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Objective: To study the risk factors of recurrence and metastasis in patients with breast cancer after modified radical mastectomy and the predictive value of serum carbohydrate antigen 125 (CA125), cyclo-oxygenase-2 (COX-2), soluble tumor necrosis factor receptor-P55 (sTNFR-P55). Methods: 109 patients with breast cancer who underwent modified radical mastectomy in The First Affiliated Hospital of Xinjiang Medical University from January 2014 to December 2016 were prospectively studied. All patients were followed up for 5 years after operation, including 2 patients who were lost to follow-up, and 107 patients who completed follow-up. According to the recurrence and metastasis within 5 years, the patients were divided into recurrence and metastasis group (n=31) and non-recurrence and metastasis group (n=76). The clinicopathological data of the patients at admission were collected. Preoperative serum CA125 was detected by electrochemiluminescence method, and preoperative serum COX-2 and sTNFR-P55 were detected by enzyme-linked immunosorbent assay. Logistic regression model was used to analyze the influencing factors of postoperative recurrence and metastasis, and receiver operating characteristic (ROC) curve was drawn to evaluate the predictive value of serum CA125, COX-2 and sTNFR-P55 on postoperative recurrence and metastasis. Results: The tumor diameter greater than 5cm, invasive non-specific carcinoma, vascular tumor thrombus, estrogen receptor (ER)/progesterone receptor (PR) negative, the constituent ratio of no endocrine therapy, TNM stage IIIA, and the number of axillary lymph node metastases 4~9 in the recurrence and metastasis group were higher than those in the non-recurrence and metastasis group (P<0.05). The levels of serum CA125, COX-2 and sTNFR-P55 in the recurrence and metastasis group were higher than those in the non-recurrence and metastasis group (P<0.05). Multivariate logistic regression analysis showed that tumor diameter greater than 5cm, invasive non-specific carcinoma, TNM stage IIIA, vascular tumor thrombus, number of axillary lymph node metastases 4~9, increased CA125, increased COX-2, and increased sTNFR-P55 were independent risk factors for recurrence and metastasis within 5 years after modified radical mastectomy (OR=1.318, 1.213, 1.223, 1.137, 1.257, 1.241, 1.313, 1.351, P<0.05). Serum CA125, COX-2 and sTNFR-P55 could effectively predict postoperative recurrence and metastasis of breast cancer, and the area under the curve (AUC) was 0.803, 0.749 and 0.761, respectively. The AUC of combined prediction of postoperative recurrence and metastasis of the three indexes was 0.915, and the sensitivity and specificity were 0.94 and 0.83, respectively. Conclusion: Tumor diameter, invasive non-specific carcinoma, TNM stage, vascular tumor thrombus, number of axillary lymph node metastases, and abnormal elevation of preoperative serum CA125, COX-2, sTNFR-P55 are risk factors for recurrence and metastasis within 5 years after modified radical mastectomy. Combined detection of preoperative serum CA125, COX-2 and STNFR-P55 can predict the risk of recurrence and metastasis after modified radical mastectomy. [ABSTRACT FROM AUTHOR]

Breast cancer is the most common cancer in women worldwide with rising prevalence. The human epidermal growth factor receptor 2 (HER2) is crucial to the biological behavior and pathogenic mechanism of breast cancer. Approximately 45%- 55% of all subtypes of breast cancer have low expression of HER2, which are classified as HER2 immunohistochemistry staining 1+ or 2+ and in situ hybridization (ISH) negative. Although in most cases, HER2 low expression (HER2-low) breast cancer is still classified as HER2 negative or triple negative in clinical practice, HER2-low differs from HER2 not detected (HER2-0) breast cancer not only in HER2 expression levels, there are also differences in terms of estrogen receptor (ER) status, primary tumor volume, lymph node involvement, and pathologic complete response (pCR) following neoadjuvant therapy and disease-free survival (DFS). In clinical trials targeting early-stage HER2-low breast cancer, the NSABP B-31 and N9831 trials demonstrated the possibilities for breast cancer patients to benefit from adjuvant trastuzumab therapy; however, in phase III prospective randomized controlled study NSABP B-47, trastuzumab did not alter invasive disease-free survival (iDFS), 5-year interval without distant recurrence, or overall survival (OS) in patients with HER2-low breast cancer. Recent years have seen the emergence of clinical trials for targeted treatments for advanced HER2-low breast cancer, focusing mostly on trastuzumab, lapatinib, and antibody-drug conjugate (ADC), such as trastuzumab emtansine (T-DM1), DS-8201 (also known as trastuzumab deruxtecan, T-DXd, Enhertu), and SYD985. Phase III trial CALGB9840 demonstrated a lack of therapeutic effect of trastuzumab and a narrow therapeutic window that could not be overcome by changing the dose of lumretuzumab in HER2 non-over-expressed breast cancer, respectively. Two randomized phase III trials (EGF30001 and EGF100151) both found that receiving lapatinib did not improve progression-free survival (PFS) in patients with HER2-low breast cancer. T-DM1 sensitivity was initially observed in patients with HER2-low breast cancer in the single-arm phase II studies 4258g and 4374g, but results were still uncertain because of the small number of patients. The phase III clinical study DESTINY-Breast04 proved the safety and efficacy of DS-8201 (5.4 mg/kg) in HER2-low metastatic breast cancer. The phase I clinical trial proved the efficacy and safety of 1.2 mg/kg SYD985 intravenously in HER2-low breast cancer. Additionally, there are currently ongoing clinical trials for several novel anti-HER2 therapeutics, including novel ADC drugs (RC48-ADC, ARX788, A166, etc.), bispecific antibodies (KN026, ZW25, ertumaxomab, etc.), and breast cancer vaccines (nelipepimut-S, GP2, AE37, etc.). In this paper, we will review the major clinical trials of targeted therapies for HER2-low breast cancer. [ABSTRACT FROM AUTHOR]

