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乳腺导管原位癌的腋窝评估:对临床实践指南诊断准确性的挑战。

Axillary evaluation in ductal cancer in situ of the breast: challenging the diagnostic accuracy of clinical practice guidelines.

机构信息

Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.

Breast Unit, Department of Surgery, Uppsala University Hospital, Uppsala, Sweden.

出版信息

Br J Surg. 2021 Sep 27;108(9):1120-1125. doi: 10.1093/bjs/znab149.

DOI:10.1093/bjs/znab149
PMID:34089583
Abstract

BACKGROUND

Staging of the axilla is not routine in ductal cancer in situ (DCIS) although invasive cancer is observed in 20-25 per cent of patients at final pathology. Upfront sentinel lymph node dissection (SLND) is advocated in clinical practice guidelines in certain situations. These include expected challenges in subsequent SLN detection and when the risk for invasion is high. Clinical practice guidelines are, however, inconsistent and lead to considerable practice variability.

METHODS

Clinical practice guidelines for upfront SLND in DCIS were identified and applied to patients included in the prospective SentiNot study. These patients were evaluated by six independent, blinded raters. Agreement statistics were performed to assess agreement and concordance. Receiver operating characteristic curves were constructed, to assess guideline accuracy in identifying patients with underlying invasion.

RESULTS

Eight guidelines with relevant recommendations were identified. Interobserver agreement varied greatly (kappa: 0.23-0.9) and the interpretation as to whether SLND should be performed ranged from 40-90 per cent and with varying concordance (32-88 per cent). The diagnostic accuracy was low with area under the curve ranging from 0.45 to 0.55. Fifty to 90 per cent of patients with pure DCIS would undergo unnecessary SLNB, whereas 10-50 per cent of patients with invasion were not identified as 'high risk'. Agreement across guidelines was low (kappa = 0.24), meaning that different patients had a similar risk of being treated inaccurately.

CONCLUSION

Available guidelines are inaccurate in identifying patients with DCIS who would benefit from upfront SLNB. Guideline refinement with detailed preoperative work-up and novel techniques for SLND identification could address this challenge and avoid overtreatment.

LAY SUMMARY

The decision whether to operate on the axilla in women with a diagnosis of ductal cancer in situ (DCIS) is based on the risk of an undiagnosed underlying invasive cancer and on the concern that resection of the breast will not allow for accurate axillary mapping afterwards. Guidelines stem from older knowledge and are heterogeneous. In this study, different breast cancer guidelines were tested in a patient cohort from the SentiNot prospective trial for uniformity of interpretation and diagnostic accuracy. Results show that guidelines did not allow for easy and uniform interpretation and had the predictive ability of the toss of a coin. This suggests that guidelines regarding the need of axillary evaluation in patients operated for DCIS need to be revised and that techniques that will address the conundrum should be developed.

摘要

背景

尽管在最终病理检查中 20-25%的患者存在浸润性癌,但腋窝分期在导管癌原位(DCIS)中并非常规操作。在某些情况下,临床实践指南提倡在初始阶段进行前哨淋巴结活检(SLND)。这些情况包括在后续 SLN 检测中存在挑战,以及侵袭风险较高的情况。然而,临床实践指南并不统一,导致实践存在很大差异。

方法

确定了 DCIS 初始 SLND 的临床实践指南,并将其应用于前瞻性 SentiNot 研究中纳入的患者。这些患者由六名独立的、盲法的评估员进行评估。采用一致性统计分析评估一致性和一致性。构建了接收者操作特征曲线,以评估指南在识别潜在浸润患者方面的准确性。

结果

确定了 8 条具有相关建议的指南。观察者间的一致性差异很大(kappa:0.23-0.9),对于是否应进行 SLND 的解释范围为 40-90%,且一致性不同(32-88%)。诊断准确性较低,曲线下面积范围为 0.45 至 0.55。50-90%的单纯 DCIS 患者将接受不必要的 SLNB,而 10-50%的浸润患者未被识别为“高危”。指南之间的一致性较低(kappa=0.24),这意味着不同的患者具有相似的不准确治疗风险。

结论

现有的指南在识别从初始 SLNB 中获益的 DCIS 患者方面并不准确。通过详细的术前检查和用于 SLND 识别的新技术对指南进行细化,可以解决这一挑战并避免过度治疗。

非专业人士摘要

在诊断为导管癌原位(DCIS)的女性中,是否对腋窝进行手术的决定取决于是否存在未诊断出的潜在浸润性癌的风险,以及切除乳房后是否无法准确进行腋窝映射的担忧。指南源于旧知识,且具有异质性。在这项研究中,不同的乳腺癌指南在 SentiNot 前瞻性试验的患者队列中进行了测试,以测试其解释的一致性和诊断准确性。结果表明,指南无法进行轻松和统一的解释,其预测能力与抛硬币相同。这表明,需要对接受 DCIS 手术的患者进行腋窝评估的指南进行修订,并应开发解决这一难题的技术。

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引用本文的文献

1
Delayed Sentinel Lymph Node Dissection in Patients with a Preoperative Diagnosis of Ductal Cancer In Situ by Preoperative Injection with Superparamagnetic Iron Oxide (SPIO) Nanoparticles: The SentiNot Study.术前注射超顺磁氧化铁(SPIO)纳米颗粒诊断导管原位癌患者的延迟前哨淋巴结活检:SentiNot 研究。
Ann Surg Oncol. 2023 Jul;30(7):4064-4072. doi: 10.1245/s10434-022-13064-0. Epub 2023 Jan 31.