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1.  A 10-year follow-up of treatment outcomes in patients with early stage breast cancer and clinically negative axillary nodes treated with tangential breast irradiation following sentinel lymph node dissection or axillary clearance 
We compare long-term outcomes in patients with node negative early stage breast cancer treated with breast radiotherapy (RT) without the axillary RT field after sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND). We hypothesize that though tangential RT was delivered to the breast tissue, it at least partially sterilized occult axillary nodal metastases thus providing low nodal failure rates. Between 1995 and 2001, 265 patients with AJCC stages I–II breast cancer were treated with lumpectomy and either SLND (cohort SLND) or SLND and ALND (cohort ALND). Median follow-up was 9.9 years (range 8.3–15.3 years). RT was administered to the whole breast to the median dose of 48.2 Gy (range 46.0–50.4 Gy) plus boost without axillary RT. Chi-square tests were employed in comparing outcomes of two groups for axillary and supraclavicular failure rates, ipsilateral in-breast tumor recurrence (IBTR), distant metastases (DM), and chronic complications. Progression-free survival (PFS) was compared using log-rank test. There were 136/265 (51%) and 129/265 (49%) patients in the SLND and ALND cohorts, respectively. The median number of axillary lymph nodes assessed was 2 (range 1–5) in cohort SLND and 18 (range 7–36) in cohort ALND (P < 0.0001). Incidence of AFR and SFR in both cohorts was 0%. The rates of IBTR and DM in both cohorts were not significantly different. Median PFS in the SLND cohort is 14.6 years and 10-year PFS is 88.2%. Median PFS in the ALND group is 15.0 years and 10-year PFS is 85.7%. At a 10-year follow-up chronic lymphedema occurred in 5/108 (4.6%) and 40/115 (34.8%) in cohorts SLND and ALND, respectively (P = 0.0001). This study provides mature evidence that patients with negative nodes, treated with tangential breast RT and SLND alone, experience low AFR or SFR. Our findings, while awaiting mature long-term data from NSABP B-32, support that in patients with negative axillary nodal status such treatment provides excellent long-term cure rates while avoiding morbidities associated with ALND or addition of axillary RT field.
doi:10.1007/s10549-010-1167-6
PMCID: PMC3623372  PMID: 20853176
Sentinel lymph node sampling; Axillary lymph node dissection; Breast cancer; Tangential breast radiotherapy; Radiotherapy
2.  COMPLICATION RATES IN PATIENTS WITH NEGATVE AXILLARY NODES 10-YEARS AFTER LOCAL BREAST RADIOTHERAPY FOLLOWING EITHER SENTINEL LYMPH NODE DISSECTION OR AXILLARY CLEARANCE 
Background
We assess complication rates in node negative breast cancer patients treated with breast radiotherapy (RT) only after sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND).
Materials and Methods
Between 1995 and 2001, 226 women with AJCC stage I-II breast cancer were treated with lumpectomy, either SLND or SLND+ALND, and had available toxicities in follow-up: 111/136 (82%) and 115/129 (89%) in SLND and ALND groups, respectively. RT targeted the breast to median dose of 48.2Gy (range, 46.0-50.4Gy) without axillary RT. Chi-square tests compared complication rates of two groups for axillary web syndrome (AWS), seroma, wound infection, decreased range of motion (ROM) of the ipsilateral shoulder, paresthesia, and lymphedema.
Results
Median follow-up was 9.9 years (range, 8.3 -15.3 years). Median number of nodes assessed was 2 (range, 1-5) in SLND and 18 (range, 7-36) in ALND (p<0.0001). Acute complications occurred during the first 2 years and were AWS, seroma, and wound infection. Incidences of seroma 5/111 (4.5%) in SLND and 16/115 (13.9%) in ALND (p<0.02, respectively) and wound infection 3/111 (2.7%) in SLND and 10/115 (8.7%) in ALND (p<0.05, respectively) differed significantly. AWS was not statistically different between the groups. At 10-years, the only chronic complications were decreased ROM of the shoulder 46/111 (41.4%) in SLND and 92/115 (80.0%) in ALND (p<0.0001), paresthesia 12/111 (10.8%) in SLND and 39/115 (33.9%) in ALND (p<0.0001), and lymphedema assessed by patients 10/111 (10.0%) in SLND and 39/115 (33.9%) in ALND (p<0.0001). Chronic lymphedema, assessed by clinicians, occurred in 6/111 (5.4%) in SLND and 21/115 (18.3%) in ALND cohorts, respectively (p<0.0001).
Conclusion
Our mature findings support that in patients with negative axillary nodal status SLND and breast RT provide excellent long-term cure rates while avoiding morbidities associated with ALND or addition of axillary RT field.
doi:10.1097/COC.0b013e3182354bda
PMCID: PMC4064796  PMID: 22134519
sentinel lymph node; axillary lymph node dissection; breast cancer; radiotherapy; complication rates; lymphedema; paresthesia; decreased range of motion; seroma; axillary web syndrome
3.  Five-year follow-up of treatment outcomes in patients with early-stage breast cancer and clinically negative axillary nodes treated with no lymph node dissection or axillary clearance 
Background
Sentinel lymph node biopsy has steadily replaced axillary lymph node dissection (ALND) for staging clinically node-negative breast cancer. However, ALND remains standard management of the axilla when a tumor-positive sentinel lymph node is identified.
Methods
We identified 460 patients with breast cancer (clinically T1/T2N0M0) from the database for 1999–2004. Patient age ranged from 26 to 81 (median 50) years. Patients who underwent mastectomy or breast-conserving surgery with or without ALND were compared for regional recurrence, disease-free survival, and overall survival.
