Omission Of Axillary Dissection Research Articles

Escalation and De-Escalation of Adjuvant Radiotherapy in Early Breast Cancer: Strategies for Risk-Adapted Optimization.

Postoperative radiotherapy (RT) is recommended after breast-conserving surgery and mastectomy (with risk factors). Consideration of pros and cons, including potential side effects, demands the optimization of adjuvant RT and a risk-adapted approach. There is clear de-escalation in fractionation-hypofractionation should be considered standard. For selected low-risk situations, PBI only or even the omission of RT might be appropriate. In contrast, tendencies toward escalating RT are obvious. Preoperative RT seems attractive for patients in whom breast reconstruction is planned or for defining the tumor location more precisely with the potential of giving ablative doses. Dose escalation by a (simultaneous integrated) boost or the combination with new compounds/systemic treatments may increase antitumor efficacy but also toxicity. Despite low evidence, RT for oligometastatic disease is becoming increasingly popular. The omission of axillary dissection in node-positive disease led to an escalation of regional RT. Studies are ongoing to test if any axillary treatment can be omitted and which oligometastatic patients do really benefit from RT. Besides technical improvements, the incorporation of molecular risk profiles and also the response to neoadjuvant systemic therapy have the potential to optimize the decision-making concerning if and how local and/or regional RT should be administered.

Clipping the Positive Lymph Node in Patients with Clinically Node Positive Breast Cancer Treated with Neoadjuvant Chemotherapy: Impact on Axillary Surgery in the ISPY-2 Clinical Trial

BackgroundFor patients with clinically node-positive (cN+) breast cancer undergoing neoadjuvant chemotherapy (NAC), retrieving previously clipped, biopsy-proven positive lymph nodes during sentinel lymph node biopsy [i.e., targeted axillary dissection (TAD)] may reduce false negative rates. However, the overall utilization and impact of clipping positive nodes remains uncertain.Patients and MethodsWe retrospectively analyzed cN+ ISPY-2 patients (2011–2022) undergoing axillary surgery after NAC. We evaluated trends in node clipping and associations with type of axillary surgery [sentinel lymph node (SLN) only, SLN and axillary lymph node dissection (ALND), or ALND only] and event-free survival (EFS) in patients that were cN+ on a NAC trial.ResultsAmong 801 cN+ patients, 161 (20.1%) had pre-NAC clip placement in the positive node. The proportion of patients that were cN+ undergoing clip placement increased from 2.4 to 36.2% between 2011 and 2021. Multivariable logistic regression showed nodal clipping was independently associated with higher odds of SLN-only surgery [odds ratio (OR) 4.3, 95% confidence interval (CI) 2.8–6.8, p < 0.001]. This was also true among patients with residual pathologically node-positive (pN+) disease. Completion ALND rate did not differ based on clip retrieval success. No significant differences in EFS were observed in those with or without clip placement, both with or without successful clip retrieval [hazard ratio (HR) 0.85, 95% CI 0.4–1.7, p = 0.7; HR 1.8, 95% CI 0.5–6.0, p = 0.3, respectively].ConclusionClip placement in the positive lymph node before NAC is increasingly common. The significant association between clip placement and omission of axillary dissection, even among patients with pN+ disease, suggests a paradigm shift toward TAD as a definitive surgical management strategy in patients with pN+ disease after NAC.

Omission of Axillary Dissection in Node Positive Breast Cancer After Neoadjuvant Systemic Therapy

IntroductionGuidelines recommend axillary lymph node dissection (ALND) for ypN + positive patients as patients receiving neoadjuvant systemic therapy (NST) were excluded from trials omitting ALND in pN + patients. We sought to characterize trends in omission of ALND in patients with ypN + disease. MethodsAdult women with invasive breast carcinoma in the National Cancer Database between 2012 and 2019 who received NST (chemotherapy or endocrine) and had ypN + disease were included. Patients were excluded if they did not have definitive surgery within eight months of diagnosis. The primary study outcome was completion of ALND versus omission. Differences in demographics, tumor characteristics, and treatment were identified using bivariate and multivariate logistic regression models. ResultsIn total, 103,121 women were included. Most had cT1 (26%) or cT2 (45%) tumors, cN + disease (71%), and ductal histology (83%). 69% of patients received neoadjuvant chemotherapy and 31% neoadjuvant endocrine without chemotherapy (30% both). ALND was performed in 77% of patients. Omission of ALND became more prevalent each year from 2012 (14%) to 2019 (34%). On multivariate modeling, year of diagnosis, black race, cN status, higher grade, estrogen receptor+/HER2-receptor subtype, and mastectomy were associated with increased prevalence of ALND. Age, Charlson/Deyo comorbidity index score, endocrine versus chemotherapy, and adjuvant radiation were not associated with receipt of ALND. ConclusionsDespite guidelines recommending ALND, omission is common in patients with ypN + breast cancer after NST. Omission of ALND increased significantly over time and is associated with clinical and demographic factors. Future study is needed to determine the oncologic safety of this approach.

