Efficacy and safety of lenalidomide for the treatment of acute myeloid leukemia: a systematic review and meta-analysis

Abstract

BackgroundLenalidomide is effective for the treatment of low-risk myelodysplastic syndromes with deletion 5q abnormalities. However, whether lenalidomide leads to a significant improvement in treatment response and overall survival (OS) in cases of acute myeloid leukemia (AML) remains controversial. A systematic review and a meta-analysis were performed to evaluate the efficacy and safety of lenalidomide in the treatment of AML.MethodsClinical studies were identified from the Cochrane Central Register of Controlled Trials, PubMed, Embase, and ClinicalTrials.gov. Efficacy outcomes included overall response rate (ORR), complete remission (CR), and OS. Safety was evaluated based on the incidence of grade 3 and 4 treatment-related adverse events (AEs).ResultsEleven studies were included in our meta-analysis; collectively these studies featured 407 AML patients. Pooled estimates for overall ORR and CR were 31% (95% CI: 26%–36%) and 21% (95% CI: 16%–27%), respectively. Thrombocytopenia, anemia, neutropenia, and infection were the most common grade 3 and 4 AEs.ConclusionLenalidomide may have some clinical activity in AML, but the population that would benefit from lenalidomide and incorporating lenalidomide into combination drug strategies need to be better defined.

Immunomodulatory Drugs in Acute Myeloid Leukemia Treatment

“…Probably, the most significant results occur following two combination therapies—lenalidomide plus cytarabine and lenalidomide plus 5-AZA, suggesting a possible synergic action of these molecules. The most important studies reported a response rate of approximately 30% for these two combinations [ 31 ]. It was shown that the cytogenetic risk had exerted only a minimal impact on the outcomes of lenalidomide-based regimens.…”

“…The use of lenalidomide in studies reported in literature is generally in a particular subset of AML patients—untreated elderly patients, poor cytogenetic risk or R/R patients. A meta-analysis and systematic review by Chun-Hong Xie et al [ 31 ] reported that in AML patients treated with lenalidomide as monotherapy, the CR rate was relatively low (14%) and the ORR was 22%. In a phase 2 study by Fehniger et al [ 32 ], untreated AML patients aged 60 years or more (median age, 71 years) received high dose (HD) lenalidomide (50 mg/day) for up to two 28-day-cycles.…”

“…Relevant safety data showed that the most common side effects of lenalidomide monotherapy were myelosuppression, fatigue and electrolyte disturbance. Infection and neutropenic fever are the most frequent complications [ 31 ].…”

“…Thirteen (68%) out of 19 patients completed at least one induction cycle and 4 (30.8%) out of 13 evaluable patients obtained a CR/CRi. In a systematic review and meta-analysis by Xie et al [ 31 ], some studies on lenalidomide and 5-AZA in AML patients were considered. The analysis revealed that the CR rate was 22% and the ORR was 31%.…”

<p>Efficacy and toxicity of cladribine for the treatment of refractory acute myeloid leukemia: a meta-analysis</p>

“…A modified version of the Newcastle-Ottawa Scale for cohort studies was used to assess the quality of studies 19,20. The quality and risk of bias for all eligible papers in this systematic review were evaluated independently by two investigators.…”