Results
Patients with ALND (n = 308) were compared with the no ALND group (n = 152). Five-year overall survival and disease-free survival were not significantly different between the two groups, while there was a significant difference between them for regional recurrence. Of the 152 patients who did not undergo axillary dissection, four developed ipsilateral axillary disease, most of whom were rescued by delayed axillary dissection. Further, the criterion for identifying lymphedema was used, ie, a 2 cm circumferential change at any measured location. As a result, the incidence of lymphedema in the ALND group was 12.7%, while it was not seen in the non ALND group.
Conclusion
There is a possibility that ALND may be omitted for cT1/T2N0M0 breast cancer through a combination of hormone therapy and adjuvant chemotherapy.
doi:10.2147/BCTT.S36054
PMCID: PMC3846707  PMID: 24367200
breast cancer; axillary lymph node dissection
4.  Morbidity Results from the NSABP B-32 Trial Comparing Sentinel Lymph Node Dissection versus Axillary Dissection 
Journal of surgical oncology  2010;102(2):111-118.
Background and Objectives
Three year post-surgical morbidity levels were compared between patients with negative sentinel lymph node dissection alone (SLND) and those with negative sentinel node dissection and negative axillary lymph node dissection (ALND) in the NSABP B-32 trial.
Methods
A total of 1975 ALND and 2008 SLND node negative breast cancer patients had shoulder range of motion and arm volumes assessed along with self reports of arm tingling and numbness. Relative shoulder abduction deficits and relative arm volume differences between ipsilateral and contralateral arms were calculated.
Results
Shoulder abduction deficits ≥ 10% peaked at one week for the ALND (75%) and SLND (41%) groups. Arm volume differences ≥ 10% at 36 months were evident for the ALND (14%) and SLND (8%) groups. Numbness and tingling peaked at 6 months for the ALND (49%, 23%) and SLND (15%, 10%) groups. Logistic regression correlates of residual morbidity included treatment group, age, handedness, tumor size, systemic chemotherapy and radiation to the axilla.
Conclusions
Although residual morbidity for both treatment groups was evident, the results of the NSABP B-32 study indicate the superiority of the SLND compared to the ALND treatment approach relative to post-surgical morbidity outcomes over a three year follow-up period.
doi:10.1002/jso.21535
PMCID: PMC3072246  PMID: 20648579
shoulder abduction; arm swelling; numbness; tingling
5.  Sentinel lymph node biopsy: technique validation at the Setúbal Medical Centre, Portugal 
ecancermedicalscience  2009;3:124.
Aims:
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.
Methods:
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.
Results:
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).
Conclusions:
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.
doi:10.3332/ecancer.2008.124
PMCID: PMC3224010  PMID: 22275996
6.  Management of the axilla in patients with breast cancer 
The Indian Journal of Surgery  2010;71(6):328-334.
This article reviews the changes in management of the axilla in patients with breast cancer in the last decade. It discusses the recent advances, existing controversies and provides evidence-based guidelines for use in clinical practice.
Sentinel lymph node (SLN) biopsy has replaced the more morbid axillary lymph node dissection (ALND) and four node sampling for axillary nodal staging. Blue dye guided four node sampling is an acceptable alternative when radioisotope facilities are not available. ALND is reserved for patients with proven axillary lymph node involvement.
Preoperative axillary ultrasound and fine-needle aspiration cytology or core biopsy of suspicious lymph nodes reliably identifies around 30% of node positive patients. Intraoperative assessment of the SLN using frozen section or real time molecular assays enables surgeons to perform one stage ALND in node positive patients. For those patients in whom intra-operative SLN assessment is negative, but whose final pathology reveals SLN metastasis, standard treatment has been to perform a completion ALND. Predictive models can be used to identify a lowrisk group of SLN-positive patients in whom routine ALND may not be necessary. In the future, completion ALND for microscopic disease will not be the standard of care but axillary radiotherapy may be an alternative with equal control and less morbidity.
doi:10.1007/s12262-009-0089-1
PMCID: PMC3452737  PMID: 23133186
Axillary lymph node dissection; Blue dye; Breast cancer; Four node sampling; Lymphatic mapping; Radioisotope; Sentinel lymph node biopsy
7.  Outcomes of Sentinel Lymph Node Dissection Alone vs. Axillary Lymph Node Dissection in Early Stage Invasive Lobular Carcinoma: A Retrospective Study of the Surveillance, Epidemiology and End Results (SEER) Database 
PLoS ONE  2014;9(2):e89778.
Background
The American College of Surgeons Oncology Group (ACOSOG) Z0011 trial demonstrated no difference in local-regional recurrence (LRR), disease-specific survival (DSS) or overall survival (OS) for sentinel lymph node dissection (SLND) and completion axillary lymph node dissection (ALND) among patients undergoing breast-conserving therapy for clinical T1–T2, N0 breast cancer with 1 or 2 positive SLNs. However, Only 7% of study participants had invasive lobular carcinoma (ILC). Because ILC has a different pattern of metastases, frequently presenting as small foci requiring immunohistochemistry for detection, the applicability of ACOSOG Z0011 trial data to ILC patients is unclear.
Study Design
We identified all ILC patients in the Surveillance, Epidemiology, and End Results (SEER) database (1998–2009) who met the ACOSOG Z0011 eligibility criteria. Patients were evaluated on the basis of the extent of axillary surgery (SLND alone or ALND), and the clinical outcomes of these 2 groups were compared.
Results
1269 patients (393 SLND and 876 ALND) were identified from the SEER database. At a median follow-up time of 71 months, there were no differences in OS or disease-specific survival between the two groups.
Conclusion
SLND alone may result in outcomes comparable to those achieved with ALND for patients with early-stage ILC who meet the ACOSOG Z0011 eligibility criteria.
doi:10.1371/journal.pone.0089778
PMCID: PMC3934955  PMID: 24587029
8.  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.
doi:10.3332/ecancer.2013.319
PMCID: PMC3660161  PMID: 23717340
sentinel lymph node biopsy; axillary lymph node dissection; magnetic resonance imaging; ultrasmall paramagnetic iron oxide
9.  Impact of the ACOSOG Z0011 Criteria Applied to a Contemporary Patient Population 
Background
The ACOSOG Z0011 trial concluded that axillary lymph node dissection (ALND) may not be necessary for all patients with sentinel lymph node (SLN) metastasis undergoing breast-conserving therapy (BCT). The aim of this study was to assess applicability of Z0011 results to our patient population and determine what percentage may be affected by these results.
