Axillary Treatment In Patients Research Articles

Oncologic outcome of response-guided axillary treatment in patients with cN1 breast cancer after primary systemic therapy.

514 Background: In breast cancer, the majority of clinically node positive (cN1) patients are treated with primary systemic treatment (PST), with increasing rates of axillary pathologic complete response (pCR). Evidence supporting tailoring axillary treatment according to the response is growing. However, it is still debatable whether ALND is beneficial in cN1 patients with residual nodal disease and if any further axillary treatment is necessary in patients achieving pCR. In this study, we present the four-year oncologic outcome of cN1 patients undergoing either axillary radiation treatment or no axillary treatment according to the ‘Marking Axillary lymph nodes with Radioactive Iodine seeds’ (MARI)-protocol. Methods: Between 2014 and 2021, we prospectively enrolled patients with node positive breast cancer and 1 - 3 involved axillary lymph nodes on FDG-PET/CT pre-PST, who were treated according to the MARI-protocol. Patients with residual disease of the MARI node (ypN1) received axillary radiotherapy (RT), while patients with a pCR of the MARI node (ypN0) received no further axillary treatment. The primary endpoint was the axillary recurrence rate. Secondary endpoints include invasive disease free survival (iDFS) and overall survival (OS), calculated using the Kaplan-Meier method. Results: Of the 367 included patients, more than half (54%, n= 198) had hormonal receptor positive (HR+)/Human Epidermal growth factor 2 negative (HER2-) breast cancer; 59 patients (16%) had HR+/HER2+; 39 patients (11%) had HR-/HER2+ and 71 patients (19%) had triple negative (TN) subtype. Median age was 49 (IQR 41 – 56) years. 231 (63%) patients who had ypN1 received RT and 136 patients (37%) who achieved ypN0 received no further axillary treatment. Median follow up was 49 (IQR 32 – 70) months. Axillary recurrence rate was 3.5% ( n= 8) in patients with ypN1 and 0.7% ( n= 1) in patients with ypN0. Most axillary recurrences ( n= 6) occurred simultaneously with distant metastases in the ypN1 group. In patients with ypN1, the iDFS was 86% and the OS 93%; in ypN0 patients, the iDFS was 93% and the OS 98%. Conclusions: Response-guided axillary treatment in patients with limited nodal disease according to the MARI protocol is associated with favorable oncologic outcome without performing ALND’s. De-escalation can therefore be considered safe. [Table: see text]

De-escalation of axillary treatment in the event of a positive sentinel lymph node biopsy in cT1-2 N0 breast cancer treated with mastectomy: nationwide registry study (BOOG 2013-07).

Trials have demonstrated the safety of omitting completion axillary lymph node dissection in patients with cT1-2 N0 breast cancer operated with breast-conserving surgery who have limited metastatic burden in the sentinel lymph node. The aim of this registry study was to provide insight into the oncological safety of omitting completion axillary treatment in patients operated with mastectomy who have limited-volume sentinel lymph node metastasis. Women diagnosed in 2013-2014 with unilateral cT1-2 N0 breast cancer treated with mastectomy, with one to three sentinel lymph node metastases (pN1mi-pN1a), were identified from the Netherlands Cancer Registry, and classified by axillary treatment: no completion axillary treatment, completion axillary lymph node dissection, regional radiotherapy, or completion axillary lymph node dissection followed by regional radiotherapy. The primary endpoint was 5-year regional recurrence rate. Secondary endpoints included recurrence-free interval and overall survival, among others. In total, 1090 patients were included (no completion axillary treatment, 219 (20.1%); completion axillary lymph node dissection, 437 (40.1%); regional radiotherapy, 327 (30.0%); completion axillary lymph node dissection and regional radiotherapy, 107 (9.8%)). Patients in the group without completion axillary treatment had more favourable tumour characteristics and were older. The overall 5-year regional recurrence rate was 1.3%, and did not differ significantly between the groups. The recurrence-free interval was also comparable among groups. The group of patients who did not undergo completion axillary treatment had statistically significantly worse 5-year overall survival, owing to a higher percentage of non-cancer deaths. In this registry study of patients with cT1-2 N0 breast cancer treated with mastectomy, with low-volume sentinel lymph node metastasis, the 5-year regional recurrence rate was low and comparable between patients with and without completion axillary treatment.

