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1.  Reliability of Sentinel Lymph Node Biopsy after Neoadjuvant Chemotherapy in Breast Cancer Patients 
Journal of Breast Cancer  2013;16(4):378-385.
Sentinel lymph node biopsy (SLNB) is an accurate and effective means of axillary nodal staging in early breast cancer. However its indication after neoadjuvant chemotherapy (NAC) is under constant debate. The present study evaluates the reliability of SLNB in assessing axillary nodal status after NAC.
Data from 281 patients who had received NAC and subsequent SLNB were reviewed. The identification and false negative rates of SLNB were determined and the clinicopathologic factors associated with false negative results were investigated using univariate analysis.
The identification rate of SLNB after NAC was 93.6% and the false negative rate was 10.4%. Hormone receptor status, especially progesterone receptor positivity, was significantly associated with false negative results. The accuracy of intraoperative frozen section examination of sentinel lymph nodes was 91.2%.
The identification rate of SLNB and the accuracy of intraoperative frozen section examination after NAC are comparable to the results without NAC in patients with early breast cancer. However considering the high false negative rates, general application of SLNB after NAC should be avoided. Patients with progesterone-positive tumors and non-triple-negative breast cancers may be a select group of patients in whom SLNB can be employed safely after NAC, but further studies are necessary.
PMCID: PMC3893339  PMID: 24454459
Breast neoplasms; Neoadjuvant therapy; Sentinel lymph node biopsy
2.  Ductal Carcinoma In Situ and Sentinel Lymph Node Biopsy 
Journal of Breast Cancer  2011;14(4):301-307.
Axillary lymph node status is the strongest prognostic indicator of survival for women with breast cancer. The purpose of this study was to evaluate whether sentinel lymph node biopsy (SLNB) is required in patients with an initial diagnosis of ductal carcinoma in situ (DCIS).
A retrospective analysis was performed of 78 patients with an initial diagnosis of DCIS between December 2002 and April 2010 and who proceeded to have either SLNB or axillary node dissection performed as part of their primary surgical procedure. The study focused on the rates of axillary node metastasis and the underestimation of invasive carcinoma at an initial diagnosis.
Forty-eight patients underwent SLNB and 18 patients underwent axillary node dissection. Only 1 of 66 patients (1.5%) had a positive sentinel lymph node. After definite surgery, the final diagnosis was changed to invasive ductal carcinoma (IDC) in 12 patients and DCIS with microinvasion in 2 patients; 14 of 78 patients (17.9%) were therefore underestimated at preoperative histological examinations. In 35 patients who were diagnosed DCIS by core needle biopsy (CNB), 13 patients (37.1%) were upstaged into IDC or DCIS with microinvasion in the final diagnosis. The statistically significant factors predictive of invasive breast cancer were a large tumor size and HER2 overexpression.
The rates of SLNB positivity in pure DCIS are very low, and there is continuing uncertainty about its clinical importance. However in view of the high rate of underestimation of invasive carcinoma in patients with an initial diagnosis of DCIS, SLNB appears to be appropriate in these patients, especially in the case when DCIS is diagnosed by a core needle biopsy. In patients with an initial diagnosis of DCIS by CNB, SLNB should be considered as part of the primary surgical procedure, when preoperative variables show a tumor larger than 2.35 cm and with HER2 overexpression.
PMCID: PMC3268927  PMID: 22323917
Breast; Ductal carcinoma in situ; Sentinel lymph node
3.  What is the future of axillary surgery for breast cancer? 
ecancermedicalscience  2013;7:319.
The Z11 trial demonstrated a subgroup of patients with low axillary burden who do not benefit from axillary lymph node dissection (ALND) at short-term follow-up when treated with adjuvant whole-breast radiotherapy and systemic therapy. We consider the role of sentinel lymph node biopsy (SLNB) and look at and beyond the Z11 trial to consider further imaging studies, which may offer truly minimally invasive management of the axilla and relegate SLNB to the realms of history.
Regional lymph node status provides information regarding staging, local control, and prognostic outcomes in all cancers. This information was provided in breast cancer by axillary lymph node dissection (ALND). This changed with the development of sentinel lymph node biopsy (SLNB) [1, 2]. Sentinel lymph nodes (SLNs) are defined as the first lymph nodes receiving lymphatic drainage from the primary tumour and therefore the most likely to harbour metastatic cancer via lymphatic spread. SLNB is now the standard of care in patients with a clinically and radiologically clear axilla in early-stage breast cancer.
PMCID: PMC3660161  PMID: 23717340
sentinel lymph node biopsy; axillary lymph node dissection; magnetic resonance imaging; ultrasmall paramagnetic iron oxide
4.  Axillary Recurrence After a Tumor-Positive Sentinel Lymph Node Biopsy Without Axillary Treatment: A Review of the Literature 
Annals of Surgical Oncology  2012;19(13):4140-4149.
Sentinel lymph node biopsy (SLNB) has become standard of care as a staging procedure in patients with invasive breast cancer. A positive SLNB allows completion axillary lymph node dissection (cALND) to be performed. The axillary recurrence rate (ARR) after cALND in patients with positive SLNB is low. Recently, several studies have reported a similar low ARR when cALND is not performed. This review aims to determine the ARR when cALND is omitted in SLNB-positive patients.
