SLNB

SLNB
  • 文章类型: Journal Article
    背景:目前的指南不建议对导管原位癌(DCIS)进行常规前哨淋巴结活检(SLNB),除了在乳房切除术或微创疾病的设置。这项研究旨在评估接受DCIS前期乳房切除术的女性的全国SLNB利用率,确定SLNB利用率的预测因子,并确定SLNB阳性的百分比。
    方法:使用NCDB对2012年至2017年接受前期乳房切除术的临床DCIS女性进行了回顾性队列分析。比较了接受SLNB和未接受SLNB的患者的人口统计学和临床病理变量。使用多因素logistic回归模型来确定与SLNB利用和SLNB阳性相关的因素。
    结果:约38,973例患者符合纳入标准:34,231例(88%)接受SLNB,4742例(12%)无手术腋窝分期。大多数患者年龄在50-69岁(51%),非西班牙裔白人(71%),私人保险(66%)。在多变量分析中,老年患者接受SLNB的可能性较小(P<0.01),而DCIS分级较高的患者更有可能接受SLNB(P<0.01)。在接受SLNB的患者中(n=34,231),只有1,149(3.4%)有淋巴结参与。非西班牙裔黑人患者SLNB阳性的几率增加(P<0.01),而那些患有雌激素受体阳性疾病的患者节点阳性的可能性较小(OR0.68,P<.001)。
    结论:虽然88%的患者患有SLNB,只有3.4%的人发现节点阳性。鉴于如此低的利率,在选择低级别患者时考虑SLNB遗漏是合理的,接受前期乳房切除术的激素受体阳性DCIS。
    BACKGROUND: Current guidelines do not recommend routine sentinel node biopsy (SLNB) for ductal carcinoma in situ (DCIS), except in the setting of mastectomy or microinvasive disease. This study aimed to evaluate national SLNB utilization in women undergoing upfront mastectomy for DCIS, identify predictors of SLNB utilization, and determine the percentage with a positive SLNB.
    METHODS: A retrospective cohort analysis was performed using the NCDB of women with clinical DCIS who underwent upfront mastectomy between 2012 and 2017. Demographic and clinicopathologic variables were compared between patients who underwent SLNB and those who did not. Multivariate logistic regression models were used to identify factors associated with SLNB utilization and positive SLNB.
    RESULTS: About 38,973 patients met inclusion criteria: 34,231 (88%) underwent SLNB and 4742 (12%) had no surgical axillary staging. Most patients were age 50-69 (51%), non-Hispanic White (71%), with private insurance (66%). On multivariate analysis, older patients were less likely to receive SLNB (P < .01), while patients with higher grade DCIS were more likely to undergo SLNB (P < .01). In those who underwent SLNB (n = 34,231), only 1,149 (3.4%) had nodal involvement. Non-Hispanic Black patients had increased odds of a positive SLNB (P < .01), while those with estrogen receptor positive disease were less likely to be node positive (OR 0.68, P < .001).
    CONCLUSIONS: While 88% of patients had a SLNB, only 3.4% were found to be node positive. Given this low rate, it is reasonable to consider SLNB omission in select patients with low grade, hormone receptor positive DCIS undergoing upfront mastectomy.
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  • 文章类型: Journal Article
    在这项研究中,我们收集不同分期子宫内膜癌(EC)患者的围手术期和术后随访数据,以评估前哨淋巴结活检(SLNB)在子宫内膜癌手术中的作用.
    回顾性分析2018年1月至2022年4月行根治性子宫切除术的186例子宫内膜癌患者。患者分为四组。A组包括诊断为IA期1级和2级子宫内膜样EC并接受SLNB的患者。B组包括未接受SLNB的IA期1级和2级子宫内膜样EC患者。C组包括较高级别的子宫内膜样EC患者,其中基于SLNB结果进行系统性淋巴结清扫术。D组包括未接受SLNB并直接进行系统性淋巴结清扫的较高级别的子宫内膜样EC患者。临床,病理资料,收集所有患者的随访信息.
    在A组和B组中,对67例IA1期和2期子宫内膜癌患者中的36例进行了SLNB,SLN阳性率为5.6%。在围手术期结局和术后随访方面,两组之间没有显着差异。相反,在119例高级别子宫内膜癌患者中,52接受SLNB,有20名患者表现出SLN阳性,导致SLN阳性率为38.4%。然而,接受SLNB的决定在这些患者的围手术期结局和术后随访中没有产生显著差异.