This house believes that: MARI/TAD is better than sentinel node biopsy after PST for cN+ patients.

The increasing use and effectiveness of primary systemic treatment (PST) enables tailored locoregional treatment. About one third of clinically node positive (cN+) breast cancer patients achieve pathologic complete response (pCR) of the axilla, with higher rates observed in Human Epidermal growth factor Receptor (HER)2-positive or triple negative (TN) breast cancer subtypes. Tailoring axillary treatment for patients with axillary pCR is necessary, as they are unlikely to benefit from axillary lymph node dissection (ALND), but may suffer complications and long-term morbidity such as lymphedema and impaired shoulder motion. By combining pre-PST and post-PST axillary staging techniques, ALND can be omitted in most cN+patients with pCR. Different post-PST staging techniques (MARI/TAD/SN) show low or ultra-low false negative rates for detection of residual disease. More importantly, trials using the MARI (Marking Axillary lymph nodes with Radioactive Iodine seeds) procedure or sentinel lymph node biopsy (SLNB) as axillary staging technique post-PST have already shown the safety of tailoring axillary treatment in patients with an excellent response. Tailored axillary treatment using the MARI procedure in stage I-III breast cancer resulted in 80% reduction of ALND and excellent five-year axillary recurrence free interval (aRFI) of 97%. Similar oncologic outcomes were seen for post-SLNB in stage I-II patients. The MARI technique requires only one invasive procedure pre-NST and a median of one node is removed post-PST, whereas for the SLNB and TAD techniques two to four nodes are removed. A disadvantage of the MARI technique is its use of radioactive iodine, which is subject to extensive regulations.

Estadificación ganglionar tras terapia sistémica primaria en mujeres con cáncer de mama y afectación ganglionar al diagnóstico

ObjectiveThe main objective of this study is to analyze the efficacy of combined axillary marking (lymph node clipping and sentinel lymph node biopsy (SLNB)) for axillary staging in patients with primary systemic treatment (PST) and pathologically confirmed node-positive breast cancer at diagnosis. The secondary objective is to determine the impact of lymph node marking in the suppression of axillary lymph node dissection (ALND) in the study group. MethodsWe conducted a prospective study in which lymph node staging was performed using wire localization of positive lymph nodes and a SLNB with dual tracer. All patients who presented no metastatic involvement of the sentinel lymph node (SLN) or clip/wire-marked lymph node were spared an ALND. The multidisciplinary committee agreed on axillary treatment for patients with lymph node involvement. ResultsEighty one patients met the inclusion criteria. We identified and extirpated the clip/wire-marked node in 80 of 81 patients (98.8%), with SLNB performed successfully in 88,9% of patients. The SLN and wire-marked node matched in 78.9% of patients; 76.2% of patients did not undergo ALND. ConclusionsThe combined axillary marking (clip and SLNB) in patients with metastatic lymph node at diagnosis and PST offers a high identification rate (98.8%%) and a high correlation between the wire-marked lymph node and the SLN (78.9%%). This procedure has enabled the suppression of ALND in 76.2% of patients.

Lymph node staging after primary systemic therapy in women with breast cancer and lymph node involvement at diagnosis

ObjectiveThe main objective of this study is to analyze the efficacy of combined axillary marking (lymph node clipping and sentinel lymph node biopsy (SLNB)) for axillary staging in patients with primary systemic treatment (PST) and pathologically confirmed node-positive breast cancer at diagnosis. The secondary objective is to determine the impact of lymph node marking in the suppression of axillary lymph node dissection (ALND) in the study group. MethodsWe conducted a prospective study in which lymph node staging was performed using wire localization of positive lymph nodes and a SLNB with dual tracer. All patients who presented no metastatic involvement of the sentinel lymph node (SLN) or clip/wire-marked lymph node were spared an ALND. The multidisciplinary committee agreed on axillary treatment for patients with lymph node involvement. Results: Eighty one patients met the inclusion criteria. We identified and extirpated the clip/ wire-marked node in 80 of 81 patients (98.8%), with SLNB performed successfully in 88,9% of patients. The SLN and wire-marked node matched in 78.9% of patients; 76.2% of patients did not undergo ALND. ConclusionsThe combined axillary marking (clip and SLNB) in patients with metastatic lymph node at diagnosis and PST offers a high identification rate (98.8%) and a high correlation between the wire-marked lymph node and the SLN (78.9%). This procedure has enabled the suppression of ALND in 76.2% of patients.

