BACKGROUND:Biologics are widely used to manage the side effects of cancer treatment (e.g., epoetin alfa is used to treat chemotherapy-induced anemia [CIA] and granulocyte colony-stimulating factors [G-CSFs] are used to treat chemotherapy-induced neutropenia [CIN]). As several patents for biologics used in cancer treatment have expired, a number of companies have developed supportive care biosimilars (e.g., epoetin alfa biosimilar, filgrastim biosimilar, pegfilgrastim biosimilar). OBJECTIVE:The objective of this study was to synthesize current evidence on the efficacy and safety of supportive care biosimilars compared with their reference biologics in oncology. METHODS:We searched PubMed, Embase, the Cochrane library, ClinicalTrials.gov, ISI Web of Science and several Chinese databases from their inception dates to December 31, 2018 for randomized controlled trials (RCTs) or comparative observational studies that compared the efficacy and safety of supportive care biosimilars and their reference biologics in oncology. We pooled results separately for RCTs and observational studies, as such studies involve different patient populations and are designed differently. We pooled binary outcomes using risk ratios (RR) with confidence intervals (CIs) and continuous outcomes using weighted mean differences (WMD) with 95% CIs, then conducted subgroup and sensitivity analyses. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to rate the quality of evidence. RESULTS:We identified 28 studies that compared biosimilars of G-CSF or epoetin alfa: one RCT and five cohort studies (total N = 2816) of epoetin alfa biosimilars, and 13 RCTs and 9 cohort studies (total N = 23,043) of G-CSF biosimilars [corrected]. Despite involving different populations, RCTs and observational studies comparing biosimilars and reference biologics indicated similar efficacy and safety results. Overall, there was no statistically significant difference in any efficacy or safety outcomes between any biosimilars and their corresponding original biologics (all p > 0.05). The quality of GRADE evidence of efficacy and safety outcomes was moderate or low. Findings were robust for all prespecified subgroup and sensitivity analyses. CONCLUSION:Existing evidence suggests highly comparable efficacy and safety profiles for supportive care biosimilars and their reference biologics in oncology.

译文

背景:生物制剂被广泛用于治疗癌症的副作用(例如,依泊汀α被用于治疗化学疗法引起的贫血[CIA],粒细胞集落刺激因子[G-CSFs]被用于治疗化学疗法引起的中性粒细胞减少[ CIN])。随着用于癌症治疗的生物制剂的几项专利到期,许多公司已经开发了支持性护理生物仿制药(例如,epoetin alfa生物仿制药,非格司亭生物仿制药,pegfilgrastim生物仿制药)。
目的:本研究的目的是综合比较支持治疗生物仿制药与其参考生物制剂在肿瘤学中的有效性和安全性。
方法:从开始至2018年12月31日,我们从PubMed,Embase,Cochrane图书馆,ClinicalTrials.gov,ISI Web of Science和几个中文数据库中搜索了随机对照试验(RCT)或比较观察性研究,以比较疗效和安全性支持治疗生物仿制药及其在肿瘤学中的参考生物制剂。我们分别汇总了RCT和观察性研究的结果,因为这些研究涉及不同的患者人群并且设计不同。我们使用具有置信区间(CI)的风险比(RR)合并二元结果,并使用具有95%CI的加权平均差(WMD)合并连续结果,然后进行亚组和敏感性分析。我们使用了建议评估,发展和评估的等级(GRADE)方法来评估证据的质量。
结果:我们确定了28项比较G-CSF或epoetin alfa生物仿制药的研究:1项RCT和5项epoetin alfa生物仿制药的队列研究(总N = 2816),以及13项RCT和9项G-CSF或epoetin alfa的生物仿制药。 CSF生物仿制药[已更正]。尽管涉及不同人群,但随机对照试验和观察性研究比较了生物仿制药和参考生物制剂,显示出相似的疗效和安全性结果。总体而言,任何生物仿制药与其相应的原始生物仿制药之间,在任何功效或安全性结果上均无统计学意义的差异(所有p> 0.05)。 GRADE疗效和安全性结果证据的质量为中度或低度。对于所有预先指定的亚组和敏感性分析,结果都是可靠的。
结论:现有证据表明支持治疗生物仿制药及其在肿瘤学中的参考生物制剂具有相当的疗效和安全性。

+1
+2
100研值 100研值 ¥99课程
检索文献一次
下载文献一次

去下载>

成功解锁2个技能,为你点赞

《SCI写作十大必备语法》
解决你的SCI语法难题!

技能熟练度+1

视频课《玩转文献检索》
让你成为检索达人!

恭喜完成新手挑战

手机微信扫一扫,添加好友领取

免费领《Endnote文献管理工具+教程》

微信扫码, 免费领取

手机登录

获取验证码
登录