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JAMA Sep 2017The results of the American College of Surgeons Oncology Group Z0011 (ACOSOG Z0011) trial were first reported in 2005 with a median follow-up of 6.3 years. Longer... (Randomized Controlled Trial)
Randomized Controlled Trial
Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial.
IMPORTANCE
The results of the American College of Surgeons Oncology Group Z0011 (ACOSOG Z0011) trial were first reported in 2005 with a median follow-up of 6.3 years. Longer follow-up was necessary because the majority of the patients had estrogen receptor-positive tumors that may recur later in the disease course (the ACOSOG is now part of the Alliance for Clinical Trials in Oncology).
OBJECTIVE
To determine whether the 10-year overall survival of patients with sentinel lymph node metastases treated with breast-conserving therapy and sentinel lymph node dissection (SLND) alone without axillary lymph node dissection (ALND) is noninferior to that of women treated with axillary dissection.
DESIGN, SETTING, AND PARTICIPANTS
The ACOSOG Z0011 phase 3 randomized clinical trial enrolled patients from May 1999 to December 2004 at 115 sites (both academic and community medical centers). The last date of follow-up was September 29, 2015, in the ACOSOG Z0011 (Alliance) trial. Eligible patients were women with clinical T1 or T2 invasive breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases.
INTERVENTIONS
All patients had planned lumpectomy, planned tangential whole-breast irradiation, and adjuvant systemic therapy. Third-field radiation was prohibited.
MAIN OUTCOMES AND MEASURES
The primary outcome was overall survival with a noninferiority hazard ratio (HR) margin of 1.3. The secondary outcome was disease-free survival.
RESULTS
Among 891 women who were randomized (median age, 55 years), 856 (96%) completed the trial (446 in the SLND alone group and 445 in the ALND group). At a median follow-up of 9.3 years (interquartile range, 6.93-10.34 years), the 10-year overall survival was 86.3% in the SLND alone group and 83.6% in the ALND group (HR, 0.85 [1-sided 95% CI, 0-1.16]; noninferiority P = .02). The 10-year disease-free survival was 80.2% in the SLND alone group and 78.2% in the ALND group (HR, 0.85 [95% CI, 0.62-1.17]; P = .32). Between year 5 and year 10, 1 regional recurrence was seen in the SLND alone group vs none in the ALND group. Ten-year regional recurrence did not differ significantly between the 2 groups.
CONCLUSIONS AND RELEVANCE
Among women with T1 or T2 invasive primary breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases, 10-year overall survival for patients treated with sentinel lymph node dissection alone was noninferior to overall survival for those treated with axillary lymph node dissection. These findings do not support routine use of axillary lymph node dissection in this patient population based on 10-year outcomes.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT00003855.
Topics: Adult; Aged; Aged, 80 and over; Axilla; Breast Neoplasms; Combined Modality Therapy; Disease-Free Survival; Female; Follow-Up Studies; Humans; Lymph Node Excision; Lymphatic Metastasis; Mastectomy, Segmental; Middle Aged; Multivariate Analysis; Neoplasm Invasiveness; Sentinel Lymph Node; Sentinel Lymph Node Biopsy; Survival Rate
PubMed: 28898379
DOI: 10.1001/jama.2017.11470 -
Seminars in Oncology Dec 2020This historical surgical retrospection focuses on the temporal de-escalation axillary surgery, focusing on the unceasing efforts of researchers toward new challenges, as... (Review)
Review
This historical surgical retrospection focuses on the temporal de-escalation axillary surgery, focusing on the unceasing efforts of researchers toward new challenges, as documented by extensive studies and trials. Axillary surgery has evolved, aiming to offer the best oncologic treatment and improve the quality of life of women. Axillary lymph-node dissection (ALND) has been replaced by sentinel lymph-node biopsy (SLNB) in women with early clinically node-negative breast cancer, providing adequate axillary nodal staging information with minimal morbidity, and becoming the standard of care in the management of breast cancer. However, this is only the beginning. Strategies in defining systemic and radiotherapeutic treatments have gradually been optimized, offering increasingly refined and targeted breast cancer treatment tools. In recent years, the paradigm of completion ALND after a positive SLNB has been questioned, and several studies have led to revolutionary changes in clinical practice. Moreover, the increasingly pivotal role played by neoadjuvant chemotherapy (NAC) has had a profound effect on the extent of axillary surgery, paving the way to a more finite "targeted" procedure in women with node-positive breast cancer who convert to negative nodes clinically after NAC. The utility of SLNB itself and its subsequent omission in women with negative nodes clinically and breast conservative surgery is also under scientific evaluation. The changes over time in the surgical approach to breast cancer have been numerous and significant. The novel emerging perspective characterized by recent advances in biology and genetics, in dedicated axillary ultrasound imaging and chemotherapy regimens, is the present reality that points to the future of axillary node treatment in breast cancer.
