A nomogram predictive of non-sentinel lymph node involvement in breast cancer patients with a sentinel lymph node micrometastasis

Purpose

Predictive factors of non-sentinel lymph node (NSN) involvement at axillary lymph node dissection (ALND) have been studied in the case of sentinel node (SN) involvement, with validation of a nomogram. This nomogram is not accurate for SN micrometastasis. The purpose of our study was to determine a nomogram for predicting the likelihood of NSN involvement in breast cancer patients with a SN micrometastasis.

Methods

We collated 909 observations of SN micrometastases with additional ALND. Characteristics of the patients, tumours and SN were analysed.

Results

Involvement of SN was diagnosed 490 times (53.9%) with standard staining (HES) and 419 times solely on immunohistochemical analysis (IHC) (46.1%). NSN invasion was observed in 114 patients (12.5%), whereas 62.3% (71) had only one NSN involved and 37.7% (43) two or more NSN involved. In multivariate analysis, significant predictive factors were: tumour size (pT stage ≤10 mm or >11 and ≤20 or >20 mm [odds ratio (OR) 2.1 and 3.43], micrometastases detected by HES or IHC [OR 1.64], presence or absence of lymphovascular invasion (LVI) [OR 1.76], tumour histological type mixed or not [OR 2.64]. The rate and probability of NSN involvement with the model are given for 24 groups, with a representation by a nomogram.

Conclusion

One group, corresponding to 10.1% of the patients, was associated with a risk of NSN involvement of less than 5%, and five groups, corresponding to 29.8% of the patients, were associated with a risk ≤10%. Omission of ALND could be proposed with minimal risk for a low probability of NSN involvement.     

Observational study of blue dye-assisted four-node sampling for axillary staging in early breast cancer

Background

The use of radioisotopes (RIs) is regulated and not all institutions have nuclear medicine facilities for sentinel node biopsy (SNB). We previously reported blue dye-assisted four-node axillary sampling (4NAS/dye) to be a suitable method for detecting sentinel nodes (SNs) without RIs. Here, we present an interim report on an observational study of this technique.

Methods

From May 2003 to June 2008, 234 early breast cancer patients underwent SNB with 4NAS/dye. Lymphatic mapping was performed by injection of patent blue, and axillary sampling was performed until 4 SNs were detected. Patients with metastatic SNs underwent axillary lymph node dissection (ALND) at levels I and II, while SN-negative patients did not undergo further axillary procedures.

Results

The SN identification rate was 99%. In total, 44 patients were diagnosed with metastatic disease by using the 4NAS/dye technique and underwent ALND; the remaining 189 patients did not undergo ALND (the SNB group). After a median follow-up period of 54 months, only 1 patient (0.5%) in the SNB group developed axillary recurrence. For the 4NAS/dye procedure, blue SNs were harvested in 220 patients (94%) and only unstained SNs were harvested in 13 patients (6%). Among the 44 patients with SN metastases, foci were found in blue SNs in 37 patients (84%), while they were found in only unstained SNs in 7 patients (16%).

Conclusions

SNB with 4NAS/dye is a safe and reliable technique for treatment of early breast cancer patients. This technique may be particularly useful for surgeons who do not have access to radioisotope facilities.     

The frequency of presentation and clinico-pathological characteristics of symptomatic versus screen detected ductal carcinoma in situ of the breast

Introduction

DCIS accounts for 20% of screen-detected breast cancers, but also presents symptomatically. Historically, approximately 5% of DCIS was thought to be symptomatic, but accurate evaluation of the presentation of symptomatic DCIS is needed to determine its incidence and tumour biology.

Methods

Clinico-pathological details of a consecutive series of patients presenting to a single breast-unit, with a pre-operative diagnosis of DCIS, were selected. Data included age, mode of presentation, pre-operative clinical and radiographical findings. The final tumour histology, operation, size, grade, ER status (and HER2 expression in invasive cases) were recorded.