ATNEC: A multicenter, randomized trial investigating whether axillary treatment can be avoided in patients with T1-3N1M0 breast cancer with no residual cancer in the lymph glands after neoadjuvant chemotherapy.

TPS615 Background: Neoadjuvant chemotherapy (NACT) results in eradication of cancer in the axillary nodes in 40-70% of patients. This raises questions about the benefit of further axillary treatment in patients with no evidence of residual nodal disease (ypN0) post NACT. Methods: Design: ATNEC is a phase 3, randomized (1:1), multi-center UK trial, with embedded economic evaluation. Patients with proven axillary node metastases on needle biopsy receive NACT followed by sentinel node biopsy (SNB). If the sentinel nodes have converted to benign (ypN0), ATNEC randomly assigns patients to axillary treatment (nodal radiotherapy [ART] or axillary nodal clearance [ALND]) vs no further axillary treatment. Stratification: Institution, type of surgery (breast conserving surgery vs mastectomy), receptor status (triple negative vs HER2 positive vs ER positive and/or PR positive and HER2 negative).Inclusion criteria: Age ≥ 18; Male or female; T1-3N1M0 breast cancer at diagnosis (pre-NACT); FNA or core biopsy confirmed axillary nodal metastases at presentation; ER and HER2 status evaluated on primary tumor; Received standard NACT as per local guidelines; Imaging of the axilla to assess response to NACT;Dual tracer SNB post-NACT and at least 3 nodes removed (sentinel nodes and marked node): If a single tracer is used, the patient is eligible if the involved node is marked pre-NACT and at least 3 nodes removed (including the marked node), If axillary node sampling is performed following failed localization of sentinel nodes, patient is eligible if at least 3 nodes removed (including the marked node), If node is not marked, or marked node is not removed, patient is eligible if the histology report shows evidence of down-staging with complete pathological response in at least one node and at least 3 nodes removed; No evidence of nodal metastases post NACT (ypN0). Exclusion criteria: Bilateral invasive breast cancer; SNB prior to NACT; Previous ipsilateral axillary nodal surgery; Previous cancer within last 5 years or concomitant malignancy. Aims: To assess whether omitting further axillary treatment (ALND & ART) for patients with early-stage breast cancer and axillary nodal metastases on needle biopsy - who after NACT have no residual nodal disease on SNB (ypN0) - is non-inferior to axillary treatment in terms of disease-free survival, and reduces lymphoedema at 5 years. Statistical methods: All analyses will be carried out on an intention-to-treat basis to preserve randomization, avoid bias from exclusions and preserve statistical power. Radiotherapy Quality Assurance: Study has in-built radiotherapy QA program that will be coordinated by National Radiotherapy Trials QA (RTTQA) group. Target accrual: 1,900 Status: Recruiting. As of 11-Feb-2022, 39 sites open, 87 patients enrolled, 31 randomized. Clinical trial information: NCT04109079.

Axillary management in T1-3N1M0 breast cancer patients with needle biopsy proven nodal metastases at presentation after neoadjuvant chemotherapy (ATNEC).