Topics: Axilla; Breast Neoplasms; Chemotherapy, Adjuvant; History, 15th Century; History, 16th Century; History, 17th Century; History, 18th Century; History, 19th Century; History, 20th Century; History, 21st Century; History, Ancient; History, Medieval; Humans; Lymph Node Excision; Sentinel Lymph Node Biopsy
PubMed: 33131896
DOI: 10.1053/j.seminoncol.2020.09.001 -
Nature Communications Mar 2020Accurate identification of axillary lymph node (ALN) involvement in patients with early-stage breast cancer is important for determining appropriate axillary treatment...
Accurate identification of axillary lymph node (ALN) involvement in patients with early-stage breast cancer is important for determining appropriate axillary treatment options and therefore avoiding unnecessary axillary surgery and complications. Here, we report deep learning radiomics (DLR) of conventional ultrasound and shear wave elastography of breast cancer for predicting ALN status preoperatively in patients with early-stage breast cancer. Clinical parameter combined DLR yields the best diagnostic performance in predicting ALN status between disease-free axilla and any axillary metastasis with areas under the receiver operating characteristic curve (AUC) of 0.902 (95% confidence interval [CI]: 0.843, 0.961) in the test cohort. This clinical parameter combined DLR can also discriminate between low and heavy metastatic burden of axillary disease with AUC of 0.905 (95% CI: 0.814, 0.996) in the test cohort. Our study offers a noninvasive imaging biomarker to predict the metastatic extent of ALN for patients with early-stage breast cancer.
Topics: Adult; Aged; Aged, 80 and over; Axilla; Breast; Breast Neoplasms; Deep Learning; Elasticity Imaging Techniques; Female; Humans; Image Processing, Computer-Assisted; Lymph Node Excision; Lymph Nodes; Lymphatic Metastasis; Mastectomy; Middle Aged; Neoplasm Staging; Preoperative Period; Prognosis; Prospective Studies; ROC Curve; Reference Standards; Ultrasonography
PubMed: 32144248
DOI: 10.1038/s41467-020-15027-z -
The Oncologist Feb 2020The detection of lymph node metastasis affects the management of patients with primary breast cancer significantly in terms of staging, treatment, and prognosis. The... (Review)
Review
The detection of lymph node metastasis affects the management of patients with primary breast cancer significantly in terms of staging, treatment, and prognosis. The main goal for the radiologist is to determine and detect the presence of metastatic disease in nonpalpable axillary lymph nodes with a positive predictive value that is high enough to initially select patients for upfront axillary lymph node dissection. Features that are suggestive of axillary adenopathy may be seen with different imaging modalities, but ultrasound is the method of choice for evaluating axillary lymph nodes and for performing image-guided lymph node interventions. This review aims to provide a comprehensive overview of the available imaging modalities for lymph node assessment in patients diagnosed with primary breast cancer. IMPLICATIONS FOR PRACTICE: The detection of lymph node metastasis affects the management of patients with primary breast cancer. The main goal for the radiologist is to detect lymph node metastasis in patients to allow for the selection of patients who should undergo upfront axillary lymph node dissection. Features that are suggestive of axillary adenopathy may be seen with mammography, computed tomography, and magnetic resonance imaging, but ultrasonography is the imaging modality of choice for evaluating axillary lymph nodes. A normal axillary lymph node is characterized by a reniform shape, a maximal cortical thickness of 3 mm without focal bulging, smooth margins, and, depending on size, a discernable central fatty hilum.