Results

375 patients had a pre-operative histological diagnosis of DCIS. 308 (82%) screen-detected (median age 59), 67 (18%) presented via symptomatic clinics (median age 50). At final histology 286 (74%) were pure DCIS, and 67 (23%) had an invasive focus. 43% (29/67) of symptomatic cases had an invasive focus at final histology versus 19% (60/308) screen-detected (p ≤ 0.001). 31% (9/29) of symptomatic, versus 10% (6/60) of screen-detected cases with invasion were node positive (p = 0.05). 45% (28/62) intermediate/high-grade symptomatic cases had an invasive focus at final histology, compared to 19% (57/297) intermediate/high-grade screen-detected cases. 86% (212/248) screen-detected pure DCIS was ER positive compared to 68% (26/38) symptomatically presenting pure DCIS (p ≤ 0.001). Overall, 13% (38/248) pure DCIS presented symptomatically (p = 0.001).

Conclusions

Overall, thirteen percent of pure DCIS present symptomatically. Nearly half of symptomatically presenting DCIS at core biopsy has an occult invasive focus and is more frequently ER negative. Symptomatic DCIS with an invasive focus is more likely to have lymph node involvement.     

Impact of sentinel node tumor burden on outcome of invasive breast cancer patients

Background

The tumor status of the axillary lymph nodes is one of the most important prognostic factors in women with early breast cancer (BC). Sentinel lymph node (SLN) biopsy has become the standard staging procedure for patients with invasive BC, largely replacing axillary lymph nodes dissection (ALND). The exact impact on prognosis of SLN tumor burden is still object of controversy. The aim of this study was to correlate the tumor burden in the SLN with the outcome in a large cohort of women.

Patients and methods

1040 consecutive patients with clinical stage I–III invasive BC were prospectively collected on our Institutional BC database from January 2001 to January 2007. Patients were stratified into the following four groups based on the tumor burden of the SLN: macrometastases, tumor deposit ≥2 mm; micrometastases, tumor deposit ≥0.2 mm and <2 mm; isolated tumor cells (ITC), isolated tumor cells or tumor deposit <0.2 mm; negative, in case of patients with no evidence of tumor.

Results

At a median follow-up of 8.5 years, the tumor burden of SLN metastases resulted significant predictor of DFS (P < 0.0001) and OS (P = 0.042). Multivariate analysis showed that the tumor burden of SLN metastases and Ki 67 proliferative index maintained the statistical significance.

Conclusion

Patients with SLN micrometastases or ITC, do not seem to have a worse DFS or OS compared with SLN negative cases. There is a significant decrease in DFS and OS in patients with macrometastatic disease in the SLN.     

Ratio of marked and excised sentinel lymph nodes and scintigraphic appearance time in melanoma patients with negative sentinel lymph node

Aim

Metastases can occur in up to 15% of all melanoma patients with negative sentinel lymph node examination (SN –). We retrospectively investigated the number of preoperatively marked sentinel lymph nodes (SNs) with lymphoscintigraphy and effectively surgically removed SNs in SN – patients with cutaneous melanoma ≥0.5 mm. Ratio of these parameters was calculated and impact of this ratio as well as impact of scintigraphic appearance time (SAT) on disease progression was studied.

Materials and methods

Data on 122 SN – patients — 70 women (58%), mean age 56.5 years — were analyzed. Mean follow-up time was 58 months.

Results

Mean tumour thickness of all patients was 2.3 mm. In 51 patients (42%) the number of SNs marked in lymphoscintigraphy was higher than excised in surgery, in 47 patients (38%) the same number as marked was excised and in 24 patients (20%) a lower number was marked than excised. Metastases occurred in 17 patients (14%) after a mean time of 24.8 months. Mean tumour thickness (5.4 mm) was significantly higher in these patients than in the other patients (p = 0.000). Ratio of marked and excised SNs had no influence on disease progression; the only parameter influencing outcome was tumour thickness (p = 0.000). Short SAT was significantly associated with higher tumour thickness (p = 0.004).

