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针对淋巴瘤、实体瘤和脑肿瘤的儿童、青少年及年轻成人临床试验中缺乏与治疗相关的死亡率定义:一项系统综述。

Lack of treatment-related mortality definitions in clinical trials of children, adolescents and young adults with lymphomas, solid tumors and brain tumors: a systematic review.

作者信息

Tran Thai Hoa, Lee Michelle, Alexander Sarah, Gibson Paul, Bartels Ute, Johnston Donna L, Portwine Carol, Silva Marianna, Pole Jason D, Sung Lillian

机构信息

Division of Haematology/Oncology, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario M5G 1X8, Canada.

出版信息

BMC Cancer. 2014 Aug 26;14:612. doi: 10.1186/1471-2407-14-612.

DOI:10.1186/1471-2407-14-612
PMID:25155014
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4152582/
Abstract

BACKGROUND

There is a lack of standardized definition for treatment-related mortality (TRM), which represents an important endpoint in cancer. Our objective was to describe TRM definitions used in studies of children, adolescents and young adults with lymphomas, solid tumors and brain tumors.

METHODS

We conducted a systematic review of studies enrolling children, adolescents and young adults with lymphomas, solid tumors and brain tumors in which an anti-cancer intervention was randomized, or all study designs in which TRM was a primary or secondary outcome. We searched Ovid MEDLINE, EMBASE and Evidence-Based Medicine Reviews from 1980 to June 2013. Two reviewers evaluated study eligibility and abstracted data.

RESULTS

In total, 67 studies were included and consisted of 62 randomized therapeutic trials and 5 TRM studies. None of the studies (0/67) provided a definition for TRM. Only one randomized trial of rhabdomyosarcoma provided a definition of early death.

CONCLUSIONS

We were unable to identify any TRM definitions used in studies of children, adolescents and young adults with lymphomas, solid tumors and brain tumors. Given that a proportion of this patient population may receive intensive treatment, there is an urgent need for consensus-based definitions of TRM for use across clinical trials.

摘要

背景

治疗相关死亡率(TRM)缺乏标准化定义,而它是癌症研究中的一个重要终点。我们的目的是描述在淋巴瘤、实体瘤和脑肿瘤的儿童、青少年及年轻成人研究中所使用的TRM定义。

方法

我们对纳入淋巴瘤、实体瘤和脑肿瘤的儿童、青少年及年轻成人且进行了抗癌干预随机分组的研究,或所有以TRM作为主要或次要结局的研究设计进行了系统评价。我们检索了1980年至2013年6月的Ovid MEDLINE、EMBASE和循证医学评价数据库。两名评价者评估研究的纳入资格并提取数据。

结果

总共纳入了67项研究,包括62项随机治疗试验和5项TRM研究。没有一项研究(0/67)给出TRM的定义。只有一项横纹肌肉瘤的随机试验给出了早期死亡的定义。

结论

我们未能识别出在淋巴瘤、实体瘤和脑肿瘤的儿童、青少年及年轻成人研究中所使用的任何TRM定义。鉴于该患者群体中有一部分可能接受强化治疗,迫切需要基于共识的TRM定义以用于各项临床试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4b32/4152582/abacae69ccad/12885_2014_4795_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4b32/4152582/abacae69ccad/12885_2014_4795_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4b32/4152582/abacae69ccad/12885_2014_4795_Fig1_HTML.jpg

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