    对于IA期1级和2级子宫内膜样EC,淋巴结阳性发生率低,在这个亚群中省略SLNB是一个可行的选择。在子宫内膜样EC的其他阶段,根据SLNB结果,接受常规系统性淋巴结清扫术的患者和接受系统性淋巴结清扫术的患者的围手术期和术后随访数据无显著差异.因此,如果SLNB不可用,PLND的标准程序仍然是获得淋巴结状态信息的一种选择,尽管与此手术相关的手术并发症。
    UNASSIGNED: In this study, we collected perioperative and postoperative follow-up data from patients with endometrial cancer (EC) at different stages to evaluate the role of sentinel lymph node biopsy (SLNB) in endometrial cancer surgery.
    UNASSIGNED: A total of 186 endometrial cancer patients undergoing radical hysterectomy from January 2018 to April 2022 were retrospectively analyzed. Patients were classified into four groups. Group A comprised patients diagnosed with stage IA grade 1 and 2 endometrioid EC who underwent SLNB. Group B comprised patients with stage IA grade 1 and 2 endometrioid EC who did not undergo SLNB. Group C comprised patients with higher-grade endometrioid EC, wherein systematic lymph node dissection was performed based on SLNB results. Group D comprised patients with higher-grade endometrioid EC who did not undergo SLNB and instead underwent direct systematic lymph node dissection. Clinical, pathological data, and follow-up information for all patients were collected.
    UNASSIGNED: In Group A and B, SLNB was performed on 36 out of 67 patients with IA stage 1 and 2 endometrial cancer, yielding a SLN positivity rate of 5.6%. There were no significant differences observed between the two groups regarding perioperative outcomes and postoperative follow-up. Conversely, among 119 patients with higher-grade endometrial cancer, 52 underwent SLNB, with 20 patients exhibiting SLN positivity, resulting in a SLN positivity rate of 38.4%. However, the decision to undergo SLNB did not yield significant differences in perioperative outcomes and postoperative follow-up among these patients.
    UNASSIGNED: For stage IA grade 1 and 2 endometrioid EC, the incidence of lymph node positivity is low, omitting SLNB in this subpopulation is a feasible option. In other stages of endometrioid EC, there is no significant difference in perioperative and postoperative follow-up data between patients undergoing routine systematic lymphadenectomy and those undergoing systematic lymphadenectomy based on SLNB results. Therefore, if SLNB is not available, the standard procedure of PLND remains an option to obtain information about lymph node status, despite the surgical complications associated with this procedure.
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  • 文章类型: Journal Article
    背景:乳腺癌相关淋巴水肿(BCRL)在前哨淋巴结活检(SLNB)和腋窝淋巴结清扫(ALND)后存在重大风险,特别是影响少数民族,风险增加两倍。腋下反向标测(ARM),一种新颖的技术,显示出降低BCRL率的潜力,然而,它在少数民族中的效用缺乏足够的探索。因此,我们的研究目的是调查不同种族群体中ARM对BCRL的效用和结果.
    方法:对2019年1月至2022年7月的ARM患者进行回顾性图表回顾,使用SOZO®评分以3个月的间隔监测24个月以上的患者,与术前基线比较。
    结果:在212名患者中,83%属于少数民族。SLNB的发生率为83%,ALND为17%,62.3%接受了放射治疗。淋巴结阳性占31.6%,22.2%的淋巴结呈蓝色,25.9%的淋巴结呈蓝色。在已识别的蓝色节点中,70.2%被切除,包括51.5%的交叉节点。3例患者出现淋巴水肿,导致1.4%的BCRL率。与少数民族在ALND后的历史BCRL发病率40.4%相比,我们的研究报告了8%的显著较低的比率(p<0.001).
    结论:ARM程序可显著降低少数民族的BCRL。ARM和生物阻抗谱的组合导致1.4%的显着低BCRL率。值得注意的是,我们的研究中没有患者在24个月随访时发生腋窝复发.然而,有必要进行更大样本量的未来研究,以更好地了解ARM技术在该人群中的实用性.
