Purpose: The 21-gene recurrence score (RS) can guide adjuvant chemotherapy decisions in the multidisciplinary treatment (MDT) of patients with early breast cancer. This study aimed to evaluate the influence of the 21-gene RS assay on patient’ compliance with MDT and its association with disease outcomes. Methods: Patients diagnosed with pN0-1, hormone receptor-positive, human epidermal growth factor receptor-2-negative breast cancer between January 2013 and June 2019 were enrolled. A logistic regression model was used to identify parameters associated with treatment adherence. Prognostic indicators were evaluated using the Cox proportional hazard models. Results: After the assay, patients were less likely to violate the treatment plan (14.9% vs. 23.1%, p < 0.001), and higher compliance rates were observed for chemotherapy (p = 0.042), radiotherapy (p = 0.012), and endocrine therapy (p < 0.001). Multivariable analysis demonstrated that the 21-gene RS assay (odds ratio [OR], 1.43; 95% confidence interval [CI], 1.09–1.88; p = 0.009) was independently associated with MDT compliance. Moreover, compliance with MDT was independently associated with better disease-free survival (hazard ratio, 0.43; 95% CI, 0.29–0.64; p < 0.001), regardless of the 21-gene RS assay (interaction p = 0.842). Conclusion The 21-gene RS assay improved the MDT compliance rate in patients with early breast cancer. Adherence to MDT is associated with a better prognosis.

Multi-gene assays have emerged as crucial tools for risk stratification in early-stage breast cancer. This study aimed to evaluate the prognostic significance of the 21-gene recurrence score (RS) in Chinese patients with pN0-1, estrogen receptor-positive (ER
Biomarkers, Tumor/genetics* ; Breast Neoplasms/pathology* ; Female ; Humans ; Neoplasm Recurrence, Local/pathology* ; Neoplasm Staging ; Prognosis ; Receptor, ErbB-2/genetics* ; Receptors, Estrogen

Objective:To analyze the relationship between plasma fibrinogen(FIB) within normal range and microalbuminuria in elderly patients with type 2 diabetes mellitus.Methods:A total of 869 elderly subjects with type 2 diabetes mellitus admitted to the Department of Endocrinology of Shanghai Fifth People′s Hospital from October 2012 to October 2014 were included in the study. The patients were divided into four groups based on the quartile level of FIB: Q1 group(<2.42 g/L), Q2 group(2.42-2.89 g/L), Q3 group(2.90-3.61 g/L), and Q4 group(≥3.62 g/L). The relationship between FIB and urinary albumin/creatinine ratio(UACR) was analyzed.Results:With the increasing of FIB, the level of UACR was significantly elevated( P<0.05). Pearson correlation analysis showed that FIB was positively associated with age, duration of diabetes, creatinine(Cr) and UACR in men and women( P<0.01). Multiple regression analysis showed that FIB was an independent factor of UACR( P<0.01). Logistic regression analysis showed that the risks of microalbuminuria and macroalbuminuria were respectively 4.536 folds(95% CI 2.516-8.175, P<0.01) and 13.314 folds(95% CI 2.925-60.612, P<0.01) in Q4 group, and 2.177 folds(95% CI 1.273-3.724, P<0.01) and 4.098 folds(95% CI 1.101-19.226, P<0.05) in Q3 group as compared with Q1 group after adjused by following factors: gender, age, duration of diabetes, body mass index(BMI), systolic blood pressure(SBP), diastolic blood pressure(DBP), fasting plasma glucose(FPG), HbA 1C, total cholesterol(TC), triglyceride(TG), low density lipoprotein-cholesterol(LDL-C), Cr, alanine aminotransferase(ALT), as well as smoking and drinking behavior. Based on the cut off values to UACR 30 mg/g and 300 mg/g, the receiver operating characteristic curve(ROC) was used to evaluate the value of FIB for UACR. The optimal cut-off value of FIB was 3.18 g/L and 3.22 g/L respectively. Conclusions:Plasma FIB was closely associated with microalbuminuria in elderly patients with type 2 diabetes mellitus, which may be considered as one of the predictors for diabetic nephropathy.