Inequalities in the omission of axillary dissection in sentinel lymph node positive patients in the Netherlands: Innovative hospitals are early adopters of a de-escalating approach.

During the last decade completion axillary lymph node dissection (cALND) was gradually omitted in sentinel lymph node positive (SLN+) breast cancer patients. However, adoption varies among hospitals. We analyzed factors associated with the omission of cALND in all Dutch SLN+ patients. As one of the focus hospital-related factors we defined "innovative" as the percentage of gene-expression profile (GEP) deployment within the indicated group of patients per hospital as a proxy for early adoption of innovations. cT1-2N0M0 SLN+ patients treated between 2011 and 2018 were selected from the Netherlands Cancer Registry. Hospitals were defined to be innovative based on their GEP use. Multivariable logistic regression (MLR) was performed to assess the relationship between innovative capacity, patient-, treatment- and hospital-related characteristics and cALND performance. 14 317 patients were included. Treatment in a hospital with high innovative capacity was associated with a lower probability of receiving cALND (OR 0.69, OR 0.46 and OR 0.35 in modestly, fairly and very innovative, respectively). Other factors associated with a lower probability of receiving a cALND were age 70 and 79 years and ≥79 years (ORs 0.59 [95% CI: 0.50-0.68] and 0.21 [95% CI: 0.17-0.26]) and treatment in an academic hospital (OR 0.41 [95% CI: 0.33-0.51]). Factors associated with an increased probability of undergoing cALND were HR-/HER2- tumors (OR 1.46 [95% CI: 1.19-1.80]), macrometastatic lymph node involvement (OR 6.37 [95% CI: 5.70-7.13]) and mastectomy (OR 4.57 [95% CI: 4.09-5.10]). Patients treated in a hospital that early adopted innovations were less likely to receive cALND. Our findings endorse the need for studies on barriers and facilitators of implementing innovations.

Potential Impact of the Z0011 Trial on the Omission of Axillary Dissection: A Retrospective Cohort Study.

To evaluate the number of patients with early-stage breast cancer who could benefit from the omission of axillary surgery following the application of the Alliance for Clinical Trials in Oncology (ACOSOG) Z0011 trial criteria. A retrospective cohort study conducted in the Hospital da Mulher da Universidade Estadual de Campinas. The study population included 384 women diagnosed with early-stage invasive breast cancer, clinically negative axilla, treated with breast-conserving surgery and sentinel lymph node biopsy, radiation therapy, chemotherapy and/or endocrine therapy, from January 2005 to December 2010. The ACOSOG Z0011 trial criteria were applied to this population and a statistical analysis was performed to make a comparison between populations. A total of 384 patients underwent breast-conserving surgery and sentinel lymph node biopsy. Of the total number of patients, 86 women underwent axillary lymph node dissection for metastatic sentinel lymph nodes (SNLs). One patient underwent axillary node dissection due to a suspicious SLN intraoperatively, thus, she was excluded from the study. Among these patients, 82/86 (95.3%) had one to two involved sentinel lymph nodes and met the criteria for the ACOSOG Z0011 trial with the omission of axillary lymph node dissection. Among the 82 eligible women, there were only 13 cases (15.9%) of lymphovascular invasion and 62 cases (75.6%) of tumors measuring up to 2 cm in diameter (T1). The ACOSOG Z0011 trial criteria can be applied to a select group of SLN-positive patients, reducing the costs and morbidities of breast cancer surgery.