A literature search was performed in the PubMed database with the search terms “breast cancer,” “sentinel lymph node biopsy,” “axillary” and “recurrence.” Articles with data regarding follow-up of patients with SLNB-positive breast cancer were identified. To be eligible, patients should not have received cALND and ARR should be reported.
Thirty articles were analyzed. This resulted in 7,151 patients with SLNB-positive breast cancer in whom a cALND was omitted (median follow-up of 45 months, range 1–142 months). Overall, 41 patients developed an axillary recurrence. 27 studies described 3,468 patients with micrometastases in the SLNB, of whom 10 (0.3 %) developed an axillary recurrence. ARR varied between 0 and 3.7 %. Sixteen studies described 3,268 patients with macrometastases, 24 (0.7 %) axillary recurrences were seen. ARR varied between 0 and 7.1 %. Details regarding type of surgery and adjuvant treatment were lacking in the majority of studies.
ARR appears to be low in SLNB-positive patients even when a cALND is not performed. Withholding cALND may be safe in breast cancer selected patients such as those with isolated tumor cells or micrometastatic disease.
PMCID: PMC3505491  PMID: 22890590
American journal of surgery  2008;196(4):562-565.
Accuracy of sentinel lymph node biopsy (SLNB) and rate of axillary recurrence in multicentric (MC)/multifocal (MF) breast cancer are reported.
From 1999–2006, 93 patients with MC/MF breast cancer underwent SLNB; 41 had axillary lymph node dissection (ALND) regardless of SLN pathology (group 1) and 52 had ALND only if a SLN was positive (group 2). Patient demographics, SLN techniques, and pathology were recorded.
There were no differences between the two groups with respect to patient age, tumor size, grade, stage, histology, or method of SLN detection. The incidence of axillary metastasis was greater in group 1 patients (68%) compared to group 2 patients (12%) (p<0.01). In group 1, the sensitivity and specificity of SLNB were 93% and 100%, with a false negative rate of 7%. None of the 52 patients in group 2 experienced an axillary recurrence (median follow-up 4.8 years).
The accuracy of SLNB in MC/MF breast cancer is comparable to that observed in unifocal breast cancer. Despite a lower rate of SLN positivity in those undergoing SLNB only, axillary recurrence is not observed.
PMCID: PMC4077037  PMID: 18760396
Breast Cancer; Multicentric (MC); Multifocal (MF); Sentinel Lymph Node Biopsy (SLNB)
6.  Survival analysis following sentinel lymph node biopsy: a validation trial demonstrating its accuracy in staging early breast cancer 
Few long-term follow-up studies prove sentinel lymph node biopsy (SLNB) effectively stages breast cancer without the further evaluation of a completion axillary dissection. Our prospective study addressed this issue, enrolling 345 women with clinically node-negative breast cancer who underwent SLNB from October 1997 through December 2000. The median age of the patients in the study was 56.7 years. Average primary tumor size was 1.42 cm. Ninety-three patients had a positive sentinel lymph node (27%); 70 (75.3%) of these patients underwent completion axillary dissection, while 23 patients (24.7%) declined further surgery. Most (91.3%) of the patients who declined further surgery had evidence of micrometastatic disease only. The median follow-up period for all patients was 60 months. No tumor recurrences in the axilla were reported in either sentinel node-negative or -positive patients. The local and systemic recurrence rates were 3.1% and 4% in node-negative patients and 2.2% and 4.3% in node-positive patients. Two patients (0.9%) in the node-negative group and 6 (6.5%) in the node-positive group died of their disease. Estimated 5-year disease-free survival rates were 96% for node-negative patients and 87% for node-positive patients (P = 0.02). The clinical false-negative rate of the SLNB in this study was 0%. This long-term validation trial proves the accuracy of the SLNB and its extremely low false-negative rate. The findings indicate that patients with a positive SLNB have significantly different survival rates than patients with a negative SLNB.
PMCID: PMC1200707  PMID: 16200155
7.  Sentinel Lymph Node Biopsy in Early Breast Cancer: The Experience of the European Institute of Oncology in Special Clinical Scenarios 
Breast Care  2011;6(3):208-214.
While axillary nodal status is still one of the most important prognostic factors in breast cancer, sentinel lymph node biopsy (SLNB) has evolved as a main procedure to strongly reduce postsurgical morbidity improving early and long-term quality of life.
Material and Methods
Between 1996 and 2010, we performed 18,884 SLNBs for breast cancer, successfully confirming the validity of this technique and its positive impact on patients' quality of life, even though decision-making processes for adjuvant treatment strongly depend on biological features.
This paper summarizes published data mainly collected in our institute considering special clinical scenarios such as ductal intraepithelial neoplasia, intramammary sentinel nodes, multicentric breast cancer, prior breast surgery, previous breast aesthetic surgery, second axillary SLNB, pregnant patients, primary chemotherapy, and male patients.
In general, we believe that SLNB represents the standard procedure for axillary staging in virtually all clinical situations, even in those which were previously considered a contraindication for this procedure. At the moment, the only contraindication to SLNB is the presence of documented axillary metastases.
