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The National Health Commission of the People's Republic of China has formulated the Quality Control Indexes for Oncology (2023 edition) , with the objective of improving medical quality scientifically, refined and standardized. Among these indexes, the rate of pretreatment clinical TNM staging and the coincidence rate of evaluation of pretreatment TNM staging lay national standards for patients to formulate rational and targeted treatment strategies. This article reviewed the literature and referred to Chinese Medical Association Clinical Practice Guide for Breast Surgery , and presented recommendations for the hot topics of breast surgery, such as pathological sampling of the breast specimen, sentinel lymph node biopsy for early-stage breast cancer, breast conserving surgery, axillary lymph node dissection, breast reconstruction surgery, endoscopic-assisted breast surgery, the principles of surgical treatment for metastatic breast cancer, neoadjuvant treatment for advanced disease, and surgical grade of breast surgery, which have been widely concerned in recent years, to help improve homogenization of breast cancer treatment in China.

Objective: To investigate the clinicopathological features and prognosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2 -) breast cancer., Methods: In the study, 3 035 consecutive breast cancer patients diagnosed in Breast Disease Center, Peking University First Hospital from January 2008 to December 2017 were collected. The prognostic signi-ficance of important pathological factors in HR +/HER2 - patients with complete clinicopathological information was analyzed., Results: Within the 1 920 (63.26%) cases of HR +/HER2 - breast cancer, there were 1 624 cases with complete clinicopathological data, of which, 124 cases (7.64%) recurred and/or metastasized and 63 cases died of the disease, and the 5-year overall survival (OS) rate and disease-free survival (DFS) rate was 93.0% and 92.6% respectively. The stage of pT1-2 was 92.80%, while pN0 was 69.03%. 89.66% cases belonged to histologically non-specific type and 30.11%, 55.60%, 14.29% were credited to Grade 1, 2 and 3 respectively. The distribution of ER negative, low or high expression groups were 1.60%, 2.09% and 96.31%, while PR were 6.83%, 10.47%, 82.70%, respectively. The group of Ki67 index < 10% was 19.52%, ≥10% & < 20% for 32.02%, ≥20% for 48.46%. Survival analysis showed that cases with pT1 stage had lower risk of recurrence than those with pT3, while cases with pT2 and pT3 had shorter DFS than those with pT1, with higher risk of recurrence and metastasis. Analysis proved that both pN stage and histological grade were negatively correlated with DFS. The cases with pN0, pN1 and pN2 were lower risk of recurrence than those with pN3, while cases with Grade 1 and 2 had lower risk of recurrence than cases with Grade 3. And the group of Ki67 index ≥20% showed higher risk of recurrence and metastasis. The prognostic significance of ER expression in HR+/HER2- breast cancer was not significant. However, the negative/low PR expression groups showed higher risk of recurrence and metastasis, of which PR < 10% group had shortest DFS and OS, followed by 10%-60% group and then > 60% group. The most common site of metastasis was bone (55 cases, 44.35%), while cases with liver metastasis (30 cases, 24.20%) had the worst outcome., Conclusion: Our study revealed that pT, pN, Grade, HR expression level and Ki67 index were important prognostic factors for HR +/HER2 - breast cancer, although there are variables in prognostic value. Factors of pN and Grade showed independent prognostic significance. PR expression level had prognostic significance for the risk of recurrence and metastasis. The stratified level of PR expression (< 10%, 10%-60%, >60%) had independent prognostic value, showing successively longer DFS and OS, lower risk of recurrence. PR>60% group had the longest DFS and OS as well as the lowest risk of recurrence.

