PMID- 27824902 OWN - NLM STAT- MEDLINE DCOM- 20170706 LR - 20181202 IS - 1932-6203 (Electronic) IS - 1932-6203 (Linking) VI - 11 IP - 11 DP - 2016 TI - Efficacy and Safety of Lenalidomide for Treatment of Low-/Intermediate-1-Risk Myelodysplastic Syndromes with or without 5q Deletion: A Systematic Review and Meta-Analysis. PG - e0165948 LID - 10.1371/journal.pone.0165948 [doi] LID - e0165948 AB - BACKGROUND: Lenalidomide could effectively induce red blood cell (RBC) transfusion independence (TI) in patients with lower-risk (Low/Intermediate-1) myelodysplastic syndrome (MDS) with or without 5q deletion. However whether lenalidomide ultimately improves the overall survival (OS) of lower-risk MDS patients and reduces the progression to AML remains controversial. METHOD: A meta-analysis was conducted to examine the efficacy and safety of lenalidomide in the treatment of lower-risk MDS. Efficacy was assessed according to erythroid hematologic response (HI-E), cytogenetic response (CyR), OS and AML progression. Safety was evaluated based on the occurrence rates of grades 3-4 adverse events (AEs). RESULTS: Seventeen studies were included consisting of a total of 2160 patients. The analysis indicated that the overall rate of HI-E was 58% with 95% confidence interval (CI) of 43-74%. The pooled estimates for the rates of CyR, complete CyR, and partial CyR were 44% (95% CI 19-68%), 21% (95% CI 13-30%) and 23% (95% CI 15-32%), respectively. The patients with 5q deletion had significantly higher rate of HI-E and CyR than those without 5q deletion (P = 0.002 and 0.001, respectively). The incidences of grades 3-4 neutropenia, thrombocytopenia, leukopenia, anemia, deep vein thrombosis, diarrhea, fatigue and rash were 51% (95% CI 30-73%), 31% (95% CI 20-42%), 9% (95% CI 5-13%), 7% (95% CI 2-12%), 3% (95% CI 2-5%), 3% (95% CI 1-5%), 2% (95% CI 1-4%) and 2% (95% CI 1-3%), respectively. Lenalidomide significantly improved OS (HR: 0.62, 95% CI 0.47-0.83, P = 0.001) and lowered the risk of AML progression in del(5q) patients (RR: 0.61, 95% CI 0.41-0.91, P = 0.014). CONCLUSIONS: In spite of the AEs, lenalidomide could be effectively and safely used for the treatment of lower-risk MDS patients with or without 5q deletion. FAU - Lian, Xin-Yue AU - Lian XY AD - Department of Hematology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, People's Republic of China. FAU - Zhang, Zhi-Hui AU - Zhang ZH AD - Department of Hematology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, People's Republic of China. FAU - Deng, Zhao-Qun AU - Deng ZQ AD - Laboratory Center, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, People's Republic of China. FAU - He, Pin-Fang AU - He PF AD - Laboratory Center, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, People's Republic of China. FAU - Yao, Dong-Ming AU - Yao DM AD - Laboratory Center, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, People's Republic of China. FAU - Xu, Zi-Jun AU - Xu ZJ AD - Laboratory Center, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, People's Republic of China. FAU - Wen, Xiang-Mei AU - Wen XM AD - Laboratory Center, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, People's Republic of China. FAU - Yang, Lei AU - Yang L AD - Laboratory Center, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, People's Republic of China. FAU - Lin, Jiang AU - Lin J AD - Laboratory Center, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, People's Republic of China. FAU - Qian, Jun AU - Qian J AD - Department of Hematology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, People's Republic of China. LA - eng PT - Journal Article PT - Meta-Analysis PT - Review PT - Systematic Review DEP - 20161108 PL - United States TA - PLoS One JT - PloS one JID - 101285081 RN - 0 (Immunologic Factors) RN - 4Z8R6ORS6L (Thalidomide) RN - F0P408N6V4 (Lenalidomide) RN - Chromosome 5q Deletion Syndrome SB - IM MH - Anemia, Macrocytic/*drug therapy/genetics MH - Chromosome Deletion MH - Chromosomes, Human, Pair 5/genetics MH - Humans MH - Immunologic Factors/adverse effects/*therapeutic use MH - Lenalidomide MH - Myelodysplastic Syndromes/*drug therapy/genetics MH - Thalidomide/adverse effects/*analogs & derivatives/therapeutic use MH - Treatment Outcome PMC - PMC5100926 COIS- The authors have declared that no competing interests exist. EDAT- 2016/11/09 06:00 MHDA- 2017/07/07 06:00 PMCR- 2016/11/08 CRDT- 2016/11/09 06:00 PHST- 2016/05/17 00:00 [received] PHST- 2016/10/20 00:00 [accepted] PHST- 2016/11/09 06:00 [entrez] PHST- 2016/11/09 06:00 [pubmed] PHST- 2017/07/07 06:00 [medline] PHST- 2016/11/08 00:00 [pmc-release] AID - PONE-D-16-20004 [pii] AID - 10.1371/journal.pone.0165948 [doi] PST - epublish SO - PLoS One. 2016 Nov 8;11(11):e0165948. doi: 10.1371/journal.pone.0165948. eCollection 2016.