Abstract：
BACKGROUND: Genomic tumour profiling has a crucial role in the management of patients with solid cancers, as it helps selecting and prioritising therapeutic interventions based on prognostic and predictive biomarkers, as well as identifying markers of hereditary cancers. Harmonised approaches to interpret the results of genomic testing are needed to support physicians in their decision making, prevent inequalities in precision medicine and maximise patient benefit from available cancer management options.
METHODS: The European Society for Medical Oncology (ESMO) Translational Research and Precision Medicine Working Group assembled a group of international experts to propose recommendations for preparing clinical genomic reports for solid cancers. These recommendations aim to foster best practices in integrating genomic testing within clinical settings. After review of available evidence, several rounds of surveys and focused discussions were conducted to reach consensus on the recommendation statements. Only consensus recommendations were reported. Recommendation statements were graded in two tiers based on their clinical importance: level A (required to maintain common standards in reporting) and level B (optional but necessary to achieve ideal practice).
RESULTS: Genomics reports should present key information in a front page(s) followed by supplementary information in one or more appendices. Reports should be structured into sections: (i) patient and sample details; (ii) assay and data analysis characteristics; (iii) sample-specific assay performance and quality control; (iv) genomic alterations and their functional annotation; (v) clinical actionability assessment and matching to potential therapy indications; and (vi) summary of the main findings. Specific recommendations to prepare each of these sections are made.
CONCLUSIONS: We present a set of recommendations aimed at structuring genomics reports to enhance physician comprehension of genomic profiling results for solid cancers. Communication between ordering physicians and professionals reporting genomic data is key to minimise uncertainties and to optimise the impact of genomic tests in patient care.
METHODS: The European Society for Medical Oncology (ESMO) Translational Research and Precision Medicine Working Group assembled a group of international experts to propose recommendations for preparing clinical genomic reports for solid cancers. These recommendations aim to foster best practices in integrating genomic testing within clinical settings. After review of available evidence, several rounds of surveys and focused discussions were conducted to reach consensus on the recommendation statements. Only consensus recommendations were reported. Recommendation statements were graded in two tiers based on their clinical importance: level A (required to maintain common standards in reporting) and level B (optional but necessary to achieve ideal practice).
RESULTS: Genomics reports should present key information in a front page(s) followed by supplementary information in one or more appendices. Reports should be structured into sections: (i) patient and sample details; (ii) assay and data analysis characteristics; (iii) sample-specific assay performance and quality control; (iv) genomic alterations and their functional annotation; (v) clinical actionability assessment and matching to potential therapy indications; and (vi) summary of the main findings. Specific recommendations to prepare each of these sections are made.
CONCLUSIONS: We present a set of recommendations aimed at structuring genomics reports to enhance physician comprehension of genomic profiling results for solid cancers. Communication between ordering physicians and professionals reporting genomic data is key to minimise uncertainties and to optimise the impact of genomic tests in patient care.
摘要：
背景：基因组肿瘤分析在实体癌患者的治疗中具有至关重要的作用，因为它有助于根据预后和预测性生物标志物选择和优先考虑治疗干预措施，以及识别遗传性癌症的标志物。需要协调的方法来解释基因组测试的结果，以支持医生的决策，防止精准医学的不平等，并从可用的癌症管理选择中最大限度地提高患者的利益。
方法：欧洲肿瘤医学学会（ESMO）转化研究和精准医学工作组召集了一组国际专家，为准备实体癌的临床基因组报告提出建议。这些建议旨在促进在临床环境中整合基因组测试的最佳实践。在审查现有证据后，进行了几轮调查和重点讨论，以就建议声明达成共识。只报告了协商一致的建议。建议声明根据其临床重要性分为两个等级：A级（在报告中保持通用标准所需）和B级（可选但为获得理想实践所必需）。
结果：基因组学报告应在首页提供关键信息，然后在一个或多个附录中提供补充信息。报告应分为以下部分：（i）患者和样品详细信息；（ii）测定和数据分析特征；（iii）样品特异性测定性能和质量控制；（iv）基因组改变及其功能注释；（v）临床可操作性评估和与潜在治疗适应症的匹配；（vi）主要发现的总结。提出了准备这些部分的具体建议。
结论：我们提出了一系列建议，旨在构建基因组学报告，以增强医师对实体癌基因组分析结果的理解。订购医生和报告基因组数据的专业人员之间的沟通是减少不确定性并优化基因组测试在患者护理中的影响的关键。
方法：欧洲肿瘤医学学会（ESMO）转化研究和精准医学工作组召集了一组国际专家，为准备实体癌的临床基因组报告提出建议。这些建议旨在促进在临床环境中整合基因组测试的最佳实践。在审查现有证据后，进行了几轮调查和重点讨论，以就建议声明达成共识。只报告了协商一致的建议。建议声明根据其临床重要性分为两个等级：A级（在报告中保持通用标准所需）和B级（可选但为获得理想实践所必需）。
结果：基因组学报告应在首页提供关键信息，然后在一个或多个附录中提供补充信息。报告应分为以下部分：（i）患者和样品详细信息；（ii）测定和数据分析特征；（iii）样品特异性测定性能和质量控制；（iv）基因组改变及其功能注释；（v）临床可操作性评估和与潜在治疗适应症的匹配；（vi）主要发现的总结。提出了准备这些部分的具体建议。
结论：我们提出了一系列建议，旨在构建基因组学报告，以增强医师对实体癌基因组分析结果的理解。订购医生和报告基因组数据的专业人员之间的沟通是减少不确定性并优化基因组测试在患者护理中的影响的关键。
