Real World Study Of 2290 Early-stage Cancer Breast Patients With Sentinel Lymph Node Biopsy And Axillary Lymph Node Dissection

BackgroundTreatment for breast cancer has embraced a new era of precision medicine and formed into a multidisciplinary and comprehensive mode of therapy,in which surgical treatment has been playing a significant role.As a critical component of breast cancer surgery,axillary surgery can evaluate tumor staging,direct comprehensive therapy and judge the prognosis.In recent years,sentinel lymph node biopsy(SLNB)has gradually replaced axillary lymph node dissection(ALND)and has been considered as standard treatment for ancillary surgery in early breast cancer patients.As the result of the late start,regional technical differences and diverse acceptance to SLNB,there are numerous cases of surgeries for both SLNB and ALND in clinical practice,which can be considered as the realistic reflection of current SLNB situation in China.Based on CSCO breast cancer database,we have collected and summarized parts of cases and completed the real world studies.ObjectiveThe aim of study is,by filtering and analyzing the patients' information of SLNB and ALND,to summarize the situation of SLNB and analyze the correlation between the results of SLNB and non-sentinel lymph node(n-SLN)metastasis in real world,therefore offering real world basis on selecting target groups for SLNB and recommended groups who should not receive ALND after SLNB.MethodBased on CSCO BC database,cases of patients admitted from January 2008 to May2017 and meanwhile meeting the following requirements were selected.Inclusion criteria: EBC patients(1)who were confirmed by pathological diagnosis;(2)who had received ALND without any consideration of SLNB results;(3)who had complete information.Exclusion criteria: EBC patients(1)who had recurrence or metastasis;(2)who had preoperative anti-cancer therapy;(3)who had more than 6 SLN;(4)who had surgery history of axillary.Clinical records on sentinel general information,preoperative TNM stages,SLNB results,ALND results of eligible patients were collected.Implementation of SLNB of patients enrolled was evaluated and analyzed on the basis of SLNB Evaluation Standard from Louisville University of United States.Results1.A total of 2290 patients were enrolled into the research.SLNB accuracy ofsubjects was 95.9% with false negative rate 6.9%.2.Among 946 clinical SLN positive patients,SLN metastasis were found in 788 cases,accounting for 83.3% of all clinical axillary positive cases.ALN positive cases were 837,making up 86.6% of all axillary positive cases.Both rates were higher remarkably than that of clinical axillary negative groups(p<0.001).3.There was a negative correlation between numbers of SLNB and false negative rates(p<0.05).All cases of SLN negative were divided into two groups based on situation that the numbers of SLN were either equal to or less than 3 or greater than 3.Two groups of false negative rates compared statistically significant difference(p=0.0017).There was no correlation between clinical T state and false negative rates.4.Among SLN negative patients,there was correlation between the numbers of SLN and rates of axillary lymph node metastasis(p<0.05).All cases of SLN negative were divided into two groups based on situation that the numbers of SLN were either equal to or less than 1 or greater than 1.Two groups of axillary lymph node metastasis rates compared statistically significant difference(p= 0.042).5.Among SLN positive patients,there was correlation between numbers of SLN positive and cases of n-SLN metastasis(p<0.001).There was correlation between rates of SLN positive and n-SLN metastasis(p=0.001).6.Among patients with 1 SLN positive,subgroup with equal to or greater than 3SLN negative had as high as 34.7% in n-SLN positive rate,undergoing relatively lower risk of metastasis(p < 0.001).Among patients with 2 SLN positive,subgroup with equal to or greater than 2 SLN negative had a proportion of 34.8% in n-SLN positive rate,suffering from relatively lower risk of metastasis(p<0.001).Among patients with1-2 SLN positive,patients with clinical T1 state had lower n-SLN positive rate than patients with clinical T2 or T3 state.(p=0.010,p=0.016)Conclusions1.Results of enrolled groups indicated that under the current domestically medical resources circumstances,the accuracy and false negative rate of SLNB in China was consistent with the overall guideline requirements.The ALND in SLN negative patients could be completely removed or cancelled.There was,nevertheless,large proportion of patients having ALND while they were SLN negative,which could be regarded as overtreatment.2.The above-mentioned patients had higher risk of axillary metastasis and greater rate of sentinel positive,which belonged to SLN biopsy contraindication.It is,therefore,highly necessary and imperative to implement clinical guidelines in diagnosing and treating breast cancer.3.There were correlations between false negative rates and numbers of SLNB.False negative rates decreased with the increase in times of SLNB.When the number of SLNB was equal to or greater than 4,the false negative rate significantly and consequently reduced.However,when number of SLNB was greater than 1,SLN false negative and accuracy rates were essentially in accord with international consensus and guidelines.4.It was recommended that SLN negative patients should not receive ALND.The proportion of n-SLN positive patients in SLN negative subjects decreased with the growth of SLNB times.Due to the higher risks of n-SLN positive,the patients with SLN “0/1” should make cautious decision whether they should not receive ALND based on preoperative conditions.5.In patients with SLN positive,there was a positive correlation between the numbers and rates of SLN positive and n-SLN metastasis.6.When patients had 1 to 2 SLN positive and their detected SLN numbers were equaled to or greater than 4,they demonstrated relatively higher rate of n-SLN negative.It is comparatively safe for them to be exempted from ALND,but further confirmation on postoperative survival rates and tumor recurrence is fundamentally of tremendous necessity.Furthermore,to those patients,the increase in numbers of detected SLN negative has no influence on n-SLN negative rates.