PMCID: PMC3132968  PMID: 21779226
Sentinel node; Breast cancer; Axillary dissection; Axillary staging
8.  Feasibility of sentinel lymph node biopsy in breast cancer patients clinically suspected of axillary lymph node metastasis on preoperative imaging 
Generally, sentinel lymph node biopsy (SLNB) is performed in patients with clinically negative axillary lymph node (LN). This study was to assess imaging techniques in axillary LN staging and to evaluate the feasibility of SLNB in patients clinically suspected of axillary LN metastasis on preoperative imaging techniques (SI).
A prospectively maintained database of 767 breast cancer patients enrolled between January 2006 and December 2009 was reviewed. All patients were offered preoperative breast ultrasound, magnetic resonance imaging, and positron emission tomography scanning. SI patients were regarded as those for whom preoperative imaging was “suspicious for axillary LN metastasis” and NSI as “non-suspicious for axillary LN metastasis” on preoperative imaging techniques. Patients were subgrouped by presence of SI and types of axillary operation, and analyzed.
For 323 patients who received SLNB, there was no statistically significant difference in axillary recurrence (P=0.119) between SI and NSI groups. There also was no significant difference in axillary recurrence between SLNB and axillary lymph node dissection (ALND) groups in 356 SI patients (P=0.420). The presence of axillary LN metastasis on preoperative imaging carried 82.1% sensitivity and 45.9% specificity for determining axillary LN metastasis on the final pathology.
SLNB in SI patents is safe and feasible. Complications might be avoided by not performing ALND. Therefore, we recommend SLNB, instead of a direct ALND, even in SI patients, for interpreting the exact nodal status and avoiding unnecessary morbidity by performing ALND.
PMCID: PMC3663684  PMID: 23693028
Breast; Lymph node; Metastasis; Sentinel lymph node biopsy
9.  Is the sentinel lymph node biopsy more sensitive for the identification of positive lymph nodes in breast cancer than the axillary lymph node dissection? 
SpringerPlus  2013;2:275.
Since the routine clinical use of the sentinel lymph node (SLN) procedure, questions have been raised concerning an increase in the overall percentage of node-positive patients. The goal of our study was to compare the sensitivity of the SLN procedure and the axillary lymph node dissection (ALND) for the identification of positive lymph nodes in breast cancer.
The incidence of axillary node metastasis in SLNB and ALND specimens from patients undergoing operative treatment of a primary breast carcinoma was compared retrospectively.
Logistic regression models were used to analyze the effect of various predictors on the presence of positive lymph nodes. We constructed a multivariate model including the procedure and these predictors that have shown to be related to lymph node involvement in univariate analysis. The probability of finding positive lymph nodes was thus calculated in both groups correcting for relevant predictors of lymph node involvement.
The SLNB group included 830 patients, the ALND group 320. In a multivariate analysis, adjusting for the number of foci, tumor location in the breast, tumor size, LVI, ER, PR, tumor grade and histological subtype, the probability of finding positive lymph nodes was higher with SLNB procedure than with an ALND. However, this difference was not statistically significant (OR 0.7635; CI 0.5334-1.0930, p 0.1404).
For comparable tumors, SLNB procedure is at least as sensitive as ALND for detecting positive lymph nodes.
PMCID: PMC3699711  PMID: 23961380
Sentinel lymph node biopsy; Axillary lymph node dissection; Breast cancer; Lymph nodes
10.  Sentinel lymphnode biopsy in early breast cancer using methylene blue dye and radioactive sulphur colloid — a single institution Indian experience 
The Indian Journal of Surgery  2008;70(3):111-119.
Axillary lymph node dissection is an established procedure in breast cancer staging. However, it is associated with unpleasant side effects. A promising alternative to assess axillary lymph node status in early breast cancer patients is Sentinel Lymph Node Biopsy (SLNB). Isosulfan blue has traditionally been the dye used to identify the Sentinel Lymph Node (SLN). This article is a validation study of SLNB using methylene blue dye and radioactive sulphur colloid in early breast cancer Indian patients.
Materials & Methods
With written informed consent, 100 patients with cytology or biospy proven carcinoma breast, clinical stage T1/ T2 N0 M0, underwent SLNB using combination of methylene blue dye & radioactive technetium 99m sulphur colloid as a part of validation study from June 2003 to February 2006. After validation study, from March 2006 to February 2007, 35 patients have undergone SLNB followed by complete axillary clearance in only those patients with SLNB being positive for metastases.
In all 100 patients of the validation study SLN was identified. Total number of cases with positive axillary nodes was 27, out of which SLN was only positive node for metastases in 69% of cases. The overall sensitivity, specificity, positive predictive valve and negative predictive valve of SLNB 96.2%, 100%, 100% and 98.6% respectively with false negative rate of 3.7%. In subsequent 35 patients who underwent SLNB followed by complete axillary clearance, SLNs was identified in all the cases.
SLNB is effective in early breast cancer patients of Indian population. SLNB using combination of methylene blue dye and radio-active Tc99m sulphur colloid can stage the axilla with high accuracy & low risk of false negativity in early breast cancer patients.
PMCID: PMC3452444  PMID: 23133037
Sentinel lymph node biopsy; Methylene blue dye; Tc99m radioactive sulfur colloid; Early breast cancer; Indian patients
11.  Value of Sentinel Lymph Node Biopsy in Breast Cancer Patients with Previous Excisional Biopsy 
Journal of Breast Cancer  2012;15(1):87-90.