Study Design
Patients with clinical T1-2,N0 breast cancer treated with surgery first between 1994 and 2009 who had 1–2 positive SLNs were included in this study. Kaplan-Meier survival curves were calculated and log-rank used to compare overall survival (OS) and disease-free survival (DFS) for ALND vs. SLN dissection (SLND) alone in two patient populations: patients undergoing BCT or total mastectomy (TM) and patients undergoing BCT only.
Results
Of 861 patients, 188 (21.8%) underwent SLND alone. Of 488 (56.7%) patients who underwent BCT, 125 (25.6%) had SLND alone. Of 412 patients undergoing TM, 67 (16.3%) had SLND alone. Patients undergoing ALND were significantly younger, had larger tumors, macrometastasis and extranodal extension in both populations. Compared with the Z0011 cohort, our BCT patients had more T1 tumors (76.0% vs 69.3%, P = .01) and more grade II–III tumors (87.3% vs 76.2%, P < .0001). After adjusting for T-stage, there were no significant differences in DFS and OS between patients undergoing SLND alone or ALND in both populations.
Conclusions
Examination of our breast cancer patients with Z0011 trial criteria suggests that almost 75% of SLN-positive patients would be candidates to avoid ALND if they undergo BCT.
doi:10.1016/j.jamcollsurg.2012.09.005
PMCID: PMC4331643  PMID: 23122536
ACOSOG Z0011; node-positive breast cancer; axillary lymph node dissection; sentinel lymph node dissection; survival
10.  Prediction of macrometastasis in axillary lymph nodes of patients with invasive breast cancer and the utility of the SUV lymph node/tumor ratio using FDG-PET/CT 
Background
Axillary lymph node dissection (ALND) is important for improving the prognosis of patients with node-positive breast cancer. However, ALND can be avoided in select micrometastatic cases, preventing complications such as lymphedema or paresthesia of the upper limb. To appropriately omit ALND from treatment, evaluation of the axillary tumor burden is critical. The present study evaluated a method for preoperative quantification of axillary lymph node metastasis using positron emission tomography/computed tomography (PET/CT).
Methods
The records of breast cancer patients who received radical surgery at the Gifu University Hospital (Gifu, Japan) between 2009 and 2014 were reviewed. The axillary lymph nodes were preoperatively evaluated by PET/CT. Lymph nodes were dissected by sentinel lymph node biopsy (SLNB) or ALND and were histologically diagnosed by experienced pathologists. The maximum standardized uptake value (SUVmax) was measured in both the axillary lymph node (SUV-LN) and primary tumor (SUV-T). The SUV-LN/T ratio (NT ratio) was calculated by dividing the SUV-LN by the SUV-T, and the efficacies of the NT ratio and SUV-LN were compared using receiver operating characteristic (ROC) curve analysis. The diagnostic performance was also compared between the techniques with the McNemar test.
Results
A total of 171 operable invasive breast cancer patients were enrolled, comprising 69 node-positive patients (macrometastasis (Mac): n = 55; micrometastasis (Mic): n = 14) and 102 node-negative patients (Neg). The NT ratio for node-positive patients was significantly higher than in node-negative patients (0.5 vs. 0.316, respectively, P = 0.041). The NT ratio for Mac patients (0.571) was significantly higher than in Mic (0.227) and Neg (0.316) patients (P <0.01 and P = 0.021, respectively). The areas under the curves (AUCs) by ROC analysis for the NT ratio and SUV-LN were 0.647 and 0.811, respectively (P <0.01). In patients with an SUV-T ≥2.5, the modified AUCs for the NT ratio and SUV-LV were 0.757 and 0.797 (not significant).
Conclusion
The NT ratio and SUV-LN are significantly higher in patients with axillary macrometastasis than in those with micrometastasis or no metastasis. The NT ratio and SUV-LN can help quantify axillary lymph node metastasis and may assist in macrometastasis identification, particularly in patients with an SUV-T ≥2.5.
Electronic supplementary material
The online version of this article (doi:10.1186/s12957-014-0424-2) contains supplementary material, which is available to authorized users.
doi:10.1186/s12957-014-0424-2
PMCID: PMC4336728
Axillary lymph node; Macrometastasis; Breast cancer; PET/CT; NT ratio
11.  Evaluation of the metastatic status of lymph nodes identified using axillary reverse mapping in breast cancer patients 
Background
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.
Methods
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.
Results
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.
Conclusions
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.
doi:10.1186/1477-7819-10-233
PMCID: PMC3527301  PMID: 23116152
Breast cancer; Axillary reverse mapping; Fine needle aspiration cytology; Fluorescence image
12.  Sentinel lymph node biopsy in breast cancer patients after overnight migration of radiolabelled sulphur colloid 
Postgraduate Medical Journal  2004;80(947):546-550.
Objective: To evaluate the performance and feasibility of sentinel lymph node biopsy in breast cancer patients using technetium-99m (99mTc) sulphur colloid and gamma probe.
Methods: From May 2000 to March 2001, 70 patients with a tumour less than 5 cm with clinically negative axillary lymph nodes underwent sentinel node biopsy followed by standard axillary dissection. 99mTc sulphur colloid was injected around the primary tumour the day before surgery and a gamma probe was used to detect the sentinel lymph node during the surgical procedure. Sentinel lymph node biopsy was compared with standard axillary dissection for its ability to accurately reflect the final pathological status of the axillary nodes.