Objective: To examine the efficacy of docetaxel, carboplatin plus trastuzumab regimen (TCH) as neoadjuvant setting in early-stage human epidermal growth factor receptor 2 (HER2) positive breast cancer. Methods: Totally 522 patients diagnosed with early-stage HER2 positive breast cancer at Breast Disease Center, Peking University First Hospital between January 2013 to December 2018 were enrolled, which constituted 21.8% (522/2 394) of early-stage invasive breast cancer. Clinical pathological factors were retrospectively analyzed. There were 113 female patients underwent TCH neoadjuvant chemotherapy, aging 52(13) years (range: 23 to 69 years). Pathologic complete pathological response(pCR) was defined as ypT0N0M0, and the rate of pCR was calculated. Kaplan-Meier method and Log-rank test were used for survival comparison. Results: Patients who received trastuzumab-based therapy( n =294) had higher disease-free survival (DFS) compared with those who omitted trastuzumab( n =177) (84.4% vs. 72.4%, χ²=4.095, P =0.046). Eighteen of 113 patients (15.9%) experienced grade 3 to 4 chemotherapy-realted toxicity. Grade 3 to 4 neutropenia occurred in 12 patients, while grade 3 to 4 diarrhea occurred in 6 patients. Thirty-one of 113 (27.4%) patients achieved pCR. DFS and overall survival (OS) were similar between patients who achieved pCR and non-pCR (DFS: 91.8% vs. 85.0%, OS: 92.5% vs. 90.5%, all P> 0.05). According to Miller-Payne system, patients who achieved G4 to G5 had improved DFS compared with G1 to G3 (89.6% vs. 81.5%, χ²=5.340, P =0.021), but they had similar OS (91.4% vs. 89.1%, χ²=1.008, P =0.315). Conclusions: TCH is an effective regimen in neoadjuvant setting for patients with HER2 positive breast cancer. Patients who achieved G4 to G5 had improved DFS.

Objective: To investigate the clinicopathologic features of synchronous bilateral breast cancer (SBBC) and prognostic factors. Methods: The clinicopathologic features of patients with SBBC treated in Peking University First Hospital from January 2008 to March 2019 were retrospectively analyzed. Results: Of all 4 111 patients diagnosed with breast cancer, 57(1.4%) cases were diagnosed with SBBC.Forty-three (75.4%) patients were treated with bilateral mastectomy. The median follow-up time was 58 months. The 5-year disease-free survival of SBBC was 80.7% and 5-year overall survival was 84.1%. The N stage and HER2 status of second primary breast cancer were associated with prognosis by univariated analysis ( Z =5.866 and 4.231, both P <0.05). Conclusion: Majority of patients with SBBC were treated with bilateral mastectomy. While therapeutic strategy of SBBC should take both tumor burden and biomarker status of bilateral breast cancer into consideration.

Objective: The incidence of breast cancer in Chinese women continues to rise. The large breast cancer cohort studies in China are relatively scarce. There are many bottlenecks in the construction of large clinical cohort for breast cancer diagnosis, treatment, and prognoses, such as inconsistent standards, high rates of lost follow-up, repeated construction, and inability to share. To better solving the difficulties and problems faced by large-scale clinical cohort research in China, this project will cooperate with several tertiary A hospitals to establish a breast cancer cohort in Chinese women. It also provides a data platform and technical support for breast cancer multi-center clinical cohort research. Methods: Based on the evidence-based medicine and expert opinion and consensus, we established a breast cancer cohort standardized indicator set-recording baseline information, diagnosis and treatment-related information of the enrolled patients, and collecting biological specimens. According to the technical specification of long-term follow-up for the endpoint, data management, and data security and in the large population-based cohort study, a standardized follow-up system for the diagnosis, treatment, and prognosis of breast cancer prospective cohorts is formed. Results: Based on standardized data sets and the computer discipline's advantage from the University of Science and Technology Beijing, we integrate the new information technology methods, including dynamic information collection terminals and social networks. Thus, the quality of control programs on compliance and intelligence data was improved, and a Chinese women breast cancer cohort database was developed. By February 2020, 12 147 patients were included in the clinical cohort database. Biological specimens'resources in cohort construction were collected and cooperated with Shandong University to research the multi-center quality control system and shared evaluation system of biobanks. Building an open and shared biobank network and forming a full chain of breast cancer research platform. Conclusion: With the implementation of the "13(th) Five-Year Plan" precision medicine research, this study provides a research foundation for precision diagnosis and treatment of breast cancer and provides data support for the country to formulate relevant medical policies.

In recent years, with the improvement of screening and early diagnosis, the overall prognosis of breast cancer patients has been greatly improved in China. Breast reconstruction is an option to improve cosmetic outcomes and quality of life for the patients received mastectomy, this procedure has attracted a lot of attention. The breast reconstruction surgery is recommended by the 2018 NCCN Clinical Practice Guidelines in Oncology for Breast Cancer in patients with appropriate indications. Despite the high proportion of breast reconstruction after mastectomy in western countries, Chinese breast surgeon should objectively understand the differences in breast structure and cultural backgrounds between Chinese and foreign women, and conduct rigorous clinical practice on the basis of calm thinking. In particular, it should be clearly recognized that we have more local advanced and high-risk cases in newly diagnosed breast cancer patients. Making efforts to improve the overall survival for patients with breast cancer must be the top priority for our surgeon. Breast reconstruction for all patients without identifying the distinction of personal characters and indications should be avoided, and the pursuing of high proportion of clinical data with no consideration of the realities of clinical practice in China should also be avoided. The indication of breast reconstruction for breast cancer patients received mastectomy must be strictly determined by the surgeon.

