Routine Axillary Lymph Node Dissection Research Articles

Abstract PS01-04: To dissect or not to dissect? The surgeon’s perspective on the prediction of ≥ 4 axillary lymph node metastasis in cN0 T1-2 breast cancer: A comparative analysis of the per-protocol population of the SINODAR-ONE clinical trial

Abstract Objectives The role of axillary surgery in the management of breast cancer (BC) has evolved considerably over the past decades, with only a few routine indications for axillary lymph node dissection (ALND) remaining in clinical practice. However, de-escalation of axillary surgery, especially in BC patients with 1-3 positive sentinel lymph nodes (SLNs) challenges the recently established criteria for adjuvant treatment (i.e., combination therapy with abemaciclib, endocrine therapy, and chemotherapy in patients with ≥ 4 positive nodes). The question remains as to whether these patients should undergo further ALND to determine whether ≥ 4 nodes are positive. To further investigate the latest controversies in axillary management of BC patients and predict the presence of ≥ 4 axillary lymph node metastasis, we evaluated and compared patients ≥ 4 positive nodes in the per-protocol population of the SINODAR-ONE clinical trial. Patients in the standard arm (ALND) of the per-protocol population were evaluated, and a comparison of characteristics between patients with ≥ 4 metastatic lymph nodes versus patients with 1-3 metastatic lymph nodes was performed. Categorical variables were compared using the chi-square test or Fisher’s exact test, as appropriate. Multivariable analysis was performed using a logistic regression model to identify independent predictors of ≥4 axillary lymph node metastasis. Results: Overall, 403 cN0 T1-2 BC patients in the per-protocol population were randomized to receive ALND. Of these, 65 and 338 patients presented with ≥ 4 or 1-3 axillary lymph node metastasis, respectively. Invasive lobular BC (26.2% versus 14.5% if other histology, odds ratio (OR)=4.185, 95% confidence interval (95%CI)= 1.284-1.443, p= 0.041), G3 (38.5% versus 21.3% if G1-2, OR=5.930, 95%CI= 2.134-2.289, p= 0.015), pT2 (46.2% versus 30.5% if pT1, OR=5.260, 95%CI= 15.330-16.346, p= 0.022), and 2 positive SLNs (32.3% versus 13.6% if 1 positive SLN, OR=13.188, 95%CI= 1.179-1.280, p< 0.0001) were found to significantly increase the probability to present ≥4 axillary lymph node metastasis at definitive histopathological evaluation. Conclusions: The introduction of abemaciclib and other combination therapies has the potential to impact the surgical management of the axilla. Our results suggest that a minority of cN0 T1-2 BC patients may be understaged if ALND is not performed. However, the improvements and increasing effectiveness of combination therapies may sufficiently control and treat the axillary tumor-burden left behind, potentially reducing the need for extensive axillary surgery, as demonstrated by the promising 3-year oncological outcomes of the SINODAR-ONE trial. Although ALND may still be considered, after multidisciplinary team discussion, in individual patients presenting with specific risk factors for additional axillary disease (lobular, G3, pT2 BC with 2 positive SLNs), our suggestion is that routine ALND is not indicated for systemic therapy decision-making in the upfront surgical setting. Citation Format: Damiano Gentile, Wolfgang Gatzemeier, Andrea Sagona, Erika Barbieri, Alberto Bottini, Alberto Testori, Valentina Errico, Simone Di Maria Grimaldi, Giulia Caraceni, Shadya Darwish, Giuseppe Canavese, Corrado Tinterri. To dissect or not to dissect? The surgeon’s perspective on the prediction of ≥ 4 axillary lymph node metastasis in cN0 T1-2 breast cancer: A comparative analysis of the per-protocol population of the SINODAR-ONE clinical trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PS01-04.

Abstract GS02-02: Are nodal ITCs after neoadjuvant chemotherapy an indication for axillary dissection? The OPBC05/EUBREAST-14R/ICARO study

Abstract GS02-02: Are nodal ITCs after neoadjuvant chemotherapy an indication for axillary dissection? The OPBC05/EUBREAST-14R/ICARO study

Evaluation of Axilla With Sentinel Lymph Node Biopsy (Using Methylene-Blue) and Reverse Axillary Mapping (Using Fluorescein) to Validate Optimum and Safe Axillary Dissection in Breast Cancer.