Topics: Axilla; Breast Neoplasms; Female; Humans; Lymph Node Excision; Lymph Nodes; Lymphatic Metastasis; Neoplasm Staging; Sensitivity and Specificity; Sentinel Lymph Node Biopsy
PubMed: 32043792
DOI: 10.1634/theoncologist.2019-0427 -
JAMA Oncology Dec 2021Prospective trials have demonstrated sentinel lymph node (SLN) false-negative rates of less than 10% when 3 or more SLNs are retrieved in patients with clinically...
IMPORTANCE
Prospective trials have demonstrated sentinel lymph node (SLN) false-negative rates of less than 10% when 3 or more SLNs are retrieved in patients with clinically node-positive breast cancer rendered clinically node-negative with neoadjuvant chemotherapy (NAC). However, rates of nodal recurrence in such patients treated with SLN biopsy (SLNB) alone are unknown because axillary lymph node dissection (ALND) was performed in all patients, limiting adoption of this approach.
OBJECTIVE
To evaluate nodal recurrence rates in a consecutive cohort of patients with clinically node-positive (cN1) breast cancer receiving NAC, followed by a negative SLNB using a standardized technique, and no further axillary surgery.
DESIGN, SETTING, AND PARTICIPANTS
From November 2013 to February 2019, a cohort of consecutively identified patients with cT1 to cT3 biopsy-proven N1 breast cancer rendered cN0 by NAC underwent SLNB with dual tracer mapping and omission of ALND if 3 or more SLNs were identified and all were pathologically negative. Metastatic nodes were not routinely clipped, and localization of clipped nodes was not performed. The study was performed in a single tertiary cancer center.
INTERVENTION
Omission of ALND in patients with cN1 breast cancer after NAC if 3 or more SLNs were pathologically negative.
MAIN OUTCOME AND MEASURES
The primary outcome was the rate of nodal recurrence among patients with cN1 breast cancer treated with SLNB alone after NAC.
RESULTS
Of 610 patients with cN1 breast cancer treated with NAC, 555 (91%) converted to cN0 and underwent SLNB; 234 (42%) had 3 or more negative SLNs and had SLNB alone. The median (IQR) age of these 234 patients was 49 (40-58) years; median tumor size was 3 cm; 144 (62%) were ERBB2 (formerly HER2)-positive, and 43 (18%) were triple negative. Most (212 [91%]) received doxorubicin-based NAC; 205 (88%) received adjuvant radiotherapy (RT), and 164 (70%) also received nodal RT. At a median follow-up of 40 months, there was 1 axillary nodal recurrence synchronous with local recurrence in a patient who refused RT. Among patients who received RT (n = 205), there were no nodal recurrences.
CONCLUSIONS AND RELEVANCE
This cohort study found that in patients with cN1 disease rendered cN0 with NAC, with 3 or more negative SLNs with SLNB alone, nodal recurrence rates were low, without routine nodal clipping. These findings potentially support omitting ALND in such patients.
Topics: Axilla; Breast Neoplasms; Cohort Studies; Female; Humans; Lymph Node Excision; Middle Aged; Neoadjuvant Therapy; Prospective Studies; Sentinel Lymph Node Biopsy
PubMed: 34617979
DOI: 10.1001/jamaoncol.2021.4394 -
Journal of Clinical Oncology : Official... Apr 2016Placing clips in nodes with biopsy-confirmed metastasis before initiating neoadjuvant therapy allows for evaluation of response in breast cancer. Our goal was to...
Improved Axillary Evaluation Following Neoadjuvant Therapy for Patients With Node-Positive Breast Cancer Using Selective Evaluation of Clipped Nodes: Implementation of Targeted Axillary Dissection.
PURPOSE
Placing clips in nodes with biopsy-confirmed metastasis before initiating neoadjuvant therapy allows for evaluation of response in breast cancer. Our goal was to determine if pathologic changes in clipped nodes reflect the status of the nodal basin and if targeted axillary dissection (TAD), which includes sentinel lymph node dissection (SLND) and selective localization and removal of clipped nodes, improves the false-negative rate (FNR) compared with SLND alone.
METHODS
A prospective study of patients with biopsy-confirmed nodal metastases with a clip placed in the sampled node was performed. After neoadjuvant therapy, patients underwent axillary surgery and the pathology of the clipped node was compared with other nodes. Patients undergoing TAD had SLND and selective removal of the clipped node using iodine-125 seed localization. The FNR was determined in patients undergoing complete axillary lymphadenectomy (ALND).
