Evaluating The Clinical Effect Of Axillary Retention Meeting The Z0011study Criteria

Objective:A single-center retrospective study was conducted to evaluate the long-term therapeutic effects of patients who did not receive axillary lymph node dissection and those who received axillary lymph node dissection on the basis of the Z0011 criterion,in order to provide more clinical evidence for the extension of the Z0011 criterion in China.Methods:This study included breast cancer patients conforming to the Z0011 criteria who admitted to the First Hospital of Jilin University from January2013 to December 2021.The clinical and pathological characteristics,treatment protocols and follow-up data of were retrospectively reviewed.The patients were divided into two groups according to the type of axillary surgery:the sentinel lymph node biopsy(SLNB)group and the axillary lymph node dissection after sentinel lymph node biopsy(ALND)group.Chi-square test and Fisher’s exact test were used to compare the differences between groups.Kaplan-Meier method was used to draw the survival analysis curve,followed by Log-Rank test.P<0.05 was considered statistically significant.Results:123 patients with breast cancer met the criteria of Z0011,of which 2 did not meet the criteria of this study.121 patients with early breast cancer were included in the follow-up analysis,of which 73 patients were included in the SLNB group,and 48 patients were included in the ALND group.The percentage of patients with preserved axilla conforming to Z0011 standard increased from 0% in 2013 to 83.8% in 2021.In this study,the incidence of macro metastasis(91.3% vs 71.2%,P=0.009)and the arm swelling,impaired limb mobility(50.0% vs 20.0%,P = 0.001)in the ALND group were significantly higher than those in the SLNB group,and the rest showed no statistical difference.Compared with the Z0011 trial,117 patients with invasive ductal carcinoma(96.6% vs 84.0%,P < 0.001),113 patients with hormone receptor-positive carcinoma(93.4% vs 83.7%,P=0.007),and 75 patients with positive lymphovascular invasion(62.0% vs 35.2%,P<0.001),There were 97 patients receiving adjuvant chemotherapy(80.2% vs 58.0%,P<0.001)and 102 patients receiving adjuvant endocrine therapy(84.3% vs 46.6%,P < 0.001),which were significantly higher than those in the Z0011 trial.There were no statistically significant differences in mean age,clinical stage,number of positive sentinel lymph nodes and number of patients treated by adjuvant radiotherapy.After a median follow-up of 37 months,the 3-year overall survival rate was 97.0% in the SLNB group and 100% in the ALND group(P= 0.776),and the 3-year disease-free survival rate was 93.9% in the SLNB group and 100% in the ALND group,with no statistical difference between the two groups(P=0.054).Conclusions:This study showed that the results of Z0011 trial had a positive impact on surgeons and patients in China.sentinel lymph node biopsy was found in early breast cancer patients who were eligible for c T1-2N0M0,did not receive neoadjuvant systemic therapy,underwent breast-conserving surgery and planned to undergo adjuvant radiotherapy and systemic treatment after surgery,and it was feasible to avoid axillary lymph node dissection.