Introduction Sentinel lymph node biopsy (SLNB) has replaced routine axillary lymph node dissection (ALND) in node-negative axillae. In cases where the axilla needs to be dissected, one must dissect below the uppermost intercostobrachial nerve (ICBN) to avoid damaging arm lymphatics. Methods One milliliter of methylene blue dye was injected around the areola. Fluorescein dye (1 ml) was injected into the upper arm. After SLNB and ALND, the axilla was visualized under blue light. The location of fluorescent lymphatics was mapped with respect to the uppermost ICBN. Results The identification rate of sentinel lymph nodes and arm lymphatics was 100%. Arm lymphatics were above ICBN in 86.7%. The false negative rate of SLNB was 13%, with sensitivity and specificity of 87% and 100%, respectively. Conclusions SLNB using the single-dye technique has results comparable to dual agent studies that utilizeblue dye and radioactive colloid. The uppermost ICBN could define the superior limit of axillary dissection.

Abstract OT1-06-01: Preservation of axillary lymph nodes in breast cancer patients undergoing mastectomy with 1-2 metastatic sentinel lymph nodes: The current status and future perspectives of the multicenter randomized clinical trial SINODAR-ONE

Abstract Introduction: Axillary lymph node dissection (ALND) has always been part of breast cancer (BC) treatment. However, during the past 25 years, the surgical management of the axilla has shifted towards a more conservative approach. Until now, ALND has remained the standard surgical technique when the sentinel lymph node (SLN) is macrometastatic. However, ALND may now be considered overtreatment for early-stage BC. The SINODAR-ONE trial is a prospective non-inferiority multicenter randomized study aimed at assessing the role of ALND in patients undergoing either breast-conserving surgery (BCS) or mastectomy for T1-2 BC presenting 1-2 macrometastatic SLNs. Objectives: The primary endpoint was to evaluate whether sentinel lymph node biopsy (SLNB) only was associated with clinically relevant worsening of the prognosis compared with ALND in terms of overall survival (OS). The secondary endpoint was to evaluate whether there was increased regional (lymph node recurrence) or distant recurrence in terms of recurrence-free survival (RFS) in patients with macrometastatic SLN who did not undergo ALND. Methods: Patients were randomly assigned (1:1 ratio) to either removal of ≥10 axillary level I/II non-SLNs followed by adjuvant therapy (standard arm) or no further axillary treatment (experimental arm). Results: The trial started in April 2015 and ceased in April 2020, involving 889 patients. The majority of the patients (75.2%) underwent BCS; 328 of 439 patients (74.7%) in the standard treatment arm, and 333 of 440 patients (75.7%) in the experimental treatment arm. 218 patients (24.8%) underwent mastectomy. SLN status at randomization was comparable between the two groups of treatment, with a median number of two SLNs removed and a median number of one positive SLN in both arms. The median number of non-SLNs identified at definitive histopathological evaluation was 16 (interquartile range [IQR] 12–21) in the ALND group. Overall, 193 of 439 patients (44.0%) in the standard treatment arm had additional macrometastases in the removed axillary lymph nodes. However, the median number of positive non SLNs was 0 (IQR 0–1) in the ALND group. Median follow-up was 34.0 months. There were eight deaths (ALND, 4; SNLB only, 4), with a 5-year cumulative mortality of 5.8% and 2.1% in the standard and experimental arm, respectively (p = 0.984). There were 26 recurrences (ALND 11; SNLB only, 15), with a 5-year cumulative incidence of recurrence of 6.9% and 3.3% in the standard and experimental arm, respectively (p = 0.444). Only one axillary lymph node recurrence was observed in each arm. The 5-year OS rates were 98.9% and 98.8%, in the ALND and SNLB only arm, respectively (p = 0.936). Conclusion: The 3-year survival and relapse rates of T1-2 BC patients with 1-2 macrometastatic SLNs treated with SLNB only, and adjuvant therapy, were not inferior to those of patients treated with ALND. These results do not support the use of routine ALND in patients undergoing BCS. However, given the low number of patients treated with mastectomy, there is no certainty that ALND omission can be extended also to this sub-group. In order to collect further evidence regarding the safety of the experimental treatment in patients candidates for mastectomy, the reopening of the enrollment of these patients as part of a single-arm experimental study started in June 2022. Citation Format: Damiano Gentile, Wolfgang Gatzemeier, Andrea Sagona, Erika Barbieri, Alberto Testori, Valentina Errico, Alberto Bottini, Simone Di Maria Grimaldi, Giulia Caraceni, Luca Boni, Paolo Bruzzi, Bethania Fernandes, Davide Franceschini, Ruggero Spoto, Rosalba Torrisi, Marta Scorsetti, Armando Santoro, Giuseppe Canavese, Corrado Tinterri. Preservation of axillary lymph nodes in breast cancer patients undergoing mastectomy with 1-2 metastatic sentinel lymph nodes: The current status and future perspectives of the multicenter randomized clinical trial SINODAR-ONE [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT1-06-01.