RESULTS
Of 208 patients enrolled in this study, 191 underwent ALND, with residual disease identified in 120 (63%). The clipped node revealed metastases in 115 patients, resulting in an FNR of 4.2% (95% CI, 1.4 to 9.5) for the clipped node. In patients undergoing SLND and ALND (n = 118), the FNR was 10.1% (95% CI, 4.2 to 19.8), which included seven false-negative events in 69 patients with residual disease. Adding evaluation of the clipped node reduced the FNR to 1.4% (95% CI, 0.03 to 7.3; P = .03). The clipped node was not retrieved as an SLN in 23% (31 of 134) of patients, including six with negative SLNs but metastasis in the clipped node. TAD followed by ALND was performed in 85 patients, with an FNR of 2.0% (1 of 50; 95% CI, 0.05 to 10.7).
CONCLUSION
Marking nodes with biopsy-confirmed metastatic disease allows for selective removal and improves pathologic evaluation for residual nodal disease after chemotherapy.
Topics: Adult; Aged; Antineoplastic Agents; Axilla; Breast Neoplasms; Chemotherapy, Adjuvant; False Negative Reactions; Female; Humans; Lymph Node Excision; Lymph Nodes; Lymphatic Metastasis; Middle Aged; Neoadjuvant Therapy; Neoplasm Staging; Neoplasm, Residual; Prospective Studies; Sentinel Lymph Node Biopsy
PubMed: 26811528
DOI: 10.1200/JCO.2015.64.0094 -
JAMA Surgery Oct 2023The role of axillary lymph node dissection (ALND) to determine nodal burden to inform systemic therapy recommendations in patients with clinically node (cN)-positive... (Randomized Controlled Trial)
Randomized Controlled Trial Observational Study
IMPORTANCE
The role of axillary lymph node dissection (ALND) to determine nodal burden to inform systemic therapy recommendations in patients with clinically node (cN)-positive breast cancer (BC) is currently unknown.
OBJECTIVE
To address the association of ALND with systemic therapy in cN-positive BC in the upfront surgery setting and after neoadjuvant chemotherapy (NACT).
DESIGN, SETTING, AND PARTICIPANTS
This was a prospective, observational, cohort study conducted from August 2018 to June 2022. This was a preplanned study within the phase 3 randomized clinical OPBC-03/TAXIS trial. Included were patients with confirmed cN-positive BC from 44 private, public, and academic breast centers in 6 European countries. After NACT, residual nodal disease was mandatory, and a minimum follow-up of 2 months was required.
EXPOSURES
All patients underwent tailored axillary surgery (TAS) followed by ALND or axillary radiotherapy (ART) according to TAXIS randomization. TAS removed suspicious palpable and sentinel nodes, whereas imaging-guidance was optional. Systemic therapy recommendations were at the discretion of the local investigators.
RESULTS
A total of 500 patients (median [IQR] age, 57 [48-69] years; 487 female [97.4%]) were included in the study. In the upfront surgery setting, 296 of 335 patients (88.4%) had hormone receptor (HR)-positive and Erb-B2 receptor tyrosine kinase 2 (ERBB2; formerly HER2 or HER2/neu)-negative disease: 145 (49.0%) underwent ART, and 151 (51.0%) underwent ALND. The median (IQR) number of removed positive lymph nodes without ALND was 3 (1-4) nodes compared with 4 (2-9) nodes with ALND. There was no association of ALND with the proportion of patients undergoing adjuvant chemotherapy (81 of 145 [55.9%] vs 91 of 151 [60.3%]; adjusted odds ratio [aOR], 0.72; 95% CI, 0.19-2.67) and type of systemic therapy. Of 151 patients with NACT, 74 (51.0%) underwent ART, and 77 (49.0%) underwent ALND. The ratio of removed to positive nodes was a median (IQR) of 4 (3-7) nodes to 2 (1-3) nodes and 15 (12-19) nodes to 2 (1-5) nodes in the ART and ALND groups, respectively. There was no observed association of ALND with the proportion of patients undergoing postneoadjuvant systemic therapy (57 of 74 [77.0%] vs 55 of 77 [71.4%]; aOR, 0.86; 95% CI, 0.43-1.70), type of postneoadjuvant chemotherapy (eg, capecitabine: 10 of 74 [13.5%] vs 10 of 77 [13.0%]; trastuzumab emtansine-DM1: 9 of 74 [12.2%] vs 11 of 77 [14.3%]), or endocrine therapy (eg, aromatase inhibitors: 41 of 74 [55.4%] vs 36 of 77 [46.8%]; tamoxifen: 8 of 74 [10.8%] vs 6 of 77 [7.8%]).