Conclusion

Our study indicates that, in routine clinical practice, it suffices to harvest the first SN, as the ratio of marked and excised SNs has no impact on disease progression.     

Ultrasound and fine needle aspiration cytology of the axilla in the pre-operative identification of axillary nodal involvement in breast cancer

Aims

Pre-operative diagnosis of axillary nodal involvement in breast cancer allows one-stage axillary surgery. We evaluated the efficacy of axillary ultrasound (US) with US guided fine needle aspiration cytology (FNAC) in the diagnosis of axillary nodal involvement.

Methods

Over a 13-month period, we performed US of 369 axillae in patients with screen-detected (n = 278) and symptomatic (n = 91) invasive carcinoma of the breast, at the same time as US of the primary tumour. If abnormal lymph nodes were demonstrated, a single US guided FNAC of the most abnormal node was performed. US and FNAC results were compared with the final histology of the surgically excised lymph nodes.

Results

Among the 369 axillae studied, 102 had nodal macrometastases and 38 (37%) were identified by US guided FNAC. The rate was 33% in screen-detected and 44% in symptomatic patients. Sensitivity increased with increasing numbers of positive axillary nodes, and the more abnormal the appearances of the nodes on US.

Conclusion

US with FNAC of the most abnormal node allows pre-operative detection of a third of node positive axillae in screen-detected and over 40% of those with symptomatic breast cancer, allowing one-stage axillary surgery avoiding the sentinel node biopsy step in these patients.     

Quantitation of sentinel node metastatic burden and Her-2/neu over-expression accurately predicts residual axillary nodal involvement and extranodal disease in breast cancer

Background data

Recent literature has suggested that completion axillary lymph node dissection (ALND) in breast carcinoma patients with positive SLN may not be necessary. However, a method for determining the risk of non-SLN or extranodal disease remains to be established.

Aims

To determine if pathological variables from primary tumors and sentinel lymph node (SLN) metastases could predict the probability of non-sentinel lymph node (NSLN) metastases and extranodal disease in patients with breast carcinoma and SLN metastases.

Methods

84 women with T1-3 breast cancer and clinically-negative axillae underwent completion ALND. Maximum diameter and width of SLN metastases were measured to calculate metastatic area. When multiple SLNs contained metastases, areas were summed to calculate the Total Metastatic Area (TMA). Multiple linear regression models were used to identify predictive factors.

Results

Her-2/neu over-expression increased the odds of NSLN metastases (OR 4.3, p = 0.01) and extranodal disease (OR 7.9, p < 0.001). Independent SLN predictors were ≥1 positive SLN (OR, 7.35), maximum diameter and area of SLN metastases (OR 2.26, 1.85 respectively) and TMA (OR, 2.12). Maximum metastatic diameter/SLN diameter (OR 3.71, p = 0.04) and the area of metastases/SLN area (OR 3.4, p = 0.04) were predictive. For every 1 mm increase in diameter of SLN metastases, the odds of NSLN extranodal disease increased by 8.5% (p = 0.02). TMA >0.40 cm² was an independent predictor for NSLN metastases and extranodal disease.

Conclusion

Her-2/neu over-expression and parameters assessing metastatic burden in the SLN, particularly TMA, predicted the presence of NSLN involvement and extranodal disease in patients with breast carcinoma and SLN metastases.     

Persistent pain,sensory disturbances and functional impairment after immediate or delayed axillary lymph node dissection

Background

Patients treated with 2-step axillary lymph node dissection (ALND) may be at increased risk of nerve damage due to more challenging surgery than an ALND immediately after a sentinel lymph node biopsy (SLNB), and thus more at risk for persistent pain after breast cancer treatment (PPBCT). The aim of this study was to examine PPBCT, sensory disturbances and functional impairment in patients treated with a 2-step ALND compared to patients with an SLNB followed by an immediate ALND, and patients with ALND without a prior SLNB.

