Completion Axillary Lymph Node Dissection Research Articles

Evaluating the role of level 3 axillary lymph node dissection in metastatic melanoma: Can we predict involvement?

MSLT-2 and DECOG-SLT established that immediate complete axillary lymph node dissection (CLND) did not correlate with an increase in melanoma-specific survival when compared with active ultrasound observation in patients with sentinel lymph node(SLN)-positivedisease. After those trials, there was a shift towardperforming CLND only for clinically node-positive disease. With these changes, we sought to determine the role of level III axillary lymph nodes in bulky disease and how the use of neoadjuvant therapy may impact the rate of positivity in level III axillary nodes. We performed a retrospective chart review on all patients who underwent axillary CLND for cutaneous melanoma by one surgeon at an academic center from 2014 to 2022. These patients underwent CLND based on either having SLN+ disease or having clinically palpable or radiographically bulky disease. Of 95 patients included, there were 7 (7.3%) patients with level III positivity. One was SLN+ (1.0%), while 3 (3.1%) had bulky disease and neoadjuvant therapy, and 3 (3.1%) had bulky disease without neoadjuvant therapy. No preoperative factors were identified that predicted level III involvement. After performing CLND, the patients who had clinically palpable or radiographically bulky disease and neoadjuvant therapy had higher percent necrosis of nodes in levels I and II but not III.At 5 years, overall survival and recurrence-free survival were improved in those without level III involvement (58%and 64%, respectively) when compared to those with level III involvement (41% and50%), though this was not statistically significant. Further study may identify better prognostic factors for level III positivity, allowing for the possibility of dissecting only levels I and II or even replacing CLND with targeted node dissections.

Factors Associated With Additional Axillary Disease in Patients With Positive Sentinel Lymph Nodes After Neoadjuvant Chemotherapy for Breast Cancer.

Background: In previous studies, breast cancer patients with positive sentinel lymph node(s) (SLN) after neoadjuvant chemotherapy (NAC) frequently had additional nonSLN involvement. Per guidelines, residual SLN disease warrants completion axillary lymph node dissection (cALND), which has increased morbidity. Given recent improvements in NAC, we hypothesized that nonSLN positivity may be lower than previously reported for certain subgroups.Methods: We retrospectively reviewed breast cancer patients who received NAC and had positive lymph nodes on SLN biopsy or targeted axillary dissection and underwent cALND at one institution in 1/2018-8/2023. Associations between nonSLN positivity and clinicopathologic factors were assessed with Fisher's exact test and multivariable logistic regression.Results: There were 122 female patients. Median age was 48years. Initially, 15 patients (12.3%) were cN0 and 107 patients (87.7%) were cN1. Largest SLN deposit was macrometastasis in 96 patients (78.7%), micrometastasis in 23 patients (18.9%), and isolated tumor cells in 3 patients (2.5%). Overall, 53 patients (43.4%) had nonSLN involvement. NonSLN positivity was higher in patients with cN1, ER+ HER2-, ypT2-3, SLN macrometastasis, and multiple positive SLN. On multivariable analysis, cN1 and ER+ HER2- remained associated with nonSLN positivity.Discussion: Among patients with positive SLN after NAC, clinically node positive and ER+ HER2- patients were more likely to have nonSLN involvement. Our findings support guidelines to consider omitting cALND in clinically node negative patients. With improving NAC, optimal axillary sampling, and radiation, omitting cALND may be safe in some clinically node positive triple negative or HER2+ patients with low volume residual disease, but further research is needed.

Abstract GS02-06: Recurrence-free survival following sentinel node-positive breast cancer without completion axillary lymph node dissection – first results from the international randomized SENOMAC trial

Abstract Background The omission of a completion axillary lymph node dissection (cALND) after a positive sentinel lymph node (SLN) biopsy in patients with clinically node-negative breast cancer has been demonstrated to yield survival outcomes non-inferior to routine cALND in breast-conserving surgery followed by whole-breast irradiation (ACOSOG Z0011 and IBCSG 23-01 trials), and to axillary radiotherapy (RT) regardless of breast surgery (EORTC AMAROS trial). Mainly due to the under-representation of mastectomy patients, and a limited number of observed events compromising statistical power, the international randomized SENOMAC trial was initiated in 2015. The main aim of this non-inferiority trial was to address knowledge gaps relating to individuals treated by mastectomy, those with larger tumors and those with SLN extracapsular extension. Method The SENOMAC trial (NCT 02240472) enrolled patients with cT1-3cN0 primary breast cancer and 1-2 SLN macrometastases at 67 sites in five countries between January 27, 2015, and December 31, 2021. Participants were randomized 1:1 between cALND (standard) and omission of cALND (intervention). Stratification was per country. Breast-conserving surgery and mastectomy were eligible surgical interventions. Preoperative axillary ultrasound was mandatory; patients with non-palpable suspicious axillary lymph nodes, even if proven metastatic by biopsy, were eligible. SLN extracapsular extension was allowed. Adjuvant radiotherapy was dictated by national guidelines and not by the trial protocol. Statistical sample size calculation was based on the primary outcome overall survival. Non-inferiority was defined as a 5-year overall survival not worsened by more than 2.5% when refraining from cALND after the observation of 190 all-cause deaths in a target sample size of 3000 included patients. In the present analysis, the pre-specified secondary outcome of recurrence-free survival is reported. Results Out of 2766 randomized individuals, 2539 comprised the per-protocol population: 1204 in the standard and 1335 in the intervention group. Median follow-up was 37.1 months (1.5-75.0) and median age at inclusion 61 years (range 20-94). Most tumors belonged to the luminal subtype (93.6%); tumor stage was T1 in 1358 (53.5%), T2 in 1034 (40.7%) and T3 in 146 participants (5.8%). Out of 347 participants with suspicious lymph nodes on ultrasound, 36 had confirmed non-palpable metastasis. SLN extracapsular extension was reported in 866 (34.1%). The breast was conserved in 1621 (63.8%) and a mastectomy performed in 918 (36.2%) patients. Most patients (2127, 83.8%) received radiotherapy including nodal target volumes. In 34.1% of the standard group, additional non-SLN metastases were identified on cALND. Overall, 104 recurrences were reported, 54 (4.5%) in the standard and 50 (3.7%) in the intervention group. Of these, 11 recurrences were found in the ipsilateral axilla: 5 (0.4%) and 6 (0.5%), respectively. Recurrence-free survival did not differ between groups (country-adjusted HR 0.89, 95% CI 0.65-1.20). Conclusion Despite extended inclusion criteria, there was no difference in recurrence-free survival whether cALND was omitted (intervention) or not (standard). Patients undergoing mastectomy will specifically be addressed in subgroup analyses. Long-term follow-up is crucial considering the high proportion of luminal cancers. Citation Format: Jana de Boniface, Tove Tvedskov, Bergkvist Leif, Jan Frisell, Yvette Andersson, Sara Alkner, Malin Sund, Roger Olofsson Bagge, Dan Lundstedt, Oreste Davide Gentilini, Michalis Kontos, Toralf Reimer, Birgitte Offersen, Thorsten Kühn, Lisa Rydén, Peer Christiansen. Recurrence-free survival following sentinel node-positive breast cancer without completion axillary lymph node dissection – first results from the international randomized SENOMAC trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr GS02-06.

