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儿童癌症治疗后的继发原发性肿瘤 - 德国巢式病例对照研究 STATT-SCAR 的设计与描述。

Subsequent primary neoplasms after childhood cancer therapy - design and description of the German nested case-control study STATT-SCAR.

机构信息

Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.

Federal Offices for Radiation Protection, Neuherberg, Germany.

出版信息

Cancer Causes Control. 2024 Jan;35(1):33-41. doi: 10.1007/s10552-023-01760-5. Epub 2023 Aug 2.

Abstract

BACKGROUND

Subsequent primary neoplasms (SPN) are among the most severe late effects and the second most frequent cause of death in childhood cancer patients. In this paper we introduce method and properties of the STATT-SCAR study (Second Tumor After Tumor Therapy, Second Cancer After Radiotherapy), which is a joint nested matched case-control study to evaluate the impact of chemotherapy (STATT) as well as radiotherapy (SCAR) on the risk of developing a SPN.

METHODS

Based on the cohort of the German childhood cancer registry (GCCR), we selected patients diagnosed with a first neoplasm before age 15 or younger between 1980 and 2014. We selected those with a SPN at least half a year after the first neoplasm, and matched up to four controls to each case. Therapy data were acquired from various sources, including clinical study centers and treating hospitals. To analyze the impact of radiotherapy, organ doses were estimated by using reconstructed treatment plans. The effect of chemotherapy was analyzed using substance groups summarized after isotoxic dose conversion.

RESULTS

1244 cases with a SPN were identified and matched with 4976 controls. Treatment data were acquired for 83% of all match groups (one case and at least one control). Based on preliminary analyses, 98% of all patients received chemotherapy and 54% of all patients were treated with radiotherapy.

CONCLUSIONS

Based on our data, detailed analyses of dose response relationships and treatment element combinations are possible, leading to a deeper insight into SPN risks after cancer treatments.

TRIAL REGISTRATION

The study is registered at the German clinical trial register (DRKS) under number DRKS00017847 [45].

摘要

背景

继发原发性肿瘤(SPN)是儿童癌症患者最严重的晚期并发症之一,也是第二大常见死亡原因。在本文中,我们介绍了 STATT-SCAR 研究(肿瘤治疗后的第二肿瘤、放射治疗后的第二癌症)的方法和特征,这是一项联合嵌套匹配病例对照研究,旨在评估化疗(STATT)和放疗(SCAR)对 SPN 发病风险的影响。

方法

基于德国儿童癌症登记处(GCCR)的队列,我们选择了 1980 年至 2014 年期间年龄在 15 岁以下或更年轻时首次诊断患有肿瘤的患者。我们选择了在首次肿瘤后至少半年发生 SPN 的患者,并为每个病例匹配了至多 4 名对照。治疗数据来自多个来源,包括临床研究中心和治疗医院。为了分析放疗的影响,我们使用重建的治疗计划来估计器官剂量。使用经过等毒剂量转换后的物质组来分析化疗的影响。

结果

共确定了 1244 例 SPN 病例,并与 4976 例对照进行了匹配。所有匹配组(一个病例和至少一个对照)中,有 83%的组获得了治疗数据。根据初步分析,所有患者中有 98%接受了化疗,54%的患者接受了放疗。

结论

基于我们的数据,可以对剂量反应关系和治疗元素组合进行详细分析,从而更深入地了解癌症治疗后 SPN 的风险。

试验注册

该研究在德国临床试验注册处(DRKS)注册,编号为 DRKS00017847[45]。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4a6/10764383/ae7fed1a9c63/10552_2023_1760_Fig1_HTML.jpg

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