Abstract SP023: State of the art treatment for neoadjuvant/adjuvant triple negative breast cancer

Abstract Systemic therapy for triple negative breast cancer (TNBC) is currently limited to chemotherapy, with the major questions being the nature and timing of the chemotherapy and optimizing locoregional management of the primary tumor. While TNBC carries the worst prognosis of the clinical subtypes, this prognosis has improved with modern treatment approaches (Cossetti RJ, JCO 2015), and there are subsets within TNBC that have excellent outcomes. Giving the chemotherapy neoadjuvantly has real clinical value. Cytoreduction can facilitate breast conserving surgery (BCS); 42-53% of patients considered ineligible convert to BCS-eligible after chemotherapy (Golshan M et al, Ann Surg 2015 and JAMA Surg 2020). A negative sentinel lymphadenectomy post-chemotherapy is reliable if dual tracer is used and at least three sentinel nodes are retrieved (Boughey J, JAMA 2013), and a high proportion of node-positive breast cancer can be converted to node-negative, allowing omission of axillary dissection and minimizing risk of lymphedema (Pilewskie M, Morrow M, JAMA Oncol 2017). Two ongoing trials in patients with up-front node-positive disease are examining omitting radiation in those converting to node-negative (NSABP B-51, NCT01872975), and axillary radiation instead of dissection in those that remain pathologically node-positive (A011202, NCT01901094). Pathologic complete response (pCR) to chemotherapy across all subtypes of breast cancer carries a markedly better prognosis compared with residual disease. In CALGB 40603, at over 5 years’ followup, 86% of pCR versus 57% of residual disease patients were event-free (Sikov W, SABCS 2019). CREATE-X enrolled approximately 900 patients with HER2-negative tumors and residual disease after chemotherapy, one-third TNBC, who were randomized to the addition of capecitabine versus standard adjuvant treatment. At 3.5 years’ followup, there was a benefit to adding capecitabine, driven by the TNBC subset in whom there was an absolute 14% difference in disease-free and 8.5% difference in overall survival (Masuda, NEJM 2017). For these two reasons (surgical optimization and risk stratification with treatment decisions driven by residual disease status), in TNBC patients appropriate for chemotherapy neoadjuvant timing is preferred. The nature of the regimens has evolved also during the modern era. The key improvements in chemotherapy includes the addition of taxanes to anthracyclines (Hayes DF, NEJM 2007), the use of dose dense schedules made possible through the development of growth factors (Citron M, JCO 2003), and efforts to minimize anthracycline use. The ABC Trials were a joint analysis of several trials examining anthracycline/taxane-based regimens (TAC or dose-dense AC-T) versus a similar duration (six cycles) of docetaxel plus cyclophosphamide (TC). While underpowered for subset analyses, in the 1300 TNBC patient cohort, anthracycline/taxane regimens outperformed TC, although the absolute benefits were modest in node-negative (2.5%) compared with node-positive (&amp;gt;10%) (Blum J, JCO 2017). For this reason, the preferred regimen in TNBC remains anthracycline/taxane-based. A separate consideration is the incorporation of platinums. Several trials have demonstrated that adding carboplatin significantly increases the pCR rate. However the impact on relapse has been mixed (in underpowered trials); it is reasonable to add in high clinical risk where surgical optimization is desired but is not considered a standard addition to reduce risk of recurrence. Future advances include further surgical and radiation optimization, the potential for using clinical and biomarker analyses to identify low risk TNBC that need no chemotherapy at all, and the incorporation of immune checkpoint inhibitors, which in two neoadjuvant trials have demonstrated significantly increased pCR. Citation Format: LA Carey. State of the art treatment for neoadjuvant/adjuvant triple negative breast cancer [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr SP023.

135 Poster - Omission of axillary dissection after neoadjuvant chemotherapy for node-positive primary breast cancer

Background: Anthracycline and taxane-based neoadjuvant chemotherapy (NAC) has been shown to downstage axillary lymph nodes in approximately 40% of node-positive patients. However, the feasibility of sentinel lymph node biopsy (SLNB) following NAC for initially node-positive patients is unclear because of high false-negative rates reported in previous trials. The aim of this study was to evaluate whether axillary lymph node dissection (ALND) could be safely omitted for patients with clinically node-positive breast cancer treated with NAC.