TPS600 Background: Neoadjuvant chemotherapy (NACT) results in eradication of cancer in the axillary nodes in 40% to 70% of patients. This raises questions about the benefit of further axillary treatment in those patients with no evidence of residual nodal disease (ypN0) after NACT. Methods: Design: ATNEC is a phase 3, randomised (1:1), multi-centre trial, with embedded economic evaluation, comparing standard axillary treatment (axillary lymph node dissection [ALND] or axillary radiotherapy [ART]) with no further axillary treatment in T1-3N1M0 breast cancer patients with needle biopsy proven axillary nodal metastases, who after NACT have no residual nodal disease (ypN0) on dual tracer sentinel node biopsy (SNB) and removal of at least 3 nodes (sentinel nodes and marked involved node). Stratification: Institution, type of surgery (breast conserving surgery vs mastectomy), receptor status (triple negative vs HER2 positive vs ER positive and/or PR positive and HER2 negative). Inclusion criteria are: Age ≥ 18, Male or female, T1-3N1M0 breast cancer at diagnosis (pre-NACT), FNA or core biopsy confirmed axillary nodal metastases at presentation, ER and HER2 status evaluated on primary tumour, received standard NACT as per local guidelines, ultrasound of the axilla at completion of NACT, dual tracer SNB after NACT and at least 3 nodes removed (sentinel nodes and marked node), no evidence of nodal metastases post NACT (ypN0). Exclusion criteria are: bilateral invasive breast cancer, SNB prior to NACT, marked node not removed except where at least one node removed shows evidence of down-staging with complete pathological response e.g. fibrosis/scarring and at least 3 nodes removed, previous ipsilateral axillary surgery, previous cancer within last 5 years or concomitant malignancy except basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, in situ or stage 1 melanoma, contra- or ipsilateral in situ breast cancer. Aims: To assess whether, omitting further axillary treatment (ALND and ART) for patients with early stage breast cancer and axillary nodal metastases on needle biopsy - who after NACT have no residual nodal disease on SNB (ypN0) - is non-inferior to axillary treatment in terms of disease free survival, and reduces the risk of lymphoedema at 5 years. Statistical methods: All analyses will be carried out on an intention-to-treat basis to preserve randomisation, avoid bias from exclusions and preserve statistical power. Radiotherapy quality assurance: Study has in-built radiotherapy QA programme that will be co-ordinated by National Radiotherapy Trials QA (RTTQA) group. Target accrual: 1900. Trial status: Recruiting. Number of sites: 100. Clinical trial information: NCT04109079.

Axillary management in early breast cancer with onset surgical management and positive sentinel lymph node.

Over the years, the management of early breast cancer has evolved by leaps and bounds, as has the concept of axillary staging and armpit surgical management. Five randomised studies exist that evaluate the possibility of omitting regional locus surgical axillary treatment in patients with early breast cancer and positive sentinel lymph nodes without it having an impact on the prognosis of the disease in selected cases. A review of the literature on the management of the axilla in early breast cancer is presented.

Combining Wire Localization of Clipped Nodes with Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Node-Positive Breast Cancer: Preliminary Results from a Prospective Study.

The ideal technique for lymph node staging for patients with pathologically confirmed node-positive breast cancer at diagnosis and neoadjuvant chemotherapy (NAC) is unclear. The aim of this study was to analyze the feasibility of wire/clip localization and sentinel lymph node biopsy (SLNB) for the axillary staging of these patients. We conducted a prospective study in which lymph node staging was performed using wire localization of positive lymph nodes and an SLNB with dual tracer. All patients who presented no metastatic involvement of the sentinel lymph node (SLN) or clip/wire-marked lymph node were spared an axillary lymph node dissection (ALND). The multidisciplinary committee agreed on axillary treatment for patients with lymph node involvement. Forty-two patients met the inclusion criteria. We identified and extirpated the clip/wire-marked node in all patients (100%), with SLNB performed successfully in 95.3% of patients. The SLN and wire-marked node matched in 80% of patients; 73.8% of patients did not undergo ALND. Several studies have evaluated the efficacy of various procedures for lymph node marking for women with prechemotherapy lymph node involvement. Most of the studies reported high identification rates (> 94.8%), with false negative rates of < 7%. Similarly, our study allows us to conclude that combined axillary marking (clip and SLNB) in patients with metastatic lymph node at diagnosis and NAC offers a high identification rate (100%) and a high correlation between the wire-marked lymph node and the SLN (80%). This procedure has enabled the suppression of ALND for a significant number of patients (73%).

Feasibility of radioguided occult lesion localization of clip-marked lymph nodes for tailored axillary treatment in breast cancer patients treated with neoadjuvant systemic therapy