Sentinel lymph node biopsy (SLNB) in breast cancer patients with clinically negative axilla will ensure axillary dissection only for cases with lymph node metastasis and provide information about pathologic staging as accurate as the axillary dissection. It was shown that SLNB could be successfully performed regardless of the type of biopsy. The aim of this study was to investigate the feasibility of SLNB after excisional biopsy.
One hundred patients diagnosed with excisional biopsy or guide wire-localization and operated on with SLNB between February 2007 and March 2009 were retrospectively analyzed. SLNB was performed with 10 cc of 1% methylene blue alone or both methylene blue and 1 mCi of Tc-99m nanocolloid combination. Age, tumor localization and size, length of the biopsy incision, size of the biopsy specimen, multifocality, lymphovascular invasion, tumor grade, staining with methylene blue, localization, number and metastatic status of the lymph nodes stained, and success rate with a gamma probe were evaluated.
Sentinel lymph node (SLN) could not be identified in 9 (16.9%) of patients in the methylene blue group (n=53). In the combination group (n=47), SLN could not be identified in one patient. Of 32 patients with negative SLNB, metastatic involvement was found to be present in 5 patients after axillary lymph node dissection (false negatives). The average numbers of SLNs found in the methylene blue group and combination group were 1.4 and 1.6, respectively. SLN detection and false negative rates in the methylene blue group were 83% and 15.7%, respectively. The rates for the combination group were 98% and 6.4%, respectively. None of the parameters related to patient, tumor or process were found to affect detection rates of SLN.
Only SLNB using a combination method is a safe and reliable technique for breast cancer patients diagnosed with excisional biopsy.
PMCID: PMC3318180  PMID: 22493633
Biopsy; Breast neoplasms; Methylene blue; Sentinel lymph node biopsy
12.  Sentinel Lymph Node Biopsy for Patients with Breast Cancer: Five-Year Experience 
The Permanente Journal  2005;9(1):77-83.
Background: Sentinel lymph node biopsy (SLNB) is rapidly gaining acceptance as a diagnostic tool for staging breast cancer.
Objective: Analyze trends among surgeons and facilities in Kaiser Permanente Northern California (KPNC) in adopting SLNB to stage cases of breast cancer and assess success in locating the sentinel node.
Methods: Retrospective review of data for patients whose breast cancer was staged using SLNB and axillary lymph node dissection between July 1997 through December 2002 at KPNC. Rates of false-negative results were calculated and stratified by surgeons' experience with SLNB.
Results: The number of SLNB procedures performed each month increased steadily from fewer than ten (in late 1998) to about 80 per month (in mid-2002) and were done at 17 facilities. Of the 132 surgeons who performed SLNB, most had done fewer than 15 procedures. The false-negative result rate overall was 6.53% (95% CI 4.75%, 8.73%); for surgeons who performed <30 procedures the rate was 8.58% (95% CI 5.52%, 12.60%); for surgeons who performed 20 to 30 procedures the rate was 13.08% (95% CI 7.34%, 20.98%); and for surgeons who performed more than 30 procedures the rate was 5.05% (95% CI 3.07%, 7.78%).
Conclusions: SLNB is rapidly being adopted at KPNC to stage cases of breast cancer and surgeons achieve an acceptable 6.53% false-negative result rate overall. The higher false-negative rate for surgeons who performed 20 to 30 procedures suggests that departments should expand efforts to monitor and proctor these surgeons.
PMCID: PMC3108420  PMID: 21687490
13.  A Longitudinal Comparison of Arm Morbidity in Stage I–II Breast Cancer Patients Treated with Sentinel Lymph Node Biopsy, Sentinel Lymph Node Biopsy Followed by Completion Lymph Node Dissection, or Axillary Lymph Node Dissection 
Annals of Surgical Oncology  2010;17(9):2384-2394.
Long-term shoulder and arm function following sentinel lymph node biopsy (SLNB) may surpass that following complete axillary lymph node dissection (CLND) or axillary lymph node dissection (ALND). We objectively examined the morbidity and compared outcomes after SLNB, SLNB + CLND, and ALND in stage I/II breast cancer patients.
Materials and Methods
Breast cancer patients who had SLNB (n = 51), SLNB + CLND (n = 55), and ALND (n = 65) were physically examined 1 day before surgery (T0), and after 6 (T1), 26 (T2), 52 (T3), and 104 (T4) weeks. Differences in 8 parameters between the affected and unaffected arms were calculated. General linear models were computed to examine time, group, and interaction effects.
All outcomes changed significantly, mostly nonlinearly, over time (T0–T4). Between T1 and T4, limitations decreased in abduction (all groups); anteflexion, abduction-exorotation, abduction strength (SLNB + CLND, ALND); flexion strength (SLNB + CLND); and arm volume (SLNB, SLNB + CLND). At T4, limitations in anteflexion (SLNB, ALND), abduction (SLNB + CLND, ALND), exorotation (ALND), abduction-exorotation (all groups), and volume (SLNB + CLND, ALND) increased significantly compared with T0. The SLNB group showed an advantage in anteflexion, abduction, abduction-exorotation, and volume. Groups changed significantly but differently over time in anteflexion, abduction, abduction/exorotation, abduction strength, flexion strength, and volume. Effect sizes varied from 0.19 to 0.00.
