PurposeTo develop a nomogram model to predict overall survival in HR+/HER2- subtype advanced breast cancer.MethodsA total of 3,577 ABC (advanced breast cancer) patients from 21 hospitals in China were involved in this study from January 2012 to December 2014. From all ABC patients, 1,671 HR+/HER2- ABC patients were extracted and enrolled in our study. A nomogram was built based on univariable and multivariable Cox regression analyses, identifying independent predictors. The discriminatory and predictive capacities of the nomogram were assessed using the ROC (receiver operating characteristic) curve and calibration plots.ResultsUnivariable and multivariable analysis found that ER (estrogen receptor) status, MFIs (metastatic-free intervals), first-line therapy options, the number of metastatic sites, and whether local therapy for metastatic sites was chosen, were significantly related to overall survival (all P < 0.05). These variables were incorporated into a nomogram to predict the 2- year, 3-year, and 5-year OS (overall survival) of ABC patients. The AUC (the area under the curve) of the nomogram was 0.748 (95% CI (confidence interval):0.693-0.804) for 5-year OS in the training cohort and 0.732 (95% CI: 0.676-0.789) for the validation cohort. The calibration curves revealed good consistency between actual survival and nomogram prediction in the training and validation cohorts. Additionally, the nomogram showed an excellent ability to stratify patients into different risk cohorts.ConclusionWe established a nomogram that provided a more straightforward predictive model for the outcome of HR+/HER2- ABC subtype patients and, to some extent, assisted physicians in making the personalized therapeutic option.

Background Triple‐negative breast cancer (TNBC) is the most aggressive type of breast cancer. Immune checkpoint inhibitors (ICIs) have been widely used to treat various tumors and have changed the landscape of tumor management, but the data from real‐world studies of ICIs for TNBC treatment remain limited. The aim of this study was to evaluate the efficacy of ICIs in the treatment of patients with advanced TNBC in a real‐world setting and to explore possible correlates. Methods The clinical data of advanced TNBC patients who received ICI treatment in the Chinese People's Liberation Army (PLA) General Hospital were collected. Treatment responses, outcomes and adverse events (AEs) were assessed. Results Eighty‐one patients were included in the study. The confirmed objective response rate (ORR) was 32.1%, and the disease control rate (DCR) was 64.2%. The median progression‐free survival (PFS) was 4.2 months, and the median overall survival (OS) was 11.0 months. PFS and OS were longer in patients who achieved clinical benefit from ICIs and shorter in patients who received later‐line ICIs and higher levels of inflammation; specifically, patients with higher TILs had longer PFS. Overall AEs were tolerable. Conclusions ICIs are effective in the treatment of advanced TNBC, and the adverse reactions are tolerable. A panel of biomarkers including LDH, ALP, and bNLR were identified to predict the efficacies of ICIs in TNBC treatment.

e13090 Background: Triple-negative breast cancer (TNBC) is the most aggressive type of breast cancer. The lack of specific targets leads in fewer effective treatments and poor prognosis. Immunotherapy has become a new generation of treatment approach in addition to surgery, radiotherapy, chemotherapy, endocrine therapy and targeted therapy. Immune checkpoint inhibitors (ICIs) have been widely used in the clinical treatment of various tumors and changed the landscape of tumor treatment, but the data from real-world studies of ICIs for TNBC remain limited. Methods: Clinical data of patients with advanced TNBC treated with ICIs in Chinese People’s Liberation Army General Hospital were collected from January 2004 to December 2022. The effect of different factors on patient response and prognosis was analyzed using Kaplan-Meier survival curves. The relationship between clinical, pathological characteristics, hematological indicators, and efficiency were analyzed using univariate and multifactorial Cox regressions. Objective Response Rate (ORR), Disease Control Rate (DCR), Progression-free Survival (PFS), Overall survival (OS), and adverse events (AEs) were assessed. Results: Eighty-one patients were enrolled in the study. Median follow-up was 26.3 months (range, 16.0 - 36.6 months). Confirmed ORR was 32.1% and DCR was 64.2%. The median PFS was 4.2 months and the median OS was 11.0 months. Eastern Cooperative Oncology Group (ECOG) performance status score ≥ 1, applying ICIs in 2nd and later lines, with liver metastases, with more than two sites of metastases, lactate dehydrogenase (LDH) ≥ 194.3 U/L, alkaline phosphatase (ALP) ≥ 104.7 U/L, neutrophil-to-lymphocyte ratio at baseline (bNLR) ≥ 2.7, NLR before the second dose of immunotherapy (NLR2) ≥ 2.2, platelet to lymphocyte ratio before the second dose of immunotherapy (PLR2) ≥ 165.6 were associated with a poorer prognosis. Patients with effective initial treatment, tumor - infiltrating lymphocytes (TIL) ≥ 20%, derived neutrophil-to-lymphocyte ratio (dNLR) ≤ 1.9, LDH < 194.3 U/L and bNLR < 2.5 prior to ICI treatment have a better prognosis. Conclusions: ICIs were effective in advanced TNBC with tolerable adverse effects, and we have identified a series of biomarkers associated with PFS and OS. Randomized controlled clinical trials are warranted to validate our findings.

Purpose: A definition of human epidermal growth factor receptor-2 (HER2)-low was recently proposed with the development of novel antibody-drug conjugates (ADCs). Current studies on HER2-low are associated with metastatic breast cancer (BC), and less is known about early stage BC. Hence, a retrospective study was conducted based on HER2-low early BC to comprehensively analyze its clinicopathological features and prognostic roles compared with HER2 immunohistology(IHC) 0. Method: Patients with HER2-negative early BC (N = 999) diagnosed at our institution from January 2010 to December 2015 were enrolled in this study. We compared clinicopathological characteristics and survival outcomes, including disease-free survival (DFS) and overall survival (OS), between the HER2 IHC0 and HER2-low groups. Result: HER2-low BC accounts for 83.6% of the entire cohort, with a higher proportion of estrogen receptor (ER) levels (> 10 %) and progesterone receptor (PgR) positivity compared with HER2 IHC0. Survival analysis revealed a significantly longer OS in HER2-low BC than that of HER2 IHC0. Patients with HER2-low in the hormone receptor (HR)-positive group had longer OS than that of HER2 IHC0. A longer OS of HER2-low was also observed in HR-negative group. No significant differences were observed in the DFS. Conclusion: HER2-low BC may not be regarded as a unique BC group in this real-world population because of similar clinicopathological features and prognostic roles, especially in HR-positive cases. Whether HER2-low is a distinct subgroup remains to be supported and validated by additional data, both at the clinical and molecular levels.