We were unable to directly assess clinical axillary lymph node status using the SEER-Medicare database. Patients who underwent lumpectomy followed by whole-breast radiation as their definitive local management were considered eligible.
Finally, we examined the number of positive nodes. The ACOSOG Z inclusion criteria 4 , 5 was applied to the overall cohort to determine the proportion of patients within the SEER Medicare database with newly diagnosed invasive breast cancer who would meet the eligibility criteria. Descriptive statistics for demographic and clinical characteristics were generated.
Similar data and statistics for those undergoing mastectomy that would have otherwise been eligible under ACOSOG Z if they had undergone lumpectomy were also assessed. Of the 13, women with positive lymph nodes, 6, women underwent lymphatic mapping and were assumed to have clinically negative axilla. Fifty-one percent underwent lumpectomy, with receipt of mastectomy being the most common reason patients with a positive lymph node did not meet eligibility for ACOSOG Z An additional patients had 3 positive lymph nodes.
Table 3 presents the demographics of these two groups. Given the high rate of SLN only in the lymph node positive lumpectomy patients, practice patterns for those patients who underwent mastectomy as the definitive breast surgery were examined to see how rates of completion ALND compared.
In general, axillary surgery practices for patients undergoing mastectomy paralleled that seen for patients treated with lumpectomy and whole breast radiation. Prior to the results of ACOSOG Z being reported in , several observational studies reported similar survival and local recurrence outcomes for patients with early stage primary tumors and a low burden of axillary disease, regardless of whether they underwent a completion ALND or not.
Although these studies cannot be directly extrapolated to patients with proven nodal metastases, they further support the trend away from ALND in breast cancer and may have contributed to the patterns of care observed in our study.
What about those patients with SLN metastases who underwent mastectomy? There is some limited data to support this practice. In this trial, all patients with a positive SLN underwent completion dissection.
However, SLNs of patients found to be node negative underwent central review using both routine and immunohistochemical staining; occult metastases were identified in Of these patients, were managed with mastectomy. There are several limitations to this study. However, population level data assessing actual dissemination will not be available for several years. Therefore, we cannot precisely identify our eligible cohort.
We addressed this limitation by presenting categories of the number of positive nodes. In our analysis, we considered those with 1—2 nodes positive to be our most conservative estimate of potential eligible patients, although this likely underestimates eligible patients as some of those patients with 3 positive nodes could be considered eligible if some of those nodes were identified at ALND rather than SLN.
Additionally, we used receipt of SLN mapping as a surrogate for clinically negative axilla. This may underestimate eligible patients if some surgeons had slow adoption of SLN biopsy as an alternative to ALND as standard of care. It is noteworthy that the trend away from completion ALND in older patients with low volume axillary disease extended in our cohort to patients receiving mastectomy.
Future work will need to better define the role of completion ALND for subgroups who do not meet eligibility for AOCOSOG Z, but for whom the risk of axillary recurrence is low, particularly those patients with low volume axillary disease treated with mastectomy.
Interpretation and reporting of these data are the sole responsibility of the authors. National Center for Biotechnology Information , U. The stability of these results over time is important because patients with hormone receptor—positive breast cancer, who comprise the majority of study participants and the majority of breast cancer patients in the United States, are known to be at prolonged risk for disease recurrence.
Although the annual rate of distant recurrence after completion of 5 years of endocrine therapy has been reported to range from 0. Because the patient characteristics were well balanced, any decrease in disease-free survival or overall survival in the SLND alone group would have been anticipated to occur due to an increase in regional recurrences; however, only a single regional recurrence was observed in the SLND alone group with additional follow-up in the ACOSOG Z Alliance trial.
Consistent with this finding, the incremental decreases in disease-free survival 3. In an adjusted analysis, well documented prognostic factors such as age, hormone receptor status, tumor size, and the use of adjuvant therapy but not elimination of ALND were associated with overall survival. Although the initial results of the ACOSOG Z study generated controversy, 17 , 18 management of women in the United States with sentinel node metastases changed substantially as a result of the study.
In that study, age younger than 50 years and a triple-negative subtype predicted a greater use of ALND, a practice neither supported by the reported 5-year outcomes of ACOSOG Z, 9 nor by the findings of the current report.
The role of nodal irradiation, specifically in ACOSOG Z and in the management of patients with node-positive breast cancer, is controversial. In addition, the unplanned analysis showed that no survival differences were observed among patients treated with conventional tangent-field irradiation or nodal-field irradiation.