Initial declines in range of motion and strength were followed by recovery, although not always to presurgery levels. Range of motion and volume outcomes were better for SLNB than ALND, but not strength. SLNB surpassed SLNB + CLND in 2 of the range of motion variables. The clinical relevance of these results is negligible.
PMCID: PMC2924495  PMID: 20221902
14.  Which Patients Need an Axillary Clearance after Sentinel Node Biopsy? 
Sentinel lymph node biopsy (SLNB) is a safe and accurate minimally invasive method for detecting axillary lymph node (ALN) involvement in the clinically negative axilla thereby reducing morbidity in patients who avoid unnecessary axillary lymph node dissection (ALND). Although current guidelines recommend completion ALND when macro- and micrometastatic diseases are identified by SLNB, the benefit of this surgical intervention is under debate. Additionally, the management of the axilla in the presence of isolated tumour cells (ITCs) in SLNB is questioned. Particularly controversial is the prognostic significance of minimal SLNB metastasis in relation to local recurrence and overall survival. Preliminary results of the recently published Z0011 trial suggest similar outcomes after SNB or ALND when the SN is positive, but this finding has to be interpreted with caution.
PMCID: PMC3262558  PMID: 22295211
15.  Factors that determine whether a patient receives completion axillary lymph node dissection after a positive sentinel lymph node biopsy for breast cancer in British Columbia 
Canadian Journal of Surgery  2011;54(4):237-242.
Completion axillary lymph node dissection (CALND) is recommended in the setting of positive sentinel lymph node biopsy (SLNB) but is associated with a higher rate of postoperative complications. In this study, the characteristics and outcomes of patients who did and did not have CALND are compared.
We identified all patients with breast cancer with positive sentinel lymph nodes (SLNs) who did not have concurrent CALND from 2003 to 2006 using a prospectively collected database (British Columbia Cancer Breast Outcomes database) and retrospective chart review. Patient and tumour characteristics were compared between those who received CALND and those who did not.
Among 185 patients with positive SLNs identified by SLNB, 90 had a CALND and 95 had no further surgical therapy. Patients who did not receive CALND had more sentinel nodes removed (p < 0.001), a lower percentage of positive SLNs (p < 0.001) and lower pathologic N stage (p = 0.044) than those who did receive CALND. The size of the breast lesion, size of the largest SLN deposit, estrogen receptor status, grade, lymphovascular invasion, histology and multifocality were not significantly different between groups. Sixty-two percent of women who did not have CALND received radiation to the axilla. Postoperative complication rates (including lymphedema) were higher in the CALND group (21%) compared with the SLNB group (7%). The rates of locoregional recurrence (1% in both groups) and systemic metastases (6% in the CALND group v. 8% in the SLNB group) were similar at 36 months’ follow-up.
Compared with women who had CALND, women who did not receive CALND had on average a lower N stage with 3 or more SLNs removed and less than 50% node positivity. Most of these women received radiation therapy to the axilla and had comparable recurrence rates to those who had CALND.
PMCID: PMC3191897  PMID: 21651836
16.  Sentinel lymph node biopsy for breast cancer using methylene blue dye manifests a short learning curve among experienced surgeons: a prospective tabular cumulative sum (CUSUM) analysis 
BMC Surgery  2009;9:2.
The benefits of sentinel lymph node biopsy (SLNB) for breast cancer patients with histologically negative axillary nodes, in whom axillary lymph node dissection (ALND) is thereby avoided, are now established. Low false negative rate, certainly with blue dye technique, mostly reflects the established high inherent accuracy of SLNB and low axillary nodal metastatic load (subject to patient selection). SLN identification rate is influenced by volume, injection site and choice of mapping agent, axillary nodal metastatic load, SLN location and skill at axillary dissection. Being more subject to technical failure, SLN identification seems to be a more reasonable variable for learning curve assessment than false negative rate.
Methylene blue is as good an SLN mapping agent as Isosulfan blue and is much cheaper. Addition of radio-colloid mapping to blue dye does not achieve a sufficiently higher identification rate to justify the cost. Methylene blue is therefore the agent of choice for SLN mapping in developing countries.
The American Society of Breast Surgeons recommends that, for competence, surgeons should perform 20 SLNB but admits that the learning curve with a standardized technique may be "much shorter". One appropriate remedy for this dilemma is to plot individual learning curves.
Using methylene blue dye, experienced breast surgeons performed SLNB in selected patients with breast cancer (primary tumor < 5 cm and clinically negative ipsilateral axilla). Intraoperative assessment and completion ALND were performed for standardization on the first 13 of 24 cases. SLN identification was plotted for each surgeon on a tabular cumulative sum (CUSUM) chart with sequential probability ratio test (SPRT) limits based on a target identification rate of 85%.
The CUSUM plot crossed the SPRT limit line after 8 consecutive, positively identified SLN, signaling achievement of an acceptable level of competence.
Tabular CUSUM charting, based on a justified choice of parameters, indicates that the learning curve for SLNB using methylene blue dye is completed after 8 consecutive, positively identified SLN. CUSUM charting may be used to plot individual learning curves for trainee surgeons by applying a proxy parameter for failure in the presence of a mentor (such as failed SLN identification within 15 minutes).