    BACKGROUND: Breast cancer-related lymphedema (BCRL) poses a significant risk following sentinel lymph node biopsy (SLNB) and axillary lymph node dissection (ALND), particularly affecting ethnic minorities, with a twofold increased risk. Axillary reverse mapping (ARM), a novel technique, shows potential in reducing BCRL rates, yet its utility in ethnic minorities lacks sufficient exploration. Therefore, our study aims to investigate the utility and outcomes of ARM on BCRL in an ethnic diverse group.
    METHODS: A retrospective chart review of ARM patients from January 2019 to July 2022 was conducted, monitoring patients over 24 months at 3-month intervals using SOZO® scores, with comparisons with preoperative baselines.
    RESULTS: Of the 212 patients, 83% belonged to ethnic minorities. SLNB was performed in 83%, ALND in 17%, and 62.3% underwent radiation therapy. Positive lymph nodes were found in 31.6%, with 22.2% exhibiting blue nodes and 25.9% exhibiting blue lymphatics. Of identified blue nodes, 70.2% were excised, including 51.5% crossover nodes. Lymphedema occurred in 3 patients, resulting in a BCRL rate of 1.4%. Compared with an historical BCRL incidence of 40.4% following ALND in ethnic minorities, our study reported a significantly lower rate of 8% (p < 0.001).
    CONCLUSIONS: The ARM procedure can significantly lower BCRL in ethnic minority groups. The combination of ARM and bioimpedance spectroscopy led to a remarkably low BCRL rate of 1.4%. Notably, none of the patients in our study developed an axillary recurrence at 24-month follow-up. Nevertheless, future studies with larger sample sizes are warranted to better understand the utility of the ARM technique in this population.
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  • 文章类型: Journal Article
    用于治疗黑色素瘤的Mohs显微手术(MMS)比广泛的局部切除术(WLE)具有多种优势,包括完整的组织学边缘评估,当天切除和闭合,并在关键解剖部位保留健康组织。最近,大量的临床数据证明了MMS治疗黑色素瘤的有效性,导致新出现的患者安全考虑发生的治疗费用,肿瘤分期的风险,前哨淋巴结活检(SLNB)的护理协调失败。彩信提供保险箱,有效,以及基于价值的原位黑色素瘤(MIS)和侵袭性黑色素瘤(IM)治疗,特别是在冷冻切片上使用免疫组织化学。与WLE相比,MMS治疗显示类似或改善局部肿瘤复发的结果,黑色素瘤特异性生存率,和长期随访的总生存率。肿瘤分期风险低,如果存在,对临床管理的改变是最小的。对于符合条件的头颈部IM病例,应在MMS之前进行SLNB的讨论。虽然具有挑战性,已经证明了SLNB与MMS的成功多学科协调。在这里,我们对MMS治疗皮肤黑色素瘤的证据进行了详细的临床回顾,并就解决目前围绕MIS和IM外科治疗模式不断发展的争议提出了建议.
    Mohs Micrographic Surgery (MMS) for treatment of melanoma offers several advantages over wide local excision (WLE), including complete histologic margin evaluation, same-day resection and closure, and sparing of healthy tissue in critical anatomic sites. Recently, a large volume of clinical data demonstrating efficacy in MMS treatment of melanoma was published, leading to emerging patient safety considerations of incurred treatment costs, risk of tumor upstaging, and failure of care coordination for sentinel lymph node biopsy (SLNB). MMS offers a safe, effective, and value-based treatment for both melanoma in situ (MIS) and invasive melanoma (IM), particularly with immunohistochemistry use on frozen sections. Compared to wide local excision, MMS treatment demonstrates similar or improved outcomes for local tumor recurrence, melanoma-specific survival, and overall survival at long-term follow-up. Tumor upstaging risk is low, and if present, alteration to clinical management is minimal. Discussion of SLNB for eligible head and neck IM cases should be done prior to MMS. Though challenging, successful multidisciplinary coordination of SLNB with MMS has been demonstrated. Herein, we provide a detailed clinical review of evidence for MMS treatment of cutaneous melanoma and offer recommendations to address current controversies surrounding the evolving paradigm of surgical management for both MIS and invasive melanoma (IM).