Objective: To study the risk factors of recurrence and metastasis in patients with breast cancer after modified radical mastectomy and the predictive value of serum carbohydrate antigen 125 (CA125), cyclo-oxygenase-2 (COX-2), soluble tumor necrosis factor receptor-P55 (sTNFR-P55). Methods: 109 patients with breast cancer who underwent modified radical mastectomy in The First Affiliated Hospital of Xinjiang Medical University from January 2014 to December 2016 were prospectively studied. All patients were followed up for 5 years after operation, including 2 patients who were lost to follow-up, and 107 patients who completed follow-up.According to the recurrence and metastasis within 5 years, the patients were divided into recurrence and metastasis group (n=31) and non-recurrence and metastasis group (n=76). The clinicopathological data of the patients at admission were collected. Preoperative serum CA125 was detected by electrochemiluminescence method, and preoperative serum COX-2 and sTNFR-P55 were detected by enzyme-linked immunosorbent assay. Logistic regression model was used to analyze the influencing factors of postoperative recurrence and metastasis, and receiver operating characteristic (ROC) curve was drawn to evaluate the predictive value of serum CA125, COX-2 and sTNFR-P55 on postoperative recurrence and metastasis. Results: The tumor diameter greater than 5cm, invasive non-specific carcinoma, vascular tumor thrombus, estrogen receptor (ER) /progesterone receptor (PR) negative, the constituent ratio of no endocrine therapy,TNM stage ⅢA, and the number of axillary lymph node metastases 4~9 in the recurrence and metastasis group were higher than those in the non-recurrence and metastasis group (P＜0.05). The levels of serum CA125, COX-2 and sTNFR-P55 in the recurrence and metastasis group were higher than those in the non-recurrence and metastasis group (P＜0.05). Multivariate logistic regression analysis showed that tumor diameter greater than 5cm, invasive non-specific carcinoma, TNM stage ⅢA, vascular tumor thrombus, number of axillary lymph node metastases 4~9, increased CA125, increased COX-2, and increased sTNFR-P55 were independent risk factors for recurrence and metastasis within 5 years after modified radical mastectomy (OR=1.318, 1.213, 1.223, 1.137, 1.257, 1.241, 1.313, 1.351, P＜0.05). Serum CA125, COX-2 and sTNFR-P55 could effectively predict postoperative recurrence and metastasis of breast cancer, and the area under the curve (AUC) was 0.803, 0.749 and 0.761, respectively. The AUC of combined prediction of postoperative recurrence and metastasis of the three indexes was 0.915, and the sensitivity and specificity were 0.94 and 0.83, respectively. Conclusion: Tumor diameter, invasive non-specific carcinoma, TNM stage, vascular tumor thrombus, number of axillary lymph node metastases, and abnormal elevation of preoperative serum CA125, COX-2, sTNFR-P55 are risk factors for recurrence and metastasis within 5 years after modified radical mastectomy. Combined detection of preoperative serum CA125, COX-2 and STNFR-P55 can predict the risk of recurrence and metastasis after modified radical mastectomy. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the value of preoperative detection of carbohydrate antigen 125 (CA125), osteopontin (OPN), chemokine ligand 8 (CXCL8) and neutrophil lymphocyte ratio (NLR) in evaluating recurrence and metastasis risk of breast cancer patients undergoing modified radical mastectomy. Methods: 384 patients with modified radical mastectomy whow ere treated in our hospital from April 2015 to April 2016 were divided into non recurrent metastasis group (n=345) and recurrent metastasis group(n=39) according to postoperative recurrence and metastasis. Compared with CA125, OPN, CXCL8 and NLR in relapse metastasis group and non recurrence metastasis group, multivariate regression analysis was used to analyze the influencing factors of recurrence and metastasis after modified radical mastectomy. The receiver operating characteristic (ROC) curve was used to determine the value of CA125, OPN, CXCL8 and NLR in evaluating the recurrence and metastasis risk of breast cancer patients undergoing modified radical mastectomy. Results: The levels of CA125, OPN, CXCL8 and NLR in recurrence and metastasis group were higher than those in non recurrence and metastasis group(P<0.05). Postoperative recurrence and metastasis of modified radical mastectomy were related to tumor diameter, clinical stage, preoperative neoadjuvant chemotherapy, human epidermal growth factor receptor 2 (HER2), lymph node metastasis, histological type, cell proliferation marker antigen (Ki-67), estrogen receptor(ER) / progesterone receptor (PR), P53, postoperative radiotherapy, postoperative endocrine therapy (P<0.05). Multivariate Logistic regression analysis showed that OPN was high, CXCL8 was high, NLR was high, tumor diameter was greater than 2 cm, lymph node metastasis was positive, ER/PR was double negative, clinical stage was III stage, and preoperative neoadjuvant chemotherapy was not a risk factor for recurrence and metastasis of breast cancer after modified radical mastectomy (P<0.05). The area under the curve (AUC) of preoperative CA125, OPN, CXCL8 and NLR was 0.855, which was higher than that of each index. Conclusion: The recurrence and metastasis of breast cancer after modified radical mastectomy are related to OPN, CXCL8, NLR, tumor diameter, lymph node metastasis, ER/PR, clinical stage and preoperative neoadjuvant chemotherapy. The combined detection of CA125, OPN, CXCL8 and NLR before operation is of high value in evaluating postoperative recurrence and metastasis. [ABSTRACT FROM AUTHOR]