Methods

The study is a cross-sectional questionnaire study, comparing 2847 women treated with ALND in Denmark in 2005–2008. 196 patients treated with a 2-step ALND were compared with 1558 patients treated with an ALND after SLNB and 1093 with an ALND without a prior SLNB.

Results

Overall prevalence of PPBCT and sensory disturbances was high, with about 55% reporting PPBCT and 77% reporting sensory disturbances in all groups. No differences were found between the groups on prevalence and intensity of PPBCT (p = 0.92), sensory disturbances (p = 0.32), and functional consequences (p = 0.35).

Conclusions

A 2-step ALND does not modify the risk of developing PPBCT compared to an immediate ALND.     

Treatment outcomes and unfavorable prognostic factors in patients with occult breast cancer

Aims

The purpose of this study was to evaluate the treatment outcomes and prognostic factors in patients with occult breast cancer (OBC).

Methods

We retrospectively analyzed 95 patients with OBC who were treated at our facility between January 1998 and June 2010. Of the 95 patients, 64 underwent mastectomy plus axillary lymph node dissection (ALND) with or without post-mastectomy radiation (Mast + ALND group), 13 underwent ALND followed by ipsilateral breast radiotherapy (BR + ALND group) and the remaining 18 were treated with ALND (ALND group).

Results

Patients who underwent Mast + ALND or BR + ALND had significantly improved rates of locoregional recurrence-free survival (LRFS) and recurrence/metastasis-free survival (RFS) than patients who only underwent ALND (p < 0.05). There were no significant differences in the LRFS (p = 0.718), RFS (p = 0.935) and breast cancer-specific survival (BCSS) (p = 0.991) rates between the patients who underwent Mast + ALND compared with those who received BR + ALND. Multivariate analysis revealed that patients with four or more involved lymph nodes had significantly worse outcomes (p = 0.042, HR = 4.63, 95% CI = 1.66–32.47 for BCSS and p = 0.038, HR = 3.62, 95% CI = 1.08–20.77 for RFS).

Conclusions

Patients with OBC who received ALND and subsequent breast radiotherapy had similar outcomes to patients who underwent mastectomy. The presence of four or more involved lymph nodes may independently predict poor outcomes of OBC.     

The significance of immunohistochemistry positivity in sentinel nodes which are negative on haematoxylin and eosin in breast cancer

Introduction

Sentinel lymph node (SLN) biopsy allows a more detailed examination of a smaller number of lymph nodes in patients with clinically node negative breast cancer. Immunohistochemistry detects small tumour burden not routinely seen on haematoxylin and eosin (H&E). The significance of such findings remains to be fully elucidated.

Aim

To assess the axillary disease burden of patients in whom the sentinel lymph node biopsy was positive on immunohistochemistry and negative on H and E.

Methods

An analysis of patients who underwent SLN mapping for breast cancer at St Vincent's University Hospital from January 1st, 2000 to December 31st, 2006 was conducted. All SLNs were assessed by serial H&E and IHC sections. Patients with micrometastases (0.2–2 mm) underwent a completion axillary lymph node dissections (CLND). Patients with ITC (<0.2 mm) were individually discussed and a CLND was performed selectively based on additional clinicopathological criteria and patient preference. Analysis of the additional nodes from CLND was performed. Patients were followed for a median of 27 months (range 12–72 months).

Results

1076 patients who underwent SLN were included for analysis. 211 (20%) had a positive SLN biopsy using H&E. Forty-nine patients (5%) had a negative SLN on H&E which was positive on IHC. Of these, 15 had micrometastases and underwent a CLND. Two had further axillary nodal disease. ITC were found in the remaining 34 patients. Sixteen of these patients underwent a CLND. Five of this group had further nodal disease.

Conclusion

Micrometastases and isolated tumour cells, detected only by immunohistochemical analysis of sentinel lymph nodes, are associated with further positive nodes in the axilla in up to 15% of patients. This upstaging of disease may impact upon patient outcome.     