Abstract PO4-20-05: An open label phase III randomized trial to evaluate the efficacy of Post-chemotherapy Axillary Conservation Surgery in breast cancer (PACS)

Abstract Background- Axillary lymph nodes (ALN) status is the most important prognostic factor in breast cancer. Traditionally, a complete axillary lymph node dissection (ALND) has been standard of care for those patients who have a positive node pre-chemotherapy. However, lately axillary conservation is paving its way in the post-chemotherapy setting as well to avoid significant morbidity of ALND. Most sentinel node biopsy studies have failed to achieve the desired false negative rate(FNR). (Boughey JC et al, JAMA. 2013 Oct; Kuehn T et al, Lancet Oncol. 2013; Boileau JF et al, J Clin Oncol. 2015 Jan).We previously reported a low FNR of low axillary sampling (LAS) in the post-chemotherapy setting. (Parmar et al, JCO-GO, 2021) We are conducting a phase III, randomised controlled trial of LAS versus complete ALND in post-chemotherapy negative (ypN0) axilla. Aims and objectives- The primary objective is to assess the non-inferiority of LAS in patients who are rendered ypN0 by pre-operative chemotherapy with disease-free survival as primary end point. The secondary objectives are comparing the morbidity of ALND (lymphedema, paraesthesia, and shoulder dysfunction) in the LAS and ALND arms, and to evaluate the impact on overall survival, local, regional, and distant recurrence free survival and quality of life. Trial design- This is a prospective, open label, randomised, phase III trial where histologically proven, non-metastatic, cT1-4,N0-2 breast cancer patients who are rendered ycN0 after pre-operative systemic chemotherapy are being accrued. Patients with prechemo N3 disease, inflammatory breast cancer, recurrent disease, pregnancy associated breast cancer are being excluded from the study. The chemotherapy regimens and surgical assessment is as per standard institutional protocols. After obtaining informed consent, patients undergo LAS during surgery and lymph nodes(LN) are sent for frozen section analysis. If any LN is found to be involved, a complete ALND is carried out. If the staging procedure is negative, then patients are randomised into 2 groups- observation v/s complete ALND. Stratification factors are T stage, N stage, Hormone receptor status, Her2 receptor status and number of chemotherapy cycles taken. Morbidity assessment is done with- Constans shoulder score, arm volumetry, paraesthesia assessment, and a QOL questionnaire- Self-reported Breast cancer Lymphedema Symptom Experience Index (BCLSEI). A baseline assessment pre-surgery is followed by 6 monthly morbidity assessments and regular oncologically relevant follow-up up to 5 years. A two-sided log-rank test with an overall sample size of 2316 with a 10% dropout rate (1158 in ALND and 1158 in LAS group) achieves 80% power at a 0.05 significance level to detect a hazard ratio of 1.16 (upper limit of non-inferiority) when the proportion surviving in the control group is 0.71. An interim analysis will be carried out at 25% events and conditional power will be calculated. If the conditional power is below 20%, then the study will be discontinued for futility. The study has been approved by Institutional Ethics Committee (CTRI/2022/07/044461) Expected Study and Results- We started accrual in February 2023 and have screened 63 and randomized 45 patients until now. Ours is a first large randomised prospective study in the post-chemotherapy axillary management setting which will help us understand the efficacy of axillary conservation surgery in patients who are node negative post neoadjuvant chemotherapy. In future, lesser morbid procedures than LAS like targeted axillary dissection can be tested in the same trial. However, LAS as a technique of axillary conservation suits resource constraints and high volume setting such as ours. Citation Format: Shalaka Joshi, Jessicka Shah, Pallavi Daphale, Rohini Hawaldar, Anuradha Daptardar, Ayushi Sahay, Tanuja Shet, Palak Popat, Tabassum Wadasadawala, Nita Nair, Vani Parmar, Bipin Bandre, Shabina Siddique, Vaibhav Vanmali, Sudeep Gupta, Rajendra Badwe. An open label phase III randomized trial to evaluate the efficacy of Post-chemotherapy Axillary Conservation Surgery in breast cancer (PACS) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-20-05.