PMCID: PMC2640353  PMID: 19173714
17.  Eight-year experience with the intraoperative frozen section examination of sentinel lymph node biopsy for breast cancer in a North-Italian university center 
Sentinel lymph node biopsy (SLNB) completely changed the impact of breast surgery on patients psycho-physical wellness, reducing morbidity associated with complete axillary lymph node dissection (CALND) while granting an adequate breast cancer staging. We reviewed our experience with the SLNB in a University Clinic. We collected data about all breast cancer patients submitted to SLNB from 2002 to 2010, and analyzed them with R (version 2.15.2), considering significant p<0.05. We performed 615 SLNBs on 607 patients, with a mean age of 59.86 (±10.76). Sentinel node detection rate resulted 99,7%, with a mean number of biopsied nodes of 1.64 (±0.67), axillary localization in 98% of cases, and negative intraoperative histological finding in the 86.2% of cases. Prevalence of ITCs, micrometastasis, macrometastasis and pericapsular metastasis resulted respectively 0.6%, 4.9%, 7.5% and 8.8%. Among women who received CALND, mean number of examined nodes was 16.36 (±6.19) and mean number of metastatic non-sentinel nodes was 0.97 in case of micrometastasis, 2.65 in case of macrometastasis, and up to 9.88 when pericapsular invasion was described. To conclude, our data confirm the role of nodal metastasis size in the prediction of non-sentinel node involvement, but further studies are required in order to better assess the role of ITCs and micrometastasis in the diagnostic and therapeutic management of breast cancer, with the final aim to reduce the surgical complications of axilla demolition when unnecessary.
PMCID: PMC3885492  PMID: 24427358
Breast cancer; breast invasive cancer; sentinel lymph node biopsy; sentinel lymph node; micrometastasis
18.  Feasibility of Sentinel Lymph Node Biopsy in Breast Cancer Patients with Initial Axillary Lymph Node Metastasis after Primary Systemic Therapy 
Journal of Breast Cancer  2011;14(2):147-152.
Primary systemic therapy (PST) downstages up to 40% of initial documented axillary lymph node (ALN) metastases in breast cancer. The current surgical treatment after PST consists of breast tumor resection and axillary lymph node dissection (ALND). This strategy, however, does not eliminate unnecessary ALND in patients with complete remission of axillary metastases. The aim of this study was to examine the accuracy of sentinel lymph node biopsy (SLNB) after PST among patients with documented ALN metastasis at presentation and to identify the rate of pathologic complete-remission (CR) with ALN after PST.
We analyzed 66 patients with ALN metastasis that was pathologically proven preoperatively who underwent SLNB and concomitant ALND after PST. Axillary ultrasound (AUS) was used to evaluate the clinical response of initially documented ALN metastasis after PST. Intraoperative lymphatic mapping was performed using blue dye with or without radioisotope.
After PST, 34.8% of patients had clinical CR of ALN on AUS and 28.8% patients had pathologic CR of ALN. The overall success rate of SLNB after PST was 87.9%, and the sentinel lymph node identification rate in patients with clinical CR was 95.7%. In patients with successful lymphatic mapping, 70.7% of patients had residual axillary metastases. The overall accuracy and false-negative rate were 87.9% and 17.1% in all patients: 95.5% and 10.0% in patients with clinical CR of ALN, and 83.3% and 19.4% in patients with residual axillary disease after PST.
Our findings suggest that SLNB may be feasible in patients with initial documented ALN metastasis who have clinical CR for metastatic ALN after PST. Further investigation in a prospective setting should be performed to confirm our results.
PMCID: PMC3148541  PMID: 21847411
Breast neoplasms; Primary systemic therapy; Sentinel lymph node biopsy
19.  Prevalence of Lymphedema in Women With Breast Cancer 5 Years After Sentinel Lymph Node Biopsy or Axillary Dissection: Objective Measurements 
Journal of Clinical Oncology  2008;26(32):5213-5219.
Sentinel lymph node biopsy was adopted for the staging of the axilla with the assumption that it would reduce the risk of lymphedema in women with breast cancer. The aim of this study was to determine the long-term prevalence of lymphedema after SLN biopsy (SLNB) alone and after SLNB followed by axillary lymph node dissection (SLNB/ALND).
Patients and Methods
At median follow-up of 5 years, lymphedema was assessed in 936 women with clinically node-negative breast cancer who underwent SLNB alone or SLNB/ALND. Standardized ipsilateral and contralateral measurements at baseline and follow-up were used to determine change in ipsilateral upper extremity circumference and to control for baseline asymmetry and weight change. Associations between lymphedema and potential risk factors were examined.
Of the 936 women, 600 women (64%) underwent SLNB alone and 336 women (36%) underwent SLNB/ALND. Patients having SLNB alone were older than those having SLNB/ALND (56 v 52 years; P < .0001). Baseline body mass index (BMI) was similar in both groups. Arm circumference measurements documented lymphedema in 5% of SLNB alone patients, compared with 16% of SLNB/ALND patients (P < .0001). Risk factors associated with measured lymphedema were greater body weight (P < .0001), higher BMI (P < .0001), and infection (P < .0001) or injury (P = .02) in the ipsilateral arm since surgery.
