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

Miao, Liyun; Wang, Shu; Cui, Shude; Duan, Xuening; Fan, Zhimin; Yu, Zhengping

doi:10.1038/srep15241

Cited by 19 publications

(16 citation statements)

References 34 publications

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“…Based on these results, American Society of Clinical Oncology Clinical Practice Guideline and National Comprehensive Cancer Network (NCCN) recommend that women who meet the Z0011 criteria may not undergo ALND 7 , 8 . Increasing number of patients undergo SLN biopsy which could avoid the underlying morbidity of ALND 9 – 11 .However, a subset of patients with limited disease burden on SLN may have relatively high aggressive behavior and poor survival after SLNB. Thus, it is important to explore the poor prognostic factors in breast cancers with SLNs involvement.…”

Section: Introductionmentioning

confidence: 99%

Clinical significance of extranodal extension in sentinel lymph node positive breast cancer

Xia

Yang

et al. 2020

Sci Rep

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The precise stage of lymph node (LN) metastasis is a strong prognostic factor in breast cancers, and sentinel lymph node (SLN) is the first station of nodal metastasis. A number of patients have extranodal extension (ENE) in SLN, whereas the clinical values of ENE in SLN in breast cancers are still in exploration. The aim of our study was to evaluate the predictive and prognostic values of ENE in SLN in breast cancers, and to investigate the feasibility of ENE to predict non-SLN metastasis, nodal burden, disease free survival (DFS) and overall survival (OS) in clinical practice. 266 cases of primary invasive breast cancer (cT1-2N0 breast cancer) underwent SLN biopsy and axillary lymph node dissection (ALND) between 2008 and 2015 were extracted from the pathology database of Fudan University Shanghai Cancer Center. ENE in SLN was defined as extension of neoplastic cells through the lymph-nodal capsule into the peri-nodal adipose tissue, and was classified as no larger than 2 mm and larger than 2 mm group. The associations between ENE and clinicopathological features, non-SLN metastasis, nodal burden, DFS, and OS were analyzed. In the 266 patients with involved SLN, 100(37.6%) were positive for ENE in SLN. 67 (25.2%) cases had ENE no larger than 2 mm in diameter, and 33(12.4%) had ENE larger than 2 mm. Among the clinicopathological characteristics, the presence of ENE in SLN was associated with higher pT and pN stages, PR status, lympho-vascular invasion. Logistic regression analysis indicated that patients with ENE in SLN had higher rate of non-SLN metastasis (OR4.80, 95% CI 2.47–9.34, P < 0.001). Meanwhile, in patients with SLN micrometastasis or 1–2 SLNs involvement, ENE positive patients had higher rate of non-SLN metastasis, comparing with ENE negative patients (P < 0.001, P = 0.004 respectively). The presence of ENE in SLN was correlated with nodal burden, including the pattern and number of involved SLN (P < 0.001, P < 0.001 respectively), the number of involved non-SLN and total positive LNs (P < 0.001, P < 0.001 respectively). Patients with ENE had significantly higher frequency of pN2 disease (P < 0.001). For the disease recurrence and survival status, Cox regression analysis showed that patients with ENE in SLN had significantly reduced DFS (HR 3.05, 95%CI 1.13–10.48, P = 0.008) and OS (HR 3.34, 95%CI 0.74–14.52, P = 0.092) in multivariate analysis. Kaplan–Meier curves and log-rank test showed that patients with ENE in SLN had lower DFS and OS (for DFS: P < 0.001; and for OS: P < 0.001 respectively). Whereas no significant difference was found in nodal burden between ENE ≤ 2 mm and > 2 mm groups, except the number of SLN metastasis was higher in patients with ENE > 2 mm. Cox regression analysis, Kaplan–Meier curves and log-rank test indicated that the size of ENE was not an independent factor of DFS and OS. Our study indicated that ENE in SLN was a predictor for non-SLN metastasis, nodal burden and prognosis in breast cancers. Patients with ENE in SLN had a higher rate of non-SLN metastasis, higher frequency of pN2 disease, and poorer prognosis. Patients with ENE in SLN may benefit from additional ALND, even in SLN micrometastasis or 1–2 SLNs involvement patients. The presence of ENE in SLN should be evaluated in clinical practice. Size of ENE which was classified by a 2 mm cutoff value had no significant predictive and prognostic values in this study. The cutoff values of ENE in SLN need further investigation.

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Section: Introductionmentioning

confidence: 99%

Clinical significance of extranodal extension in sentinel lymph node positive breast cancer

Xia

Yang

et al. 2020

Sci Rep

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“…We believe that the results of our pilot study regarding the Chinese patient population will have a great effect on the clinical practice of Chinese surgeons in treating patients with breast cancer. [6] 132 39% Delpech [5] 87 29% Miao Liu [15] 151 25.2% Verheuvel [19] 625 26% Ngui [7] 22 27.3% Present study 27 25.94%…”

Section: Discussionmentioning

confidence: 99%

“…In 2014, we led a retrospective analysis and found that the clinicopathological factors were not statistically different between the eligible group in China and the Z0011 cohort. These findings laid the foundation for omitting ALND in Chinese patients according to the Z0011 criteria [15]. However, no prospective clinical trial result has been reported in the Chinese population.…”

Section: Introductionmentioning

confidence: 99%

Application of the ACOSOG Z0011 Criteria to Chinese Patients with Breast Cancer: A Prospective Study