A population based study of variations in operation rates for breast cancer,of comorbidity and prognosis at diagnosis: Failure to operate for early breast cancer in older women

Background

Older women are less likely to have surgery for operable breast cancer. This population-based study examines operation rates by age and identifies groups which present with early or late disease.

Methods

37 000 cancer registrations for 2007 were combined with Hospital Episode Statistics comorbidity data for England. Operation rates were examined by age, ethnicity, deprivation, comorbidity, screen-detection, tumour size, grade and nodal status. Early and late presentation were correlated with Nottingham Prognostic Index (NPI) groups and tumour size.

Results

The proportion of women not having surgery increased from 7–10% at ages 35–69 to 82% from age 90. From age 70, the proportion not having surgery rose by an average of 3.1% per year of age. Women with a Charlson Comorbidity Index score of ≥1 (which increased with age), with tumours >50 mm or who were node positive, were less likely to have surgery. Although women aged 70–79 were more likely to have larger tumours, their tumours were also more likely to have an excellent or good NPI (p < 0.001). Good prognosis tumours were more likely to be screen-detected, and less likely in women aged 0–39, the deprived and certain ethnic groups (p < 0.02).

Conclusions

From age 70 there is an increasing failure to operate for breast cancer. Younger women and certain ethnic groups presented with more advanced tumours. Older women had larger tumours which were otherwise of good prognosis, and this would not account for the failure to operate which may in part be related to comorbidity in this age group.     

The real-time intra-operative evaluation of sentinel lymph nodes in breast cancer patients using One Step Nucleic Acid Amplification (OSNA) and implications for clinical decision-making

Introduction

One Step Nucleic Acid Amplification (OSNA) method for the intraoperative analysis of sentinel lymph nodes (SLNs) in breast cancer, obviates a second operation to the axilla and thereby expedites progression to adjuvant therapy. Recent NICE guidelines have approved OSNA as a method of sentinel node diagnosis to support the above case.¹

Method

This is a single centre prospective cohort analysis of all patients undergoing breast cancer surgery including sentinel node biopsy from February 2010 to June 2012. Patients with negative SLN(s) on OSNA had no further axillary surgery. A validation phase was performed prior to using OSNA routinely. Those with micrometastases underwent a level 1 clearance, and >one SLN with macrometastases, underwent treatment by level 2 axillary dissection. The length of time from sentinel node retrieval to OSNA result was recorded.

Results

Four hundred and forty nodes were analysed in 212 patients with a mean age of 55 years (range 24–98). The sensitivity and specificity of OSNA was 93% and 94% respectively in cases of macrometastases. The process required additional median anaesthesia time of 20 min (range −48 to +65 min). Non-sentinel node positivity was 5% and 48% for micrometastasis and macrometastasis respectively.

Conclusion

OSNA identified 62 of 212 patients with at least one positive sentinel node, thereby sparing 29% from a second procedure to clear the axilla subsequently. The median waiting time of 20 min for node results from completion of breast procedure is acceptable and allows for an efficient operating list. OSNA can be incorporated into routine practice and with improved methods of imaging preoperatively, can be an excellent adjunct to the breast cancer patient pathway of care.     

Avoidance of axillary lymph node dissection in selected patients with node-positive breast cancer

Aims

Currently, it is standard practice to avoid ALND in patients with negative SLN, whereas this procedure is mandated for those with positive SLN. However, there has been some debate regarding the necessity of complete ALND in all patients with positive SLN. This review article discusses the issues related to eliminating the need for ALND in selected patients with positive nodes.

Methods

A review of the English language medical literature was performed using the MEDLINE database and cross-referencing major articles on the subject, focusing on the last 10 years.