When compared with SLNB/ALND, SLNB alone results in a significantly lower rate of lymphedema 5 years postoperatively. However, even after SLNB alone, there remains a clinically relevant risk of lymphedema. Higher body weight, infection, and injury are significant risk factors for developing lymphedema.
PMCID: PMC2652091  PMID: 18838709
20.  Prevalence of Lymphedema in Women With Breast Cancer 5 Years After Sentinel Lymph Node Biopsy or Axillary Dissection: Patient Perceptions and Precautionary Behaviors 
Journal of Clinical Oncology  2008;26(32):5220-5226.
Sentinel lymph node (SLN) biopsy was adopted for the staging of the axilla with the assumption that it would reduce the risk of lymphedema in women with breast cancer. This study was undertaken to examine patient perceptions of lymphedema and use of precautionary behaviors several years after axillary surgery.
Patients and Methods
Nine hundred thirty-six women who underwent SLN biopsy (SLNB) alone or SLNB followed by axillary lymph node dissection (SLNB/ALND) between June 1, 1999, and May 30, 2003, were evaluated at a median of 5 years after surgery. Patient-perceived lymphedema and avoidant behaviors were assessed through interview and administered a validated instrument, and compared with arm measurements.
Current arm swelling was reported in 3% of patients who received SLNB alone versus 27% of patients who received SLNB/ALND (P < .0001), as compared with 5% and 16%, respectively, with measured lymphedema. Only 41% of patients reporting arm swelling had measured lymphedema, and 5% of patients reporting no arm swelling had measured lymphedema. Risk factors associated with reported arm swelling were greater body weight (P < .0001), higher body mass index (P < .0001), infection (P < .0001), and injury (P = .007) in the ipsilateral arm since surgery. Patients followed more precautions if they had measured or perceived lymphedema.
Body weight, infection, and injury are significant risk factors for perceiving lymphedema. There is significant discordance between the presence of measured and patient-perceived lymphedema. When compared to SLNB/ALND, SLNB-alone results in a significantly lower rate of patient-perceived arm swelling 5 years postoperatively, and is perceived by fewer women than are measured to have it.
PMCID: PMC2652092  PMID: 18838708
21.  Sentinel lymph node biopsy: technique validation at the Setúbal Medical Centre, Portugal 
ecancermedicalscience  2009;3:124.
To evaluate the accuracy of sentinel lymph node biopsy in breast cancer patients at this institution, using combined technetium-99m (99mTc) sulphur colloid and patent blue vital dye.
From March 2007 to July 2008, 50 patients with a tumour of less than 3 cm and with clinically negative axillary lymph nodes underwent sentinel lymph node biopsy (SLNB), followed by axillary lymph node dissection (ALND). Sub-areolar 99mTc sulphur colloid injection was performed the day before surgery, and patent blue vital dye was also injected sub-areolarly at least 5 minutes before surgery. Sentinel lymph node was identified during the surgical procedure, using a gamma probe and direct vision. All sentinel nodes underwent frozen section analysis. Later haematoxylin and eosin staining and immunohistochemical analysis were performed. Finally, SLNB was compared with standard ALND for its ability to accurately reflect the final pathological status of the axillary nodes.
The sentinel lymph node (SLN) was identified in 48 of 50 patients (96%). The number of sentinel lymph nodes ranged from one to four (mean 1.48) and non-sentinel nodes ranged from seven to 27 (mean 14.33). Of the 48 patients with successfully identified SLNs, 29.17% (14/48) were histologically positive. Sensivity of the SLN to predict axilla was 93.75%; accuracy was 97.96%. The SLN was falsely negative in one patient—6.25% (1/16).
The SLNB represents a major advance in the surgical treatment of breast cancer as a minimally invasive procedure predicting the axillary lymph node status. This validation study demonstrates the accuracy of the SLNB and its reasonable false negative rate when performed in our institute. It can now be used as the standard method of staging in patients with early breast cancer at this institution.
PMCID: PMC3224010  PMID: 22275996
22.  How Many Sentinel Lymph Nodes Are Enough for Accurate Axillary Staging in T1-2 Breast Cancer? 
Journal of Breast Cancer  2011;14(4):296-300.
During a sentinel lymph node biopsy (SLNB) for breast cancer, the appropriate number of sentinel lymph nodes (SLNs) to be removed for accurate axillary staging is still controversial. We hypothesized that there might be an optimal threshold number of SLNs. We investigated how many SLNs should be removed to achieve an acceptable accuracy and ensure minimal morbidity.
We reviewed data of 328 patients with invasive breast cancer who underwent SLNB followed by complete level I and II axillary dissection between January 2004 and December 2005. The false negative rate (FNR) and accuracy of SLNB according to the number of removed SLNs were evaluated.
The mean number of SLNs removed was 3.0 (range, 1-14), and that of total retrieved axillary lymph nodes was 17.5 (range, 10-40). In total, 111 (33.8%) patients had positive nodes on the permanent pathological report. Among them, 12 patients had negative SLNs; thus, the overall FNR of SLNB was 10.8% (12/111) and the accuracy was 96.3% (316/328). The FNR was 26.6% for a single SLN, 8.0% for two, and 11.1% for three. In cases where four or more SLNs were removed, the FNR decreased to 0% and accuracy reached 100%.