Peng

Liu

Tong

et al. 2020

Preprint

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Background: Although the ACOSOG Z0011 study showed axillary lymph node dissection (ALND) could be avoided in a specific population of sentinel lymph node positive patients, it’s not widely accepted by Chinese surgeons. We conducted a prospective single-arm study to confirm whether or not the results of Z0011 are applicable to Chinese patients. Methods: Patients conforming to the Z0011 criteria were prospectively enrolled at the Peking University People’s Hospital Breast Center from November 2014 to June 2019. Clinicopathological features of the study group were compared with the Z0011 study. Lymphedema after surgery, incidence of local-regional recurrence, and survival were analyzed. Results: One hundred forty-two patients who met Z0011 eligibility criteria were enrolled in this study; 115 had sentinel lymph node biopsy (SLNB) alone. When comparing with the Z0011 trial, younger patients were included (median age, 52 [26- 82] years vs 54 [25-90] years; P = 0.03). Among clinical T stage, tumor histology, hormone status, lymphovascular invasion, and the number of positive sentinel lymph nodes (SLNs), no statistically significant differences were observed. More patients received adjuvant chemotherapy and endocrine therapy (90.85% vs 58.0% and 80.99% vs 46.6% respectively, P < .001). A similar percentage of patients received radiotherapy, but more nodal radiotherapy procedures were carried out in our study (54.5% vs 16.9%). After median follow-up of 29 months, only 1 patient (0.9%) had ipsilateral breast tumor recurrence and no regional recurrence occurred. Conclusion: Our study showed that it is achievable to avoid ALND in patients eligible for Z0011 in China. Trial registration: ClinicalTrials Registered Number: NCT03606616. Registered 31 July 2018-Retrospectiverly registered, https://www.clinicaltrials.gov/ct2/show/NCT03606616?term=Wang+shu&draw=4&ra nk=21.

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“…Based on these results, American Society of Clinical Oncology Clinical Practice Guideline and National Comprehensive Cancer Network (NCCN) recommends that women who meet the Z0011 criteria may not undergo ALND [7,8] . Thus, increasing number of patients are omitting ALND in favor of SLNB can avoid the underlying morbidity of ALND [9][10][11] .However, a subset of patients with limited disease burden on SLN may have relatively high aggressive behavior and poor survival after SLNB. Thus, it is important to explore the poor prognostic factors in breast cancers with SLNs involvement.…”

Section: Introductionmentioning

confidence: 99%

Clinical significance of extranodal extension in sentinel lymph node positive breast cancers

Yang

et al. 2020

Preprint

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Background The precise stage of lymph node (LN) metastasis is a strong prognostic factor in breast cancer, and sentinel lymph node (SLN) is the first station of nodal metastasis, whereas the clinical value of extranodal extension (ENE) in SLN are still in exploration.Objective Our study aimed to evaluate the predictive and prognostic values of ENE in SLN and to investigate the feasibility of ENE to predict non-SLN metastasis, disease free survival (DFS) and overall survival (OS) in clinical practice.Methods 183 cases of primary invasive breast cancer (cT1-2N0 breast cancer with 1-2 positive SLNs) underwent SLN biopsy and axillary lymph node dissection (ALND) between 2008 and 2015 were extracted from the pathology database of Fudan University Shanghai Cancer Center. Sections were reviewed for the microscopic features of SLN, including the number and pattern of SLN metastasis, SLNs positive ratio, nodal vascular invasion (NVI), and ENE. The associations between tumor features including ENE and non-SLN metastasis, DFS and OS were analyzed. Moreover, ENE was subclassified into circumferential (CD-ENE) and perpendicular (PD-ENE) and set a threshold as 2mm or 3mm to evaluate the prognostic value of ENE.Results 73/183 (39.9 %) cases were positive for ENE in SLN. Logistic regression analysis indicated that ENE, the number and pattern of SLN involvement, SLN positive ratio, and NVI were significantly associated with the presence of non-SLN metastasis in univariate analysis. ENE, higher number of SLN involvement, SLN macrometastasis, and NVI were significantly associated with a higher rate of non-SLN metastasis in multivariate analysis. Cox regression analysis showed ENE in SLN was associated with DFS and OS in univariable analysis, but not in multivariable analysis. Whereas the size of ENE (CD-ENE and PD-ENE) subdivided by 3mm (or 2mm) cutoff values were not found as strongly prognostic factors of DFS and OS as well.Conclusions Our study indicated that ENE in SLN was a predictor for non-SLN metastasis in breast cancers, patients with ENE in SLN had a higher rate of non-SLN metastasis. ENE in SLN was associated with DFS and OS in univariable analysis, but not in multivariable analysis. The size of ENE (CD-ENE and PD-ENE) which was classified by a 3mm (or 2mm) cutoff value had no significant prognostic values in this study. The prognostic value of ENE in SLN and the cutoff values of ENE in SLN in breast cancers need further investigation.

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

Cited by 19 publications

References 34 publications

Clinical significance of extranodal extension in sentinel lymph node positive breast cancer

Clinical significance of extranodal extension in sentinel lymph node positive breast cancer

Application of the ACOSOG Z0011 Criteria to Chinese Patients with Breast Cancer: A Prospective Study

Clinical significance of extranodal extension in sentinel lymph node positive breast cancers

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