Axillary Ultrasound After Neoadjuvant Chemotherapy and Its Impact on Sentinel Lymph Node Surgery: Results From the American College of Surgeons Oncology Group Z1071 Trial (Alliance)

Boughey, Judy C.; Ballman, Karla V.; Hunt, Kelly K.; McCall, Linda; Mittendorf, Elizabeth A.; Ahrendt, Gretchen; Wilke, Lee G.; Le-Petross, Huong T.

doi:10.1200/jco.2014.57.8401

Cited by 204 publications

(150 citation statements)

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“…Negative axillary ultrasound (by central review) was associated with lower burden of disease in the axilla when the SLN remained involved. 8 Patients with a suspicious axillary ultrasound after NAC were significantly more likely to be SLN-positive at surgery (71.8%) than those with a normal axillary ultrasound (56.5%). Furthermore, patients with suspicious nodes by axillary ultrasound had a greater number of positive nodes and larger metastases (p \ 0.001).…”

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confidence: 90%

“…Furthermore, patients with suspicious nodes by axillary ultrasound had a greater number of positive nodes and larger metastases (p \ 0.001). 8 Among the patients with positive SLNs at surgery after a normal axillary ultrasound, 63% had no additional positive nodes in the ALND specimen. These findings indicate that the use axillary ultrasound can be helpful in identifying patients who despite a positive SLN after NAC have lower residual tumor burden in non-SLNs.…”

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confidence: 95%

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Optimizing Surgical Management of the Axilla After Neoadjuvant Chemotherapy: An Evolving Story

Mamounas

2018

Ann Surg Oncol

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For patients with operable breast cancer and clinically negative axilla who undergo surgery first, sentinel lymph node biopsy (SLNB) has been established as the gold standard for pathologic evaluation of the axilla. When the SLN is negative, no further surgery in the axilla is required. Traditionally, intraoperative frozen section (FS) was used to assess SLN status. However, randomized clinical trials have shown that selected patients with clinically negative axilla and limited SLN involvement can be spared from completion axillary lymph node dissection (ALND). 1,2Therefore, intraoperative FS currently is reserved primarily for patients who do not meet criteria for inclusion or were underrepresented in those trials (e.g., patients undergoing mastectomy and those who have received neoadjuvant chemotherapy [NAC] before the SLNB).During the past several years, use of NAC has expanded and currently is considered an alternative to adjuvant chemotherapy for selected patients with operable disease. 3Development of more active NAC regimens and improvements in patient selection for NAC have resulted in increasing rates of sterilization of subclinically or clinically involved axillary nodes, providing an opportunity to further de-escalate the surgical management of the axilla. For patients who undergo upfront SLNB, the volume of SLN involvement is an important predictor of the presence of non-SLN metastases 2,4,5 but whether this is also the case for patients who undergo SLNB after NAC is not known. This question is clinically important as we continue to work on further de-escalation of axillary surgery for patients who have their involved axillary nodes downstaged by NAC but are found to have small-volume disease in the SLN, either on intraoperative frozen section or on permanent pathologic evaluation.In a recent issue of the Annals of Surgical Oncology, Moo et al. 6 report on a large study from Memorial Sloan Kettering Cancer Center that aimed to determine the sensitivity of intraoperative SLN FS after NAC as well as the association between volume of disease in the SLN (by FS or permanent section) and probability of finding additional non-SLN involvement at completion ALND. During a 9-year period (2008)(2009)(2010)(2011)(2012)(2013)(2014)(2015)(2016)(2017), 702 patients (711 cancers) who had SLNB after NAC were evaluated. All the patients had clinical stage 2 or 3 disease, and about half of the patients were clinically node-positive before NAC ([ 80% of whom were histologically confirmed). All the patients were clinically node-negative by physical examination after NAC and underwent SLNB. For the patients who were clinically node-negative before NAC, SLN mapping was performed with single or dual tracers, at the surgeon's discretion, but the use of dual tracers was mandatory for the patients who were clinically node-positive before NAC.Intraoperative FS examination was routinely performed, showing that 181 patients had metastases, and 530 were negative. Of the 530 node-negative cases, 33 were positive on the final pathol...

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Optimizing Surgical Management of the Axilla After Neoadjuvant Chemotherapy: An Evolving Story

Mamounas

2018

Ann Surg Oncol

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“…Recent studies have analyzed the performance of SLNB in patients that converted from a clinically suspicious sentinel lymph node (SLN) status before to a clinically negative SLN status after PST [1,2,3]. Overall, these studies demonstrated higher false-negative rates (SLN negative, axillary nodes positive) compared to the primary operative setting.…”