Abstract GS02-02: Are nodal ITCs after neoadjuvant chemotherapy an indication for axillary dissection? The OPBC05/EUBREAST-14R/ICARO study

Abstract Background: In patients with micro- and macrometastases in the sentinel lymph node (SLN) after neoadjuvant chemotherapy (NAC), additional positive nodes are found in >60% of cases and axillary lymph node dissection (ALND) is currently considered standard of care. The likelihood of finding additional positive lymph nodes in patients with residual isolated tumor cells (ITCs) is unknown, and the benefit of ALND is unclear. As a consequence, surgical management of the axilla in these patients is not standardized. We sought to evaluate how often additional positive lymph nodes are found, to determine factors associated with ALND, and to compare oncological outcomes in patients treated with and without ALND after identification of residual ITCs in the SLN. Methods: Data were collected from 42 centers: 20 in the Oncoplastic Breast Consortium (OPBC) and EUBREAST networks, and 22 in North and South America. We included patients with cT1-4 N0-3 breast cancer at diagnosis who underwent NAC followed by axillary staging with either SLN biopsy (SLNB) or targeted axillary dissection (TAD) and were found to have residual ITCs [ypN0(i+)]. Single-tracer mapping was allowed for cN0 patients, while dual mapping or TAD was required for cN+ cases. Axillary treatment included completion ALND and/or nodal radiotherapy (RT). Competing risk analysis was performed to assess the cumulative incidence rates of any axillary recurrence (AR), locoregional recurrence (LRR), and any invasive (locoregional or distant) recurrence. Five-year cumulative incidence rates were compared between patients who underwent ALND and those who did not using the Gray’s test. Type I error rate was set to 0.05 (α). Results: We included 412 patients treated with NAC followed by surgery from 01/2009-05/2022. 146 (35.4%) had completion ALND and 266 (64.6%%) did not. Median patient age was 48 years. The majority (57%) of patients had clinical T2 tumors, and 68% had biopsy-proven N1 disease. Most were HR+/HER2- (41%) or HER2+ (39%). Most patients (80%) received anthracycline and taxane-based chemotherapy regimens. Nodal RT was administered to 83% of patients. The median number of SLNs with ITCs was 1. Patients treated with ALND were more likely to have ITCs detected on frozen section (61% v 6.7%, p< 0.001), to have N2/3 disease at presentation (15.1% v 5.6%, p=0.001) and to have LVI (40% v 26%, p=0.004) (Table 1). There was no significant trend over time in the proportion of patients undergoing completion ALND during the study period (p=0.5). In the ALND group, additional positive nodes were found in 43/146 (29.5%) of cases, and consisted of macrometastases in 11/146 (7.5%), micrometastases in 9/146 (6.2%), and ITCs in 23/146 (15.8%). 5-year rates of any AR, LRR, and any invasive recurrence in the entire cohort were 2.7% (95% CI 1.2-5.4), 2.8% (95% CI 1.2-5.4) and 16% (95% CI 11-21), respectively. There was no statistical difference between patients who underwent ALND and those who did not in any of the 3 endpoints (2.2% v 3.1%, p=0.6), (2.6% v 3.0%, p=0.4) and (14% v 18%, p=0.12), respectively. Conclusion: The likelihood of finding additional positive lymph nodes in patients with ITCs after NAC is lower than in patients with residual micro- and macrometastases, and in the majority of cases, they contain ITCs. Nodal recurrence after omission of ALND is rare in this population. Overall, these results do not support routine ALND in patients with residual ITCs. Table 1. Clinicopathological Features of the Study Cohort, Stratified by Type of Axillary Surgery Frequency (row percent) reported for categorical variables, and median (IQR) reported for continuous variables. SLNB sentinel lymph node biopsy; TAD targeted axillary dissection; SLNs sentinel lymph nodes; LNs lymph nodes; pCR pathologic complete response; ACT anthracycline and taxane; AC anthracycline; H Herceptin, HP, Herceptin and Perjeta; TC taxol (or Taxotere) and carboplatinum; LVI lymphovascular invasion; BCS breast-conserving surgery. ^ Applied to HER2- tumors only (n=252). ^^ Applies to HER2+ tumors only (n=160). # LVI was present on core biopsy or final pathology. * Applies to BCS patients only (n=175). ** Applies to mastectomy patients only (n=237). Citation Format: Giacomo Montagna, Alison Laws, Massimo Ferrucci, Mary Mrdutt, Natália Polidorio, Varadan Sevilimedu, Tracy-Ann Moo, Andrea Barrio, Marissa K. Boyle, Flavia Vidal Cabero, Daniela Cocco, Fabio Corsi, Angelena Crown, Meghan R. Flanagan, Mehmet Ali Gulcelik, Callie Hlavin, Justyna Jelinska, Hasan Karanlik, Susan Kesmodel, Henry Kuerer, Sherko Küemmel, Cornelia Leo, Tehillah Menes, Melissa Pilewskie, Nina Pislar, Nicola Rocco, Jai Min Ryu, Leonardo Soares, Christoph Tausch, M. Umit Ugurlu, CICERO URBAN, Astrid Botty van de Bruele, Denise Vorburger, Fredrik Wärnberg, Anna Weiss, Austin Williams, Stephanie Wong, Steven G. Woodward, Susie X. Sun, Jennifer Q. Zhang, M. Firdos Ziauddin, Guldeniz Karadeniz Cakmak, Nuran Bese, Thorsten Kühn, Judy Boughey, Tari King, Nina Ditsch, Maggie Banys-Paluchowski, Monica Morrow, Walter Weber. Are nodal ITCs after neoadjuvant chemotherapy an indication for axillary dissection? The OPBC05/EUBREAST-14R/ICARO study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr GS02-02.

Abstract PS18-07: Trends in Guideline Concordant Care for Inflammatory Breast Cancer: An analysis of the National Cancer Database