Preservation of Axillary Lymph Nodes Compared with Complete Dissection in T1-2 Breast Cancer Patients Presenting One or Two Metastatic Sentinel Lymph Nodes: The SINODAR-ONE Multicenter Randomized Clinical Trial.

The SINODAR-ONE trial is a prospective noninferiority multicenter randomized study aimed at assessing the role of axillary lymph node dissection (ALND) in patients undergoing either breast-conserving surgery or mastectomy for T1-2 breast cancer (BC) and presenting one or two macrometastatic sentinel lymph nodes (SLNs). The endpoints were to evaluate whether SLN biopsy (SLNB) only was associated with worsening of the prognosis compared with ALND in terms of overall survival (OS) and relapse. Patients were randomly assigned (1:1 ratio) to either removal of ≥ 10 axillary level I/II non-SLNs followed by adjuvant therapy (standard arm) or no further axillary treatment (experimental arm). The trial started in April 2015 and ceased in April 2020, involving 889 patients. Median follow-up was 34.0 months. There were eight deaths (ALND, 4; SNLB only, 4), with 5-year cumulative mortality of 5.8% and 2.1% in the standard and experimental arm, respectively (p = 0.984). There were 26 recurrences (ALND 11; SNLB only, 15), with 5-year cumulative incidence of recurrence of 6.9% and 3.3% in the standard and experimental arm, respectively (p = 0.444). Only one axillary lymph node recurrence was observed in each arm. The 5-year OS rates were 98.9% and 98.8%, in the ALND and SNLB-only arm, respectively (p = 0.936). The 3-year survival and relapse rates of T1-2 BC patients with one or two macrometastatic SLNs treated with SLNB only, and adjuvant therapy, were not inferior to those of patients treated with ALND. These results do not support the use of routine ALND.

De-escalating axillary surgery in early-stage breast cancer

The role of axillary surgery has evolved over the last three decades from routine axillary lymph node dissection (ALND) to sentinel lymph node biopsy to omission of axillary surgery altogether in select patients. This evolution has been achieved through the design and conduct of multiple clinical trials demonstrating that ALND does not impact survival and is not necessary for local control in patients with early-stage breast cancer and limited nodal involvement. Importantly, this practice-changing shift mirrored the trend towards earlier stage at diagnosis and the recognition of the interplay between local and systemic therapies in maintaining local control. There are numerous clinical scenarios today in which axillary staging can be safely avoided, including (1) DCIS treated with lumpectomy, (2) at the time of contralateral prophylactic mastectomy, and (3) in elderly patients with early-stage, HR+/HER2-clinically node-negative (cN0) disease. Ongoing clinical trials seek to expand the cohorts in which surgical nodal staging can be omitted. These populations include a broader range of early-stage, cN0 patients undergoing upfront surgery, as seen in the SOUND, INSEMA, BOOG 2013–08, SOAPET and NAUTILUS trials. Omission of axillary surgery in cN0 patients with HER2+ or triple-negative disease treated with neoadjuvant chemotherapy is also being tested in the ASICS and EUBREAST-01 trials. Continued advances in imaging and the growing role of genomic assays in selecting patients for systemic therapy are likely to further minimize the need for axillary surgery; thereby further reducing the morbidity of local therapy for women with breast cancer.

Can intraoperative ultrasound replace the frozen section in the assessment of ex vivo sentinel lymph node biopsy in early breast cancer in countries with limited resources?

