Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, China.
BMC Cancer. 2022 Nov 17;22(1):1185. doi: 10.1186/s12885-022-10284-1.
BACKGROUND: As a potential genetic biomarker, tumor mutation burden (TMB) has made progress in numerous tumors. There are limited data regarding TMB and its prognostic role is controversial in breast cancer. This systematic review and meta-analysis were conducted to assess the prognostic value of TMB on survival of breast cancer. METHODS: The databases PubMed, Embase, Web of Science, and Cochrane Library were searched for articles published through May 31, 2022. Moreover, effective data were extracted from included studies and calculated pooled effects of hazard ratio (HR) for overall survival (OS) and progression-free survival (PFS) by STATA 16.0. Heterogeneity was conducted by the I statistic and p-value. Using publication bias evaluation, sensitivity analysis, and subgroup analysis, the origin of heterogeneity was further investigated. RESULTS: They were up to 1,722 patients collected from sixteen cohorts for this analysis. The pooled effects of HR for both OS (HR: 1.14, 95% CI: 0.83,1.58, p > 0.01) and PFS (HR: 0.96, 95% CI: 0.53,1.71, p > 0.01) indicated no statistically significant difference in the high TMB and low TMB group. In immune checkpoint inhibitors (ICIs) subgroup, high TMB patients demonstrated benefit of OS (HR: 0.72, 95% CI: 0.59,0.87, p = 0.001) and PFS (HR: 0.52, 95% CI: 0.35,0.77, p < 0.001), whereas difference was not statistically significant in the non-ICIs subgroup (OS, HR:1.76, 95% CI: 0.97,3.20, p = 0.062; PFS, HR:2.31, 95% CI: 0.89,5.97, p = 0.086). In addition, sensitivity analysis revealed that the pooled effects were stable. The funnel plot and Begg's test suggested the absence of publication bias. CONCLUSION: Meta-analysis revealed that the prognostic relevance of TMB in breast cancer is limited in scope. High TMB may be associated with longer survival only in ICIs-based treatment, but the association is not evident in non-ICIs-based treatment. TRIAL REGISTRATION: [ https://www.crd.york.ac.uk/PROSPERO ], Prospective Register of Systematic Reviews (PROSPERO), identifier: CRD42022342488.
背景：肿瘤突变负担（TMB）作为一种潜在的遗传生物标志物，在许多肿瘤中取得了进展。关于 TMB 的数据有限，其在乳腺癌中的预后作用仍存在争议。本系统评价和荟萃分析旨在评估 TMB 对乳腺癌患者生存的预后价值。
方法：通过检索 PubMed、Embase、Web of Science 和 Cochrane Library 数据库，收集截至 2022 年 5 月 31 日发表的文章。此外，从纳入的研究中提取有效数据，并使用 STATA 16.0 计算总生存（OS）和无进展生存（PFS）的风险比（HR）的合并效应。通过 I 统计量和 p 值评估异质性。通过发表偏倚评估、敏感性分析和亚组分析进一步探讨异质性的来源。
结果：本分析共纳入了来自 16 个队列的 1722 名患者。高 TMB 和低 TMB 组之间的 OS（HR：1.14，95%CI：0.83，1.58，p>0.01）和 PFS（HR：0.96，95%CI：0.53，1.71，p>0.01）的 HR 合并效应无统计学差异。在免疫检查点抑制剂（ICIs）亚组中，高 TMB 患者的 OS（HR：0.72，95%CI：0.59，0.87，p=0.001）和 PFS（HR：0.52，95%CI：0.35，0.77，p<0.001）获益有统计学意义，而在非 ICIs 亚组中差异无统计学意义（OS，HR：1.76，95%CI：0.97，3.20，p=0.062；PFS，HR：2.31，95%CI：0.89，5.97，p=0.086）。此外，敏感性分析表明合并效应稳定。漏斗图和贝叶斯检验提示无发表偏倚。
结论：荟萃分析表明，TMB 在乳腺癌中的预后相关性范围有限。高 TMB 可能仅与基于 ICIs 的治疗相关的生存时间延长有关，但在基于非 ICIs 的治疗中并不明显。
试验注册：[https://www.crd.york.ac.uk/PROSPERO]，系统评价的前瞻性注册（PROSPERO），标识符：CRD42022342488。
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