results demonstrate improved outcomes with the use of bortezomib after transplantation in both conditioning and maintenance settings, especially in patients who achieved MRD negativity after induction. Patients in this study had significantly longer PFS than those on the GALGB 59090 study, strengthening the evidence of BC or BM benefit after auto-HSCT. Both treatment schedules were tolerable. However, the authors of the study draw attention to the considerable toxicity in particular, fatigue and peripheral neuropathies, which for many patients may have already been present as a result of prior therapy and transplant, can significantly affect quality of life.
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