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采用低成本双染技术对 cN0 腋窝进行前哨淋巴结活检的验证研究:资源匮乏环境的潜在解决方案。

Validation sentinel lymph node biopsy study in cN0 axilla using low-cost dual dye technique: potential solution for resource poor settings.

机构信息

Department of Surgery, Netaji Subhash Chandra Bose (NSCB) Medical College, Jabalpur, India.

Department of Pathology, Netaji Subhash Chandra Bose (NSCB) Medical College, Jabalpur, India.

出版信息

Breast Cancer Res Treat. 2022 May;193(1):105-110. doi: 10.1007/s10549-022-06556-w. Epub 2022 Mar 5.

DOI:10.1007/s10549-022-06556-w
PMID:35246773
Abstract

BACKGROUND

Sentinel lymph node biopsy (SLNB) using radio-pharmaceutical and a blue dye is gold standard for axillary staging in clinically node-negative breast cancer. High costs and limited availability of radio-pharmaceutical and/or gamma probe are major deterrents in performing SLNB in developing countries. In this study, we evaluated feasibility of SLN identification (SLN-IR) of fluorescein-guided (FG) SLNB in combination with methylene blue dye (MBD).

METHODS

This was a prospective cross-sectional non-randomized validation study in patients with clinically node-negative axilla. Patients underwent validation SLNB using fluorescein (and blue LED light) and MBD. Axillary dissection was performed irrespective of SLNB histology. SLIN-IR and False Negative Rate (FNR) were assessed for both groups.

RESULTS

The SLNs were identified in 29 (96.6%) pre-chemotherapy patients and 23 (82%) post Neoadjuvant Chemotherapy (NACT) patients. The median number of sentinel lymph nodes identified was 3 (range of 1-5) in pre-chemotherapy patients and 1 (range of 1-3) in post NACT patients. The SLN-IR using MBD was 90%, FD was 86.7% and combined MBD FD was 96.7% in pre-chemotherapy patients. The SLN-IR using MBD was 82%, FD was 71% and combined MBD FD was 82% in in post NACT patients. The false negative rate (FNR) in pre-chemotherapy group was 8.0% (MBD), 8.3% (FD) and 7.4% (MBD + FD). The FNR in post NACT group was 8.7% (MBD), 10% (FD) and 8.7% (MBD + FD).

CONCLUSION

This prospective validation study showed adequate SLN-IR and FNR using low-cost dual dyes in early breast cancer patients and can be used in low resource settings. However, SLNB in post NACT axilla though viable along with a satisfactory FNR, is associated with low identification rate and needs further evaluation.

摘要

背景

放射性药物和蓝色染料联合使用的前哨淋巴结活检(SLNB)是临床淋巴结阴性乳腺癌腋窝分期的金标准。在发展中国家,放射性药物和/或伽马探针的高成本和有限可用性是进行 SLNB 的主要障碍。在这项研究中,我们评估了荧光引导(FG)SLNB 联合亚甲蓝染料(MBD)进行 SLN 识别(SLN-IR)的可行性。

方法

这是一项在临床淋巴结阴性腋窝的患者中进行的前瞻性、非随机验证性研究。患者接受荧光素(和蓝色 LED 光)和 MBD 验证性 SLNB。无论 SLNB 组织学如何,均进行腋窝解剖。评估了两组的 SLIN-IR 和假阴性率(FNR)。

结果

在 29 例(96.6%)化疗前患者和 23 例(82%)新辅助化疗(NACT)后患者中识别出 SLN。化疗前患者的中位检出 SLN 数量为 3 个(范围为 1-5 个),NACT 后患者为 1 个(范围为 1-3 个)。在化疗前患者中,MBD 的 SLN-IR 为 90%,FD 为 86.7%,MBD+FD 的联合 SLN-IR 为 96.7%。在 NACT 后患者中,MBD 的 SLN-IR 为 82%,FD 为 71%,MBD+FD 的联合 SLN-IR 为 82%。化疗前组的假阴性率(FNR)为 8.0%(MBD)、8.3%(FD)和 7.4%(MBD+FD)。NACT 后组的 FNR 为 8.7%(MBD)、10%(FD)和 8.7%(MBD+FD)。

结论

这项前瞻性验证性研究表明,在早期乳腺癌患者中使用低成本双染料可获得足够的 SLN-IR 和 FNR,并可在资源有限的环境中使用。然而,虽然 NACT 后腋窝的 SLNB 是可行的,且 FNR 令人满意,但它与低识别率相关,需要进一步评估。

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