BackgroundSelective removal of initially tumor-positive axillary lymph nodes in breast cancer patients who underwent neoadjuvant systemic treatment (NST) improves the accuracy of nodal staging and provides the opportunity for more tailored axillary treatment. This study evaluated whether radioguided occult lesion localization (ROLL) of clip-marked lymph nodes is feasible in clinical practice.MethodsPrior to NST, a clip marker was placed inside a proven tumor-positive lymph node in all breast cancer patients (cTis-4N1-3 M0). After NST, technetium-99m-labeled macroaggregated albumin was injected in the clip-marked lymph nodes. The next day, these ROLL-marked nodes were selectively removed at surgery to evaluate the pathological response of the axilla.ResultsThirty-seven patients (38 axillae) underwent clip insertion. After NST, the clip was visible by ultrasound in 36 procedures (95%). In the other two patients, the ROLL-node injection was performed in a sonographically suspicious unclipped node (1), and near the clip under computed tomography guidance (1). Initial surgery successfully identified the ROLL-marked node with clip in 33 procedures (87%). Removed specimens in the other five procedures contained only the sonographically suspicious tumor-positive unclipped node (1), a node with signs of complete response but no clip (2), a clip without node (1), and tissue without node nor clip, and a second successful ROLL-node procedure was performed (1). Overall, 10 ROLL-marked nodes had no residual disease.ConclusionsThis study demonstrates that the ROLL procedure to identify clip-marked lymph nodes is feasible. This facilitates selective removal at surgery and may tailor axillary treatment in patients treated with NST.

Predicting non-sentinel lymph node metastasis in Australian breast cancer patients: are the nomograms still useful in the post-Z0011 era?

Axillary lymph node dissection (ALND) can be avoided in breast cancer patients with low-volume disease in the sentinel lymph nodes (SLNs) according to Z0011 trial. We believe that nomograms developed for predicting non-sentinel lymph node (NSLN) metastases can guide the axillary treatment in patients who do not fully match the criteria of Z0011 study. We identified risk factors and evaluated the performance of three nomograms to predict NSLN status in patients with positive SLNs. Data from 526 breast cancer patients with positive SLNs who underwent ALND at two Australian hospitals from 2002 to 2015 were studied. Univariate and multivariate associations for NSLN metastasis were analysed. Predictive models evaluated were MD Anderson Cancer Centre (MDA), Helsinki University Hospital and Memorial Sloan Kettering Cancer Centre. Thirty-nine per cent of patients demonstrated NSLN metastasis. The multivariate analysis identified extranodal extension (OR 3.2, 95% CI 2.07-4.80), tumour size >2 cm (OR 2.5, 95% CI 1.66-3.89), macrometastasis (OR 1.9, 95% CI 1.09-3.47), positive SLN ratio >0.5 (OR 1.7, 95% CI 1.16-2.60) and lymphovascular invasion (OR 1.6, 95% CI 1.09-2.44) as independent predictors for NSLN metastasis. MDA nomogram showed the best discrimination (area under the curve of 0.74) and a 9% false negative rate for predicted probability of NSLN metastasis ≤10%. Our results suggest that presence of extranodal extension and tumour size >2 cm may influence the need of further axillary treatment. Conversely, ALND can be safety spared in low risk patients identified by MDA nomogram.

Extent of regional lymph node surgery and impact on outcomes in patients with early-stage breast cancer and limited axillary disease undergoing mastectomy.

Management of the axilla in patients with early-stage breast cancer (ESBC) has evolved. Recent trials support less extensive axillary surgery in patients undergoing mastectomy. We examine factors affecting regional lymph node (RLN) surgery and outcomes in patients with ESBC undergoing mastectomy. Women with clinical T1/2 N0 M0 invasive BC who underwent mastectomy with 1-2 positive nodes were selected from the National Cancer Database (2004-2015). Axillary surgery was defined by number of RLNs examined: 1-5 sentinel LN dissection (SLND), and ≥ 10 axillary LND (ALND). Binary logistic regression and survival analyses were performed to assess the association between axillary surgery and clinical characteristics, and overall survival (OS), respectively. 34,243 patients were included: 13,821 SLND (40%) and 20,422 ALND (60%). SLND significantly increased from 21% (2004) to 45% (2015) (p < .001). Independent factors associated with SLND were treatment year, non-Academic centers, geographic region, tumor histology, and postmastectomy radiotherapy (PMRT). Multivariable survival analysis showed that ALND was associated with better OS (HR 0.78, 95% CI 0.72-0.83, p < .001) relative to SLND; however, there was no difference in patients with LN micrometastases treated without RT (HR 0.87, 95% CI 0.73-1.05, p = .153) or patients receiving PMRT (HR 0.92, 95% CI 0.76-1.13, p = .433). SLND has significantly increased in patients undergoing mastectomy with limited axillary disease and is influenced by patient, tumor, and treatment factors. Survival outcomes did not differ by axillary treatment for patients with LN micrometastases treated without RT or patients who received PMRT. SLND may be considered in select patients with ESBC and limited axillary disease undergoing mastectomy.