Abstract Background: Inflammatory breast carcinoma (IBC) is an aggressive form of breast cancer associated with worse survival outcomes compared with other subtypes of breast cancer. Black patients with IBC have worse survival outcomes than White patients. Trimodality treatment (TMT) which includes neoadjuvant chemotherapy (NCT) followed by modified radical mastectomy without immediate reconstruction (MRM), and postmastectomy radiotherapy (PMRT), has been associated with improved survival outcomes for patients with IBC. Whether receipt of TMT varies by race, ethnicity, and insurance status and its impact on survival is largely unknown. Methods: Adult female patients with non-metastatic IBC treated from 2010-2018 were identified from the NCDB. Guideline concordant care (GCC) was defined as TMT administered in the correct sequence. In addition, clinical tumor/nodal stage, age, race, ethnicity, facility type, patient location, insurance status, and pathologic complete response (pCR) were examined for each patient. Additional quality metrics of GCC examined included time to initiation of NACT < 60 days (TTNC) and proper surgical care defined as complete axillary lymph node dissection (>6 lymph nodes removed) at the time of MRM without reconstruction. Univariate and multivariate mixed methods were performed to determine association between patient, treatment, and facility-level factors and receipt of GCC, TTNC < 60 days, and proper surgical care. OS was estimated using the Kaplan-Meier method, and the log-rank test was used to compare groups. Results: 7,374 women with non-metastatic IBC were included. 78% were White, 17% Black, and 2.5% Asian/Pacific Islander patients; 7.7% identified as Hispanic and 92% as non-Hispanic. The majority had private insurance (51%), 29% Medicare, 14% Medicaid, 4.9% uninsured, and 1.3% other government insurance.Only 2,418 patients (32.7%) received GCC with only 29% undergoing MRM without reconstruction.Receipt of GCC was more common among patients age >50 years, patients with higher clinical nodal burden and those treated from 2010-2013 (p=0.001).Receipt of GCC did not differ by race, ethnicity, insurance status, or location.92% (6,005/7,374 patients) received NAC within 60 days of diagnosis. Both Black (OR 0.58, 95% CI 0.46-0.74, p= < 0.001) and Asian (OR 0.52, 95% CI 0.30-0.90, p= < 0.001) patients with IBC were less likely to have TTNC < 60 days when compared to White patients. Non-Hispanic patients (OR 2.24, 95% CI 1.65-3.03, p= < 0.001) and those with private insurance (OR 1.82, 95% CI 1.23-2.68, p= < 0.001) were more likely to have TTNC within 60 days of diagnosis. Patients with lower clinical nodal burden(cN0) were less likely to undergo proper surgery compared to patients with higher nodal burden(cN1-3) (p < 0.001). In addition, patients treated in a more contemporary cohort (2014-2018) were less likely to undergo proper surgery compared to patients treated earlier (2010-2013) (OR 0.82, 95% CI 0.73-0.92, p< 0.001).Among IBC patients receiving GCC, Black patients had significantly worse overall survival compared to White patients (p < 0.001) Conclusions: The majority of patients with IBC do not receive GCC and GCC has decreased since 2014 with fewer patients undergoing appropriate surgical treatment. The very low level of GCC indicates a need for multidisciplinary education, while improvement in TTNC may improve outcomes among racial/ethnic minorities. Citation Format: Brian Diskin, Audree Tadros, Varadan Sevilimedu, Amy Xu, Perri Vingan, Jonas Nelson, Yoshiko Iwai, Monica Morrow, Oluwadamilola (Lola) Fayanju. Trends in Guideline Concordant Care for Inflammatory Breast Cancer: An analysis of the National Cancer Database [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PS18-07.

Abstract PO5-02-07: Multifocal breast cancer: tumor biology and prognostic importance

Abstract >Multifocal breast cancer: tumor biology and prognostic importance Background The incidence of multifocal breast cancer (MBC) varies widely in the literature and recent reports indicate that the incidence of MBC is increasing. Several studies have shown similar tumor biology in the different foci of multifocal tumors, and it has been suggested that multifocal tumors may in fact be intramammary metastases and thus be a sign of a more aggressive cancer type than unifocal tumors. Knowledge regarding outcome and optimal treatment of MBC compared to unifocal breast cancer (UBC) is still limited. The aim of the present study was to explore if multifocal breast cancers have less favorable characteristics and prognosis compared to unifocal breast cancers. Method Patient and tumor characteristics were obtained from Breast Cancer database Sweden (BcBaSe3) including women with invasive breast cancer 2008-2019 who had undergone primary surgery. Women with distant metastases at time of diagnosis, women receiving neoadjuvant systemic therapy, and men were excluded. Overall- and breast cancer specific survival were calculated with Kaplan-Meier and Cox-regression analyses. Results A total of 71607 women met our inclusion criteria, 11961 (16.7%) with MBC and 59512 (83.3%) with UBC. Among women with MBC, 64.1% underwent mastectomy compared to 32.4% of women with UBC and 40.1% with MBC underwent complete axillary lymph node dissection compared to 23.5% of the women with UBC. MBC was associated with higher T-stage (T2 31.9% vs. 25.8% and T3 4.6% vs. 2.6%. p< 0.001) and higher N-stage (N+ 13.7% vs. 8.4%, P< 0.001), compared to UBC. MBC were more often of lobular type (18.8% vs. 12.4%, P< 0.001), of higher grade (grade 3 29.3% vs. 27.3%, p< 0.001), with positive hormone receptor status (88.4% vs. 86.7%, p< 0.001), and Her2 positivity (13.3% vs. 10.9%, p< 0.001). Adjuvant systemic treatment was more frequently administered to women with MBC, adjuvant chemotherapy (45.3% vs. 33.3%, p< 0.001) and endocrine treatment (82.9% vs. 75.3%, p< 0.001). Breast cancer specific 10- year survival was 86.4% and 88.5% for MBC and UBC respectively, hazard ratio for breast cancer death 1.19 (95 % confidence interval, 1.11- 1.28). Overall survival did not differ between the two groups (10-year survival 76.0%, p=0.35) Conclusion MBC appears to have a more aggressive tumor biology than UBC, with the exception of hormone receptor status and MBC is associated with decreased breast cancer specific survival. Further analysis of possible interactions with different treatment methods will be conducted. Citation Format: Emma Söderberg, Malin Sund, Fredrik Wärnberg, Hans Garmo, Anna-Karin Wennstig, Lars Holmberg, Greger Nilsson, Charlotta Wadsten. Multifocal breast cancer: tumor biology and prognostic importance [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-02-07.