Objective: To analyze docetaxel (T) and carboplatin (C) combined with trastuzumab (H) -TCH regimen as neoadjuvant systemic therapy in early breast cancer patients with human epidermal growth factor receptor 2 (HER-2) positive. Methods: From January 2008 to December 2014, the data of patients diagnosed as early breast cancer in Breast Disease Center of Peking University First Hospital were retrospective reviewed. The data of patients with HER-2 positive conducted TCH neoadjuvant therapy and surgery, and with the complete clinicopathological information were analyzed. Results: A total of 77 cases were enrolled in this study. We defined G2+ G3+ G4+ G5 as responsive group according to Miller-Payne grading system, the responsive rate was 84.4% (65/77). The rate of complete pathological remission (pCR) was 39.0% (30/77). The 5-year disease free survival (DFS) was 87.3%, and 5-year overall survival (OS) was 93.6%. There was a significant difference between DFS and OS in the responsive group and non-responsive group (DFS: χ 2 =6.762, P =0.009; OS: χ 2 =5.062, P =0.024). Conclusion: TCH is an effective neoadjuvant therapy for patients with HER-2 positive breast cancer, and the toxic and side effects were under control.

Objective: To study the clinicopathological characteristics and the prognostic determinants of the invasive lobular carcinoma breast cancer. Methods: This was a retrospective single-center study of invasive lobular breast cancer cases diagnosed from January 2008 to December 2014 at Peking University First Hospital Breast Disease Center. The study enrolled 68 invasive lobular breast cancer patients, which represented 3.64% (68/1 870) of total invasive breast cancer. The median age of all selected patients was 46 years ranging from 36 to 83 years. All patients were restaged based on the 8(th) edition of AJCC cancer staging system and follow-up data including disease-free survival (DFS) and overall survival (OS) were analyzed to explore the prognostic determinants. The 5-year OS and DFS were calculated using Kaplan-Meier method; the significance of correlations between clinicopathological features and prognostic factors was estimated using log-rank test. Results: There were significant differences in OS between patients with different anatomic stage, prognostic stage, lymph node metastasis, progesterone receptor (PR) expression, lymphvascular invasion and perineural invasion (χ(2:) 4.318 to 32.394, all P <0.05); significant differences in DFS were also observed between patients with different anatomic stage, prognostic stage, lymph node metastasis, PR expression, human epidermal growth factor receptor-2 expression, Ki-67 level, histological grade and lymphvascular invasion (χ(2:) 4.347 to 27.369, all P <0.05). Prognostic stages of 52.9% patients changed compared with anatomic stage, among which Luminal subtype mainly downstaged (22/30), however, triple negative subtype mainly upstaged (6/6). Conclusions: Anatomic stage, prognostic stage, lymph node metastasis, PR expression, lymphvascular invasion are the prognostic factors of invasive lobular breast cancer. Regard to invasive lobular breast cancer patients, clinicians should pay close attention to the differences between prognostic stage and anatomic stage.

Liquid biopsy is a diagnostic approach by analyzing body fluid samples. Peripheral blood is the most common sample. Urine, saliva, pleural effusion and ascites are also used. Now liquid biopsy is mainly used in the area of neoplasm diagnosis and treatment. Compared with traditional tissue biopsy, liquid biopsy is minimally invasive, convenient to sample and easy to repeat. Liquid biopsy mainly includes circulating tumor cells and circulating tumor DNA (ctDNA) detection. Detection of ctDNA requires sensitive and accurate methods. The progression of next-generation sequencing (NGS) and digital PCR promote the process of studies in ctDNA. In 2016, Nature published the result of whole-genome sequencing study of breast cancer. The study found 1 628 mutations of 93 protein-coding genes which may be driver mutations of breast cancer. The result of this study provided a new platform for breast cancer ctDNA studies. In recent years, there were many studies using ctDNA detection to monitor therapeutic effect and guide treatment. NGS is a promising technique in accessing genetic information and guiding targeted therapy. It must be emphasized that ctDNA detection using NGS is still at research stage. It is important to standardize ctDNA detection technique and perform prospective clinical researches. The time is not ripe for using ctDNA detection to guide large-scale breast cancer clinical practice at present.