What to Do with Non-visualized Sentinel Nodes? A Dutch Nationwide Survey Study

IntroductionInternational guidelines differ regarding their recommendations on axillary treatment of patients with non-visualized sentinel lymph nodes (non-vSLN). Therefore, we distributed a survey among Dutch oncological surgeons to determine their routine practice and opinion regarding axillary treatment in case of a non-vSLN, with the emphasis on whether these practices and opinions have changed since publication of the Z0011 trial.MethodsA Dutch nationwide survey containing 10 questions regarding clinical routine during the sentinel node procedure and axillary treatment of non-vSLN patients was distributed among 510 oncological surgeons.ResultsThe survey was completed by 122 (24%) oncological surgeons, of whom 116 (95%) were registered as specialized breast surgeons. These surgeons had, on average, 13 years of experience. The majority of respondents used both lymphoscintigraphy and Patent Blue during the sentinel node procedure, and 39% estimated the prevalence of a non-vSLN to be 1–2%. Most surgeons are currently more reserved when considering whether to perform an axillary lymph node dissection (ALND) than prior to publication of the Z0011 trial (15 vs. 80%, respectively). Sixty percent base their decision on various clinicopathological characteristics. Twenty-three respondents (20%) opted for an alternative axillary treatment.ConclusionThis study shows that, in daily practice, most specialized breast surgeons think that a non-vSLN is rare. If so, most currently opt not to perform an ALND, whereas a small proportion consider an alternative axillary treatment. These decisions differ than in the period prior to the Z0011 trial. More research is needed to provide optimal treatment recommendations in case of a non-vSLN.

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

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

Abstract OT2-02-05: POSNOC: Positive sentinel node—Adjuvant therapy alone versus adjuvant therapy plus clearance or axillary radiotherapy: A randomised trial looking at axillary treatment in early breast cancer

Abstract Background Women with early breast cancer that has spread to 1 or 2 sentinel nodes (SNs) undergo axillary node clearance (ANC) or axillary radiotherapy (ART). The publication of the Z11 trial challenged this practice. There are however concerns about this trial which may limit the interpretation and generalisability of its results. These issues include the proportion of patients with micrometastases, variability in radiotherapy and applicability in patients undergoing mastectomy. Therefore further randomized trials are needed to define the role of axillary treatment in patients with 1 or 2 SNs with macrometastases. The UK-ANZ POSNOC trial is asking this question and will provide a more solid evidence base to inform clinical practice. Methods Trial design: A pragmatic, randomized, multicenter, non-inferiority trial. Interventions: All participants will receive systemic adjuvant therapy according to local guidelines and radiotherapy to breast or chest wall if indicated. Women in the intervention group will receive systemic adjuvant therapy alone, whereas those receiving standard care will receive adjuvant therapy plus ANC or ART. Study population: Women with unifocal or multifocal invasive breast cancer(≤5 cm) undergoing breast conserving surgery or mastectomy, who have 1 or 2 nodes with macrometastases at SN biopsy. The sample size is 1900 women. All participants will be followed up for 5 years. Primary outcome: axillary recurrence at 5 years. Secondary outcomes: arm morbidity, quality of life, anxiety, loco-regional recurrence, distant metastasis; time to axillary recurrence, axillary recurrence-free survival, disease-free and overall survival, contralateral breast cancer, non-breast malignancy and economic evaluation. Key differences from Z11 a) stringent radiotherapy quality assurance program, b) prospective pathology reporting, b) axillary ultrasound is mandatory, b) mastectomy patients are eligible, c) axillary treatment in the standard group may be ANC or ART. Current enrollment 126 patients. Further information Web - www.posnoc.co.uk Email - posnoc@nottingham.ac.uk Citation Format: Goyal A. POSNOC: Positive sentinel node—Adjuvant therapy alone versus adjuvant therapy plus clearance or axillary radiotherapy: A randomised trial looking at axillary treatment in early breast cancer. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr OT2-02-05.

Sentinel lymph node biopsy in patients with breast ductal carcinoma in situ: Chinese experiences.