Results: The sentinel lymph node was successfully identified in 67 of 70 patients (95.71%). The number of sentinel lymph nodes ranged from 1–5 (mean 1.5) and non-sentinel nodes ranged from 5–22 (mean 13.3). Of the 67 patients with successfully identified sentinel lymph nodes, 43.28% (29/67) were histologically positive. Sensitivity of the sentinel lymph node to predict axilla was 82.75%; specificity was 100%. Positive and negative predictive values were 100% and 88.3% respectively. The sentinel lymph node was falsely negative in five patients, yielding an accuracy of 92.53%. Sentinel lymph node biopsy was more accurate for T1 tumours than for T2 tumours.
Conclusions: The gamma probe guided method after overnight migration of 99mTc sulphur colloid is technically feasible for detecting sentinel lymph nodes in most breast cancer patients, accurately predicting the axillary lymph node status, and appears more accurate for T1 lesions than for larger lesions. This minimally invasive axillary staging procedure represents a major advance in the surgical treatment of breast cancer.
doi:10.1136/pgmj.2003.016311
PMCID: PMC1743088  PMID: 15356357
13.  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.
Background
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.
Methods
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.
Results
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.
Conclusions
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.
doi:10.1245/s10434-012-2490-4
PMCID: PMC3505491  PMID: 22890590
14.  Surgical management of early stage invasive breast cancer: a practice guideline 
Canadian Journal of Surgery  2005;48(3):185-194.
Objectives
To assess the available evidence on sentinel lymph-node biopsy, and to examine the long-term follow-up data from large randomized phase III trials comparing breast-conserving therapy with mastectomy in order to make recommendations on the surgical management of early invasive breast cancer (stages I and II), including the optimum management of the axillary nodes: for the breast — modified radical mastectomy or breast-conserving therapy; for the axilla — complete axillary node dissection, axillary dissection of levels I and II lymph nodes, sentinel lymph-node biopsy or no axillary node surgery.
Outcomes
Overall survival, disease-free survival, local recurrence, distant recurrence and quality of life.
Evidence
MEDLINE, EMBASE, the Cochrane Library databases and relevant conference proceedings were searched to identify randomized trials and meta-analyses. Two members of the Practice Guidelines Initiative, Breast Cancer Disease Site Group (BCDSG) selected and reviewed studies that met the inclusion criteria. The systematic literature review was combined with a consensus process for interpretation of the evidence to develop evidence-based recommendations. This practice guideline has been reviewed and approved by the BCDSG, comprising surgeons, medical oncologists, radiation oncologists, pathologists, a medical sociologist, a nurse representative and a community representative.
Benefits, harms and costs
Breast-conserving therapy (lumpectomy with levels I and II axillary node dissection, plus radiotherapy) provides comparable overall and disease-free survival to modified radical mastectomy. Levels I and II axillary dissection accurately stages the axilla and minimizes the morbidity of axillary recurrence but is associated with lymphedema in approximately 20% of patients and arm pain in approximately 33%. Currently, there is insufficient data regarding locoregional recurrence and long-term morbidity associated with sentinel-node biopsy to advocate it as the standard of care. Breast-conserving therapy may offer an advantage over mastectomy in terms of body image, psychological and social adjustment but appears equivalent with regard to marital adjustment, global adjustment and fear of recurrence.
Recommendations
Women who are eligible for breast-conserving surgery should be offered the choice of either breast-conserving therapy with axillary dissection or modified radical mastectomy. Removal and pathological examination of levels I and II axillary lymph nodes should be the standard practice in most cases of stages I and II breast carcinoma. There is promising but limited evidence to support recommendations regarding sentinel lymph-node biopsy alone. Patients should be encouraged to participate in clinical trials investigating this procedure.
Validation
A draft version of this practice guideline and a 21-item feedback questionnaire was circulated to 201 practitioners in Ontario. Of the 131 practitioners who returned the questionnaire, 98 (75%) completed the survey and indicated that the report was relevant to their clinical practice. Eighty (82%) of these practitioners agreed that the draft document should be approved as a practice guideline.
Sponsors
The Practice Guidelines Initiative is supported by Cancer Care Ontario and the Ontario Ministry of Health and Long-Term Care.
Completion date
Jan. 21, 2003.
PMCID: PMC3211547  PMID: 16013621
15.  Breast cancer (non-metastatic) 
BMJ Clinical Evidence  2007;2007:0102.
Introduction
Breast cancer affects at least 1 in 10 women in the UK, but most present with primary operable disease, which has an 80% 5-year survival rate overall.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of interventions after breast-conserving surgery for ductal carcinoma in situ? What are the effects of treatments for primary operable breast cancer? What are the effects of interventions in locally advanced breast cancer (stage IIIB)? We searched: Medline, Embase, The Cochrane Library and other important databases up to February 2006 (BMJ Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 79 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: adding chemotherapy (cyclophosphamide/methotrexate/ fluorouracil and/or anthracycline and/or taxane-based regimens), or hormonal treatment to radiotherapy; adjuvant treatments (aromatase inhibitors, adjuvant anthracycline regimens, tamoxifen); axillary clearance; axillary dissection plus sentinel node dissection; axillary radiotherapy; axillary sampling; combined chemotherapy plus tamoxifen; chemotherapy plus monoclonal antibody (trastuzumab); extensive surgery; high-dose chemotherapy; hormonal treatment; less extensive mastectomy; less than whole breast radiotherapy plus breast conserving surgery; multimodal treatment; ovarian ablation; primary chemotherapy; prolonged adjuvant combination chemotherapy; radiotherapy (after breast-conserving surgery, after mastectomy, plus tamoxifen after breast-conserving surgery, to the internal mammary chain, and to the ipsilateral supraclavicular fossa, and total nodal radiotherapy); sentinel node biopsy; and standard chemotherapy regimens.
Key Points
Breast cancer affects at least 1 in 10 women in the UK, but most present with primary operable disease, which has an 80% 5-year survival rate overall.
In women with ductal carcinoma in situ, radiotherapy reduces local recurrence and invasive carcinoma after breast-conserving surgery, but may not improve survival.