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  • 文章类型: Journal Article
    目的:本研究的目的是显示vNOTES腹膜后清扫术和前哨淋巴结隔离术在超重和肥胖子宫内膜癌患者中的可行性和手术效果。
    方法:4例患者接受了带有前哨淋巴结的盆腔淋巴结清扫术。三名患者超重,其中一人肥胖,BMI为34.6kg/m2。通过使用NMR模式对前哨淋巴结进行可视化,从随后连续切除的其余可视化淋巴结中分别切除并标记以进行病理组织学分析。
    结果:总切除淋巴结的平均数为12.5,右侧的平均数为5.75,左侧的平均数为6.25。在病理组织学评估中没有证实转移。
    结论:vNOTES腹膜后分离前哨淋巴结是很好的选择,并有其好处,尤其是超重和肥胖患者,术后并发症较低。
    OBJECTIVE: The purpose of this study is to show the feasibility and surgical outcome of vNOTES retroperitoneal dissection and isolation of sentinel lymph nodes in overweight and obese patients with endometrial cancer.
    METHODS: Four patients had undergone pelvic lymphadenectomy with a sentinel lymph node. Three patients were overweight, and one was obese with a BMI of 34.6 kg/m2. By using NMR mode sentinel lymph node was visualized, excised and marked separately for pathohistological analysis from the rest of the visualized lymph nodes that were then consecutively excised.
    RESULTS: The mean number of overall excised lymph nodes was 12.5, and the mean number on the right side was 5.75 and 6.25 on the left side. There were no metastases verified in the pathohistological evaluation.
    CONCLUSIONS: vNOTES retroperitoneal isolation of sentinel lymph nodes is good alternative and has its benefits, especially in overweight and obese patients with satisfying low intra- and postoperative complications.
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  • 文章类型: Systematic Review
    前哨淋巴结活检是迄今为止皮肤黑色素瘤最有力的预后指标。尽管老年患者前哨淋巴结受累的发生率较低,其结果对于获得辅助治疗仍然是必要的。考虑到西方人口呈现出老龄化趋势,这是高度相关的,黑色素瘤的发病率多年来呈指数级增长,使老年患者比年轻患者更容易死于黑色素瘤。我们进行了系统评价,以研究老年黑色素瘤患者前哨淋巴结活检的预后意义。系统审查是根据PRISMA指南进行的,并在PROSPERO注册。作者搜索了Cochrane数据库,EMBASE,PubMed,和WOS。系统评价的合格研究是临床试验,观察性人口研究,临床或基于医院的队列研究,和病例对照研究。使用应用meta包的R软件程序进行meta分析。确定了六份符合纳入标准的报告。所有的研究都是回顾性的,非随机队列。本系统评价中获得的结果表明前哨淋巴结活检对疾病特异性生存率具有统计学意义(HR=2.87;95%CI:1.73-4.74),但也表明阳性结果对无病生存率具有负面影响(HR=3.41;95%CI:0.96-12.11)。这项荟萃分析显示,前哨淋巴结活检阳性并不意味着总生存率的差异,但显着影响疾病特异性生存率,并暗示对无病生存率的不利影响。
    Sentinel lymph node biopsy is the most powerful prognostic indicator to date for cutaneous melanoma. Even though elderly patients have a lower incidence of sentinel node involvement, its results are still necessary for access to adjuvant therapies. This is highly relevant considering that the Western population shows an aging trend, and the incidence of melanoma has grown exponentially over the years, making elderly patients more likely to die from melanoma than younger ones. We performed a systematic review to investigate the prognostic significance of sentinel lymph node biopsy in elderly patients with melanoma. The systematic review was conducted following the PRISMA guidelines and registered in PROSPERO. The authors searched the Cochrane Database, EMBASE, PubMed, and WOS. Eligible studies for the systematic review were clinical trials, observational population studies, clinical or hospital-based cohort studies, and case-control studies. The meta-analysis was conducted using the R software program applying the meta package. Six reports were identified to meet the inclusion criteria. All studies were retrospective, non-randomized cohorts. The results obtained in this systematic review show a statistically significant influence of sentinel lymph node biopsy on disease-specific survival (HR = 2.87; 95% CI: 1.73-4.74) but also suggest that a positive result negatively impacts disease-free survival (HR = 3.41; 95% CI: 0.96-12.11). This meta-analysis shows that a positive sentinel lymph node biopsy does not imply differences in overall survival but significantly influences disease-specific survival and suggests an unfavorable impact on disease-free survival.