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confidence: 99%

Validation of a Nomogram Predicting Non-Sentinel Lymph Node Metastases among Patients with Breast Cancer after Primary Systemic Therapy - a transSENTINA Substudy

et al. 2018

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Background: Prediction of non-sentinel lymph node (SLN) status after primary systemic therapy (PST) may allow tailored axillary staging. The aim of this analysis was to compare established nomograms from i) the primary operative (n = 6) and ii) the neoadjuvant (n = 1) setting with an optimized nomogram to predict non-SLN status in patients after PST. Methods: 181 patients converting from cN1 prior to PST to ycN0 but found to have a histologically positive SLN in the SENTINA trial were analyzed. Established models were applied. An optimized model was compiled using univariate and subsequent multivariable logistic regression (backward selection, likelihood ratio test). Results: Area-under-the-curve (AUC) values from the primary operative models showed sufficient performance (0.82-0.71). For the neoadjuvant model, the AUC was found to be inferior to prior analyses (0.66) but within published confidence intervals. The SENTINA nomogram comprised the diameter of the largest lymph node (p = 0.006, odds ratio (OR) = 1.19), tumor size prior to PST (p = 0.085, OR = 1.31), and number of all positive SLN (p = 0.083, OR = 2.04). This model was validated using a separate cohort of arm C (n = 168, AUC 0.79, 95% confidence interval 0.74-0.85). Conclusion: We validated 7 models of prediction of non-SLN among patients showing axillary conversion through PST. Our own ‘SENTINA nomogram' yielded AUC values comparable to previous nomograms.

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“…Three prospective studies have investigated the accuracy of SLNB after NAC in initially nodepositive patients and demonstrated variable FNRs; many were unacceptably high ([10 %) when the entire study population was included. [7][8][9] However, when patients with C3 SLNs were analyzed, the FNRs decreased to \10 % in most cases. With the suggested benefit of analyzing C3 SLNs, the differences in methodologies as well as a median number of 2 SLNs examined in these prospective trials, critics have questioned the feasibility of performing an accurate SLNB after NAC.…”

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confidence: 99%

“…9 All SLNs underwent central review by a single pathologist and were considered positive if any residual disease, including ITCs or micrometastases, was identified. Immunohistochemistry (IHC) was routinely used if initial H&E staining was negative.…”

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Sentinel Lymph Node Biopsy after Neoadjuvant Chemotherapy for Patients with Axillary Metastases: Can We Avoid the Unavoidable?

Schwartz

Fisher

2016

Ann Surg Oncol

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While initially implemented for patients with inoperable breast cancers, the use of neoadjuvant chemotherapy (NAC) was broadened to allow women to become candidates for breast conserving surgery.1 Clinical trials have shown no statistically significant differences in disease-free survival (DFS) and overall survival (OS) between patients who received NAC compared with those who received postoperative chemotherapy.2 Despite the evidence supporting the safety of a less extensive breast operation after a significant response to NAC, it has been a challenge to change the management of the axilla for definitive nodal staging in these patients.The safety and efficacy of sentinel lymph node biopsy (SLNB) for axillary staging was confirmed in NSABP B-32, where this technique was shown to have equivalent OS, DFS, and regional control compared with axillary lymph node dissection (ALND) in clinically node-negative patients.3 This study, along with other large prospective trials, demonstrated low false negative rates (FNR) of \10 % with very low rates of axillary recurrence (1 %). 4 The feasibility and accuracy of SLNB following NAC has been illustrated in multiple studies, most notably in NSABP B-27. 5 In this study, the SLN identification rate was 85 % with a FNR of 8 % when dual tracer techniques were used. These findings, as well as those in other retrospective studies, have allowed surgeons to comfortably perform SLNB after NAC for patients with no evidence of axillary metastases prior to NAC. However, once metastatic disease was documented within the axilla prior to NAC, an ALND was the only form of nodal staging offered at the time of the definitive breast operation for the majority of patients. With the knowledge that NAC can decrease, if not completely diminish, tumor burden within the breast as well as the axilla, and that SLNB is feasible in this patient population, why have we been so reluctant to defer ALND in women who have been downstaged to clinically node negative following NAC? Three prospective studies have investigated the accuracy of SLNB after NAC in initially nodepositive patients and demonstrated variable FNRs; many were unacceptably high ([10 %) when the entire study population was included. [7][8][9] However, when patients with C3 SLNs were analyzed, the FNRs decreased to \10 % in most cases. With the suggested benefit of analyzing C3 SLNs, the differences in methodologies as well as a median number of 2 SLNs examined in these prospective trials, critics have questioned the feasibility of performing an accurate SLNB after NAC.In this manuscript, Mamtani et al. attempted to answer this question with a single-center, prospective analysis investigating the frequency with which node-positive patients meet criteria for SLNB, with low FNR, following NAC. From 2013 to 2015, they identified 195 patients with stage II-III, node-positive disease at presentation who received NAC and completed surgery by November 2015. Those with clinical T4 or N2/N3 disease were excluded, leaving 155 evaluable patients. Of the...

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Axillary Ultrasound After Neoadjuvant Chemotherapy and Its Impact on Sentinel Lymph Node Surgery: Results From the American College of Surgeons Oncology Group Z1071 Trial (Alliance)

Cited by 204 publications

References 22 publications

Optimizing Surgical Management of the Axilla After Neoadjuvant Chemotherapy: An Evolving Story

Optimizing Surgical Management of the Axilla After Neoadjuvant Chemotherapy: An Evolving Story

Validation of a Nomogram Predicting Non-Sentinel Lymph Node Metastases among Patients with Breast Cancer after Primary Systemic Therapy - a transSENTINA Substudy

Sentinel Lymph Node Biopsy after Neoadjuvant Chemotherapy for Patients with Axillary Metastases: Can We Avoid the Unavoidable?

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