Objective: To explore the utility of circulating tumor DNA detection in early breast cancer by using next-generation sequencing. Methods: This exploratory study of circulating tumor DNA detection is for early invasive breast cancer patients treated in Breast Disease Center, Peking University First Hospital from December 2015 to July 2016. Plasma samples were collected and were used to isolate plasma cell-free DNA.Exons or hotspots of 247 cancer related genes were sequenced by next-generation sequencing. Mutations and their correlation with clinic-pathological factors were analyzed. The correlation between mutations and clinic-pathological factors was evaluated by χ(2) test or Fisher's exact test. Results: Seventy-five patients were enrolled in this study. All patients were female and aged from 31 to 88 years with median age of 58 years. All patients' clinic-pathological records were complete. Sixty-four mutations in 18 genes (ALK, BCR, ERBB2, ROS1, PDGFRA, EGFR, FGFR2, CYP1B1, CALR, CASP7, BRAF, FGFR1, FGFR3, MET, NRAS, PTEN, KIT, SOD2) were detected in 47 (62.7%) among all 75 patients.Exons were captured in 10 genes, and mutations in 2 of 3 genes analyzed were clustered. Gene mutations were not correlated with menopausal status, histological type, primary tumor (T), regional lymph nodes (N), TNM stage, histological grade, estrogen receptor status, progesterone receptor status, human epidermal growth factor receptor 2 status, Ki-67 and molecular subtype (all P >0.05). Conclusion: Circulating tumor DNA sequencing by next-generation sequencing was useful for detecting breast cancer-related mutations.

The progress of gene detection technologies represented by next generation sequencing (NGS) and digital PCR laid a foundation for studies of circulating tumor DNA (ctDNA) in breast cancer. In 2014, the NGS workgroup organized by the College of American Pathologists (CAP) published the College of American Pathologists ' Laboratory Standards for Next - Generation Sequencing Clinical Tests, which provides a blueprint for the standardization of gene testing. In 2015, the Guidelines for Diagnostic Next - generation Sequencing published by the European Society of Human Genetics claimed that NGS is unacceptable in clinical practice before studies guided by guidelines are approved. Although existing studies show the benefits of ctDNA testing in disease monitoring and prognosis analyzing, we have a ways to go to normalize the procedure and build strict detection criteria.

The aim of the present study is to investigate the efficacy and safety of dose-dense (biweekly) carboplatin and paclitaxel as a neoadjuvant treatment for operable breast cancer. Patients with previously untreated breast cancer (stages Ic-III) were treated with four cycles of paclitaxel (175 mg/m(2), intravenous drip, D1) and carboplatin (area under the curve of 5, D1). Patients with HER2+ disease simultaneously received trastuzumab (6 mg/kg initial dose with subsequent doses of 4 mg/kg biweekly). The primary endpoint was a pathologically complete response (pCR). Between January 2012 and February 2014, 110 patients were enrolled. The overall pCR rate was 35.45 % (39 of 110). The pCR rates for the different cancer subtypes were as follows: 10.53 % (2 of 19) among the patients with the luminal A subtype, 12.50 % (5 of 40) among the patients with the luminal B (HER2-) subtype, 58.33 % (14 of 24) among the patients with the luminal B (HER2+) subtype, 57.14 % (8 of 14) among the patients with the triple-negative subtype, and 76.92 % (10 of 13) among the patients with the HER2+ subtype. The patients experienced the following toxicity side effects: grade 3/4 neutropenia (N = 27, 24.55 %), grade 3/4 anemia (N = 6, 5.45 %), grade 3/4 thrombocytopenia (N = 2, 1.82 %), grade 3 alanine aminotransferase (ALT) elevation (N = 1, 0.91 %), grade 3 neuropathy (N = 3, 2.73 %), grade 3 pain (N = 2, 1.82 %), and grade 3 fatigue (N = 1, 0.91 %). In total, 19.09 % of the patients experienced treatment delay or discontinuation due to hematological toxicity, and one patient discontinued treatment due to non-hematological toxicity. Neoadjuvant biweekly paclitaxel plus carboplatin is a feasible therapy that achieved high pCR rates in patients with the HER2+, triple-negative, and luminal B (HER2+) cancer subtypes (NCT0205986).