The axillary treatment of patients with ductal carcinoma in situ (DCIS) remains controversial. The aim of the present study was to evaluate the roles of sentinel lymph node biopsy (SLNB) in patients with breast DCIS. A database containing the data from 262 patients diagnosed with breast DCIS and 100 patients diagnosed with DCIS with microinvasion (DCISM) who received SLNB between January 2002 and July 2014 was retrospectively analyzed. Of the 262 patients with DCIS, 9 presented with SLN metastases (3 macrometastases and 6 micrometastases). Patients with large tumors diagnosed by ultrasound or with tumors of high histological grade had a higher positive rate of SLNs than those without (P=0.037 and P<0.0001, respectively). Of the 100 patients with DCISM, 11 presented with metastases. Younger patients had a higher positive rate of SLNs (P=0.028). According to the results of this study and the systematic review of recent studies, the indications of SLNB for patients with DCIS are as follows: SLNB should be performed in all DCISM patients and in those DCIS patients who received mastectomy, and could be avoided in those who received breast-conserving surgery. However, SLNB should be recommended to patients who have high risks of harboring invasive components. The risk factors include a large, palpable tumor, a mammographic mass or a high histological grade.

Axillary treatment for patients with early breast cancer and lymph node metastasis: systematic review protocol

BackgroundFor patients with early breast cancer and lymph node metastasis, axillary treatment is widely recommended. This is either surgical removal of the axillary lymph nodes, or axillary radiotherapy. The rationale for axillary treatment is that it will reduce the risk of recurrence in the axilla, and may improve survival. However, both treatments are associated with adverse effects, such as lymphedema, pain and sensory loss, and are costly to the health services and to patients. With improvements in adjuvant therapy, routine axillary treatment may no longer offer any overall advantage.ObjectivesTo assess the short and long term benefits and adverse effects of routine axillary treatment (axillary lymph node clearance or axillary radiotherapy) for patients with lymph node positive early-stage breast cancer.Methods/DesignCriteria for potentially eligibility for the study will be that the participants are men and women with early breast cancer and lymph nodes with metastasis. The study compares either axillary treatment with no axillary treatment, or axillary node clearance with axillary radiotherapy, and the study is a randomized trial. Primary outcomes are axillary recurrence, disease-free and overall survival. Secondary outcomes include breast or chest wall recurrence, distant metastasis, time to axillary recurrence, axillary recurrence-free survival, arm morbidity, quality of life and health economic costs. The search strategy will include the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and WHO International Clinical Trials Registry Platform (ICTRP) search portal. Two independent reviewers will assess studies for inclusion in the review, assess study quality and extract data. Characteristics of included studies will be described. Meta-analysis will be conducted using ReVman software.CommentThis review addresses an important clinical question, and results will inform clinical practice and health care policy.

Regional Recurrence in Breast Cancer Patients With Sentinel Node Micrometastases and Isolated Tumor Cells

The impact of axillary treatment in daily practice on 5-year regional recurrence rate in breast cancer patients with isolated tumor cells or micrometastases in the sentinel node (SLN). Axillary dissection is recommended in patients with tumor-positive SLNs. But, in recent studies, regional recurrence rates seemed low if dissection was omitted. We identified all patients in The Netherlands with invasive breast cancer who had an SLN biopsy before 2006, favorable primary tumor characteristics, and node-negative disease, isolated tumor cells or micrometastases as final nodal status. The primary endpoint was regional recurrence rate. To investigate differences in recurrence rates between patients with and without axillary treatment, a proportional hazard regression was carried out correcting for potential confounders. In total, 857 patients with node-negative disease, 795 patients with isolated tumor cells, and 1028 patients with micrometastases in the SLN were included. Without axillary treatment, the 5-year regional recurrence rates were 2.3%, 2.0%, and 5.6%, respectively. Compared with patients who underwent axillary treatment, the adjusted hazard ratio for regional recurrence in patients who underwent an SLN procedure only was 1.08 (95% CI, 0.23-4.98) for node-negative disease, 2.39 (95% CI, 0.67-8.48) for isolated tumor cells, and 4.39 (95% CI, 1.46-13.24) for micrometastases. Doubling of tumor size, grade 3 and negative hormone receptor status were also significantly associated with recurrence. Not performing axillary treatment in patients with SLN micrometastases is associated with an increased 5-year regional recurrence rate. Axillary treatment is recommended in patients with SLN micrometastases and unfavorable tumor characteristics.

PD02-07: Models Predicting Non-Sentinel Node Involvement in Breast Cancer Also Predict for Regional Recurrence If the Axilla Is Not Treated.