Abstract PO3-23-01: Triple-tracer Technique for Sentinel Lymph Node Biopsy of Breast Cancer after neoadjuvant Chemotherapy using Blue-dye, Radioisotope combined with Real-time Indocyanine green(ICG) Fluorescence Imaging Procrdures

Abstract Background: For post-neoadjuvant chemotherapy (NAC) patients (pts) with BC, sentinel lymph node biopsy (SNB) was recommended using the dual-tracer mapping technique (radioisotope plus blue dye) or placing a biopsy clip into the positive node at diagnosis and identifying it at the time of surgery due to SN identification rates (IR) were lower and false negative rates (FNR) were greater for pts with local advanced breast cancer (BC) than those of pts with early stage BC in the absence of NAC. Our previous clinical trial has indicated that the real-time ICG fluorescence (RT-ICG) imaging technique could improve the diagnostic sensitivity and detection accuracy for SNB. Methods: Between April 2019 and May 2022, post-NAC SNB were successfully identified in 45 of 52 patients with stage ⅡA to ⅢB (T1-T3, N0-2, M0) who had histologically confirmed breast cancer selected to receive NAC and the standard surgeries were performed after finishing NAC. The SNs was detected by conventional procedures of blue-dye (Indigo carmine) plus 99mTc radioisotope (dual-tracer) and combined with concurrent RT-ICG technique. Clinical node positive (cN+) was diagnosed by the radiologists using axillary ultrasound, MRI and/or CT scan or assessed by fine needle aspiration cytology (FNAC). The positivity of each single SN by each single tracer (blue dye, ICG, or isotope alone) was counted and identified, respectively. All patients are required to undergo SNB followed by completion axillary lymph node dissection (CND). Then the IR and FNR of each single tracer and their summation (triple tracer) were calculated by comparing the results of the SNB and the histopathology of the resection specimens of CND. Results: Among 45 post-NAC pts, the IR and FNR of each single procedure for SNB was 45.7% and 55.6% when used Indigo Carmine blue, 70.3% and 11.1% when used RI, 82.6% and 0 when used ICG fluorescence, respectively. In contrast, the total calculation of triple tracer showed that IR reached to 100% and FNR was 0, respectively. The IR of triple tracer were 83.9% and 100% for ypN0 and ypN(+) pts after NAC, both FNR were 0%. Conclusion: Our results suggested that the triple tracer technique combining blue dye, ICG, and isotope is effective method for detection of SNs in post-neoadjuvant cN+ BC pts. The IR and FNR of SNB might be improved by this multiple tracer mapping technique, particularly for pts with ypN(+) after NAC. It is considered that the multi-tracer can complement each other for what was not able to be traced and detected by the single tracer with one mapping material, and that result in totally the improvement of identification rate of SNB. Citation Format: Hidetaka Watanabe, Yuko Takao, Yuriko Katagiri, Rie Sugihara, Uhi Toh. Triple-tracer Technique for Sentinel Lymph Node Biopsy of Breast Cancer after neoadjuvant Chemotherapy using Blue-dye, Radioisotope combined with Real-time Indocyanine green(ICG) Fluorescence Imaging Procrdures [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-23-01.

Abstract PO3-03-03: Prospective non-randomized study to compare accuracy of clinical examination under anesthesia, axillary ultrasound and histo-pathological evaluation for axillary nodal staging in women with clinically N0 early breast cancer

Abstract Introduction: Accurate assessment of axillary lymph nodes is crucial in the management of early breast cancer (EBC), especially in clinically node negative (cN0) axilla to avoid extensive axillary surgery. Clinical examination alone underestimates nodal disease in nearly 30% women with cN0 axilla. The current study compares, in cN0 axilla, the benefit of axillary ultrasonography (USG) and clinical axillary examination under anesthesia (EUA) to predict involvement of axillary lymph nodes. The gold standard in these patients however remains pathological evaluation after sentinel node biopsy/low axillary sampling (SNB/LAS) and a complete axillary lymph node dissection (ALND) if node positive. Methodology: Prospectively, 500 women with cN0 EBC were enrolled from Aug 2015 to April 2023 in a study approved by Institutional Ethics Committee. After informed consenting, a preoperative axillary USG was carried out in addition to standard breast imaging to determine number of axillary node(s) and its architecture. The USG assessment was labeled as suspicious or not and the result was blinded to the surgeons. A USG-guided FNAC was not performed as it would then be difficult to blind the surgeon and pathologist preoperatively. During surgery, an initial axillary EUA was performed before starting and any suspicious node was documented. This was followed by axillary staging by standard dual tracer SNB/LAS. A complete axillary dissection was done (level 1-3) if any node was positive on frozen section evaluation or final histopathology. Axillary node histopathology was the gold standard for comparison of effectiveness of clinical exam, USG, EUA, and SNB/LAS for prediction of axilla. Standard diagnostic tests such as sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy were used. Results: Thirty-six patients were excluded in the final analysis (disease progression, chemotherapy first, or had a surgery elsewhere). Of the eligible 464 cN0 patients, 129 were detected to have axillary metastases (27.8%) in final histopathology. The 2 interventions namely USG axilla, EUA were compared to final axillary nodal histopathology. Axillary USG reported suspicious/indeterminate node(s) in 129 (27.8%) patients. USG had a low sensitivity of 46.5% and a low PPV of 46.5% to identify a positive node. However, the specificity and NPV both were 79.4%. Axillary USG was 70.2% accurate in predicting axillary nodal involvement. EUA also had sensitivity of 60% and low PPV of 14.8%. However, the specificity of EUA was 73.4%, NPV of 95.9%; higher than that of USG. EUA was 72.4% accurate. SNB/LAS had the sensitivity of 93.3%, specificity 79.2%, NPV 82.9%, PPV 91.6% and accuracy rate 89.2% in predicting a positive axilla. Conclusions: While the fallacy of clinical exam remains at 27.8%, both USG alone (without FNAC) and EUA failed in predicting a positive axillary node. EUA fared better at predicting a negative axilla. USG guided FNAC would perhaps improve the sensitivity of USG, however additional investigations are difficult in resource constraint and high-volume center, especially, when surgical interventions like SNB or LAS remain standard of care. Table 1 Citation Format: Vani Parmar, Zeal Sanghvi, Shalaka Joshi, Nita Nair, Palak Popat, Seema Kembhavi, Souwmyashree KN, Soujanya Mynalli, Purvi Thakkar, Garvit Chitkara, Sangeeta Desai, Tanuja Shet, Rajendra Badwe. Prospective non-randomized study to compare accuracy of clinical examination under anesthesia, axillary ultrasound and histo-pathological evaluation for axillary nodal staging in women with clinically N0 early breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-03-03.

