Multidisciplinary Considerations in the Implementation of the Findings from the American College of Surgeons Oncology Group (ACOSOG) Z0011 Study: A Practice-Changing Trial

Caudle, Abigail S.; Hunt, Kelly K.; Kuerer, Henry Mark; Meric‐Bernstam, Funda; Lucci, Anthony; Bedrosian, Isabelle; Babiera, Gildy; Hwang, Rosa F.; Ross, Merrick I.; Feig, Barry W.; Hoffman, Karen E.; Litton, Jennifer K.; Şahin, Ayşegül; Yang, Wei Tse; Hortobágyi, Gabriel N.; Buchholz, Thomas A.; Mittendorf, Elizabeth A.

doi:10.1245/s10434-011-1593-7

Cited by 113 publications

(67 citation statements)

References 25 publications

(24 reference statements)

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“…women treated with breast conserving surgery, systemic therapy, and whole breast radiotherapy [15]. While these data will likely lead to a reduction in completion AxD, the American Society of Clinical Oncology and other expert opinions [46][47][48] have emphasized that this practice change should be cautiously implemented only within the population that was eligible for Z0011. There are many women, such as those treated with mastectomy or who were otherwise excluded from the Z0011 study, for whom accurate prediction tools are still relevant.…”

Section: Discussionmentioning

confidence: 99%

Which prediction models best identify additional axillary disease after a positive sentinel node biopsy for breast cancer?

Berrang

Lesperance

Truong

et al. 2012

Breast Cancer Res Treat

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To determine which web-based model best identifies women at low risk of further axillary disease after a positive sentinel lymph node (SLN+) biopsy. 673 women with T1-2cN0M0 SNB+ breast cancer who underwent completion axillary dissection (AxD) were identified. A subgroup not eligible to avoid AxD as part of the Z0011 study was defined (Z0011 exclusion group). Predicted risk of further axillary disease was generated using seven web-based models. "Low risk" was defined as a ≤10% risk of further axillary disease. False negative ("low risk" prediction but AxD+) rates (FNRs), area under the receiver operating characteristic curve (AUC), and Brier score were determined for each model. 6 of 7 models identified "low risk" patients but FNRs ranged from 14 to 30%. The Stanford and Memorial Sloan-Kettering (MSKCC) models had the best FNRs. FNRs were lower with SLN micrometastasis (7-15%) and higher in the Z0011 exclusion group (21-41%). All models under-predicted further nodal disease in low risk patients and over-predicted in higher-risk patients. The Stanford and MSKCC models were able to identify women with SLN micrometastasis with a ≤10% FNR. Models were not able to accurately identify low risk women from a cohort that would have been excluded from Z0011.

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Section: Discussionmentioning

confidence: 99%

Which prediction models best identify additional axillary disease after a positive sentinel node biopsy for breast cancer?

Berrang

Lesperance

Truong

et al. 2012

Breast Cancer Res Treat

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“…3,4 Frozen sections can cause significant destruction of potentially diagnostic tissue, and in general the quality of frozen tissue preparations may not be as high as those prepared from well-fixed tissue. 8 At our institution, most false-negative frozen section diagnoses are due to undetected micrometastasis or isolated tumor cells, and low-grade metastatic lobular carcinoma.…”

Section: Commentmentioning

confidence: 99%

“…3 The Z0011 trial has been proclaimed a practice changer, with most surgical practices rapidly accepting Z0011 criteria as part of standard axillary management allowing for the avoidance of ALND in patients with up to 2 lymph nodes with metastatic disease. [4][5][6] Despite criticisms concerning the study's lack of long-term follow up, low patient accrual, and reported protocol violations, Z0011 has made a significant impact on patients with primary BC by improving quality of life without compromising overall survival. 7 In 2014, the American Society of Clinical Oncology (ASCO) published updated guidelines regarding SLNB for patients with early-stage BC.…”

mentioning

confidence: 99%

Decline in Frozen Section Diagnosis for Axillary Sentinel Lymph Nodes as a Result of the American College of Surgeons Oncology Group Z0011 Trial

Bishop¹,

Sun²,

Ajkay³

et al. 2015

Archives of Pathology &Amp; Laboratory Medicine

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Context.-Results of the American College of SurgeonsOncology Group Z0011 trial showed that patients with early-stage breast cancer and limited sentinel node metastasis treated with breast conservation and systemic therapy did not benefit from axillary lymph node dissection. Subsequently, most pathology departments have likely seen a decrease in frozen section diagnosis of sentinel lymph nodes.Objective.-To determine the effect of the Z0011 trial on pathology practice and to examine the utility of intraoperative sentinel lymph node evaluation for this subset of patients.Design.-Pathology reports from cases of primary breast cancer that met Z0011 clinical criteria and were initially treated with lumpectomy and sentinel lymph node biopsy from 2009 to 2015 were collected. Clinicopathologic data were recorded.Results.-Sentinel lymph node biopsies sent for frozen section diagnosis occurred in 22 of 22 cases (100%) in 2009 and 15 of 22 cases (68%) in 2010 during the pre-Z0011 years, and in 3 of 151 cases (2%) collected in 2011 through 2015, considered to be post-Z0011 years. Of the 151 post-Z0011 cases, 28 (19%) had sentinel lymph nodes with metastasis, and 147 (97%) were spared axillary lymph node dissection.Conclusions.-Following Z0011, intraoperative sentinel lymph node evaluation has significantly decreased at our institution. Prior to surgery, all patients had clinically node-negative disease. After sentinel lymph node evaluation, 97% (147 of 151) of the patients were spared axillary lymph node dissection. Therefore, routine frozen section diagnosis for sentinel lymph node biopsies can be avoided in these patients.

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“…Although designed to treat the breast, it's well known that WBI also includes a significant portion of the lower axilla in the treatment field. Based on published data, 51 % of level I and 26 % of level II axillary nodes received 95 % of the prescribed dose [70][71][72][73]. Thus, the results of this trial can only be applied to patients who receive lumpectomy with radiotherapy.…”

Section: Acosog Z0011mentioning

confidence: 99%

Management of the Clinically Node-Negative Axilla in Primary Breast Cancer

Alarhayem

Jatoi

2016

Personalized Treatment of Breast Cancer

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Axillary lymph node status is an important prognostic factor in patients with primary breast cancer. Yet, management of the axilla in these patients has been controversial. Sentinel lymph node biopsy (SLNB) is a less morbid procedure with similar survival and recurrence when compared to axillary lymph node dissection (ALND) and has emerged as the standard of care for staging patients with clinically node-negative disease. The results of three randomized trials seem to suggest that completion ALND may not be necessary in all women with T1

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Multidisciplinary Considerations in the Implementation of the Findings from the American College of Surgeons Oncology Group (ACOSOG) Z0011 Study: A Practice-Changing Trial

Cited by 113 publications

References 25 publications

Which prediction models best identify additional axillary disease after a positive sentinel node biopsy for breast cancer?

Which prediction models best identify additional axillary disease after a positive sentinel node biopsy for breast cancer?

Decline in Frozen Section Diagnosis for Axillary Sentinel Lymph Nodes as a Result of the American College of Surgeons Oncology Group Z0011 Trial

Management of the Clinically Node-Negative Axilla in Primary Breast Cancer

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