In women with primary operable breast cancer, survival may be increased by full surgical excision, tamoxifen, chemotherapy, radiotherapy, ovarian ablation or trastuzumab (in women who overexpress HER2/neu oncogene). Incomplete excision may increase the risk of local recurrence, but less-extensive mastectomy that excises all local disease is as effective as radical mastectomy at prolonging survival, with better cosmetic results. Axillary clearance (removal of all axillary lymph nodes) achieves local disease control, but has not been shown to increase survival, and can cause arm lymphoedema. Sentinel lymph node biopsy or 4-node sampling may adequately stage the axilla with less morbidity compared with axillary clearance. Adjuvant tamoxifen reduces the risk of recurrence and death in women with oestrogen-positive tumours, but adverse effects begin to outweigh benefit after 5 years of treatment. Primary chemotherapy may facilitate successful breast-conserving surgery instead of mastectomy. Adjuvant combination chemotherapy improves survival compared with no chemotherapy, with greatest benefit likely with anthracycline-based regimens at standard doses for 4-6 months.Radiotherapy decreases recurrence and mortality after breast-conserving surgery. Post-mastectomy radiotherapy for women who are node-positive or at high risk of recurrence decreases recurrence and mortality, but may increase mortality in node-negative women. Adjuvant aromatase inhibitors improve disease-free survival compared with tamoxifen, but their effect on overall survival is unclear.Adjuvant taxoid regimens may improve disease-free survival over standard anthracycline-based therapy.
In women with locally advanced breast cancer, radiotherapy may be as effective as surgery or tamoxifen at increasing survival and local disease control. Adding tamoxifen or ovarian ablation to radiotherapy increases survival compared with radiotherapy alone, but adding chemotherapy may not reduce recurrence or mortality compared with radiotherapy alone.Chemotherapy alone, while widely used, does not improve survival in women with locally advanced breast cancer.
PMCID: PMC2943780  PMID: 19450345
16.  Breast Radiotherapy (RT) Using Tangential Fields (TgF): A Prospective Evaluation of the Dose Distribution in the Sentinel Lymph Node (SLN) Area as Determined Intraoperatively by Clip Placement 
Annals of Surgical Oncology  2014;21(12):3758-3765.
Background
Randomized trials have established that patients with limited involvement of sentinel lymph node (SLN) do not require axillary lymph node dissection (ALND). The similar outcome in patients with ≤2 positive SLN with or without additional ALND is attributed, in part, to tangential fields (TgF) RT. We evaluated the dose distribution in the SLN biopsy area (SLNBa) as determined intraoperatively by clips placement for radiotherapy (RT) optimization.
Methods
This prospective study included 25 patients who had breast conservation. Titanium clips were used intraoperatively to mark the SLNBa. All patients had 3D-conformal RT using standard (STgF) or high tangential fields (HTgF). Axillary levels, SLNBa, and organs at risk were contoured on a CT scan. Dose distribution and overlap between TgF and target volumes were analyzed.
Results
The average doses delivered to axilla levels I-III and SLNBa were 25, 5, 2, and 33 Gy, respectively. The average dose delivered to SLNBa was higher using HTgF with better coverage of the axilla. Only 12 of 25 patients (48 %) had their SLNBa completely covered by the TgF. There was no impact of TgF size on ipsilateral lung dose. The mean heart dose delivered using STgF was lower than HTgF.
Conclusions
In the era of SLNB, axilla and SNLBa RT technique has to be standardized to deliver adequate dose. We recommend the use of HTgF or direct axillary RT techniques (such as in AMAROS trial) in patients with metastases in SLN without ALND completion, when only TgF are expected to cure potential residual disease in the axilla.
doi:10.1245/s10434-014-3966-1
PMCID: PMC4189004  PMID: 25096388
17.  Efficiency of a Preoperative Axillary Ultrasound and Fine-Needle Aspiration Cytology to Detect Patients with Extensive Axillary Lymph Node Involvement 
PLoS ONE  2014;9(9):e106640.
Background
Recent studies have demonstrated that axillary lymph node dissection (ALND) does not affect patient survival, even in those with one or two positive sentinel lymph nodes (SLNs). On the other hand, patients with 3 or more metastatic lymph nodes are eligible for chemotherapy. Therefore, it is crucial to identify a priori patients at risk of having a high number of metastatic axillary lymph nodes for their surgical and/or clinical management. Ultrasound (US) guided Fine-Needle Aspiration (FNA) has been proven to be a useful and highly specific method for detecting metastatic axillary lymph nodes. However, only one recent study has evaluated the efficiency of this method in identifying patients with high metastatic nodal involvement. Our aim was to validate US-guided FNA as a reliable method to discriminate a priori patients with >3 metastatic lymph nodes.
Methods
A retrospective series of 1287 breast cancer patients who underwent a simultaneous preoperative breast and axillary US to stage their axilla was collected. A total of 365 patients, with either positive SLNs (278) or positive axillary lymph nodes detected via US-guided FNA (87), underwent ALND. In these two subgroups, we compared the number of metastatic lymph nodes in the axilla.
Results
The number of metastatic axillary lymph nodes in patients who underwent US-guided FNA was significantly higher (63% had >3 metastatic lymph nodes) than that in patients with SLNs positive for micro- or macrometastases (3% and 27%, respectively) (P<0.001, χ2 = 117.897).
Conclusions
Preoperative axillary US-guided FNA could act as a reliable tool in identifying breast cancer patients with extensive nodal involvement.
doi:10.1371/journal.pone.0106640
PMCID: PMC4160163  PMID: 25207643
18.  Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases: commentary on the IBCSG 23-01 Trial 
Gland Surgery  2013;2(3):128-132.
