Matthew Garrett, PharmD candidate 2015
Mercer University College of Pharmacy
Mantle-cell lymphoma is type of cancer that affects the blood. Mantle-cell lymphoma is classified as a B-cell non-Hodgkins lymphoma that’s usually effects men over the age of 60 years old.1 Mantle-cell lymphoma has a poor prognosis and the 10-year survival rate is 5%-10%.2 Bortezomib is an antineoplastic agent that is used to treat multiple myeloma. Bortezomib inhibits 26S proteasome, which regulates the intracellular concentration of specific proteins. The Food and Drug Administration has recently approved bortezomib for untreated patients with mantle cell lymphoma.3
|Title: Title: Bortezomib-Based Therapy for Newly Diagnosed Mantle-Cell Lymphoma4|
|Design||Phase 3 randomized clinical trial|
|Objective||To determine whether substituting bortezomib for vincristine in frontline R-CHOP could improve outcomes in patients with mantle-cell lymphoma.|
|Study groups||R-CHOP group (rituximab, cyclophosphamide, doxorubicin, vincristine,
VR-CAP group (bortezomib, rituximab, cyclophosphamide, doxorubicin,
|Methods||Patients were randomly assigned in a 1:1 ratio to receive six 21-day cycles of R-CHOP or VR-CAP. R-CHOP comprised rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, and vincristine 1.4 mg/m2, all administered intravenously on day 1, plus oral prednisone 100 mg/m2 administered on days 1 to 5. VR-CAP compromised intravenous bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 of each cycle, followed by rituximab, cyclophosphamide, doxorubicin, and prednisone.|
|Duration||May 2008 through December 2011||Primary Outcome Measure||Progression-free survival|
|Baseline Characteristics||Adults with newly diagnosed stage II, III, or IV mantle-cell lymphoma who were ineligible or not considered for stem-cell transplantation were eligible.|
|Results||The median progression-free survival was 14.4 months in the R-CHOP
group and 24.7 months in the VR-CAP group (hazard ratio favoring the VR-CAP group, 0.63; P<0.001)
|Adverse Events||Common Adverse Events: Diarrhea 30%, nausea 25%, fatigue 23%, decreased appetite 19%|
|Serious Adverse Events: Neutropenia 88%, thrombocytopenia 72%, leukopenia 50%|
|Percentage that Discontinued due to Adverse Evens: 8%|
|Study Author Conclusions||A significant prolongation of progression-free survival and improvements in secondary efficacy end points were observed with VR-CAP as compared with R-CHOP.|
This phase 3 clinical trial has shown that substituting bortezomib into VR-CAP therapy had more progression-free survival when compared to R-CHOP.
1. Lymphoma.org. Mantle Cell Lymphoma-Lymphoma Research Foundation – Welcome. 2015. Available at: http://www.lymphoma.org/site/pp.asp?c=bkLTKaOQLmK8E&b=6300157. Accessed March 6, 2015.
2. Emedicine.medscape.com. Mantle Cell Lymphoma. 2015. Available at: http://emedicine.medscape.com/article/203085-overview#aw2aab6b2. Accessed March 6, 2015.
3. Nlm.nih.gov. Bortezomib: MedlinePlus Drug Information. 2015. Available at: http://www.nlm.nih.gov/medlineplus/druginfo/meds/a607007.html. Accessed March 6, 2015.
4. Robak T, Huang H, Jin J, et al. Bortezomib-Based Therapy for Newly Diagnosed Mantle-Cell Lymphoma. N Engl J Med. 2015;372(10):944-953.