BackgroundAccurate staging and proper management of axillary lymph nodes (ALNs) in breast cancer patients are important for treatment. Surgical management of the axilla has evolved greatly in the last 20 years. Sentinel lymph node biopsy (SLNB), which was first investigated in the early 1990s, has replaced routine axillary lymph node dissection. This study evaluates the capability of using an ultrasound (US) as an alternative tool for the frozen section in the assessment of the ex vivo sentinel lymph node biopsy in countries with limited resources.ResultsThe study is a prospective study that included 216 female patients with early breast cancer and negative axillary lymph nodes. All excised lymph nodes were examined by the intraoperative US and frozen section examinations. All the results were correlated with the final histopathological results. The number of negative nodes by US, frozen, and paraffin section examination was 58.30%, 69.40%, and 69.40%, respectively. The number of positive nodes by the US, frozen, and paraffin section examinations was 41.70%, 30.60%, and 30.60% respectively. The sensitivity, specificity, PPV, NPV, and accuracy of US in the detection of positive lymph nodes were 95.45%, 82%, 70%, 97.62%, and 86.11%, respectively, and the sensitivity, specificity, PPV, NPV, and accuracy of frozen examination in the detection of positive lymph nodes were 90.91%, 96%, 90.91%, 96%, and 94.44%, respectively.ConclusionIntraoperative US is a good negative test in the assessment of ex vivo SLNB, but it is not a good positive test, so it cannot replace the intraoperative frozen section in the assessment of SLNs.

Feasibility of preoperative tattooing of percutaneously biopsied axillary lymph node: an experimental pilot study

BackgroundIn the last three decades, axillary lymph node dissection (ALND) has been replaced by sentinel lymph node biopsy (SLNB) in all clinically node-negative patients. However, when SLNB alone is performed in clinically node-positive patients who are rendered node-negative by neoadjuvant chemotherapy, the procedure has a high false-negative rate and other complementary procedures have been described to improve its reliability. Preoperative tattooing of the suspicious lymph node with India ink at the time of biopsy, in addition to sentinel lymph node biopsy, is a reasonable alternative. The objective of our study is to determine, in clinically node-positive patients, the feasibility of tattooing suspicious axillary lymph node at the time of percutaneous needle biopsy and its retrieval at the time of surgery.MethodsA prospective experimental study will be conducted divided into two phases—phases I and II. In phase I, 10 patients committed to undergo upfront surgery (without neoadjuvant chemotherapy) will have a suspicious lymph node tattooed by injecting India ink at the time of core needle biopsy. All patients will undergo a SLNB, during which the axilla will be inspected to determine if the tattooed lymph node can be visualized. Routine microscopic examination will follow, and concordance between the sentinel and tattooed node will also be established. In phase II, the process will be repeated for 30 patients who undergo surgery after neoadjuvant chemotherapy. The analysis will be performed in Stata version 12.DiscussionThere is a need to identify and test the techniques for the down-staged axilla in post-neoadjuvant chemotherapy patients, which are not only practical and limit the number of invasive procedures necessary but are representative of the new axillary status and help limit the extent of axillary surgery without negatively impacting outcomes. We propose that, for the patient undergoing neoadjuvant chemotherapy with a biopsy-proven disease in the axilla, this could be achieved by India ink which allows marking, identification, and retrieval of the biopsied lymph node. Retrieval of this previously biopsied lymph node along with sentinel nodes, if found to be representative of the status of the remainder of the axilla, could potentially eliminate the need for routine axillary lymph node dissection and thus limit morbidity.Trial RegistrationClinicalTrials.gov, NCT03939598. Retrospectively registered on 7 May 2019.

Sentinel lymph node biopsy following previous axillary surgery in recurrent breast cancer

IntroductionIpsilateral breast recurrence or second primary breast cancer can develop in patients who have undergone breast conserving surgery (BCS) and axillary surgery. The purpose of this study was to examine the feasibility of a reoperative sentinel lymph node biopsy (SLNB) as a repeated axillary staging procedure. Patients and methodsFrom August 2014 through January 2017 patients with locally recurrent breast cancer or with BRCA mutation requiring risk reduction mastectomy as a second surgical procedure, underwent repeat SLNB in three Hungarian Breast Units with a radiocolloid (and blue dye) technique. ResultsHundred and sixty repeat SLNBs were analysed, 80 after previous SLNB and 80 after previous total or partial axillary lymph node dissection (ALND). SLN identification was successful in 106 patients (66%); 77/80 (77.5%) and 44/80 (55%) in the SLNB and ALND groups, respectively. (p < 0.003). Extra-axillary lymph drainage was more frequent in the ALND group (19/44, 43,2% versus 7/62, 11,3%; p < 0.001). Lymphatic drainage to the contralateral axilla was observed in 14 patients (11 in the ALND group, p = 0.025), isolated parasternal drainage was detected in 4 patients (p = 0.31). Only 9/106 patients with successful repeat SLNB (8,8%, all with 1 SLN removed) had SLN metastases ConclusionsRepeat SLNB is feasible in patients with ipsilateral breast tumor recurrence or new ipsilateral primary tumor after previous BCS and axillary staging. Repeat SLNB should replace routine ALND as the standard axillary restaging procedure in recurrent disease with a clinically negative axilla. Preoperative lymphoscintigraphy is important to explore extra-axillary lymphatic drainage in this restaging setting.