Abstract OT2-02-01: A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes

Abstract Background The omission of axillary dissection for positive sentinel-node breast cancer is considered the standard treatment for patients who undergo breast conserving surgery and radiation therapy, according to the results of ACOSOG-Z0011 and AMAROS trials. On the other hand, some surgeons still think that the surgical stress of axillary dissection is minimal, and dissection is permitted. Furthermore, Z0011 contains several problems, such as insufficient number of entry cases and lack of radiation field unity. Thus, we planned a prospective trial to confirm the safety of omitting axillary dissection in patients with breast cancer and positive sentinel nodes. Trial design This is a single arm, confirmation study of three medical centers. Prior to surgery, informed consent is obtained, and patients are registered primarily. After surgery, patients with 1 to 2 positive sentinel nodes, for whom axillary dissection was omitted, are finally included in this trial at final registration. Eligibility criteria Patients with histologically-diagnosed breast cancer, Tis–2, N0 based on a core needle biopsy, will be included in this trial. Eligible patients must be between 20 and 80 years of age, with a performance status of 0–2 and adequate organ function. They must not have undergone any prior operation, radiation therapy, chemotherapy, endocrine therapy, or immunotherapy. Specific aims The primary endpoint is 5-year (y) axillary recurrence rate. Secondary endpoints are 5-y overall survival, 5-y recurrence-free survival, 5-y local recurrence-free survival, the rate of upper-limb lymphedema, quality of life, and comparison of axillary recurrence rates between patients with two or more dissected nodes and those with only one positive node. Statistical methods The expected rate of axillary recurrence is 2.0%, and non-inferiority is defined as an axillary recurrence lesser than or equal to 5% in the axillary radiotherapy group. The sample size was calculated with a study power of 80% and type I error of 10% (two-sided). The required number of patients is estimated to be 189. Present and target accrual Patient accrual from the three medical centers was initiated in July 2016. We plan to enroll a total of 189 patients at final registration in this trial. Citation Format: Jibiki N, Hirano A, Ochi T, Sakamoto A, Horiuchi K, Noguchi E, Omi Y, Ogura K, Inoue H, Kamio T, Naritaka Y, Fujibayashi M, Hiroshima K, Nagashima Y, Sakai S, Karasawa K, Okamoto T. A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr OT2-02-01.

Omission of Axillary Dissection for Minimal Node-Positive Breast Cancer

The replacement of axillary dissection (AD) with sentinel-node biopsy has been one of the great advances for women with early-stage breast cancer and

Surgeon Attitudes Toward the Omission of Axillary Dissection in Early Breast Cancer

The American College of Surgeons Oncology Group (ACOSOG) Z0011 study demonstrated the safety of sentinel node biopsy alone in clinically node-negative women with metastases in 1 or 2 sentinel nodes treated with breast conservation. Little is known about surgeon perspectives regarding when axillary lymph node dissection (ALND) can be omitted. To determine surgeon acceptance of ACOSOG Z0011 findings, identify characteristics associated with acceptance of ACOSOG Z0011 results, and examine the association between acceptance of the Society of Surgical Oncology and American Society for Radiation Oncology negative margin of no ink on tumor and surgeon preference for ALND. A survey was sent to 488 surgeons treating a population-based sample of women with early-stage breast cancer (N = 5080). The study was conducted from July 1, 2013, to August 31, 2015. Surgeons were categorized as having low, intermediate, or high propensity for ALND according to the outer quartiles of ALND scale distribution. A multivariable linear regression model was used to confirm independent associations. Of the 488 surgeons invited to participate, 376 (77.0%) responded and 359 provided complete information regarding propensity for ALND derived from 5 clinical scenarios. Mean surgeon age was 53.7 (range, 31-80) years; 277 (73.7%) were male; 142 (37.8%) treated 20 or fewer breast cancers annually and 108 (28.7%) treated more than 50. One hundred seventy-five (49.0%) recommended ALND for 1 macrometastasis. Of low-propensity surgeons who recommended ALND, only 1 (1.1%) approved ALND for any nodal metastases compared with 69 (38.6%) and 85 (95.5%) of selective and high-propensity surgeons (P < .001), respectively. In multivariable analysis, lower ALND propensity was significantly associated with higher breast cancer volume (21-50: -0.19; 95% CI, -0.39 to 0.02; >51: -0.48; 95% CI, -0.71 to -0.24; P < .001), recommendation of a minimal margin width (1-5 mm: -0.10; 95% CI, -0.43 to 0.22; no ink on tumor: -0.53; 95% CI, -0.82 to -0.24; P < .001), participation in a multidisciplinary tumor board (1%-9%: -0.25; 95% CI, -0.55 to 0.05; >9%: -0.37; 95% CI, -0.63 to -0.11; P = .02), and Los Angeles Surveillance, Epidemiology, and End Results site (-0.18; 95% CI, -0.35 to -0.01; P = .04). This study shows substantial variation in surgeon acceptance of more limited surgery for breast cancer, which is associated with higher breast cancer volume and multidisciplinary interactions, suggesting the potential for overtreatment of many patients and the need for education targeting lower-volume breast surgeons.