Abstract Background Series on breast cancer patients with sentinel node (SN) isolated tumor cells or micrometastases show low recurrence rates in the presence of SN isolated tumor cells, and varying recurrence rates in the presence of SN micrometastases. Non-SN prediction models are frequently used as a decision aid to identify patients that may not need axillary treatment, but this still needs to be validated in respect to regional recurrence. Patients and Methods We followed a cohort of 486 patients in the MIRROR-study of whom none received axillary treatment with favorable primary tumor characteristics and pN0(i+)(sn) or pN1(mi)(sn) for a median of 5 years. The patients were categorized into low or high-risk subgroups based on several published non-SN prediction models (cut-off levels between models varied from 3 to 10%), i.e. the Tenon Scoring system, MSKCC nomogram, Stanford nomogram and a Dutch model (Bolster et al.). The primary endpoint was 5-year regional recurrence-free survival. Results The overall 5-year regional recurrence rate was 3.0% (+/− 0.1%). Using the Tenon scoring system, we identified 438 patients with a low risk score of 3.5 or lower with a 5-year regional recurrence rate of 2.3% (+/− 0.8%), compared to a recurrence rate of 10.1% (+/− 0.4%) in 48 patients with a score above 3.5. For the MSKCC nomogram a low risk score of 0.10 or lower identified 300 patients with a 5-year recurrence rate of 2.8% (+/− 1.1%), and a score above 0.10 identified 166 patients with a recurrence rate of 3.4% (+/− 1.5%) (20 patients not assessable). By the Stanford nomogram a low risk cutoff level of 10% identified 21 patients without recurrence, whereas 465 patients had a 3.2% (+/−0.9%) recurrence rate. Using a Dutch model, a low risk cutoff score of 20 discriminated between 384 patients with a 5-year recurrence rate of 2.2% (+/− 0.8%) and 102 patients with a recurrence rate of 6.3% (+/− 2.9%). Further analyses with different cut-off values and subgroups will be presented at the conference. Conclusion Using several published non-SN prediction models for predicting regional recurrence, the Tenon scoring system outperformed the other models in that it identified the largest subgroup of patients with a low recurrence rate. We would recommend axillary treatment in patients classified as high risk according to the Tenon score. Funding: Netherlands Organization for Health Research and Development (ZonMw 945-06-509). Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr PD02-07.

Selective Axillary Node Sampling and Radiotherapy to the Axilla in the Management of Breast Cancer

Aims Axillary treatment for patients with early-stage breast cancer can be associated with considerable morbidity. Techniques, such as axillary node sampling (ANS) and, more recently, sentinel node biopsy, in combination with radiotherapy have the potential to reduce toxicity. A retrospective review of axillary treatment in patients with early-stage breast cancer treated at our institution between 1997 and 2003 was carried out to assess the outcome and morbidity of ANS in combination with radiotherapy. Materials and methods The treatment policy was to carry out four-node, Edinburgh-style ANS except in those cases with either palpably enlarged nodes or cytological confirmation of involvement or with clinically obvious node involvement at surgery when level 2 axillary node clearance (ANC) was carried out. Patients with involved nodes after ANS received postoperative axillary radiotherapy. Results In total, 381 patients were included, 331 received ANS and 50 received ANC. The median follow-up was 6.5 years and overall survival at 5 years was 84%. Pathologically involved nodes were found in 152/331 (50%) ANS patients and 43/50 (86%) ANC patients. The rate of local recurrence (breast or chest wall) at 5 years was 4% (95% confidence interval 1–17%) in the ANC group and 2% (95% confidence interval 1–4%) in the ANS group. The nodal recurrence rate of those undergoing ANS was 3% (11/331) compared with 6% (3/50) for those treated by ANC. The rate of clinically significant lymphoedema at 5 years was significantly higher ( P = 0.01) in the ANC arm: 18% (95% confidence interval 9–32%) compared with 5% (95% confidence interval 3–8%) in those treated by ANS. Thirty-one cases received additional supraclavicular fossa irradiation because of the involvement of more than four nodes on ANS, which may not have been available with sentinel node biopsy and has implications for current practice. Conclusions Selective ANS with the removal of a minimum of four nodes guides optimal locoregional treatment with good local control rates, low overall morbidity and may obviate the need for a second surgical procedure.