Results

Currently, complete ALND is mandated in patients with SLN macrometastases as well as those with clinically positive nodes. It is not clear whether SLN biopsy is appropriate for axillary staging in patients with initially clinically positive nodes (N1) that become clinically node-negative (N0) after neoadjuvant chemotherapy. Although there is debate regarding whether ALND should be performed in patients with micrometastases in the SLN, it seems premature to abandon ALND in clinical practice. Moreover, it remains unclear whether it is appropriate to avoid complete ALND in patients with ITC-positive SLN alone.

Conclusions

In the absence of data from randomised trials, the long-term impact of SLN biopsy alone on axillary recurrence and survival rate in patients with SLN micrometastases as well as those with ITC-positive SLN remains uncertain. These important issues must be determined by careful analysis of the results of ongoing clinical trials.     

The analysis of the outcomes and factors related to iliac–obturator involvement in cutaneous melanoma patients after lymph node dissection due to positive sentinel lymph node biopsy or clinically detected inguinal metastases

Background

We assessed clinical–pathological features and outcomes of cutaneous melanoma patients after ilio-inguinal lymph node dissection (LND) in relation to the presence of metastases in iliac–obturator nodes.

Methods

We analyzed 390 consecutive patients who underwent ilio-inguinal therapeutic LND [TLND] (237) due to clinical/cytologically detected metastases or after completion LND [CLND] (153) due to positive SLN biopsy (in one cancer centre 1994–2009). Median follow-up time was 60 months.

Results

The 5-year overall survival (OS) rate was 49% and median OS – 52 months in the entire group of patients. According to univariate analysis following factors had significant negative influence on OS: presence of metastases to iliac–obturator nodes (5-year OS for positive versus negative: 54.5% and 32%, respectively), macrometastases, higher Breslow thickness, ulceration, higher Clark level, male gender, number of metastatic lymph nodes, extracapsular extension, and, additionally in the CLND group – micrometastases size ≥0.1 mm according to the Rotterdam criteria and non-subcapsular location of micrometastases. Iliac–obturator involvement was also negative factor for OS in multivariate analysis. The presence of iliac–obturator nodal metastases correlated with the following factors: type of LND–CLND versus TLND (15% versus 27.5%) of iliac–obturator involvement, respectively), higher Breslow thickness, extracapsular extension of nodal metastases, male gender. We have not identified any metastases in iliac–obturator nodes in group of patients with micrometastases size ≤1.0 mm and primary tumour Breslow thickness <4.0 mm or no ulcerated primary tumours.

Conclusions

Metastases to iliac–obturator nodes have additional negative prognostic value for melanoma patients with inguinal basin involvement. We are able to identify the subgroup of patients after positive SLN biopsy without metastases to iliac–obturator nodes, probably requiring only inguinal LND.     

Improving staging accuracy in colon and rectal cancer by sentinel lymph node mapping: A comparative study

Aim

To compare the predictive value of sentinel lymph node (SN) mapping between patients with colon and rectal cancer.

Patients and methods

An ex vivo SN procedure was performed in 100 patients with colon and 32 patients with rectal cancer. If the sentinel node was negative, immunohistochemical analyses using two different antibodies against cytokeratins (Cam5.2 and CK 20) and one antibody against BerEp-4 were performed to detect occult tumour cells. Isolated tumour cells (<0.2 mm) were discriminated from micrometastases (0.2–2 mm).

Results

An SN was identified in 117 patients (89%), and accurately predicted nodal status in 106 patients (accuracy 91%). Both sensitivity and negative predictive value were higher in colon carcinomas than in rectal carcinomas (83% versus 57%, p = 0.06 and 93% versus 65%, p = 0.002 respectively). In patients with extensive lymph node metastases the SN procedures were less successful. Eleven of the 13 unsuccessful SN procedures were performed in patients with rectal cancer who had pre-operative radiotherapy. After immunohistochemical analysis 21 of the 73 N0 patients had occult tumour cells in their SN; eight patients had micrometastases and 13 patients had isolated tumour cells.