Abstract P3-17-08: The role of sentinel lymph node biopsy in patients with ductal carcinoma in situ. An updated meta-analysis involving 9803 patients

Abstract Background: Ductal carcinoma in situ (DCIS) is the predominant pre-invasive neoplasia of the breast. It was observed that omission of axillary dissection in those with pure DCIS had no adverse effect on survival or recurrence. Therefore, axillary dissection typically does not feature in the management of DCIS. However, it has recently been purported that in some cases of DCIS, the axillary lymph nodes may show evidence of invasive disease. Consequently, there may be a role for sentinel lymph node biopsy (SLNB) in patients with DCIS with a high risk of invasion. Materials and Methods: Systematic literature review identified 48 studies (9803 DCIS patients who underwent SLNB). Separate analyses for patients diagnosed preoperatively by core sampling and patients diagnosed postoperatively by specimen pathology were conducted to determine the percentage of patients with axillary nodal involvement. Patient factors were analysed for associations with risk of nodal involvement. Results: The mean percentage of positive SLNBs was higher in the pre-operative group (5.95% vs. 3.02%; p=0.0201). Meta-regression analysis showed a direct association with tumour size (p=0.0333) and grade(p=0.00839), but not median age nor tumour upstage rate. Conclusions: SLNB should be considered in patients with a pre-operative diagnosis of extensive and/or high-grade DCIS after a careful multidisciplinary discussion in order to identify those patients who have unrecognised axillary spread. Citation Format: Chehade HEH, Headon H, Wazir U, El Tokhy O, Kasem A, Mokbel K. The role of sentinel lymph node biopsy in patients with ductal carcinoma in situ. An updated meta-analysis involving 9803 patients [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P3-17-08.

Operation with less adjuvant therapy for elderly breast cancer

BackgroundThe standard of care for elderly women with breast cancer remains controversial. The aim of this study was to clarify the management of elderly breast cancer patients who undergo surgery. Materials and methodsThis retrospective single-center cohort study included 2276 breast cancer patients who underwent surgery between 1993 and 2014. The patients were divided into three groups according to age: ≤64 y (young), 65-74 y (older), and ≥75 y (elderly). ResultsThe elderly had more advanced stage disease at diagnosis (stage III and IV, 16.2%, 17.5%, and 22.1% for the young, older, and elderly groups, respectively). The elderly were more likely to undergo mastectomy (43.3%, 41.4%, and 50.7%, respectively), omit axillary operation (0.6%, 1.1%, and 9.3%, respectively), and skip radiotherapy after breast-conserving surgery (93.1%, 86.8%, and 29.1%, respectively). Endocrine therapy was widely used in all the groups (94.4%, 93.8%, and 90.1%, respectively), but frequency of chemotherapy was lower in the elderly regardless of hormone receptor (HR) status (40.8%, 25.5%, and 9.3% in HR(+), 87.2%, 75.3%, and 39.5% in HR(−), respectively). Although the locoregional recurrence rate was higher in the elderly (4.2%, 3.4%, and 7.0% at 5 y, respectively; P = 0.028), there were no differences among groups in distant metastasis–free survival or breast cancer–specific survival. ConclusionsAlthough elderly patients had more advanced stages of cancer and received less treatment, there were no differences in survival. Omission of axillary dissection, radiation, and chemotherapy after operation may be an option for breast cancer patients aged ≥75 y.

Omission of axillary dissection after a positive sentinel lymph-node: Implications in the multidisciplinary treatment of operable breast cancer.

