癌症患者中依维莫司所致贫血的风险：一项随机对照试验的荟萃分析。
Risk of anemia attributable to everolimus in patients with cancer: a meta-analysis of randomized controlled trials.
作者信息
Shameem Raji, Hamid Muhammad Saad, Wu Shenhong
机构信息
Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, PA, U.S.A.
Department of Internal Medicine, Wayne State University/Detroit Medical Center, Detroit, MI, U.S.A.
出版信息
Anticancer Res. 2015 Apr;35(4):2333-40.
BACKGROUND
Everolimus, an inhibitor of mammalian target of rapamycin (mTOR) used for the treatment of various solid tumors, is associated with anemia, which can lead to morbidity and treatment interruption or discontinuation. Because the underlying causes of anemia can be multifactorial, we performed a meta-analysis of randomized controlled trials (RCTs) to determine the overall risk of anemia specifically attributable to everolimus in cancer patients.
MATERIALS AND METHODS
We searched the PubMed database and abstracts presented at the American Society of Clinical Oncology annual meetings up to May 2014 for relevant studies. Eligible studies included RCTs in which everolimus alone or in combination with other agents was compared to placebo alone or with other agents in patients with cancer. Summary incidences, relative risks (RR), and 95% confidence intervals (CI) were calculated using a random- or fixed-effects model depending on the heterogeneity of the included trials. The attributable risk was determined by the incidence with everolimus minus that without everolimus in controls.
RESULTS
A total of nine RCTs with 3,678 patients (everolimus, n=2,162; controls, n=1,516) were included in our analysis. In comparison with controls, everolimus significantly increased the risk of all-grade (RR=2.18, 95% CI=1.56-3.04, p<0.001) and high-grade anemia (RR=2.63, 95% CI=1.35-5.15, p<0.001). The summary incidences of all-grade (grades 1-4) and high-grade (grades 3-4) anemia in patients treated with everolimus were 32.1% (95% CI=17.5-51.3%) and 6.9% (95% CI=4.1-11.3%) respectively, with 13.3% (95% CI=10.0-17.5%) and 4.7% (95% CI=2.8-7.7%) specifically attributable to everolimus. Risk factors of high-grade anemia attributable to everolimus included tumor type (p=0.012), with the highest seen in renal cell carcinoma (8.0%, 95% CI=5.3-11.9%), and chemotherapy (p<0.001).
CONCLUSION
There is a substantial risk of all-grade and high-grade anemia attributable to everolimus therapy for cancer.
背景
依维莫司是一种用于治疗多种实体瘤的哺乳动物雷帕霉素靶蛋白（mTOR）抑制剂，与贫血相关，贫血可导致发病，并导致治疗中断或停止。由于贫血的潜在原因可能是多因素的，我们进行了一项随机对照试验（RCT）的荟萃分析，以确定癌症患者中特别归因于依维莫司的贫血总体风险。
材料和方法
我们检索了截至2014年5月的PubMed数据库以及美国临床肿瘤学会年会的摘要，以查找相关研究。符合条件的研究包括RCT，其中将依维莫司单独或与其他药物联合使用的患者与单独使用安慰剂或与其他药物联合使用的患者进行比较。根据纳入试验的异质性，使用随机或固定效应模型计算汇总发病率、相对风险（RR）和95%置信区间（CI）。归因风险通过依维莫司治疗组的发病率减去对照组未使用依维莫司的发病率来确定。
结果
我们的分析共纳入了9项RCT，涉及3678例患者（依维莫司组，n = 2162；对照组，n = 1516）。与对照组相比，依维莫司显著增加了所有级别（RR = 2.18，95%CI = 1.56 - 3.04，p < 0.001）和高级别贫血（RR = 2.63，95%CI = 1.35 - 5.15，p < 0.001）的风险。接受依维莫司治疗的患者中，所有级别（1 - 4级）和高级别（3 - 4级）贫血的汇总发病率分别为32.1%（95%CI = 17.5 - 51.3%）和6.9%（95%CI = 4.1 - 11.3%），其中分别有13.3%（95%CI = 10.0 - 17.5%）和4.7%（95%CI = 2.8 - 7.7%）特别归因于依维莫司。归因于依维莫司的高级别贫血的风险因素包括肿瘤类型（p = 0.012），在肾细胞癌中最高（8.0%，95%CI = 5.3 - 11.9%），以及化疗（p < 0.001）。
结论
依维莫司治疗癌症存在导致所有级别和高级别贫血的重大风险。
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