Our data suggest that a SLNB should not only remove one or two of the hottest node(s) when other hot nodes exist. We also suggest that four might be an optimal threshold number of SLNs to be removed and that removal of more than four SLNs does not improve axillary staging accuracy.
PMCID: PMC3268926  PMID: 22323916
Breast neoplasms; False negative rate; Sentinel lymph node biopsy
23.  Effectiveness and cost-effectiveness of sentinel lymph node biopsy compared with axillary node dissection in patients with early-stage breast cancer: a decision model analysis 
British Journal of Cancer  2012;106(6):1045-1052.
Sentinel lymph node biopsy (SLNB) is less invasive than axillary lymph node dissection (ALND) for staging early breast cancer, and has a lower risk of arm lymphoedema and similar rates of locoregional recurrence up to 8 years. This study estimates the longer-term effectiveness and cost-effectiveness of SLNB.
A Markov decision model was developed to estimate the incremental quality-adjusted life years (QALYs) and costs of an SLNB-based staging and management strategy compared with ALND over 20 years' follow-up. The probability and quality-of-life weighting (utility) of outcomes were estimated from published data and population statistics. Costs were estimated from the perspective of the Australian health care system. The model was used to identify key factors affecting treatment decisions.
The SLNB was more effective and less costly than the ALND over 20 years, with 8 QALYs gained and $883 000 saved per 1000 patients. The SLNB was less effective when: SLNB false negative (FN) rate >13% 5-year incidence of axillary recurrence after an SLNB FN>19% risk of an SLNB-positive result >48% lymphoedema prevalence after ALND <14% or lymphoedema utility decrement <0.012.
The long-term advantage of SLNB over ALND was modest and sensitive to variations in key assumptions, indicating a need for reliable information on lymphoedema incidence and disutility following SLNB. In addition to awaiting longer-term trial data, risk models to better identify patients at high risk of axillary metastasis will be valuable to inform decision-making.
PMCID: PMC3304429  PMID: 22415293
cost; effectiveness; breast cancer; decision; model; sentinel node biopsy
24.  Implication of an Intramammary Sentinel Lymph Node in Breast Cancer: Is This a True Sentinel Node? A Case Report 
Breast Care  2010;5(2):102-104.
Intramammary lymph nodes (ILN) are often diagnosed by final histological examination. Recently, sentinel lymph node biopsy (SLNB) has been developed as a new standard in the treatment of breast cancer. However, reports describing intramammary sentinel nodes (ISLNs) are relatively rare, and the clinical significance of metastases in ISLNs is still unclear.
Case Report
We herein report a patient with breast cancer with an ISLN that was detected prior to surgery. In the current case, the ISLN contained foci of carcinoma, but the axillary SLNs (aSLN) did not contain such foci. Previous reports related to ISLNs and aSLNs, including our case, are reviewed. Interestingly, there was no case with negative ISLNs and positive aSLNs.
The current and previous cases have shown that axillary lymph node dissection (ALDN) might rely on the aSLN status but not on the ISLN status. The effect on the prognosis or clinical significance in cases with positive ISLNs has not been fully elucidated. Cases of ISLNs found by SLN navigation are discussed in relation to their clinical significance.
PMCID: PMC2931044  PMID: 20847822
Breast cancer; Intramammary node; Sentinel node
25.  Evaluation of the metastatic status of lymph nodes identified using axillary reverse mapping in breast cancer patients 
Axillary reverse mapping (ARM) is a new technique to preserve upper extremity lymphatic pathways during axillary lymph node dissection (ALND), thereby preventing lymphedema patients with breast cancer. However, the oncologic safety of sparing the nodes identified by ARM (ARM nodes), some of which are positive, has not been verified. We evaluated the metastatic status of ARM nodes and the efficacy of fine needle aspiration cytology (FNAC) in assessing ARM node metastasis.
Sixty patients with breast cancer who underwent ARM during ALND between January 2010 and July 2012 were included in this study. Twenty-five patients were clinically node-positive and underwent ALND without sentinel lymph node biopsy (SLNB). Thirty-five patients were clinically node-negative but sentinel node-positive on the SLND. The lymphatic pathway was visualized using fluorescence imaging with indocyanine green. ARM nodes in ALND field, whose status was diagnosed using FNAC, were removed and processed for histology. We evaluated the correlation between the cytological findings of FNAC and the histological analysis of excised ARM nodes.
The mean number of ARM nodes identified per patient was 1.6 ±0.9 in both groups. In most patients without (88%) and with (79%) SLNB, the ARM nodes were located between the axillary vein and the second intercostobrachial nerve. FNAC was performed for 45 ARM nodes, 10 of which could not be diagnosed. Six of the patients without SLNB (24%) and onewith SLNB (3%) had positive ARM nodes. Of these sevenpatients, four had >3 positive ARM nodes. There was no discordance between the cytological and histological diagnosis of ARM nodes status.
Positive ARM nodes were observed in the patients not only with extensive nodal metastasis but also in those with a few positive nodes. FNAC for ARM nodes was helpful in assessing ARM nodes metastasis, which can be beneficial in sparing nodes essential for lymphatic drainage, thereby potentially reducing the incidence of lymphedema. However, the success of sampling rates needs to be improved.
PMCID: PMC3527301  PMID: 23116152
Breast cancer; Axillary reverse mapping; Fine needle aspiration cytology; Fluorescence image

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