Abstract PO1-19-03: The T-REX trial: a randomized international non-inferiority trial on Tailored Regional EXternal beam radiotherapy in clinically node-negative breast cancer patients with 1-2 sentinel node macrometastases

Abstract Background: Modern systemic treatment has reduced the incidence of regional recurrences and improved survival in breast cancer (BC). It is thus questionable whether regional radiotherapy (RT) is still indicated in patients with sentinel lymph node (SLN) macrometastases. Postoperative regional RT is associated with an increased risk of arm morbidity, pneumonitis, cardiac disease, and secondary cancer. Therefore, there is a need to individualize the indication for regional RT in relation to risk of recurrence. Trial design: In this multicenter, prospective randomized phase 3 trial, eligible patients have a clinically node-negative, estrogen receptor-positive, HER2-negative BC with 1-2 SLN macrometastases, and have not undergone completion axillary lymph node dissection. Participants are randomly assigned to receive regional RT (standard arm) or not (intervention arm). Regional RT includes the axillary levels I-III and the supraclavicular fossa. Internal mammary nodes are targeted in selected patients. After breast-conserving surgery (BCS), RT to the remaining breast is given in both groups while after mastectomy, chest-wall RT is only given in the standard arm. In the intervention arm, chest wall RT may be indicated in selected cases with extensive multifocality, according to national guidelines. RT quality assurance is an integral part of the trial. In addition, material from the primary tumor, SLN metastases and any recurrences is subjected to gene expression analysis to identify both prognostic markers for locoregional recurrence and predictive markers for the benefit of regional RT. After confirmation of eligibility and written informed consent, patients are randomized 1:1 between the treatment arms. Allocation is stratified by trial site and breast surgery (BCS vs. mastectomy). Participation in T-REX should not affect decisions on systemic adjuvant treatment. Eligibility criteria: Trial inclusion and exclusion criteria are given in Table 1. Specific aims: The main aim of the trial is to investigate if the omission of regional RT is non-inferior to routine regional RT in clinically node-negative BC patients with estrogen receptor-positive, HER2-negative T1-2 tumors with 1-2 SLN macrometastases not receiving axillary lymph node dissection. Secondary aims are to investigate whether refraining from regional RT reduces arm morbidity and late RT side effects, and improves short- and long-term health-related quality of life. In addition, the use of genomic classifiers for the prognostication of locoregional recurrences and the prediction of a benefit from regional RT will be investigated. Statistical methods: Primary outcome is recurrence free survival (RFS) at five years. Non-inferiority will be declared if the outcome in the intervention arm is not more than 4.5 percentage units below the standard arm, corresponding to a hazard ratio of 1.41 assuming 88% 5-year RFS with standard treatment. Secondary outcomes include locoregional recurrence, overall survival, patient-reported arm morbidity, and health-related quality of life. Accrual: The trial will include 1350 patients in Sweden, Norway and Finland from April 2023 to December 2028. First sites have been opened in April 2023. Contact information: Primary Investigator: Sara Alkner, Skåne University Hospital, Lund University, sara.alkner@med.lu.se. Responsible for the biobank: Per Karlsson, Sahlgrenska University Hospital, Gothenburg University, per.karlsson@oncology.gu.se. Inclusion and exclusion criteria Citation Format: Sara Alkner, Jana de Boniface, Dan Lundstedt, Ingvil Mjaaland, Lisa Rydén, Johan vikström, Pär-Ola Bendahl, Erik Holmberg, Helena Sackey, Elinore Wieslander, Per Karlsson. The T-REX trial: a randomized international non-inferiority trial on Tailored Regional EXternal beam radiotherapy in clinically node-negative breast cancer patients with 1-2 sentinel node macrometastases [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-19-03.

Abstract PO3-23-07: Evaluation of the role of axillary ultrasound to estimate axillary nodal burden to guide de-escalation of upfront axillary surgery in node positive early breast cancer patients

Abstract Background: Axillary surgery is now routinely de-escalated in clinically node negative breast cancer patients with limited axillary nodal burden (up to 2 involved sentinel nodes) based on the results of ACOSOG-Z0011 and AMAROS trials. However, patients with proven axillary metastasis following on ultrasound (AUS) guided core needle biopsy (CNB), undergoing primary surgery are still subjected to an axillary lymph node dissection (ALND) irrespective of the magnitude of the axillary nodal burden. If we could predict axillary nodal burden with a low false negative rate (FNR) for the presence of extensive axillary nodal involvement, we can then hypothesize that axillary surgery could be safely de-escalated in this cohort of patients. We investigated whether pre-operative AUS suggesting limited axillary burden is sensitive enough to rule out gross axillary disease burden. Methods: A single institution retrospective study. We undertook an electronic chart review of all T1 to T3 patients undergoing upfront ALND with either mastectomy or breast conserving surgery between January 2019 and June 2023. Patients with palpable axillary nodes, locally advanced breast cancer or a completion ALND after positive sentinel lymph node biopsy (SLNB) were excluded from the study. Clinical and pathological characteristics associated with nodal burden of disease were evaluated. Limited axillary burden was defined as < 2 involved nodes with ≥3 taken as gross nodal burden for primary analyses. Sensitivity analyses were carried out with limited axillary burden defined as < 3 involved nodes (N1) and ≥4 (N2) taken as gross nodal burden. Subgroup analyses in T1 or T2 tumors were carried out as well. The probabilities of discordant events, defined as limited burden on AUS-CNB but gross burden on final histopathology evaluation (HPE), assuming 10% FNR, were estimated using inverse cumulative binomial distribution function. Results: Data on the exact number of suspicious nodes on AUS were missing for 2 patients, therefore, the final study cohort included 39 patients. The correlation between AUS nodal burden and that on HPE was moderate (Spearman’s rho = 0.48; p = 0.0018). The sensitivity and specificity of AUS in identifying gross nodal burden were 61% and 81% respectively. Observation of 9 discordant events in 22 patients with low burden on AUS ruled out an FNR of < 10% with 99.99% certainty. The sensitivity and specificity in T1/T2 subgroup were 60% and 75% respectively. The sensitivity analyses classifying N1 as limited and N2 as gross axillary burden showed the sensitivity and specificity of 35% and 82% respectively and an FNR of < 10% was ruled out with 99.996% certainty. Conclusion: Pre-operative AUS alone lacks the sensitivity and specificity to accurately predict the true axillary nodal burden to safely guide de-escalation of axillary surgery. AUS followed by targeted axillary dissection (TAD) in conjunction with a dual technique SLNB may provide the desired sensitivity and specificity to guide de-escalation of axillary surgery. A prospective evaluation of this approach is merited. Given the limited number of patients that could be enrolled in such prospective study from individual institutions, an international collaborative effort is needed to address this important research question. Citation Format: Nidhi Garg, Mangesh Thorat, Hisham Hamed, Ashutosh Kothari. Evaluation of the role of axillary ultrasound to estimate axillary nodal burden to guide de-escalation of upfront axillary surgery in node positive early breast cancer patients [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-23-07.