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  • 文章类型: Journal Article
    背景:在老年人群中使用前哨淋巴结活检(SLNB),定义为70岁以上的人,自从SLNB被纳入常规实践以来,一直存在争议。有趣的是,仍然缺乏证据,特别是关于SLNB阳性率,并发症,以及淋巴结阳性患者的后续辅助治疗。
    方法:患者合并症数据,阳性率,并发症发生率,随后的辅助治疗是在2016年至2022年间从998例患者(644例<70岁患者和354例≥70岁患者)中前瞻性收集的.
    结果:发现年龄≥70岁的患者有较高的合并症患病率,包括高血压,糖尿病和高脂血症。70岁以下和70岁以上组的平均Breslow厚度分别为2.2和2.5(p=0.03)。发现70s以下的平均有丝分裂率为3.3,70s以上的平均有丝分裂率为4.1(p=0.02)。尽管有这些结果,前哨淋巴结活检的阳性率或为阳性结果选择的治疗方案均未观察到显著差异.70岁以下的人更有可能经历感觉丧失(p<0.01),但两组并发症总数无差异。
    结论:尽管70岁及以上的患者合并症的发生率更高,研究显示,他们的并发症发生率较低,且两个年龄组的SLNB阳性率或选择的治疗方案没有显著差异.这项研究支持对老年人的SLNB进行生理年龄评估,而不是按年龄进行年龄评估。
    BACKGROUND: The use of sentinel lymph node biopsy (SLNB) in the older population, defined as those over 70 years old, has been debated since the adoption of SLNB into routine practice. Interestingly, there remains a paucity of evidence, especially regarding the rates of SLNB positivity, complications, and subsequent adjuvant therapy in those with node positivity.
    METHODS: Data on patient\'s comorbidities, positivity rates, complication rates, and subsequent adjuvant treatments were collected prospectively from 998 patients (644 patients < 70 and 354 patients ≥ 70 years old) between 2016 and 2022.
    RESULTS: Patients aged ≥ 70 were found to have a higher prevalence of comorbidities, including hypertension, diabetes and hyperlipidaemia. The mean Breslow thickness was 2.2 and 2.5 in the under and over 70 groups respectively (p = 0.03). The mean mitotic rate was found to be 3.3 in the under 70 s and 4.1 in the over 70 s (p = 0.02). Despite these results, no significant differences were observed in the positivity rates of sentinel lymph node biopsies or in the treatment options selected for positive results. The under 70 s were more likely to experience loss of sensation (p < 0.01), but no difference was found in the total number of complications between the two groups.
    CONCLUSIONS: Although patients aged 70 and above had a greater incidence of comorbidities, the study revealed that they had lower complications rates and there was no significant variation in the SLNB positivity rate or chosen treatment options between the two age groups. This study supports the move to physiological rather than chronological age assessments in SLNB of the elderly.
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  • 文章类型: Journal Article
    目的:探讨吲哚菁绿(ICG)-利妥昔单抗在前哨淋巴结活检中的临床应用价值。方法:本研究纳入156例原发性乳腺癌患者:50例患者进行剂量爬升试验,106例患者纳入验证试验。这是为了比较ICG-利妥昔单抗和联合方法在检测到的淋巴结中的一致性。结果:根据验证试验,ICG-利妥昔单抗的成像率为97.3%.与组合方法相比,荧光法的一致率为0.991(28+78/107;p<0.001)。结论:对于ICG-利妥昔单抗作为荧光靶向示踪剂,ICG93.75μg/利妥昔单抗375μg的最佳成像剂量可以显著减少次级淋巴结的成像.与组合方法相比,它有更高的一致率。
    Purpose: To explore the clinical application value of indocyanine green (ICG)-rituximab in sentinel lymph node biopsy. Methods: This study included 156 patients with primary breast cancer: 50 patients were enrolled in dose-climbing test, and 106 patients were enrolled in verification test. This was to compare the consistency of ICG-rituximab and combined method in the detected lymph nodes. Results: According to the verification test, the imaging rate of ICG-rituximab was 97.3%. Compared with the combined method, the concordance rate of fluorescence method was 0.991 (28 + 78/107; p < 0.001). Conclusion: For ICG-rituximab as a fluorescent targeting tracer, the optimal imaging dose of ICG 93.75 μg/rituximab 375 μg can significantly reduce the imaging of secondary lymph nodes. Compared with the combined method, it has a higher concordance rate.