Omission of axillary dissection in women with breast cancer and one or two positive sentinel-node biopsy is a major advancement in the management of this disease. Supported by a sound rationale and confirmed by prospective, randomized trials, omission of axillary dissection is now recommended in women who have undergone breast conserving surgery and who are candidate to adjuvant radiotherapy. Because breast cancer is best managed in the context of a multidisciplinary team, this surgical shift in the paradigm is expected to have implications that extend also to the other specialties involved in the team. In fact, the full evaluation of the axillary tumor burden has been historically considered an essential part of tumor staging and the absolute number of involved node critical information to tailor post-surgical treatments. Lack of this information in a patient with axillary involvement documented by a positive sentinel lymph-node biopsy may represent a challenge when deciding on further, post-surgical treatments. This review will address the critical aspects and the potential implications of omission of axillary dissection in the context of the multidisciplinary breast team.

Omission of Axillary Dissection According to ACOSOG Z0011: Impact on Adjuvant Treatment Recommendations

A recent, randomized trial (ACOSOG Z0011) has demonstrated that omission of completion axillary lymph node dissection (ALND) in patients with one or two sentinel lymph node (SLN) metastases treated with breast conserving therapy (BCT) does not have a negative impact on survival. This study evaluates the impact of omitting ALND on adjuvant treatment recommendations. Performing a search of our clinical database, we identified patients meeting the main inclusion and exclusion criteria of ACOSOG Z0011 treated at the University of Heidelberg Breast Center. We performed blinded mock interdisciplinary tumor boards based on patient and tumor characteristics as well as (1) SLN information or (2) final nodal status after ALND. Differences between treatment recommendations were noted and analyzed. A total of 132 patients were included; 80.3 % of these had one and 19.7 % had two metastatic sentinel nodes with a rate of micrometastases only of 19.7 %, and 39.7 % of patients had additional nonsentinel node metastases upon ALND. Overall, there was a change in adjuvant chemotherapy in 18.2 % of cases. Treatment recommendations based on ALND lead to a more aggressive therapy in 16.6 % of cases, all of them with additional metastatic nonsentinel nodes. Chemotherapy was not recommended in only two cases (1.5 %) based on ALND. Based on ALND, irradiation of the supraclavicular and infraclavicular nodes was added in 5.3 % of patients. Completion ALND for patients with one or two metastatic sentinel nodes in pT1-2 cN0 PBC treated with BCT does have a relevant impact on adjuvant treatment. This should be considered in shared decision making.

Omission of Axillary Dissection after a Positive Sentinel Node Dissection may Influence Adjuvant Chemotherapy Indications in Operable Breast Cancer Patients

This study was designed to evaluate how the omission of axillary dissection would have altered the indication for adjuvant chemotherapy (ACT) in patients with early breast cancer submitted to conservative surgery with one or two positive sentinel lymph nodes (SLNs). We identified 321 women in our institutional database who fulfilled the characteristics. All underwent completion axillary lymph node dissection (AD). Each case was blindly reviewed by our breast team in two rounds, and the total number of positive lymph nodes was disclosed only in the second. At each round, the panel chose between: (1) recommend, (2) discuss, (3) do not recommend ACT. Changes between round 1 and 2 were studied by the marginal homogeneity test. Exploratory logistic regression analyses were performed to study predictors of non-SLN involvement and of changes in the indication for ACT. AD revealed non-SLNs metastases in 96 patients (30%). Fifty-two patients (16%) had their initial indication changed at round 2 (p<0.001). Most of the changes were toward ACT (83%), and all except two occurred in patients with immunohistochemically defined luminal A and luminal B/HER2-negative tumors. In these two subgroups, a Ki67 above the median value (21%) was the only independent predictor of no change in the indication to ACT at round 2. Omission of AD in patients with one or two positive SLNs may change the indication to ACT in a significant proportion of patients with hormone receptor-positive/HER2-negative tumors. All implications should be taken into account before abandoning AD, including a possible biologically tailored surgical approach.

P3-07-04: Does Omission of Axillary Dissection after a Positive Sentinel Node Biopsy Influence Indication to Adjuvant Chemotherapy in Operable Breast Cancer Patients?