Purpose: Despite the rapid growing of cancer survivors, prior cancer history is a commonly adoptedexclusion criterion. Whether prior cancer will impact the survival of patients with advancedbreast cancer (ABC) remains uncertain. Materials and Methods: Patients with ABC diagnosed between 2004 and 2010 were identified using Surveillance,Epidemiology, and End Results (SEER) database. Timing, stage, and type were used to characterizeprior cancer. Multivariable analyses using propensity score–adjusted Cox regressionand competing risk regression were conducted to evaluate the prognostic effect of priorcancer on overall survival (OS) and breast cancer-specific survival (BCSS). Results: A total of 14,176 ABC patients were identified, of whom 10.5% carried a prior cancer history.The most common type of prior cancer was female genital cancer (32.4%); more than half(51.7%) were diagnosed at localized stage; most were diagnosed more than 5 years (42.9%)or less than 1 year (28.3%) prior to the index cancer. In multivariate analyses, patients withprior cancer presented a slightly worse OS (hazard ratio, 1.18; 95% confidence interval [CI],1.07 to 1.30; p=0.001) but a better BCSS (subdistribution hazard ratio, 0.64; 95% CI, 0.56to 0.74; p < 0.001). In subset analyses, no survival detriment was observed in patients withprior malignancy from head and neck or endocrine system, at in situ or localized stage, ordiagnosed more than 4 years. Conclusion Prior cancer provides an inferior OS but a superior BCSS for patients with ABC. It does notaffect the survival adversely in some subgroups and these patients should not be excludedfrom clinical trials.

Purpose: This retrospective study aimed to evaluate the distribution pattern and prognostic value of 21-gene recurrence score (RS) in Chinese patients with mucinous breast cancer (MC) and compared with infiltrating ductal carcinoma (IDC). Materials and Methods: Patients diagnosed with MC or IDC from January 2010 to January 2017 were retrospectively recruited. Reverse transcriptase–polymerase chain reaction assay of 21 genes was conducted to calculate the RS. Univariate and multivariate analyses were performed to assess the association between RS and clinicopathological factors. Survival outcomes including disease-free survival (DFS) and overall survival (OS) were estimated by Kaplan-Meier method and compared by log-rank test. Results: The MC cohort included 128 patients and the IDC cohort included 707 patients. The proportions of patients with a low (RS < 18), intermediate (18-30), or high risk (RS > 30) were 32.0%, 48.4%, and 19.5% in MC cohort, and 26.9%, 46.8% and 26.3% in IDC cohort. The distribution of RS varied significantly according to different Ki-67 index and molecular subtype in both cohorts. Moreover, the receipt of chemotherapy was associated with RS in both cohorts. Among patients with MC, tumor stage was related to the DFS (p=0.040). No significant differences in DFS and OS were found among MC patients in different RS risk groups (OS, p=0.695; DFS, p=0.926). Conclusion RS was significantly related to Ki-67 index and molecular subtypes in MC patients, which is similar in IDC patients. However, RS was not able to predict DFS and OS in patients with MC.

Objective: The current study aimed to evaluate the predictive performances of anatomic staging system (AS) and prognostic staging system (PS) proposed in the 8th edition American Joint Committee on Cancer (AJCC) staging manual in patients with pure mucinous breast cancer (PMBC). Methods: Clinicopathologic features and follow-up information were collected from a total of 3628 patients with PMBC. Breast cancer-specific survival (BCSS) were compared among patients in different stage groups. Likelihood ratio (LR) χ², Akaike information criterion (AIC) and Harrell′s concordance index (C-index) were used to evaluate the predictive performances of AS and PS in PMBC. Results: In PMBC, BCSS was associated with tumor size (P=0.002), lymph node status (P=0.002), grade(P=0.003), PR status(P=0.017)and the receipt of radiation. Compared to AS, 1326 patients (37.54%) underwent stage change after applying PS, with 6.50% upstaged and 37.04% downstaged. There were significant differences in BCSS among patients of different stages under the AS and PS (P<0.001). However, PS was not superior to AS in predicting prognosis (AS vs PS, LR χ²: 16.41 vs 17.5; AIC: 357.44 vs 358.35; C-index, 0.72 vs 0.73, P=0.667). Conclusions Both of AS and PS proposed in the 8th edition American Joint Committee on Cancer (AJCC) staging manual were predictive factors in patients with PMBC. Compared with AS, the PS did not show superiority in prognosis prediction among patients with PMBC.