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  • 文章类型: Journal Article
    背景和目的:仔细选择足够的SLNB候选物不仅旨在降低手术风险,同时确定SLN转移,但在确定符合辅助治疗条件的患者方面也起着至关重要的作用。目标:我们研究的目的是研究与SLNB阳性结果的可能性相关的原发性黑色素瘤的临床和组织学方面。材料和方法:本研究共纳入101例接受前哨淋巴结活检的原发性黑色素瘤患者。除了来自SLNB黑色素瘤组织病理学报告的数据外,还从组织学报告中获得了一般患者的人口统计学特征以及原发性黑色素瘤的定位和黑色素瘤特异性特征。结果:SLN结果阳性的患者Breslow厚度增加有统计学意义(3.8mmvs.1.97mm,p=0.002),更高的有丝分裂指数率(5/mm2vs.2/mm2,p=0.009),以及溃疡的存在(68.4%vs.31.6%,p=0.007)。单因素回归分析显示Breslow厚度(p=0.008),有丝分裂指数率(p=0.054),溃疡的存在(p=0.009),以及pT3-4阶段(p=0.009)是SLN阳性的显著预测因子。基于ROC曲线分析确定Breslow厚度和有丝分裂数目评分的最佳截止值。使用Breslow厚度,有丝分裂指数率,溃疡的存在,和单变量回归模型的pT3-4阶段显著系数,制定了机会预测评分。结论:新开发和提出的评分系统可以通过促进更有效的风险评估来检测黑色素瘤患者的淋巴结转移,从而帮助患者选择SLN活检。
    Background and Objectives: The careful selection of adequate SLNB candidates not only aims at reducing the surgical risk while identifying SLN metastasis, but also plays a crucial role in identifying the patients eligible for adjuvant therapy. Objectives: The purpose of our study was to investigate the clinical and histologic aspects of primary melanomas that correlate with the likelihood of a positive SLNB result. Materials and Methods: A total of 101 primary melanoma patients who underwent sentinel lymph node biopsies were included in the study. General patient demographics were obtained as well as localization and melanoma-specific characteristics of primary melanoma from histologic reports in addition to data derived from SLNB melanoma histopathology reports. Results: The patients with positive SLN results had a statistically significant increased Breslow thickness (3.8 mm vs. 1.97 mm, p = 0.002), higher mitotic index rate (5/mm2 vs. 2/mm2, p = 0.009), as well as the presence of ulceration (68.4% vs. 31.6%, p = 0.007). Univariate regression analysis showed the Breslow thickness (p = 0.008), the mitotic index rate (p = 0.054), the presence of ulceration (p = 0.009), as well as the pT3-4 stage (p = 0.009) to be significant predictors of SLN positivity. The optimal cut-off values for Breslow thickness and the number of mitoses scores were determined based on ROC curve analysis. Using the Breslow thickness, mitotic index rate, presence of ulceration, and pT3-4 stage significant coefficients from the univariate regression model, a chance prediction score was developed. Conclusions: The newly developed and proposed scoring system can aid in patient selection for SLN biopsy by facilitating a more efficient risk assessment in the detection of lymph node metastases in melanoma patients.
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  • 文章类型: Journal Article
    背景:大多数诊断为乳腺癌的患者存在淋巴结阴性疾病。前哨淋巴结活检(SLNB)通常用于腋窝分期,使腋窝淋巴结健康的患者没有治疗效果,但有因干预而患病的风险。许多研究已经开发了用于非侵入性腋窝分期的淋巴结状态预测模型,其使用的术后数据或成像特征不是诊断检查的一部分。淋巴管浸润(LVI)是淋巴结转移的最高预测因子;然而,其术前评估具有挑战性.