Breast surgical oncologists have rapidly and successfully transitioned from the routine use of axillary lymph node dissection (ALND) to sentinel lymph node (SLN) biopsy for staging the axilla in clinically node negative patients. This approach limits the use of ALND to those patients with pathologically-proven axillary lymph node metastases and has prompted great current interest in whether or not all SLN-positive patients benefit from a completion ALND. Analysis of population-based data shows a decades-long trend towards omitting ALND in patients with low volume axillary disease. Thus, even prior to publication of the results of the ACOSOG Z0011 study and the IBCSG 23-01 study, completion ALND was being performed less frequently for selected patients with nodal micrometastases. Herein we review the contribution of the recently published IBCSG 23-01 study which provides additional data to confirm that for selected patients, mainly those with small, estrogen receptor-positive tumors with low nodal disease burden undergoing breast conservation with radiation and adjuvant systemic therapy, ALND might be avoided safely. This trial, which included small numbers of patients treated by mastectomy without radiation, and lumpectomy with partial breast irradiation, suggests interest in further clinical trials investigating these important patient populations. The study’s short median follow-up however, cautions us to be clear in discussion, especially with younger patients who have otherwise biologically favorable tumors, that the long-term outcomes of SLN biopsy alone for low volume axillary disease remains unknown.
doi:10.3978/j.issn.2227-684X.2013.07.04
PMCID: PMC4115746  PMID: 25083474
Breast cancer; sentinel lymph node (SLN) biopsy; axillary lymph node dissection (ALND); micrometastatic disease
19.  Sentinel Lymph Node Surgery after Neoadjuvant Chemotherapy in Patients With Node-Positive Breast Cancer: The American College of Surgeons Oncology Group (ACOSOG) Z1071 Clinical Trial 
Importance
Sentinel lymph node (SLN) surgery provides reliable nodal staging information with less morbidity than axillary lymph node dissection (ALND) for clinically node-negative (cN0) breast cancer patients. The application of SLN surgery for staging the axilla following chemotherapy for women who initially had node-positive breast cancer (cN1) is unclear because of high false negative results reported in previous studies.
Objective
To determine the false negative rate (FNR) for SLN surgery following chemotherapy in patients initially presenting with biopsy-proven node-positive breast cancer.
Design, Setting, and Patients
The ACOSOG Z1071 trial enrolled women with clinical T0–4 N1–2, M0 breast cancer who received neoadjuvant chemotherapy. Following chemotherapy, patients underwent both SLN surgery and ALND. SLN surgery using both blue dye and a radiolabeled colloid mapping agent was encouraged.
Main Outcome Measure
The primary endpoint was the FNR of SLN surgery after chemotherapy in women who presented with cN1 disease. We examined the likelihood that the FNR in those with 2 or more SLNs examined was greater than 10%, the rate expected for women undergoing SLN surgery who present with clinically node-negative disease.
Results
Seven hundred fifty-six patients were enrolled from 136 institutions. Of 663 evaluable patients with cN1 disease, 649 underwent chemotherapy followed by both SLN surgery and ALND. A SLN could not be identified in 46 patients (7.1%). Only one SLN was excised in 78 patients (12.0%). Of the remaining 525 patients with 2 or more SLNs removed, no cancer was identified in the axillary lymph nodes of 215 patients yielding a pathological complete nodal response of 41.0% (95% CI: 36.7%–45.3%). In 39 patients, cancer was not identified in the SLNs but was found in lymph nodes obtained with ALND resulting in a FNR of 12.6% (90% Bayesian Credible Interval, 9.85%–16.05%).
Conclusions and Relevance
Among women with cN1 breast cancer receiving neoadjuvant chemotherapy who had 2 or more SLNs examined, the FNR was not found to be 10% or less. Given this FNR threshold, changes in approach and patient selection that result in greater sensitivity would be necessary to support the use of SLN surgery as an alternative to ALND.
Trial Registration
clinicaltrials.gov; trial identifier NCT00881361.
doi:10.1001/jama.2013.278932
PMCID: PMC4075763  PMID: 24101169
20.  Will early detection of non-axillary sentinel nodes affect treatment decisions? 
British Journal of Cancer  2002;87(7):691-693.
Axillary lymph node involvement is the best prognostic factor for breast cancer survival. Staging breast cancers by axillary dissection remains standard management and is part of the UK national guidelines for breast cancer treatment. In the presence of involved axillary lymph nodes best treatment has been shown to be axillary clearance (Fentiman and Mansell, 1991), but clearly for women whose nodes are uninvolved avoidance of morbidity is optimal and this will be achieved by minimal dissection of the axilla. Thus, for node-negative women the introduction of the sentinel node biopsy technique may revolutionise the approach to the axilla. These will be women with mammographic screen detected small well and moderately differentiated tumours (Hadjiloucas and Bundred, 2000). The impact of sentinel node biopsy in women who have symptomatic large tumours is unproven, and around half of these women will require a second procedure to clear their axilla or radiotherapy as treatment. Even for those women found to have involved sentinel lymph nodes the ability to use early systemic chemotherapy followed by axillary clearance or radiotherapy may provide long-term survival gains. Sentinel node biopsy should not, however, become routine practice until randomised controlled trials have proven its benefit and safety in reducing morbidity. Several randomised controlled trials (including ALMANAC) are currently underway.
British Journal of Cancer (2002) 87, 691–693. doi:10.1038/sj.bjc.6600557 www.bjcancer.com
© 2002 Cancer Research UK
doi:10.1038/sj.bjc.6600557
PMCID: PMC2364269  PMID: 12232747
breast cancer; non-axillary sentinel node; treatment
21.  Axillary lymph node dose with tangential whole breast radiation in the prone versus supine position: a dosimetric study 
Background
Prone breast positioning reduces skin reaction and heart and lung dose, but may also reduce radiation dose to axillary lymph nodes (ALNs).