Objective: To analyze the association between clinicopathological factors and clinical diagnosis, treatment and surgery of local regional recurrence (LRR) in breast cancer. Methods: A retrospective study was done to evaluate consecutive 7 823 breast cancer LRR cases between January 2009 and August 2018 at Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiaotong University School of Medicine. A total of 108 LRR patients were enrolled: 35 cases (32.4%) with ipsilateral breast tumor recurrence (IBTR) after breast conserving surgery, 40 cases (37.0%) of chest wall recurrence (CR), and 33 cases (30.6%) with regional lymph node recurrence (LNR). All patients were female, aged from 26 to 83 years with a mean of 49 years. Clinicopathological factor and its relationship with different sites of LRR and following surgical choice were analyzed by χ² test, rank-sum test and Logistic regression. Survival analysis were performed between different LRR patterns and whether undergoing second surgery. Kaplan-Meier survival curves and Log-rank tests demonstrated the distribution of overall survival. Results: Both univariate analysis and multivariate analysis found that axillary lymph nodes (ALN) status (OR=7.27, 95% CI: 1.30 to 40.53, P=0.042) and disease-free interval (OR=0.18, 95% CI: 0.06 to 0.60, P=0.013) were related to different site of LRR. Compared with patients with IBTR, LNR and CR patients had a higher rate of ALN metastasis and a shorter disease-free interval. A total of 36 LRR patients underwent following surgery. In univariate analysis, initial ALN surgery (χ²=16.705, P=0.001), pathological type (χ²=7.047, P=0.03), ALN status (χ²=10.812, P=0.002), disease-free interval (χ²=6.118, P=0.023) and LRR site(χ²=19.328, P=0.000) were associated with surgical treatment for LRR patients. Multivariate analysis demonstrated that only site of LRR was independently associated with surgery (OR=0.17, 95% CI: 0.05 to 0.65, P=0.024). The 5-year overall survival was 100% and 60.1% (P=0.018) for LRR patients treated with surgery or not. Furthermore, CR patients had significantly worse overall survival than LNR and IBTR patients, with 5-year overall survival 53.1%, 73.5%, and 100% respectively (P=0.021). Conclusions Initial lymph nodes metastasis and disease-free interval are associated with different site of LRR. LRR site significantly influenced following surgery choice after LRR, which are both related with overall survival after LRR.

Breast conserving surgery and sentinel lymph node biopsy are widely used in early breast cancer treatment. Right now, the mode of local regional recurrence (LRR) has significantly changed and the rate of ipsilateral breast tumor recurrence and axillary lymph node recurrence are steadily increasing. Due to its relatively low incidence of LRR compared with distant metastasis, inconsistent of pre-recurrence treatment, difficulty in surgical treatment, and few prospective clinical studies, there are rising new challenges for clinical management of LRR patients. In this article, based on new theory of LRR, clinical diagnosis and treatment progress, and our own clinical practice experience for LRR breast cancer patients, we propose that we should make pathological diagnosis and do systemic evaluation for LRR disease, then considering it as a curable disease, and integrating local and systemic comprehensive treatment for LRR patients, thus to improve their disease outcome.