Background: To validate the clinical value of the One-Step Nucleic Acid Amplification (OSNA) Breast Cancer System for the intraoperative detection of sentinel lymph node (SLN) metastases in early-stage breast cancer patients in a Chinese population, a prospective, multicenter trial, the China Breast Cancer Clinical Study Group (CBCSG)-001c trial, was conducted. The present study focused on the prospective comparison of the performance between OSNA and touch imprint cytology (TIC)., Methods: The retrieved SLNs were divided into sections. Alternate slices from the tissue blocks were subjected either to OSNA analysis or to postoperative histopathology evaluation through serial sectioning. TIC was performed on every sample surface of each tissue block and was used by the surgeon to determine whether to perform an immediate ALND., Results: A total of 552 patients qualified for the analysis. The sensitivity, specificity, and overall accuracy of OSNA were 87.8%, 89.6%, and 88.4%, respectively, on a per-patient basis compared with those of TIC, which were 81.3%, 96.9%, and 92.0%, respectively. OSNA detected more micrometastasis-involved nodes than TIC (52.8% vs. 25.0%; p = 0.029) on a per-node basis. Tissue allocation bias (TAB) was the main cause of discordant results. The performance of TIC varied significantly among the institutes, while the performance of OSNA was steady., Conclusions: Both OSNA and TIC can serve as qualified intraoperative assessments of SLNs. For institutes lacking the support of experienced cytopathologists, OSNA can be the first choice for the intraoperative assessment. In addition, OSNA can be applied as a complement to histopathology assessment. However, the results of the present study do not support the routine application of OSNA in the entire SLNs in place of pathology with serial sectioning., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Forty patients with breast mass and 10 female controls underwent double-phase (15 min and 3 h) 99Tcm-sestamibi (MIBI) imaging. Another four post-mastectomy patients with suspected metastases underwent total body imaging at 15 min. The 99Tcm-MIBI images of all 10 female controls showed symmetrical homogeneous radioactivity in both breasts. A focal area of increased 99Tcm-MIBI uptake in the breast tumour is considered as positive. Eleven breasts of 10 patients underwent total mastectomies with lymph node dissection, with one patient having bilateral mastectomy. These 11 breast tumours were confirmed to be infiltrating ductal carcinoma. All 11 breast carcinomas had positive early and delayed phase results with the exception of one patient who had only a focal increased uptake in early phase which happened to be the smallest size of carcinoma. Focal areas of positive MIBI uptake in the axillae in 4 of 10 patients were confirmed to be metastatic carcinoma of the breast. One patient with breast carcinoma underwent mastectomy whose 99Tcm-MIBI imaging was negative. Twelve patients undergoing excisional biopsy or lumpectomy of breast resulted in 7 fibroadenomas, 2 papillomas, 1 abscess, 1 granuloma and 1 chronic inflammation. Four of 7 fibroadenomas having hypercellularity histopathologically exhibited a focal MIBI uptake on double-phase imaging. One granulomatous disease had positive early phase but faded on the delayed image. The patients with absence of MIBI uptake included 3 fibroadenomas, 2 papillomas, 1 abscess, 1 chronic inflammation and 17 fibrous hyperplasia.(ABSTRACT TRUNCATED AT 250 WORDS)

Human lactoferrin has been found to be decreased or absent in most breast cancer and leukemia cells. In order to examine the lactoferrin gene for both structural alterations and the degree of methylation, we isolated a 2117-kilobase complementary DNA from human breast tissue. This complementary DNA was used to probe DNA extracted from normal peripheral blood, leukemia cells from patients, leukemia cell lines, and breast cancer cell lines. Immunocytochemical staining of these cells confirmed the decreased production of lactoferrin in malignancy. MspI restriction enzyme fragment patterns demonstrated genetic polymorphism which occurred in DNA from both normal and malignant cells. Polymorphism was also noted with XbaI. In this case, there were two fragment patterns that were only found in DNA from malignant cells. The degree of DNA methylation was also evaluated. The methylation pattern of DNA extracted from malignant cells was highly variable and generally less methylated than DNA extracted from normal WBCs. It is possible that the decrease in lactoferrin associated with cancer is multifactorial and includes gene structural changes as well as altered regulation. Further study is needed to determine whether the changes found in this study are the result of the malignancy or contribute to its onset or maintenance.