Bortezomib-Based Therapy for Newly Diagnosed Mantle-Cell Lymphoma
- Study type
- Clinical trial
- Study name
- LYM-3002
- Phase
- Phase 3
- Design
- Randomised phase 3 trial (VR-CAP compared with R-CHOP)
- Sample size
- 487 patients
- Source
- N Engl J Med · 2015
- Trial registration
- NCT00722137
In plain words
In this study, patients with newly diagnosed mantle-cell lymphoma who could not have a stem cell transplant were given either the standard R-CHOP regimen or a regimen in which one of the drugs (vincristine) was replaced with bortezomib (VR-CAP). Patients in the VR-CAP group stayed free of disease progression for longer and had higher 4-year overall survival. On the other hand, drops in white blood cells and platelets were more common in this group. Treatment decisions should be made with the treating doctor.
Key results
Treatment arms and regimens
6 to 8 21-day cycles of R-CHOP (rituximab, cyclophosphamide, doxorubicin and vincristine IV on day 1; oral prednisone on days 1 to 5). Exact doses in the full text of the paper.
Bortezomib 1.3 mg/m² IV on days 1, 4, 8 and 11 (rest on days 12 to 21), rituximab 375 mg/m² on day 1, cyclophosphamide 750 mg/m² on day 1, doxorubicin 50 mg/m² on day 1 and prednisone 100 mg/m² on days 1 to 5; 21-day cycles for 6 cycles (2 additional cycles were allowed in patients whose response was first recorded at cycle 6).
Source of the regimen details: FDA label for VELCADE (Clinical Studies section, previously untreated mantle cell lymphoma) for VR-CAP; R-CHOP doses in the full text of the paper
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Adults with newly diagnosed mantle-cell lymphoma who were ineligible for stem-cell transplantation or for whom transplantation was not planned.
Endpoints
Primary endpoint: progression-free survival. Secondary endpoints included complete response rate, duration of complete response, treatment-free interval and 4-year overall survival.
Safety and side effects
Rates of neutropenia and thrombocytopenia were higher in the VR-CAP group. Exact figures for grade 3 or higher adverse events are not given in the abstract.
Clinical significance and place in guidelines
This trial showed that in patients with newly diagnosed mantle-cell lymphoma who are not transplant candidates, VR-CAP is superior to R-CHOP for progression-free survival and other secondary endpoints, although with more haematological toxicity. The status of this regimen in clinical guidelines and drug approvals should be checked separately, because the abstract gives no information about them.
Limitations
Based on the abstract, the study population was limited to patients who were not transplant candidates or for whom transplantation was not planned. The superiority of VR-CAP came with increased haematological toxicity. Other limitations are not mentioned in the abstract.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.