The Relationship Between Positive Sentinel Lymph Node Biopsy and Residual Axillary Lymph Nodes Status in Early Stage Breast Cancer

Introduction: For patients with clinically negative axilla, sentinel lymph node biopsy (SLNB) is the standard method for axillary staging Because the SLBNs are the only positive nodes in approximately 40–70% of patients with pathologically proven positive axillae after completion axillary lymph node dissection (ALND), the treatment of patients with a positive SLBN has been reconsidered and the development of predictive tools that select the patients whom routine ALND could be avoided safely.

Variability in Sentinel Lymph Node Biopsy Retrieval for Breast Cancer at Aurora Health Care

Background: Axillary lymph node involvement has always been one of the most important factors in determining treatment and prognosis for breast cancer. Routine axillary lymph node dissection (ALND) was the standard treatment for breast cancer until the mid-1990s, when sentinel lymph node biopsy (SLNB) became the standard.

Impact of modern-day axillary treatment on patient reported arm morbidity and physical functioning in breast cancer patients

PurposeTo reduce arm morbidity, routine axillary lymph node dissection (ALND) is often omitted or replaced by axillary radiotherapy (AxRT) in patients with limited nodal involvement. We evaluated patient-reported arm morbidity and physical functioning in breast cancer patients undergoing modern-day axillary treatment. MethodsAll patients within the UMBRELLA cohort undergoing local radiotherapy with sentinel lymph node biopsy (SLNB), ALND and/or AxRT were selected. Patient-reported arm morbidity and physical functioning were assessed with EORTC QLQ C30/BR23 questionnaires up to eighteen months after initiation of radiotherapy. Patient-reported outcomes were compared between patients with SLNB only, ALND only, AxRT (level I–II), AxRT (level I–IV) or AxRT plus ALND by means of mixed model analysis. ResultsIn total, 949 patients were identified; 641 (68%) SLNB only, 57 (6%) ALND only, 94 (10%) AxRT level I–II, 72 (8%) AxRT level I–IV and 85 (9%) ALND + AxRT. SLNB only resulted in the least arm morbidity scores. ALND + AxRT resulted in most arm morbidity, with clinically relevant differences at 18 months. AxRT (level I–II or level I–IV) resulted in significantly less arm symptoms in the first 3 months compared to ALND. Arm symptom scores between those receiving AxRT on levels I–II and I–IV were similar. ConclusionOf all axillary management strategies, ALND plus AxRT is associated with worst patient-reported outcomes. AxRT resulted in less arm morbidity compared to ALND. Selective radiotherapy treatment of the axilla, i.e. radiotherapy of levels I–II only instead of levels I–IV, did not lead to clinically relevant reduced arm morbidity.

A RARE CASE OF TEENAGE ADENOID CYSTIC CARCINOMA OF THE BREAST

Adenoid cystic carcinoma (ACC) of the breast is very rare, accounting for only 0.1% of all breast carcinomas. Their rarity has made them difficult to study systematically with the most published series consisting of few cases or case reports; although, this existing evidence does suggest a good prognosis. ACC usually affects women, more in the sixth decade of life. However, our case has an exceptionally early onset of cancer at 16 years, the youngest ever reported in literature. Good local control can be obtained with lumpectomy and radiation or simple mastectomy for nearly all tumors. A routine axillary lymph node dissection is not recommended. We gave adjuvant radiotherapy to this patient in view of close margins and presence of lymphovascular emboli. She tolerated well with minimal side effects. Chemotherapy and hormonal therapy have no established benefit.

Treatment of the axilla in patients with primary breast cancer and low burden axillary disease: Limitations of the evidence from randomised controlled trials.