In the MA. Thus, although nodal irradiation may be added to the management of some patients with node-positive tumors based on an evaluation of their overall risk profile, the routine use of nodal irradiation for all patients with 1 or 2 sentinel node metastases managed with SLND alone may not be justified.
Ten years of follow-up confirm that women with 1 or 2 positive sentinel nodes and clinical T1 or T2 tumors undergoing lumpectomy with whole-breast irradiation and systemic therapy experience no worse local control, disease-free survival, or overall survival with elimination of ALND.
However, these conclusions apply only to patients meeting ACOSOG Z eligibility criteria and should not be extrapolated to the management of patients with positive palpable nodes, those with metastases in more than 2 sentinel nodes, patients forgoing whole-breast irradiation, those treated with mastectomy without radiation, or patients receiving neoadjuvant therapy because all of these are circumstances in which the elimination of ALND is not known to be safe.
The ongoing Positive Sentinel Node-Adjuvant Therapy Alone vs Adjuvant Therapy Plus Clearance or Axillary Radiotherapy trial for women with metastases in 1 or 2 sentinel nodes treated with breast-conserving surgery or mastectomy will provide important information about the safety of omitting ALND after mastectomy, but this study is not expected to complete accrual until This study has several limitations.
Like most large randomized trials in breast cancer management, not all biological subtypes are represented in large numbers. Differences in outcomes may be seen for patients with different individual circumstances. However, not all biological subtypes can be analyzed for small variations in locoregional treatment. Furthermore, due to low accrual and the low event rate, the study did not reach the prespecified sample size of participants or deaths.
In addition, some patients had irradiation protocol variations that could have resulted in a small alteration of outcomes; however, these patients were distributed similarly in both study groups. Among women with T1 or T2 invasive primary breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases, year overall survival for patients treated with sentinel lymph node dissection alone was noninferior to overall survival for those treated with axillary lymph node dissection.
Corresponding Author: Armando E. Author Contributions: Drs Giuliano and Ballman had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Critical revision of the manuscript for important intellectual content: All authors.
Dr Ballman also reported receiving grant support from the National Cancer Institute during the conduct of the study. Dr Hansen also reported receiving speakers fees from Genentech and Genomic Health.
No other disclosures were reported. Neither the Alliance nor the National Cancer Institute had the right to veto the submission of the manuscript. Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy Continue. Figure 1. View Large Download. Figure 2. Table 1.
Baseline Participant Characteristics. Table 2. Survival Outcomes by Study Group. Table 3. Audio Trial protocol. Axillary Node Interventions in Breast Cancer. Rao and coauthors conducted a review of the literature to summarize evidence regarding the role of axillary interventions surgical and nonsurgical in breast cancer treatment and to review the association of these axillary interventions with recurrence of axillary node metastases, mortality, and morbidity outcomes in patients with breast cancer.
Karla V. Ballman, PhD; Linda M. Giuliano, MD. Save Preferences. Privacy Policy Terms of Use. Due to the significant morbidity of ALND, including paresthesias, lymphedema, seroma, and infection, judicious use of the procedure is important. The American College of Surgeons Oncology Group ACOSOG Z trial was a multicenter noninferiority study which enrolled and randomized patients with breast cancer, T disease, clinically negative axillary nodes, 1 or 2 macrometastatic nodes on SLNB, and a plan for breast conserving therapy consisting of lumpectomy and whole-breast radiation.
Patients were randomized to either completion ALND with a minimum of 10 nodes, or to observation. The study was terminated before target enrollment of women because the observed mortality was lower than anticipated. At 5 years, there were no differences in terms of overall survival Lymphovascular invasion and lobular histology are associated with increased incidence of isolated tumor cells in sentinel lymph nodes from early-stage breast cancer patients. Lymphatic mapping and sentinel lymph node biopsy in early-stage breast carcinoma: a meta-analysis.
Incidence, treatment costs, and complications of lymphedema after breast cancer among women of working age: a 2-year follow-up study. Download references. Abigail S. Caudle MD, Kelly K. Hunt MD, Sarah M. Mittendorf MD. You can also search for this author in PubMed Google Scholar. Correspondence to Abigail S. Caudle MD or Elizabeth A. Reprints and Permissions. Caudle, A. Ann Surg Oncol 19, — Download citation.
Received : 16 April Published : 31 July
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