    目的:本文旨在外部验证多层感知器(MLP)模型,用于基于大型人群的队列(n=18,633)中的非侵入性淋巴结分期(NILS),并在同一队列中开发新的MLP。数据来自瑞典国家乳腺癌质量登记册(NKBC,2014-2017),仅包括常规和术前可用的已记录的临床病理变量。次要目的是开发和验证LVIMLP,以填补缺失的LVI状态,以增加原始NILS模型的术前可行性。
    方法:使用三个非重叠队列进行模型开发和验证。使用11至12个常规可用的预测因子开发了总共4个用于淋巴结状态的MLP和1个LVIMLP。使用三个节点状态模型来解释队列中LVI状态的不同可用性以及NKBC中的外部验证。第四节状态模型是针对80%(14,906/18,663)的NKBC病例开发的,并在其余20%(3727/18,663)中进行了验证。比较了三种估算LVI状态的替代方法。在3个节点状态模型中,使用接收器工作特征曲线(AUC)下的验证面积评估了判别能力。使用校准和决策曲线分析评估模型的临床可行性。
    结果:在NKBC(AUC0.699,95%CI0.690-0.708)中对原始NILS模型进行了外部验证,校准良好,并且有可能使16%的淋巴结阴性患者免于SLNB。LVI模型经过外部验证(AUC0.747,95%CI0.694-0.799),校准良好,但未改善节点状态模型的判别性能。在没有LVI信息的NKBC中开发了新的节点状态模型(AUC0.709,95%CI:0.688-0.729),在保持内部验证队列中具有出色的校准,导致24%的患者可能从不必要的SLNB中遗漏。
    结论:NILS模型在NKBC中进行了外部验证,其中LVI状态的归因并没有改善模型的歧视性表现。新的节点状态模型证明了使用寄存器数据的可行性,该寄存器数据仅包括使用机器学习进行NILS的术前设置中可用的变量。未来的步骤包括正在进行的NILS模型的术前验证和扩展模型,例如,乳房X线摄影图像。
    BACKGROUND: Most patients diagnosed with breast cancer present with a node-negative disease. Sentinel lymph node biopsy (SLNB) is routinely used for axillary staging, leaving patients with healthy axillary lymph nodes without therapeutic effects but at risk of morbidities from the intervention. Numerous studies have developed nodal status prediction models for noninvasive axillary staging using postoperative data or imaging features that are not part of the diagnostic workup. Lymphovascular invasion (LVI) is a top-ranked predictor of nodal metastasis; however, its preoperative assessment is challenging.
    OBJECTIVE: This paper aimed to externally validate a multilayer perceptron (MLP) model for noninvasive lymph node staging (NILS) in a large population-based cohort (n=18,633) and develop a new MLP in the same cohort. Data were extracted from the Swedish National Quality Register for Breast Cancer (NKBC, 2014-2017), comprising only routinely and preoperatively available documented clinicopathological variables. A secondary aim was to develop and validate an LVI MLP for imputation of missing LVI status to increase the preoperative feasibility of the original NILS model.
    METHODS: Three nonoverlapping cohorts were used for model development and validation. A total of 4 MLPs for nodal status and 1 LVI MLP were developed using 11 to 12 routinely available predictors. Three nodal status models were used to account for the different availabilities of LVI status in the cohorts and external validation in NKBC. The fourth nodal status model was developed for 80% (14,906/18,663) of NKBC cases and validated in the remaining 20% (3727/18,663). Three alternatives for imputation of LVI status were compared. The discriminatory capacity was evaluated using the validation area under the receiver operating characteristics curve (AUC) in 3 of the nodal status models. The clinical feasibility of the models was evaluated using calibration and decision curve analyses.
    RESULTS: External validation of the original NILS model was performed in NKBC (AUC 0.699, 95% CI 0.690-0.708) with good calibration and the potential of sparing 16% of patients with node-negative disease from SLNB. The LVI model was externally validated (AUC 0.747, 95% CI 0.694-0.799) with good calibration but did not improve the discriminatory performance of the nodal status models. A new nodal status model was developed in NKBC without information on LVI (AUC 0.709, 95% CI: 0.688-0.729), with excellent calibration in the holdout internal validation cohort, resulting in the potential omission of 24% of patients from unnecessary SLNBs.
    CONCLUSIONS: The NILS model was externally validated in NKBC, where the imputation of LVI status did not improve the model\'s discriminatory performance. A new nodal status model demonstrated the feasibility of using register data comprising only the variables available in the preoperative setting for NILS using machine learning. Future steps include ongoing preoperative validation of the NILS model and extending the model with, for example, mammography images.
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