Abstract Introduction: Based on the recently published ACSOG Z0011 study (JAMA 2011;305:569), axillary dissection (AD) may be avoided in breast cancer (BC) patients with a clinically negative axilla and a positive sentinel lymph node (SLN) biopsy receiving breast conserving surgery (BCS). Because the number of positive axillary lymph nodes (ALN) is a widely accepted prognostic marker, we evaluated the potential impact of omission of AD on indication to adjuvant chemotherapy (ACT). Patients and methods: Among 1497 patients operated at our Institution over 10 years, we identified 321 patients fulfilling the inclusion criteria of the ACSOG Z0011 study (BCS plus SLNB, cT1-2, cN0 breast cancer and 1 to 2 positive SLN). All patients underwent AD. Each case, which was anonymized, was reviewed by our breast team in two rounds. In the first round, patient age, histopathology, linfovascular invasion, tumor grade, hormone receptor, HER2, and ki67 status and number of positive SN nodes (micro and/or macrometastatic) were available. In the second round, the information on ALN was added. At each round, the panel chose between three indications: 1) Recommend ACT; 2) Discuss ACT; 3) No ACT. Results: SN was micrometastatic in 145 (45%) and macrometastatic in 176 patients (55%). ALD revealed non-SNs metastases in 96 patients (30%). Forty-four of these patients had &amp;gt;3 positive ALN (range 4–24). Indications at round 1 and 2 are summarized below. As a result of the disclosure of the total number of involved ALN, a change in the indication occurred in 51 patients (16%). The most frequent change was a recommendation to ACT (35 patients, 69% of the changes). Among these patients, 9 changed from No-ACT to recommend ACT. All except one change in the indication to ACT occurred in patients with immunohistochemically defined Luminal A and Luminal B/HER2 negative tumors and were mostly towards ACT. Conclusions: Omission of AD in patients with a positive SLN receiving BCS would have altered the indication to ACT in 16% of the patients at our Institution. Changes occurred almost exclusively in patients with hormone receptor positive/HER2−negative tumors. The implications of omission of AD must be taken into account before its widespread acceptance, including the possibility of a biologically tailored surgical approach. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P3-07-04.

Radiation field design and regional control in sentinel lymph node‐positive breast cancer patients with omission of axillary dissection

Randomized data suggest that axillary clearance is not necessary in select, clinically lymph node-negative women with positive sentinel lymph node (SLN) biopsies (SLNBs) who undergo breast-conserving surgery or receive whole-breast radiotherapy and systemic therapy. The additional value of axillary radiotherapy in these patients is unknown. The authors identified 326 patients with positive SLNBs who underwent breast-conserving surgery without axillary lymph node dissection from 1997 to 2009. SLN tumor deposits measured ≤0.2 mm in 58% of patients, 0.3 to 2.0 mm in 35% of patients, and >2 mm in 7% Patients. Ninety-three percent of patients received adjuvant radiotherapy. Radiation fields were categorized as standard tangents, high tangents, comprehensive (tangents plus supraclavicular), or partial breast to reflect coverage of the axilla. Standard tangents included both prone and supine positions. Regional failure was defined as recurrence in the ipsilateral supraclavicular, axillary, or internal mammary lymph nodes. The median follow-up was 55 months (range, 1-158 months). The 4-year rates of regional control, local control, disease-free survival, and overall survival were 99%, 98%, 95%, and 91%, respectively. Three patients had regional recurrences. Two of those patients received adjuvant radiotherapy with standard supine tangents, and 1 patient did not receive radiotherapy. No regional recurrences occurred among 66 patients who received radiotherapy in the prone position. Regional control was high (99% at 4 years) in patients who had low-volume SLN disease who did not undergo axillary dissection, regardless of whether the axilla was irradiated. Whole-breast radiation alone, including in the prone position, is sufficient treatment after breast-conserving surgery for select patients with tumor-containing SLNs who omit axillary dissection.

Strategies for subtypes—dealing with the diversity of breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011

The 12th St Gallen International Breast Cancer Conference (2011) Expert Panel adopted a new approach to the classification of patients for therapeutic purposes based on the recognition of intrinsic biological subtypes within the breast cancer spectrum. For practical purposes, these subtypes may be approximated using clinicopathological rather than gene expression array criteria. In general, systemic therapy recommendations follow the subtype classification. Thus, ‘Luminal A’ disease generally requires only endocrine therapy, which also forms part of the treatment of the ‘Luminal B’ subtype. Chemotherapy is considered indicated for most patients with ‘Luminal B', ‘Human Epidermal growth factor Receptor 2 (HER2) positive’, and ‘Triple negative (ductal)’ disease, with the addition of trastuzumab in ‘HER2 positive’ disease. Progress was also noted in defining better tolerated local therapies in selected cases without loss of efficacy, such as accelerated radiation therapy and the omission of axillary dissection under defined circumstances. Broad treatment recommendations are presented, recognizing that detailed treatment decisions need to consider disease extent, host factors, patient preferences, and social and economic constraints.