Invasive breast cancer is the second most common cancer worldwide. It is known to metastasise to the regional axillary lymph nodes but there has been debate over what is the best way to stage and treat the axilla in patients presenting with primary breast cancer. Multiple trials over the last two decades have led to a change in practice from routine axillary lymph node dissection to sentinel lymph node biopsy in patients who are clinically lymph node negative preoperatively. This has resulted in new questions regarding subsequent treatment of some patients. This review will critically appraise the evidence on axillary treatment in patients with low burden axillary disease and highlight limitations of relevant randomised controlled trials.

“Intraoperative Touch Imprint Cytology of Sentinel Nodes”, Can it Serve as an Alternative to Frozen Section? – A Prospective Comparative Study of Touch Imprint Cytology and Frozen Section in the Intra Operative Assessment of Nodal Metastasis in Carcinoma Breast.

Sentinel lymph node biopsy (SLNB) is now known to offer an excellent alternative method to routine axillary lymph node dissection in staging of breast cancer. However, this minimally invasive technique requires facilities for frozen section (FS) and intraoperative analysis, which are sadly not available at most centers in India. At the same time Touch imprint cytology (TIC), is relatively less cumbersome technique for intraoperative assessment which may provide a fast and accurate method for intraoperative assessment of sentinel lymph nodes. Aim: This study was done to assess the accuracy and feasibility of using the TIC as an alternative to FS to assess metastasis in the sentinel node. Methods: Touch imprint cytological analysis of sentinel lymph nodes was compared prospectively with frozen section and the findings obtained on routine paraffin sections. Touch imprint slides from 32 consecutive women undergoing mastectomies (from Jan 2014 to May 2016) for invasive breast cancer (all 32 were T1-T3 and with clinically N0 nodal status) were prepared during operation from multiple sections of sentinel lymph nodes, stained with haematoxylin and eosin. Results: The sensitivity of TIC was 89.47% (95% CI, 68.49-98.81%), when compared with the final histopathological result as a gold standard method. The sensitivity of the FS was 94.74% (95% CI 73.97% to 99.87%), when compared to the HPE results. The specificity of the TIC and FS when compared to HPE is 100%. Conclusion: This study has lent credibility to the possible use of TIC as an assessment tool of the sentinel node in centers where facilities for frozen section are not available and hence expanding the population of potential beneficiaries who can be spared of morbidity associated with axillary dissection

Repeat sentinel node biopsy should be considered in patients with locally recurrent breast cancer.

Most patients with locally recurrent breast cancer undergo axillary lymph node dissection (ALND). However, repeat sentinel node biopsy (SNB) could provide regional nodal staging and obviate the need for standard ALND. The Sentinel Node and Recurrent Breast Cancer (SNARB) study is a Dutch nationwide registration study conducted to determine feasibility, aberrant drainage rates, and clinical consequences of repeat SNB. A total of 536 patients with locally recurrent non-metastatic breast cancer underwent lymphatic mapping and repeat SNB in 29 Dutch hospitals. A repeat sentinel node (SN) was identified in 333 of 536 patients (62.1 %) and surgically harvested in 287 patients (53.5 %). Aberrant lymph drainage was observed in 180 (54.1 %) of the 333 patients, more often after previous ALND (81.9 %) than SNB (28.4 %; P < 0.001). In 230 patients (80.1 %), the retrieved SN was tumor negative; 17 SNs (5.9 %) contained a micrometastasis and 29 (10.1 %) a macrometastasis. Confirmation ALND in 31 repeat SN-negative patients revealed a macrometastasis in two patients (6.5 %). The negative predictive value (NPV) of repeat SNB was 93.6 %, and ALND was omitted in 109 of the 248 patients (44.0 %) with a negative repeat SN. In 29 of the 44 patients (63.0 %) with a positive SN, adjuvant treatment plans were altered based on the repeat SNB. Repeat SNB is a feasible procedure with a high NPV, leading to a change in management in a substantial proportion of patients. Therefore, repeat SNB should replace routine ALND and serve as the standard of care in recurrent breast cancer.

Abstract P1-01-08: Diagnostic accuracy of pre-operative ultrasonographic evaluation of axillary lymph nodes in breast cancer patients: Is there a place for axillary ultrasonography in future nomograms?

