Abstract
Multiple myeloma (MM) is a B-cell neoplasm with a high incidence of relapse. Bortezomib has been extensively studied for the maintenance treatment of MM. Here, we carried out a meta-analysis to determine the efficacy and safety of maintenance therapy with bortezomib. We searched for clinical trials in PubMed (Medline), Embase (OVID), and the Cochrane Library. Two randomized controlled trials (RCTs) enrolling a total of 1338 patients were included. Bortezomib maintenance statistically significantly improved both progression-free survival (PFS) (hazard ratio (HR) 0.67, 95% confidence interval (CI) = 0.51 to 0.87, P=0.003) and overall survival (OS) (HR = 0.75 therapy, 95% CI = 0.63 to 0.89, P=0.001) more than did non-bortezomib maintenance therapy. Our analysis revealed higher incidence of neutropenia (risks ratios (RR) = 1.39; 95% CI = 1.08 to 1.79), peripheral neuropathy (PN) (RR = 2.23; 95% CI = 1.38 to 3.61, P=0.001), and cardiologic events (RR = 1.91; 95% CI = 1.12 to 3.28, P=0.02) in patients with bortezomib maintenance therapy. Our meta-analysis demonstrates OS and PFS benefits of bortezomib maintenance therapy in patients with newly diagnosed MM. However, the therapy is associated with increased risk of adverse events. Additionally, more RCTs are needed for better understanding and determination of optimal bortezomib maintenance therapy in MM.
Highlights
Multiple myeloma (MM), a disease results from a proliferation of plasma cells and characterized by an elevation in immunoglobulin, is the second most frequent hematologic malignancy around the world
A phase III PETHEMA/GEM randomized trial comparing patients who received maintenance therapy after induction and autologous stem cell transplantation (ASCT) with either interferon-α or thalidomide or thalidomide plus bortezomib was included at the beginning but excluded at last due to lack of sufficient data for analysis [26]
The analysis revealed significant differences between the two arms, and the bortezomib maintenance therapy statistically showed significantly increased risk for developing neutropenia (RR = 1.39; 95% confidence interval (CI) = 1.08 to 1.79), peripheral neuropathy (PN) (RR = 2.23; 95% confidence interval (95% CI) = 1.38 to 3.61, P=0.001), and cardiologic events (RR = 1.91; 95% CI = 1.12 to 3.28, P=0.02) (Figure 4)
Summary
Multiple myeloma (MM), a disease results from a proliferation of plasma cells and characterized by an elevation in immunoglobulin, is the second most frequent hematologic malignancy around the world. Thalidomide maintenance has several limitations, including the toxic risk of peripheral neuropathy (PN), shorter OS in patients with high-risk cytogenetics [7], and less obvious improvement in OS for elderly patients [8,9,10,11]. Clinical trials using another immunomodulatory drug lenalidomide for maintenance therapy showed c 2017 The Author(s).
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