Methods
Women with early stage breast cancer treated with whole breast irradiation (WBI) in the prone position were identified. Patients treated in the supine position were matched for treating physician, laterality, and fractionation. Ipsilateral breast, tumor bed, and Level I, II, and III ALNs were contoured according to the RTOG breast atlas. Clips marking surgically removed sentinel lymph nodes (SLN)s were contoured. Treatment plans developed for each patient were retrospectively analyzed. V90% and V95% was calculated for each axillary level. When present, dose to axillary surgical clips was calculated.
Results
Treatment plans for 46 women (23 prone and 23 supine) were reviewed. The mean V90% and V95% of ALN Level I was significantly lower for patients treated in the prone position (21% and 14%, respectively) than in the supine position (50% and 37%, respectively) (p < 0.0001 and p < 0.0001, respectively). Generally, Level II & III ALNs received little dose in either position. Sentinel node biopsy clips were all contained within axillary Level I. The mean V95% of SLN clips was 47% for patients treated in the supine position and 0% for patients treated in the prone position (p < 0.0001). Mean V90% to SLN clips was 96% for women treated in the supine position but only 13% for women treated in the prone position.
Conclusions
Standard tangential breast irradiation in the prone position results in substantially reduced dose to the Level I axilla as compared with treatment in the supine position. For women in whom axillary coverage is indicated such as those with positive sentinel lymph node biopsy who do not undergo completion axillary dissection, treatment in the prone position may be inappropriate.
doi:10.1186/1748-717X-7-72
PMCID: PMC3444918  PMID: 22607612
Breast cancer; Prone; Axillary lymph nodes; Radiation; ACOSOG Z0011
22.  Trends in and Outcomes from Sentinel Lymph Node Biopsy (SLNB) Alone vs. SLNB with Axillary Lymph Node Dissection for Node-Positive Breast Cancer Patients: Experience from the SEER Database 
Annals of surgical oncology  2010;17(0 3):343-351.
Background
Complete axillary lymph node dissection (ALND) after a positive sentinel lymph node biopsy (SLNB) remains the standard practice. As nodal surgery has long been considered a staging procedure without a clear survival benefit, the need for ALND in all patients is debatable. The purpose of this study was to examine differences in survival for patients undergoing SLNB alone versus SLNB with complete ALND.
Methods
Patients with breast cancer who underwent SLNB and were found to have nodal metastases were identified from the Surveillance, Epidemiology, and End Results database (1998–2004). Clinicopathologic and outcomes data were examined for patients who underwent SLNB alone versus SLNB with ALND.
Results
We identified 26,986 patients with disease-positive lymph nodes; 4,425 (16.4%) underwent SLNB alone, and 22,561 (83.6%) underwent SLNB with ALND. Patients were significantly more likely to undergo SLNB alone if they were older (median 59 years old) or if the tumor was low grade and estrogen receptor positive. From 1998 to 2004, the proportion of patients with micrometastasis in the sentinel lymph nodes who underwent SLNB alone increased from 21.0 to 37.8% (P < 0.001). At a median follow-up of 50 months, there were no statistically significant differences in overall survival (OS) between patients who underwent SLNB alone versus complete ALND.
Conclusions
There is an increasing trend toward omitting ALND in patients with micrometastatic nodal disease identified by SLNB. Compared with SLNB alone, completion ALND does not seem to be associated with improved survival for breast cancer patients with micrometastasis in the sentinel lymph nodes.
doi:10.1245/s10434-010-1253-3
PMCID: PMC4324560  PMID: 20853057
23.  Axillary lymph node status, adjusted for pathologic complete response in breast and axilla after neoadjuvant chemotherapy, predicts differential disease-free survival in breast cancer 
Current Oncology  2013;20(3):e180-e192.
Background
Our retrospective study in breast cancer patients evaluated whether integrating subtype and pathologic complete response (pcr) information into axillary lymph node restaging after neoadjuvant chemotherapy (nac) adds significance to its prognostic values.
Methods
Patients included in the analysis had stage ii or iii disease, with post-nac axillary lymph node dissection (alnd), without sentinel lymph node biopsy before completion of nac, with definitive subtyping data and subtype-oriented adjuvant treatments. The ypN grading system was used to restage axillary lymph node status, and ypN0 was adjusted by pcr in both breast and axilla into ypN0(pcr) and ypN0(non-pcr). Univariate and multivariate survival analyses were performed.
Results
Among the 301 patients analyzed, 145 had tumours that were hormone receptor–positive (hr+) and negative for the human epidermal growth factor receptor (her2–), 101 had tumours that were positive for her2 (her2+), and 55 had tumours that were triple-negative. The rate of pcr in both breast and axilla was 11.7%, 43.6%, and 25.5% respectively for the 3 subtypes. Compared with the non-pcr patients, the pcr patients had better disease-free survival (dfs) and overall survival (os): p = 0.002 for dfs and p = 0.011 for os. In non-pcr patients, dfs and os were similar in the ypN0(non-pcr) and ypN1 subgroups, and in the ypN2 and ypN3 subgroups. We therefore grouped the ypN grading results into ypN0(pcr) (n = 75), ypN0– 1(non-pcr) (n = 175), and ypN2–3 (n = 51). In those groups, the 3-year dfs was 98%, 91%, and 56%, and the 3-year os was 100%, 91%, and 82% respectively. The differences in dfs and os between those three subgroups were significant (all p < 0.05 in paired comparisons). Multivariate Cox regression showed that subtype and ypN staging adjusted by pcr were the only two independent factors predicting dfs.
Conclusions
Axillary lymph node status after nac, adjusted for pcr in breast and axilla, predicts differential dfs in patients without prior sentinel lymph node biopsy.
doi:10.3747/co.20.1294
PMCID: PMC3671025  PMID: 23737688
Breast cancer; neoadjuvant chemotherapy; axillary restaging; pathologic complete response; prognosis
24.  Breast cancer (non-metastatic) 
Clinical Evidence  2011;2011:0102.