Abstract Background During the years there has been a significant interest in the development of clinical prediction tools to estimate the risk of having positive lymph nodes in the axilla, and thereby making it possible to plan specific therapies. A non-invasive and widely available method is axillary ultrasonography. Aim The purpose of this study was to evaluate the diagnostic accuracy of axillary ultrasonography. Patients and methods Between January 2007 and July 2011, pre-operative axillary ultrasonography was performed in 1124 consecutive primary breast cancer patients who underwent surgery with sentinel node biopsy (SNB) and/or complete axillary lymph node dissection (ALND). Suspected lymph nodes (cortex thickness &amp;gt; 2.3 mm) were further analysed by cytology or histology. In case of a negative axillary ultrasonography, standard SNB was performed during operation. In case of suspected lymph nodes with axillary ultrasonography, confirmed by biopsy, routine complete ALND was performed. Results Of the 1124 patients, 922 (82%) had unsuspected lymph nodes and 202 (18%) had suspicious lymph nodes during axillary ultrasonography. The sensitivity and specificity of axillary ultrasonography was 46.6% and 93.0% respectively in case of a macrometastases. In all cases of suspected malignancy, axillary core biopsy was performed. The sensitivity and specificity of axillary ultrasonography in combination with core biopsy was 40.5% and 97.2% respectively. With increasing number of axillary nodes the sensitivity increases: 53.9% in case of 2 macrometastases and 83.3% in case of 3 macrometastases. Conclusion Ultrasonography and core biopsy are effective in predicting the presence of axillary metastases in breast cancer patients. Especially the high specificity might be of additional value for future nomograms in the surgical treatment of breast cancer patients. In addition, the sensitivity is of greater value in case of gross nodal disease. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P1-01-08.

Routine completion axillary lymph node dissection for positive sentinel nodes in patients undergoing mastectomy is not associated with improved local control

BackgroundThe current practice of completion axillary lymph node dissection (ALND) for patients with a positive sentinel lymph node (SLN) is being questioned. This led us to examine the outcomes of patients with positive SLNs undergoing mastectomy who underwent ALND compared with those who did not. MethodsA retrospective review of cancer registry data identified 561 women with stages 1 to 3 breast cancer with positive SLNs who underwent mastectomy between 2000 and 2010. Four hundred twenty-six women underwent formal ALND and 135 were managed expectantly. Recurrence-free survival was defined as no locoregional or distant metastases. ResultsMean time to recurrence was 29.9 months. Mean follow-up for patients without recurrence was 40.3 months. Survival curves showed no significant difference in recurrence-free survival between the 2 groups (P = .23). ConclusionsIn our experience, there is no significant difference in recurrence-free survival in patients with positive SLNs undergoing mastectomy when completion ALND was not performed, suggesting that a closer look at the indications for ALND in early breast cancer be further explored.

International multicenter tool to predict the risk of four or more tumor-positive axillary lymph nodes in breast cancer patients with sentinel node macrometastases

Recently, many centers have omitted routine axillary lymph node dissection (ALND) after metastatic sentinel node biopsy in breast cancer due to a growing body of literature. However, existing guidelines of adjuvant treatment planning are strongly based on axillary nodal stage. In this study, we aim to develop a novel international multicenter predictive tool to estimate a patient-specific risk of having four or more tumor-positive axillary lymph nodes (ALN) in patients with macrometastatic sentinel node(s) (SN). A series of 675 patients with macrometastatic SN and completion ALND from five European centers were analyzed by logistic regression analysis. A multivariate predictive model was created and validated internally by 367 additional patients and then externally by 760 additional patients from eight different centers. All statistical tests were two-sided. Prevalence of four or more tumor-positive ALN in each center's series (P = 0.010), number of metastatic SNs (P < 0.0001), number of negative SNs (P = 0.003), histological size of the primary tumor (P = 0.020), and extra-capsular extension of SN metastasis (P < 0.0001) were included in the predictive model. The model's area under the receiver operating characteristics curve was 0.766 in the internal validation and 0.774 in external validation. Our novel international multicenter-based predictive tool reliably estimates the risk of four or more axillary metastases after identifying macrometastatic SN(s) in breast cancer. Our tool performs well in internal and external validation, but needs to be further validated in each center before application to clinical use.

Should we examine sentinel lymph nodes during the operation?

Axillary lymph node metastasis is one of the most important predictor of outcome in breast cancer (1,2). Currently sentinel lymph node biopsy (SLNBx) has been established as the golden standard to determine the node status (3). The concept of analyzing the first “gate keeper lymph node” to define the likelihood of further lymphatic spread has dramatically transformed the surgical approach against breast cancer. It is very well known that the routine axillary lymph node dissection (ALND) is associated with high complication rate, and the practice of selective SLNBx has significantly reduced its occurrence (4,5).