Conclusion

SN mapping accurately predicts nodal status in patients with colonic cancer. Immunohistochemical analysis demonstrates micrometastatic disease in eight out of 73 N0 patients, with a true upstaging rate of 11%. SN mapping is less reliable in patients with rectal cancer after pre-operative radiotherapy.     

Shoulder-arm morbidity in patients with sentinel node biopsy and complete axillary dissection – data from a prospective randomised trial

Background

Axillary lymph node dissection (ALND) as part of surgical treatment in breast cancer has been the standard procedure for many decades. However, patients frequently develop shoulder-arm morbidity postoperatively. Recently, sentinel node (SN) biopsy has been established as a new standard of care for axillary staging in breast cancer. This study compares postoperative morbidity between ALND and SN biopsy. The results are compared with the existing literature.

Method

Between November 2000 and September 2002, 181 women with early stage breast cancer underwent primary surgery following preoperative randomisation into two groups, a “standard group” (SN biopsy was followed by ALND) and a study group (surgical procedure consisting of only SN biopsy when histologically metastasis-free SN was present).Follow-up data (362 sessions; 6 months to 3 years after primary surgery) were available from 150 patients. A summary morbidity score was calculated from four subjective (arm-strength, arm-mobility, arm swelling, pain) and four objective (arm-strength, arm-mobility, lymphedema, sensitivity) criteria.

Results

Fifty seven patients underwent SN biopsy only. Ninety three patients underwent ALND, 57 of which had lymph nodes free of metastasis and 36 had lymph nodes with metastasis and axillary clearing. Shoulder-arm morbidity was significantly different between the groups. Patients treated with SN biopsy only scored better on subjective and objective criteria.

Summary

Postsurgical shoulder-arm morbidity is a major long-term problem in patients undergoing surgical treatment for breast cancer. This prospective study showed significantly less severe shoulder-arm morbidity following SN biopsy compared to patients undergoing ALND.     

Validation of a technique using microbubbles and contrast enhanced ultrasound (CEUS) to biopsy sentinel lymph nodes (SLN) in pre-operative breast cancer patients with a normal grey-scale axillary ultrasound

Background

In patients with breast cancer, grey-scale ultrasound often fails to identify lymph node (LN) metastases. We aimed to validate the technique of contrast-enhanced ultrasound (CEUS) as a test to identify sentinel lymph node (SLN) metastases and reduce the numbers of patients requiring a completion axillary node clearance (ANC).

Methods

371 patients with breast cancer and a normal axillary ultrasound were recruited. Patients received periareolar intra-dermal injection of microbubble contrast agent. Breast lymphatics were visualised by CEUS and followed to identify and biopsy axillary SLN. Patients then underwent standard tumour excision and either SLN excision (benign biopsy) or axillary clearance (malignant biopsy) with subsequent histopathological analysis.

Results

The technique failed in 46 patients, 6 patients had indeterminate biopsy results and 24 patients were excluded. In 295 patients with a conclusive SLN biopsy, the sensitivity of the technique was 61% and specificity 100%. Given a benign SLN biopsy result, the post-test probability that a patient had SLN metastases was 8%. 35 patients were found to have SLN metastases and had a primary ANC (29 macrometastases and 6 micrometastases/ITC). There were 22 false negative results (10 macrometastases and 12 micrometastases). Macrometastases in core biopsy specimens correlated with LN macrometastases on surgical excision.

Conclusion

Pre-operative biopsy of SLN reduced the numbers of patients requiring completion ANC. Despite the low sensitivity, only 22 patients (8%) with a benign SLN biopsy were subsequently found to have LN metastases. Without the confirmation of macrometastases on core biopsy specimens, patients with micrometastases/ITC may be inadvertently selected for primary ANC.     

Sentinel lymphadenectomy for the staging of clinical axillary node-negative breast cancer before neoadjuvant chemotherapy

Background

Several authors reported sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NC). Nevertheless, the ideal time of SLNB is still a matter of debate.

