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On 5 April 2019, Andrew Davies from the University of Southampton, Southampton, UK, and colleagues, published in the Lancet Oncology results from the phase III clinical trial REMoDL-B (randomised evaluation of molecular guided therapy for diffuse large B-cell lymphoma with bortezomib; NCT01324596).
In this multicenter, randomized, open-label, adaptive, superiority, phase III trial, the efficacy of bortezomib addition to standard chemoimmunotherapy for diffuse large B-cell lymphoma (DLBCL) was investigated. Initially, all patients received one cycle of standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) treatment. Following that, gene-expression analysis was undertaken, patients were stratified by molecular DLBCL subtype (germinal center B-cell [GCB], activated B-cell [ABC], or unclassified) and further randomized to continue R-CHOP alone or with the addition of bortezomib. The primary endpoint of the study was 30-month progression-free survival (PFS) for the GCB and ABC populations. Secondary endpoints included, 30-month PFS according to cell-of-origin subgroup, overall survival (OS), disease-free survival (DFS), response rates and duration, and toxicity.
DLBCL molecular subtype |
R-CHOP arm, n (%) |
RB-CHOP arm, n (%) |
---|---|---|
Activated B cell |
121 (26·4%) |
123 (26.8%) |
Germinal centre B cell |
240 (52·3%) |
235 (51.2%) |
Unclassified |
98 (21.4%) |
101 (22.0%) |
|
ABC subgroup |
GCB subgroup |
Unclassified subgroup |
P value |
---|---|---|---|---|
Age, years |
67 (22–86) |
63 (20–82) |
63 (20–84) |
0.0045 |
Bone marrow involvement |
33/240 (13.8%) |
66/465 (14.2%) |
42/191 (22.0%) |
0.017 |
Bulky disease >10 cm |
50/241 (20.7%) |
158/467 (33.8%) |
55/198 (27.8%) |
< 0.0001 |
This multicenter phase III trial with real-time DLBCL molecular characterisation showed that bortezomib addition to R-CHOP did not improve PFS in patients with DLBCL, despite their molecular subtype (ABC, GCB or unclassified).
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