Abstract ED11-02: Surgical controversies in IBC

Abstract In an era of treatment de-escalation, there remain questions regarding the optimal surgical management for patients with inflammatory breast cancer (IBC). For years, the standard surgical approach for patients with IBC has been modified radical mastectomy (MRM) (including complete axillary node dissection as a component of MRM) with delayed breast reconstruction. In the recent past, some authors have proposed the use of breast conserving surgery, sentinel lymph node mapping, skin-sparing mastectomy, and even immediate reconstruction as possibly appropriate procedures for the treatment of patients with IBC. In this educational session, we plan to review the available data to try and reach a conclusion on what surgical procedures appear to provide the best outcomes for patients with IBC. Citation Format: A. Lucci. Surgical controversies in IBC [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr ED11-02.

Évaluation du creux axillaire en 2024 : point de vue du chirurgien et rôle du radiologue

For patients with breast cancer, de-escalation of armpit surgical treatments happened during the last twenty years to reduce the morbidity mainly induced by complete axillary lymph node dissection, with a broadening of sentinel lymph node biopsy indications and, more recently, the development of targeted lymph node excision, with no impact on patient survival. Axillary ultrasound combined with clinical examination can predict the tumour burden in the axilla. At the same time, the radiologist's role has evolved, as they must describe the number of suspicious lymph nodes, which determines surgical management. Patients having fewer than two suspicious lymph nodes are eligible for sentinel lymph node biopsy. Ultrasound-guided fine-needle aspiration or core biopsy will provide proof of lymph node involvement.

Lymphovenous Bypass for Immediate Lymphatic Reconstruction in Breast Cancer Patients Undergoing Axillary Lymph Node Dissection: Minimizing the Risk of Upper Extremity Lymphedema.

Studies have shown a significant reduction in breast cancer-related lymphedema (BCRL) rates in patients undergoing complete axillary lymph node dissection (cALND) combined with immediate lymphatic reconstruction (ILR) using lymphovenous bypass (LVB).The purpose of this study was to determine if ILR with LVB at the time of cALND results in a decreased incidence of BCRL and its impact on patient quality of life (QOL). In this prospective cohort study, patients ≥ 18 years requiring cALND underwent ILR from 2019 to 2021. The primary outcome was bilateral upper limb volumes measured by Brørson's truncated cone formula and the Pero-System (3D Körper Scanner). The secondary outcome was QOL measured by the Lymphedema Quality of Life (LYMQOL) arm patient-reported outcome measurement. Forty-two patients consented to ILR using LVB. ILR was completed in 41 patients with a mean of 1.9 ± 0.9 lymphovenous anastomosis performed. Mean age of patients was 52.4 ± 10.5 years with a mean body mass index of 27.5 ± 4.9 kg/m2. All patients (n = 39, 100%) received adjuvant therapy after ILR. Mean follow-up was 15.2 ± 5.1 months. Five patients met criteria for lymphedema throughout the duration of the study (12.8%), with two patients having resolution, with an overall incidence of 7.7% by the end of the study period. Patients with lymphedema were found to have statistically significant lower total LYMQOL values at 18 months (8.44 ± 1.17 vs. 3.23 ± 0.56, p < 0.001). A mean increase of 0.73 ± 3.5 points was observed for overall QOL average for upper limb function at 18 months compared with 3 months (t = 0.823, p = 0.425). This study showed an incidence of 7.7% lymphedema development throughout the duration of study. We also showed that ILR has the potential to reduce the significant long-term adverse outcomes of lymphedema and improve QOL for patients undergoing cALND.

Outcomes of sentinel node biopsy according to MRI response in an association with the subtypes in cN1–3 breast cancer after neoadjuvant systemic therapy, multicenter cohort study

BackgroundThis study investigated the feasibility of sentinel lymph node biopsy (SLNB) after neoadjuvant systemic therapy (NAST) in patients with initially high nodal burden.MethodsIn the multicenter retrospective cohort, 388 individuals with cN1–3 breast cancer who underwent NAST and had SLNB followed by completion axillary lymph node dissection were included. In an external validation cohort, 267 patients with HER2+ or triple-negative breast cancer (TNBC) meeting similar inclusion criteria were included. Primary outcome was the false-negative rates (FNRs) of SLNB according to the MRI response and subtypes. We defined complete MRI responders as patients who experienced disappearance of suspicious features in the breast and axilla after NAST.ResultsIn the multicenter retrospective cohort, 130 (33.5%) of 388 patients were of cN2-3, and 55 (14.2%) of 388 patients showed complete MRI responses. In hormone receptor-positive HER2− (n = 207), complete and non-complete responders had a high FNRs (31.3% [95% CI 8.6–54.0] and 20.9% [95% CI 14.1–27.6], respectively). However, in HER2+ or TNBC (n = 181), the FNR of complete MRI responders was 0% (95% CI 0–0), whereas that of non-complete responders was 33.3% (95% CI 20.8–45.9). When we validated our findings in the external cohort with HER2+ or TNBC (n = 267), of which 34.2% were cN2-3, the FNRs of complete were 7.1% (95% CI 0–16.7).ConclusionsOur findings suggest that SLNB can be a reliable option for nodal status evaluation in selected patients who have responded well to NAST, especially in HER2+ and TNBC patients who show a complete MRI response.

