The feasibility of the ACOSOG Z0011 Criteria to Chinese Breast Cancer Patients: A Multicenter Study

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Abstract

The aim of this study was to determine the feasibility of the Z0011 criteria to Chinese breast cancer patients. An survey about the Z0011 trial was distributed and we collected 658 consecutive patients with axillary lymph node dissection (ALND) after positive sentinel lymph node (SLN) biopsy from five centers’ databases and grouped them as eligible or ineligible for omitting ALND according to the Z0011 criteria. The eligible group was compared with the cohort included in the Z0011 trial and with the ineligible group. Of the 427 respondants, 106 (24.8%) and 130 (30.4%)would not routinely perform ALND in patients meeting Z0011 criteria before and after learning of the trial results, respectively. Among the 658 patients, 151 (22.9%) were eligible and 507 were ineligible for omitting ALND. The clinicopathologic factors were not statistically different between the eligible group and the Z0011 cohort. Compared with the eligible Group, the ineligible group had significantly more T2 and T3 stage tumors, positive lymph nodes(LNs) and positive non-sentinel lymph nodes (NSLNs) (P < 0.01). The findings suggest good exportability of the Z0011 criteria to Chinese patients omitting ALND, but application of Z0011 as national treatment guideline still needs additional time and effort.

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A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer.

Umberto Veronesi, Giovanni Paganelli, Giuseppe Viale … (2003)

Although numerous studies have shown that the status of the sentinel node is an accurate predictor of the status of the axillary nodes in breast cancer, the efficacy and safety of sentinel-node biopsy require validation. From March 1998 to December 1999, we randomly assigned 516 patients with primary breast cancer in whom the tumor was less than or equal to 2 cm in diameter either to sentinel-node biopsy and total axillary dissection (the axillary-dissection group) or to sentinel-node biopsy followed by axillary dissection only if the sentinel node contained metastases (the sentinel-node group). The number of sentinel nodes found was the same in the two groups. A sentinel node was positive in 83 of the 257 patients in the axillary-dissection group (32.3 percent), and in 92 of the 259 patients in the sentinel-node group (35.5 percent). In the axillary-dissection group, the overall accuracy of the sentinel-node status was 96.9 percent, the sensitivity 91.2 percent, and the specificity 100 percent. There was less pain and better arm mobility in the patients who underwent sentinel-node biopsy only than in those who also underwent axillary dissection. There were 15 events associated with breast cancer in the axillary-dissection group and 10 such events in the sentinel-node group. Among the 167 patients who did not undergo axillary dissection, there were no cases of overt axillary metastasis during follow-up. Sentinel-node biopsy is a safe and accurate method of screening the axillary nodes for metastasis in women with a small breast cancer. Copyright 2003 Massachusetts Medical Society

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Randomized multicenter trial of sentinel node biopsy versus standard axillary treatment in operable breast cancer: the ALMANAC Trial.

Robert Mansel, Lesley Fallowfield, Mark Kissin … (2006)

Sentinel lymph node biopsy in women with operable breast cancer is routinely used in some countries for staging the axilla despite limited data from randomized trials on morbidity and mortality outcomes. We conducted a multicenter randomized trial to compare quality-of-life outcomes between patients with clinically node-negative invasive breast cancer who received sentinel lymph node biopsy and patients who received standard axillary treatment. The primary outcome measures were arm and shoulder morbidity and quality of life. From November 1999 to October 2003, 1031 patients were randomly assigned to undergo sentinel lymph node biopsy (n = 515) or standard axillary surgery (n = 516). Patients with sentinel lymph node metastases proceeded to delayed axillary clearance or received axillary radiotherapy (depending on the protocol at the treating institution). Intention-to-treat analyses of data at 1, 3, 6, and 12 months after surgery are presented. All statistical tests were two-sided. The relative risks of any lymphedema and sensory loss for the sentinel lymph node biopsy group compared with the standard axillary treatment group at 12 months were 0.37 (95% confidence interval [CI] = 0.23 to 0.60; absolute rates: 5% versus 13%) and 0.37 (95% CI = 0.27 to 0.50; absolute rates: 11% versus 31%), respectively. Drain usage, length of hospital stay, and time to resumption of normal day-to-day activities after surgery were statistically significantly lower in the sentinel lymph node biopsy group (all P .05). Sentinel lymph node biopsy is associated with reduced arm morbidity and better quality of life than standard axillary treatment and should be the treatment of choice for patients who have early-stage breast cancer with clinically negative nodes.

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Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial.

Armando E. Giuliano, Linda McCall, Peter Beitsch … (2010)

Sentinel lymph node dissection (SLND) has eliminated the need for axillary dissection (ALND) in patients whose sentinel node (SN) is tumor-free. However, completion ALND for patients with tumor-involved SNs remains the standard to achieve locoregional control. Few studies have examined the outcome of patients who do not undergo ALND for positive SNs. We now report local and regional recurrence information from the American College of Surgeons Oncology Group Z0011 trial. American College of Surgeons Oncology Group Z0011 was a prospective trial examining survival of patients with SN metastases detected by standard H and E, who were randomized to undergo ALND after SLND versus SLND alone without specific axillary treatment. Locoregional recurrence was evaluated. There were 446 patients randomized to SLND alone and 445 to SLND + ALND. Patients in the 2 groups were similar with respect to age, Bloom-Richardson score, estrogen receptor status, use of adjuvant systemic therapy, tumor type, T stage, and tumor size. Patients randomized to SLND + ALND had a median of 17 axillary nodes removed compared with a median of only 2 SN removed with SLND alone (P < 0.001). ALND also removed more positive lymph nodes (P < 0.001). At a median follow-up time of 6.3 years, there were no statistically significant differences in local recurrence (P = 0.11) or regional recurrence (P = 0.45) between the 2 groups. Despite the potential for residual axillary disease after SLND, SLND without ALND can offer excellent regional control and may be reasonable management for selected patients with early-stage breast cancer treated with breast-conserving therapy and adjuvant systemic therapy.

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Journal ID (nlm-ta): Sci Rep

Journal ID (iso-abbrev): Sci Rep

Title: Scientific Reports

Publisher: Nature Publishing Group

ISSN (Electronic): 2045-2322

Publication date (Electronic): 16 October 2015

Publication date Collection: 2015

Volume: 5

Electronic Location Identifier: 15241

Affiliations

[1 ]Breast Center, Peking University People’s Hospital , Beijing, China

[2 ]Department of Breast Surgery, Cancer Center of Henan Province, China

[3 ]Breast Disease’s Center, The first Affiliated Hospital of Peking University , China

[4 ]Department of Breast Surgery, The First Affiliated Hospital of Jilin Univesity , China

[5 ]Department of Breast Surgery, The Second Affiliated Hospital of Shandong University , China

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[a ] dr.wangshu@ 123456263.net

Article

Publisher Item ID: srep15241

DOI: 10.1038/srep15241

PMC ID: 4607940

PubMed ID: 26472518

SO-VID: dc5dbb3b-0f6a-4ed1-a0ac-9d73037d7dc1

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The feasibility of the ACOSOG Z0011 Criteria to Chinese Breast Cancer Patients: A Multicenter Study

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Most cited references 28

A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer.

Randomized multicenter trial of sentinel node biopsy versus standard axillary treatment in operable breast cancer: the ALMANAC Trial.

Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial.

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