Lymphedema following irradiation in breast cancer: A cross-sectional study

e11569 Background: Nearly 15–30% of breast cancer patients (pts) face lymphedema (LE) following locoregional therapy, incidence being higher with surgery (Sx) &amp; radiotherapy (RT) combination than with Sx alone. We intended to study the incidence of post-RT LE and associated symptoms. Method: We evaluated 104 unilateral breast cancer pts who had completed curative therapy (Sx + RT + chemotherapy ± hormone therapy HT), with a minimum follow up of 6 months. Besides demographic &amp; treatment details, symptoms associated with LE and objective measurements of upper limb circumference were recorded using an indigenous questionnaire. Results: Median age was 45 years (range 28–65). Chest wall or breast RT was delivered using medial &amp; lateral tangential portals (Cobalt-60 unit) in 88 pts &amp; with 12 MeV electrons in 18 pts. Of all pts, 77 were given supraclavicular &amp; axillary RT. HT was given to 72 pts. Pathological stages were: T1/2- 73, T3/4- 27, Tx-4; N0–44, N1–25, N2/3–33, Nx-2. Arm swelling was reported by 68 pts (mild-40, moderate-28). Other symptoms included reduced range of motion (mild-52, moderate-24), fatigue (48), pain (28), numbness (20), infections (12), shoulder droop (12) and local tenderness (8). Forty-four pts reported having psychological stress (mild-40, moderate-4). Nearly 60% had symptoms mandating change in physical activity (mild-56, moderate-8). Dominant hand was involved in 57 pts. Shoulder exercises were advised in 84 pts; compliance was poor in 16, average in 32, &amp; good in 36. Only 36 pts were advised compression garments, compliance being poor in 28, average in 4 &amp; good in 4. Objective measurements revealed a difference of ≥3 cm in 27 pts in mid-arm circumference (MAC) (median 5.5 cm, maximum 8 cm) &amp; 34 pts in forearm circumference (FAC) (median 3.5, maximum 7 cm). There was no significant association between MAC or FAC with age, stage, body surface area, basal metabolic index, Sx type, chemotherapy or HT. Perceived LE and objective measurements correlated well. MAC difference &gt;3 cm was seen in 28.5% (22/77) pts who received axillary RT and in 18.5% (5/27) of those who received only local RT. Conclusions: LE, with its associated complications, is often understudied in breast cancer survivors. Revision of Sx and RT policies (e.g., omission of axillary dissection &amp; RT in selected pts) may help minimise LE. No significant financial relationships to disclose.

Predictive model of axillary lymph node involvement in women with small invasive breast carcinoma: axillary metastases in breast carcinoma.

Axillary lymph node involvement (ALNI) remains the most accurate predictive factor for recurrence risk and survival in patients with invasive breast carcinoma (IBC) and is an essential element in therapeutic decisions. However, axillary dissection (AD) is responsible for several side effects and is now discussed in small IBC. The objective of this study was to define a predictive model of ALNI by using clinical and histologic variables available before surgery. The authors studied 795 cases of IBC (T0, T1, T2 < or = 4 cm; N0; M0) treated between 1980 and 1997 by conservative surgery and radiation therapy. All cases had axillary dissection with at least 10 lymph nodes removed. A stepwise logistic regression analysis was performed to build a predictive model of ALNI. The authors then used the jackknife resampling technique to produce unbiased estimates of the probabilities of ALNI along with their confidence intervals. The global ALNI rate was 25.7%. The final predictive model included clinical tumor size, location, and histologic subtype and grade as variables independently associated with ALNI. The estimated probability of ALNI varied from 6% to 45%, according to case characteristics for these variables. These results show that the omission of AD in surgical procedures for these tumors is debatable. Even when ALNI rates were low, the superior bounds of the confidence intervals could be high. Consequently, we do not recommend to omit AD in women whose estimated risks are higher than 25%. Women with a risk of ALNI lower than 25% could benefit from the sentinel lymph node procedure with, likewise, a limited risk of false-negative.