ObjectiveTo systematically evaluate the efficacy of lenalidomide in the treatment of patients with multiple myeloma(MM) and the risk of related severe infection.
MethodsPubMed, Embase and Cochrane library controlled trials were searched by computer, to identify research literature of the randomized controlled trials (RCT) of the efficacy of lenalidomide in the treatment of MM and the risk of related severe infection. Patients in study group were treated with lenalidomide or a combination of lenalidomide and dexamethasone, while placebo, dexamethasone or a combination of placebo and dexamethasone were used in control group. Two researchers independently screened the literature according to the literature set in this study and excluded criteria to evaluate the quality of the included literature and extract the data. A Meta-analysis of disease-free survival (PFS), overall survival (OS), incidence of severe infection, incidence of severe respiratory tract infection, andRRof severe infection of MM were performed using R3.3.1 software. Modified Jadad scale was used for RCT quality evaluation.
ResultsA total of 7 RCT literatures were included according to the inclusion criteria of this study through literature screening. A total of 4 007 MM patients were enrolled, of whom 2 117 cases were in study group, and 1 890 cases in control group. Seven literatures were high quality RCT. The results of Meta-analysis were as follows. ① Compared with the control group, the 3-years PFS of the study group was significantly prolonged (HR=0.54, 95%CI: 0.36-0.82,P=0.004), but the 3-years OS was not significantly beneficial (HR=0.84, 95%CI: 0.62-1.14,P=0.262). ②The incidence of severe infection in MM patients was 6.67%-21.47%, the overall incidence was 14.01%(95%CI: 11.01%-17.02%). The incidence of respiratory tract severe infection was 46%(95%CI: 27%-65%). Compared with the control group, theRRof related severe infection in study group was increased (RR=1.92, 95%CI: 1.59-2.33,P<0 .000 1).
ConclusionsAlthough lenalidomide can benefit the PFS of MM patients, it has no significant improvement on the OS of patients.The risk of related severe infection caused by lenalidomide is very high, especially serious respiratory tract infection.
