Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2017 Jul 11;8(28):46593-46600.
doi: 10.18632/oncotarget.16235.

Lenalidomide and the risk of serious infection in patients with multiple myeloma: a systematic review and meta-analysis

Li Ying  1 , Tong YinHui  2 , Zheng Yunliang  3 , Haozhen Sun  1
Affiliations
Meta-Analysis

Lenalidomide and the risk of serious infection in patients with multiple myeloma: a systematic review and meta-analysis

Li Ying et al. Oncotarget. .

Abstract

The immunomodulatory drug lenalidomide is highly effective against newly diagnosed and relapsed/refractory multiple myeloma (MM), but serious and even fatal infections have been associated with its use. In this meta-analysis, we assessed the overall risk of infection to MM patients treated with lenalidomide. Eleven phase II or III clinical trials, comprising 3,210 subjects, were selected from the Embase, Pubmed, and Cochrane Library databases, from the Clinical Trial Registration website, and from meeting abstracts and virtual presentations at the American Society of Clinical Oncology. Main outcome measures were overall incidence, relative risk (RR), and 95% confidence intervals (CIs) of reported infection events. Fixed-effect or random-effect models were used in the statistical analyses, depending on the between-study heterogeneity. The overall incidence of high-grade infection was 14.32% (95% CI: 12.08%-16.90%) and high-grade infection's pooled RR was 2.23 (95% CI: 1.71-2.91, P < 0.0001) for all 11 studies evaluated. No evidence of publication bias for the incidence of high-grade infection was detected using Begg's funnel plot and Egger's test (P = 0.2; 95% CI: -1.70, 1.23). From this meta-analysis, it appears lenalidomide use is associated with an increased risk of high-grade infection. Moreover, fatal infection events occurred only in patients treated with lenalidomide; no infection-related deaths were observed among controls. These data indicate that accurate diagnosis and optimal management of infection in MM patients treated with lenalidomide could be critical for treatment efficacy.

Keywords: incidence; infection; lenalidomide; meta-analysis; multiple myeloma.

PubMed Disclaimer

Conflict of interest statement

CONFLICTS OF INTEREST

There are no financial/commercial conflicts of interest involving any of the authors of this study.

Figures

Figure 1
Figure 1. Flow chart demonstrating the process of study selection
Figure 2
Figure 2. Forest plot for meta-analysis of incidence of high-grade infection in patients assigned lenalidomide
Figure 3
Figure 3. Relative risk of lenalidomide-associated high-grade infection
Figure 4
Figure 4. Funnel plot of the incidence of high-grade infection versus the study's standard error
See this image and copyright information in PMC

References

    1. Xiao R, Miller JA, Margetis K, Lubelski D, Lieberman IH, Benzel EC, Mroz TE. Predicting the progression of vertebral fractures in patients with multiple myeloma. Spine J. 2015 doi: 10.1016/j.spinee.2015.12.014. - DOI - PubMed
    1. Hou J, Du X, Jin J, Cai Z, Chen F, Zhou DB, Yu L, Ke X, Li X, Wu D, Meng F, Ai H, Zhang J, et al. A multicenter, open-label, phase 2 study of lenalidomide plus low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: the MM-021 trial. J Hematol Oncol. 2013;6:41. doi: 10.1186/1756-8722-6-41. - DOI - PMC - PubMed
    1. Zonder JA, Hussein MA, Bolejack V, Moore DF, Sr, Whittenberger BF, Abidi MH, Durie BGM, Barlogie B. Superiority of Lenalidomide (Len) Plus High-Dose Dexamethasone (HD) Compared to HD Alone as Treatment of Newly-Diagnosed Multiple Myeloma (NDMM): Results of the Randomized, Double-Blinded, Placebo-Controlled SWOG Trial S0232. Blood. 2007;110 abstract.
    1. Rajkumar SV, Hayman SR, Lacy MQ, Dispenzieri A, Geyer SM, Kabat B, Zeldenrust SR, Kumar S, Greipp PR, Fonseca R, Lust JA, Russell SJ, Kyle RA, et al. Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma. Blood. 2005;106:4050–3. doi: 10.1182/blood-2005-07-2817. - DOI - PMC - PubMed
    1. Handa H, Saitoh T, Murakami H. [Immunomodulatory effects of lenalidomide]. [Article in Japanese] Nihon Rinsho. 2015;73:156–61. - PubMed

MeSH terms