CONCLUSION
Results of this cohort study suggest that patients without ALND were significantly understaged. However, ALND did not inform systemic therapy recommendations.
Topics: Humans; Female; Middle Aged; Breast Neoplasms; Sentinel Lymph Node Biopsy; Lymphatic Metastasis; Cohort Studies; Prospective Studies; Lymph Node Excision; Lymph Nodes; Neoadjuvant Therapy; Axilla
PubMed: 37466971
DOI: 10.1001/jamasurg.2023.2840 -
The Surgical Clinics of North America Dec 2021Breast surgical oncology is a rapidly evolving field with significant advances shaped by practice-changing research. Three areas of ongoing controversy are (1) high... (Review)
Review
Breast surgical oncology is a rapidly evolving field with significant advances shaped by practice-changing research. Three areas of ongoing controversy are (1) high rates of contralateral prophylactic mastectomy (CPM) in the United States despite uncertain benefit, (2) indications for and use of neoadjuvant chemotherapy (NACT) and endocrine therapy (NET), and (3) staging and treatment of the axilla, particularly after neoadjuvant systemic therapy. We discuss the patient populations for whom CPM may or may not be beneficial, indications for NACT and NET, and the trend toward de-escalation of locoregional axillary treatment.
Topics: Antineoplastic Agents; Antineoplastic Agents, Hormonal; Axilla; Breast Neoplasms; Combined Modality Therapy; Female; Humans; Lymph Node Excision; Mammaplasty; Mastectomy; Neoadjuvant Therapy; Neoplasm Staging; Prophylactic Mastectomy
PubMed: 34774266
DOI: 10.1016/j.suc.2021.06.002 -
Ugeskrift For Laeger Mar 2024Surgical treatment of breast cancer has changed towards less invasive procedures as summarised in this review. Breast conserving surgery (BCS) and radiotherapy (RT) are... (Review)
Review
Surgical treatment of breast cancer has changed towards less invasive procedures as summarised in this review. Breast conserving surgery (BCS) and radiotherapy (RT) are now recommended as standard of care. Several flexible marking methods for removal of non-palpable tumours have gradually replaced wire-guided localisation. Neoadjuvant systemic treatment increases tumour shrinkage and BCS and may lead to omission of axillary clearance (AC). The prognostic significance of AC in patients with metastases to 1-2 sentinel nodes at primary surgery is questioned. Results from the SENOMAC trial are expected to change guidelines from AC to axillary RT.
Topics: Female; Humans; Axilla; Breast Neoplasms; Lymph Node Excision; Lymph Nodes; Lymphatic Metastasis; Mastectomy, Segmental; Sentinel Lymph Node Biopsy
PubMed: 38533870
DOI: 10.61409/V01230033 -
Chirurgia (Bucharest, Romania : 1990) 2014The present paper is a presentation of our technique of axillopexy, used after the excision of the axillary lymph nodes in 29 cases of breast cancer patients. We have...
The present paper is a presentation of our technique of axillopexy, used after the excision of the axillary lymph nodes in 29 cases of breast cancer patients. We have used this technique after Madden modified radical mastectomy or after quadrantectomy for tumors in the external quadrants of the mammary gland. We have studied and compared with a 30 case control group, the duration of the lymphorrhagia the moment of removing the drains, the presence absence of other local complications. We have also measured the time until the beginning of the oncological postoperative therapy. Every one of the aspects we have studied was improved in the axillopexy group.
Topics: Axilla; Breast Neoplasms; Case-Control Studies; Drainage; Female; Humans; Lymph Node Excision; Mastectomy, Modified Radical; Mastectomy, Segmental; Romania; Treatment Outcome
PubMed: 25149619
DOI: No ID Found