Introduction
Breast cancer affects at least 1 in 10 women in the UK, but most present with primary operable disease, which has an 80% 5-year survival rate overall.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of interventions after breast-conserving surgery for ductal carcinoma in situ? What are the effects of treatments for primary operable breast cancer? What are the effects of interventions in locally advanced breast cancer (stage 3B)? We searched: Medline, Embase, The Cochrane Library, and other important databases up to April 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 83 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: adding chemotherapy (cyclophosphamide/methotrexate/fluorouracil and/or anthracycline and/or taxane-based regimens), or hormonal treatment to radiotherapy; adjuvant treatments (aromatase inhibitors, adjuvant anthracycline regimens, tamoxifen); axillary clearance; axillary dissection plus sentinel node dissection; axillary radiotherapy; axillary sampling; combined chemotherapy plus tamoxifen; chemotherapy plus monoclonal antibody (trastuzumab); extensive surgery; high-dose chemotherapy; hormonal treatment; less extensive mastectomy; less than whole-breast radiotherapy plus breast-conserving surgery; multimodal treatment; ovarian ablation; primary chemotherapy; prolonged adjuvant combination chemotherapy; radiotherapy (after breast-conserving surgery, after mastectomy, plus tamoxifen after breast-conserving surgery, to the internal mammary chain, and to the ipsilateral supraclavicular fossa, and total nodal radiotherapy); sentinel node biopsy; and standard chemotherapy regimens.
Key Points
Breast cancer affects at least 1 in 10 women in the UK, but most present with primary operable disease, which has an 80% 5-year survival rate overall.
In women with ductal carcinoma in situ (DCIS), radiotherapy reduces local recurrence and invasive carcinoma after breast-conserving surgery. The role of tamoxifen added to radiotherapy for DCIS remains unclear because of conflicting results.
In women with primary operable breast cancer, survival may be increased by full surgical excision, tamoxifen, chemotherapy, radiotherapy, ovarian ablation, or trastuzumab (in women who over-express HER2/neu oncogene). Incomplete excision may increase the risk of local recurrence, but less-extensive mastectomy that excises all local disease is as effective as radical mastectomy at prolonging survival, with better cosmetic results. Axillary clearance (removal of all axillary lymph nodes) achieves local disease control, but has not been shown to increase survival, and can cause arm lymphoedema. Sentinel lymph node biopsy or 4-node sampling may adequately stage the axilla with less morbidity compared with axillary clearance. Adjuvant tamoxifen reduces the risk of recurrence and death in women with oestrogen-positive tumours. Primary chemotherapy may facilitate successful breast-conserving surgery instead of mastectomy. Adjuvant combination chemotherapy improves survival compared with no chemotherapy, with greatest benefit likely with anthracycline-based regimens at standard doses for 4 to 6 months.Radiotherapy decreases recurrence and mortality after breast-conserving surgery. Post-mastectomy radiotherapy for women who are node-positive or at high risk of recurrence decreases recurrence and mortality. Adjuvant aromatase inhibitors improve disease-free survival compared with tamoxifen, but their effect on overall survival is unclear. Adjuvant taxane-based regimens may improve disease-free survival over standard anthracycline-based therapy.
In women with locally advanced breast cancer, radiotherapy may be as effective as surgery or tamoxifen at increasing survival and local disease control. Adding tamoxifen or ovarian ablation to radiotherapy increases survival compared with radiotherapy alone, but adding chemotherapy may not reduce recurrence or mortality compared with radiotherapy alone.We don't know if chemotherapy alone improves survival in women with locally advanced breast cancer as we found few trials.
PMCID: PMC3217212  PMID: 21718560
25.  Value of frozen section and primary tumor factors in determining sentinel lymph node spread in early breast carcinoma 
Introduction
Sentinel lymph node biopsy (SLNB) is the standard of care to assess the metastasis in breast carcinoma. Accuracy of intraoperative frozen section examination to evaluate SLN in detecting metastasis is important as it determines the further management of axilla. Primary tumor characteristics determining the metastasis to the lymph node will help in predicting the probability of spread and to determine the nature of disease. It also helps in refining selection of patients for SLNB. We evaluated all these criteria on Indian patients for the better management.
Materials and methods
Between January 2005 and April 2009, 114 consecutive patients of all age group of both sex, with cytology or biopsy proven carcinoma breast, clinical stage T1/T2 N0 M0 at Manipal Comprehensive Cancer Center, Manipal Hospital, Bangalore were subjected to SLNB and introperative frozen examination. First 75 cases had complete axillary clearance irrespective of SLNB result and subsequently, positive cases underwent axillary lymph node dissection (ALND). Age of the patient and primary tumor characteristics like size, grade, lymphovascular invasion (LVI), perineural invasion, ER/PR status, Her2-neu status and histological sub-types were evaluated for predicting the SLN metastasis. Feasibility of SLNB in previously treated patient is also evaluated.
Results
The age of the patient ranged from 23 to 87 years and its association with SLN spread is not significant. Frozen section examination had accuracy of 97.37% in determining metastatic sentinel node with sensitivity of 96.15% and specificity of 100% with value P < 0.001. SLN remained significant indicator of the status of rest of axilla with value P < 0.001. Primary tumor characteristics like histological subtypes, grade (P = 0.353), ER/PR status (P = 0.839), Her2-neu status (P =0.296) were not significantly associated with SLN metastasis. Size of the primary tumor (P = 0.002), LVI (P < 0.001), perineural invasion (P = 0.084+) were significant factors determining the SLN metastasis. SLNB evaluation had no false negative values in previously treated breast.
Conclusion
SLNB is a valuable method of determining the axillary nodal metastasis. Intraoperative frozen section examination is highly ac-curate in detecting nodal metastasis. Primary tumor characteristics like size, LVI and perineural invasion are significant in predicting SLN metastasis. SLNB remains an important method of predicting axillary metastasis even in previously treated breast carcinomas.
doi:10.1007/s13193-010-0008-8
PMCID: PMC3420992  PMID: 22930615
Sentinel lymph node; Breast carcinoma; Metastasis

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