Methods

We evaluated the feasibility and the accuracy of SLNB before NC using a combined procedure (blue dye and radio-labelled detection) before NC. Axillary lymph node dissection (ALND) was performed after completion of NC in a homogeneous cohort study with clinically axillary node-negative breast cancer.

Results

Among the 20 women who had metastatic SLNB (65%), 4 (20%) had additional metastatic node on ALND. By contrast, all the 11 women who had no metastatic SLNB had no involved nodes in the ALND. The SLN identification rate before NC was 100% with any false negative.

Conclusions

SLNB before NC is a feasible and an accurate diagnostic tool to predict the pre-therapeutic axilla status. These findings suggest that ALND may be avoided in patients with a negative SLNB performed before NC.     

Clinical impact of false-negative sentinel lymph nodes in breast cancer

Aims

To evaluate the incidence of false-negative (FN) sentinel lymph node (SLN) cases, their correlation with a series of clinico-pathologic parameters and their impact on adjuvant treatment indications and on clinical axillary relapse in the setting of a multicentric clinical trial comparing SLN biopsy with axillary lymph node dissection (ALND).

Methods

A series of 697 patients with primary breast cancer ≤ 3 cm were randomized to SLN biopsy associated with ALND (ALND arm) or to SLN biopsy followed by ALND only if the SLN was metastatic (SLN arm). The FN SLN rate was assessed in the ALND arm. A series of 11 clinico-pathological parameters were tested for a possible association with FN results. The indications for adjuvant treatments were evaluated by considering both the FN nodal stages, as indicated by the SLN, and the true positive axillary status, as indicated by completion ALND. The occurrence of clinically evident axillary recurrences was evaluated in the two arms.

Results

The FN rate was 16.7%. Of the clinico-pathologic parameters tested, only a tumour size ≤ 2 cm and the presence of a single metastatic axillary node was significantly associated with a risk of FN (p = 0.033 and p = 0.018, respectively). The FN SLN would have led to different adjuvant therapy indications in 12/18 cases. At 56 months, no clinically evident axillary nodal recurrences were present in the ALND arm patients, whereas one case of axillary recurrence was detected in the SLN arm patients.

Conclusions

FN SLN biopsy is not uncommon, especially in the presence of a small primary tumour with a single nodal metastasis. An FN finding can lead to less than optimal adjuvant treatment. However, the clinical impact of FN in terms of axillary recurrence at 56 months was minimal.     

Breast cancer surgery without suction drainage: The impact of adopting a ‘no drains’ policy on symptomatic seroma formation rates

Aim

To determine the effect of a ‘no drains’ policy on seroma formation and other complications in women undergoing breast cancer surgery.

Materials and methods

Before May 2010 drains were routinely used in our unit following mastectomy ± axillary surgery and axillary lymph node dissection (ALND) ± wide local excision (WLE). Since then, a ‘no drains’ policy has been adopted. Data was collected prospectively between 01/12/06 and 30/11/11 to compare symptomatic seroma, wound infection, re-admission and re-operation rates in women treated with a drain and those without.

Results

596 women were included in the study. 247 women underwent modified radical mastectomy (MRM) and ALND (Group 1), 184 MRM ± sentinel lymph node biopsy (SLNB)/axillary node sampling (ANS) (Group 2) and 165 ALND ± WLE (Group 3).In group 1, 149 had a drain, in group 2, 62, and in group 3, 50.Within each group, the presence or absence of a drain did not significantly affect the rate of symptomatic seroma, number of aspirations performed, wound infection rates or the incidence of complications requiring re-admission. Having a drain was associated with lower volumes of seroma aspirated. In all three groups, the presence of a drain was associated with a longer hospital stay (p < 0.001).

Conclusion

This study suggests that MRM ± ALND/SLNB/ANS and ALND ± WLE can be performed without the use of suction drains without increasing seroma formation and other complication rates. Adopting a ‘no-drains’ policy may also contribute to earlier hospital discharge.