PURPOSE: The purpose of this study was to investigate the changes of tumor infiltrating lymphocytes (TILs) between core needle biopsy (CNB) and surgery removed sample (SRS) in early stage breast cancer patients and to identify the correlating factors and prognostic significance of TILs changes. MATERIALS AND METHODS: A retrospective study was carried out on 255 patients who received CNB and underwent surgical resection for invasive breast cancer. Stromal TILs levels of CNB and SRS were evaluated respectively. Tumors with ≥50% stromal TILs were defined as lymphocyte-predominant breast cancer (LPBC). Clinicopathological variables were analyzed to determine whether there were factors associated with TILs changes. Log-rank tests and Cox proportional hazards models were used to analyze the influences of TILs and TILs changes on survival. RESULTS: SRS-TILs (median, 10.0%) were significant higher than CNB-TILs (median, 5.0%; p<0.001). Younger age (<60 years, p=0.016) and long surgery time interval (STI, ≥4 days; p=0.003) were independent factors correlating with higher TILs changes. CNB-LPBC patients showed better breast cancer-free interval (BCFI, p=0.021) than CNB-non-LPBC (CNB-nLPBC) patients. Patients were categorized into four groups according to the LPBC change pattern from CNB to SRS: LPBC→LPBC, LPBC→nLPBC, nLPBC→LPBC, and nLPBC→nLPBC, with estimated 5-year BCFI 100%, 100%, 69.7%, and 86.0% (p=0.016). nLPBC→LPBC pattern was an independent prognostic factor of worse BCFI (hazard ratio, 2.19; 95% confidence interval, 1.06 to 4.53; p=0.035) compared with other patterns. CONCLUSION: TILs were significantly higher in SRS than in CNB. Higher TILs changes were associated with younger age and long STI. Changing from nLPBC to LPBC after CNB indicated a worse BCFI, which needs further validation.
Biopsy, Large-Core Needle ; Breast Neoplasms ; Breast ; Humans ; Lymphocytes, Tumor-Infiltrating ; Prognosis ; Proportional Hazards Models ; Retrospective Studies ; Sexually Transmitted Diseases

PURPOSE: This study was aimed at identifying the influence of initial weight and weight change during neoadjuvant chemotherapy (NAC) on pathologic complete response (pCR) and long-term survival in Chinese patients with operable breast cancer. METHODS: We conducted a retrospective study using data from 409 female patients who received NAC for stage II or III breast cancer and had complete record of body mass index (BMI) before and after NAC. BMI of < 25 kg/m² was categorized as normal weight/underweight (NW/UW); 25.0–29.9 kg/m² was categorized as overweight (OW); ≥30 kg/m² was categorized as obese (OB). BMI change was defined as the difference in BMI between day 1 of the first cycle of NAC and the day before surgery. A BMI gain or loss of > 2 kg/m² following NAC was considered to be significant, else was considered stable. The study end points included pCR rates, disease-free survival (DFS), and overall survival (OS). RESULTS: The median follow-up time was 43.2 (8.9–93.6) months. The average BMI was 23.40 ± 3.04 kg/m² before NAC and 23.66 ± 3.02 kg/m² after NAC (t = −3.604, p < 0.001). The pCR rate was 25.3% in the NW/UW group and 24.1% in the OW/OB group (p = 0.811), and was similar between the BMI-gain (23.3%) and the BMI-stable/loss (25.1%) groups (p = 0.787). Initial BMI was an independent prognostic factor for DFS (hazard ratio, 1.69; 95% confidence interval [CI], 1.13–2.53; p = 0.011) but not for OS, while BMI-gain was an independent prognostic factor for both DFS (hazard ratio, 2.09; 95% CI, 1.28–3.42; p = 0.003) and OS (hazard ratio, 1.97; 95% CI, 1.04–3.74; p = 0.039). CONCLUSION: BMI increased after NAC in Chinese breast cancer patients. Initial BMI and BMI change during NAC were not associated with pCR but were reversely associated with survival.
Asian Continental Ancestry Group ; Body Mass Index ; Breast Neoplasms ; Breast ; Disease-Free Survival ; Drug Therapy ; Female ; Follow-Up Studies ; Humans ; Neoadjuvant Therapy ; Overweight ; Polymerase Chain Reaction ; Retrospective Studies ; Weight Gain