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。
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.
机构信息
Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
Department of Surgery, Uppsala University Hospital, Uppsala, Sweden.
出版信息
Ann Surg Oncol. 2023 Jul;30(7):4064-4072. doi: 10.1245/s10434-022-13064-0. Epub 2023 Jan 31.
BACKGROUND
Difficulty in preoperatively assessing the risk for occult invasion or surgery that precludes future accurate axillary mapping in patients with ductal cancer in situ (DCIS) account for overutilization of SLND.
METHODS
Prospective, multicenter, cohort study, including women with any DCIS planned for mastectomy or DCIS grade 2 and > 20 mm, any DCIS grade 3, any mass-forming DCIS and any planned surgery. Patients received an interstitial SPIO injection during breast surgery, but no upfront SLND was performed. If invasion was identified on final pathology, delayed SLND (d-SLND) was performed separately with the coadministration of isotope ± blue dye (BD). Study outcomes were proportion of upfront SLNDs that were avoided, detection rates during d-SLND, and impact on healthcare costs.
RESULTS
In total, 78.7% of study participants (N = 254, mean age 60 years, mean DCIS size 37.8 mm) avoided upfront SLND. On d-SLND (median 28 days, range 9-46), SPIO outperformed Tc with (98.2% vs. 63.6%, p < 0.001) or without BD (92.7% vs. 50.9%, p < 0.001) and had higher nodal detection rate (86.9% vs. 32.3%, p < 0.001) and with BD (93.9% vs. 41.4%, p < 0.001). Only 27.9% of all SLNs retrieved were concordant for Tc and SPIO. Type of breast procedure (WLE vs. oncoplastic BCT vs. mastectomy) affected these outcomes and accounted for the low performance of Tc (p < 0.001). d-SLND resulted in a 28.1% total cost containment for women with pure DCIS on final pathology (4190 vs. 5828 USD, p < 0.001).
CONCLUSIONS
Marking the SLN with SPIO may avoid overtreatment and allow for accurate d-SLND in patients with DCIS.
背景
术前评估隐匿性浸润或手术的难度，以及在原位导管癌（DCIS）患者中妨碍未来准确腋窝绘图的手术，导致 SLND 的过度使用。
方法
前瞻性、多中心队列研究，纳入计划接受乳房切除术的任何 DCIS 或 DCIS 分级 2 且>20mm、任何 DCIS 分级 3、任何肿块形成的 DCIS 以及任何计划手术的患者。患者在乳房手术期间接受间质 SPIO 注射，但未进行 upfront SLND。如果最终病理发现浸润，则单独进行延迟 SLND（d-SLND），同时联合使用同位素±蓝染剂（BD）。研究结果为避免 upfront SLND 的比例、d-SLND 期间的检出率以及对医疗保健成本的影响。
结果
共有 78.7%的研究参与者（N=254，平均年龄 60 岁，平均 DCIS 大小 37.8mm）避免了 upfront SLND。在 d-SLND（中位数 28 天，范围 9-46）中，SPIO 的表现优于 Tc（98.2%比 63.6%，p<0.001）或不使用 BD（92.7%比 50.9%，p<0.001），且淋巴结检出率更高（86.9%比 32.3%，p<0.001），联合 BD 时更高（93.9%比 41.4%，p<0.001）。所有 SLN 中只有 27.9%的 Tc 和 SPIO 结果一致。乳房手术类型（WLE 与保乳整形术与乳房切除术）影响了这些结果，导致 Tc 的表现不佳（p<0.001）。在最终病理为纯 DCIS 的女性中，d-SLND 导致总成本降低了 28.1%（4190 比 5828 美元，p<0.001）。
结论
用 SPIO 标记 SLN 可以避免过度治疗，并允许在 DCIS 患者中进行准确的 d-SLND。
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