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.

Comparison of clinical characteristics between ACOSOG Z0011-eligible cohort and sentinel lymph node-positive breast cancer patients in Hong Kong.

The American College of Surgeons Oncology Group (ACOSOG) Z0011 trial resulted in de-escalation of axillary surgery among early-stage breast cancer patients with low-volume sentinel lymph node (SLN) disease undergoing breast-conserving surgery and radiation therapy. Nevertheless, the mastectomy rate in the Chinese population remains high. This study compared the clinical characteristics of the ACOSOG Z0011-eligible cohort with SLN-positive breast cancer patients in Hong Kong. This retrospective analysis of a prospectively maintained database at a university-affiliated breast cancer centre in Hong Kong was performed from June 2014 to May 2019. The database included all patients with clinical tumour (T) stage T1 or T2 invasive breast carcinoma, no palpable adenopathy, one or two positive SLNs on histological examination, and no prior neoadjuvant systemic treatment. Comparisons were made between the mastectomy and breast-conserving treatment groups in our cohort, along with the sentinel-alone arm in the ACOSOG Z0011 trial. One hundred and seventy-one patients met the inclusion criteria: 112 underwent mastectomy and 59 underwent breast-conserving treatment. Our mastectomy group had higher prevalences of T2 tumours (P<0.001), lymphovascular invasion (P<0.001), and SLN macrometastases (P=0.004) compared with the ACOSOG Z0011 cohort. However, in our patient population, mean pathological size slightly differed between the mastectomy and breast-conserving treatment groups (2.2 cm vs 1.8 cm; P=0.005). Other histopathological features were similar. This study demonstrated that clinicopathological features were comparable between SLN-positive breast cancer patients undergoing mastectomy and those undergoing breast-conserving treatment. Low-risk SLN-positive mastectomy patients may safely avoid completion axillary lymph node dissection.

Does Breast Surgery Type Alter Incidental Axillary Irradiation? A Dosimetric Analysis of the "Sentinel Envahi et Randomisation du Curage" SERC Trial.

An incidental axillary dose of adjuvant radiotherapy using tangential beams is usually given after breast-conserving surgery for breast cancer. The goal of this sub-study was to evaluate this incidental dose in the setting of post-mastectomy radiotherapy (PMRT) according to two different radiotherapy techniques. Patients participating in a randomized SERC trial who received PMRT in a single center were included. We collected the incidental axillary dose delivered to the Berg level 1 using different dosimetric parameters and compared two techniques using Student's t-test: three-dimensional conformal radiotherapy (3D-CRT) and volumetric arc therapy (VMAT). We analyzed radiotherapy plans from 52 patients who received PMRT from 2012 to 2021. The mean dose delivered to the Berg level 1 was 37.2 Gy. It was significantly higher with VMAT than with 3D-CRT-43.6 Gy (SD = 3.1 Gy) versus 34.8 Gy (SD = 8.6 Gy) p < 0.001. Eighty-four percent of the Berg level 1 was covered by 40 Gy isodose in the VMAT group versus 55.5% in the 3D-CRT group p < 0.001. On the Berg level 1, PMRT gives a dose at least equivalent to the one given by post-breast-conserving surgery radiotherapy, making it possible to limit completion axillary lymph node dissections in select pN1a patients treated with a mastectomy. Modern radiotherapy techniques like VMAT tend to increase this incidental dose.

Reevaluating Axillary Lymph Node Dissection in Total Mastectomy for Low Axillary Burden Breast Cancer: Insights from a Meta-Analysis including the SINODAR-ONE Trial.

Complete axillary lymph node dissection (cALND) was previously the standard of care for breast cancer (BC) patients with axillary node disease or macro-metastases found via sentinel lymph node biopsy (SLNB). However, due to significant morbidity, contemporary management now considers a more selective approach, influenced by studies like ACOSOG Z0011. This trial showed that cALND could be omitted without compromising local control or survival in patients with low axillary nodal disease burden undergoing breast-conserving therapy, radiotherapy, and systemic therapy. The relevance of this approach for women with low axillary nodal burden undergoing total mastectomy (TM) remained unclear. A PubMed search up to September 2023 identified 147 relevant studies, with 6 meeting the inclusion criteria, involving 4184 patients with BC and low-volume axillary disease (1-3 positive lymph nodes) undergoing TM. Postmastectomy radiotherapy receipt was similar in both groups. After a mean 7.2-year follow-up, both the pooled results and the meta-analysis revealed no significant differences in overall survival. The combined analysis of the published studies, including the subgroup analysis of the SINODAR-One trial, indicates no survival advantage for cALND over SLNB in T1-T2 breast cancer patients with 1-3 positive sentinel lymph nodes (pN1) undergoing mastectomy. This suggests that, following a multidisciplinary evaluation, cALND can be safely omitted. However, the impact of other patient, tumor, and treatment factors on survival requires consideration and therefore further prospective trials are needed for conclusive validation.

Sentinel Node Biopsy Positivity: Is Axillary Dissection Always Necessary? – A Retrospective Analysis

Breast cancer remains a significant health concern, with predictions indicating a rise in global incidence. While the primary focus is on oncological radicality, the aesthetic and psychological impacts of surgical interventions, such as radical mastectomy, cannot be ignored. This study, conducted over 8 years, aimed to identify factors that can prevent unnecessary lymphadenectomy. The research analyzed various parameters, including age, BMI, tumor size, and immunohistochemistry, to determine their correlation with axillary lymph node invasion. The results highlighted the importance of tumor size and estrogen receptor status in predicting axillary lymph node metastasis. The study underscores the value of sentinel lymph node biopsy in early breast cancer treatment, emphasizing its benefits over complete axillary lymph node dissection.