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BACKGROUND@#Endocrine therapy (ET) and ET-based regimens are the preferred first-line treatment options for hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (HR+/HER2- MBC), while chemotherapy (CT) is commonly used in clinical practice. The aim of this study was to investigate the efficacy and clinical outcome of ET and CT as first-line treatment in Chinese patients with HR+/HER2- MBC.@*METHODS@#Patients diagnosed with HR+/HER2-MBC between January 1st, 1996 and September 30th, 2018 were screened from the Chinese Society of Clinical Oncology Breast Cancer database. The initial and maintenance first-line treatment, progression-free survival (PFS), and overall survival (OS) were analyzed.@*RESULTS@#Among the 1877 included patients, 1215 (64.7%) received CT and 662 (35.3%) received ET as initial first-line treatment. There were no statistically significant differences in PFS and OS between patients receiving ET and CT as initial first-line treatment in the total population (PFS: 12.0 vs. 11.0 months, P = 0.22; OS: 54.0 vs . 49.0 months, P =0.09) and propensity score matched population. For patients without disease progression after at least 3 months of initial therapy, maintenance ET following initial CT (CT-ET cohort, n = 449) and continuous schedule of ET (ET cohort, n = 527) had longer PFS than continuous schedule of CT (CT cohort, n = 406) in the total population (CT-ET cohort vs. CT cohort: 17.0 vs . 8.5 months; P <0.01; ET cohort vs . CT cohort: 14.0 vs . 8.5 months; P <0.01) and propensity score matched population. OS in the three cohorts yielded the same results as PFS.@*CONCLUSIONS@#ET was associated with similar clinical outcome to CT as initial first-line treatment. For patients without disease progression after initial CT, switching to maintenance ET showed superiority in clinical outcome over continuous schedule of CT.
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Humans , Female , Breast Neoplasms/metabolism , Receptor, ErbB-2/metabolism , Progression-Free Survival , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Disease Progression , Treatment OutcomeABSTRACT
Real-world study is increasingly becoming an important source of evidence for changing clinical practice, especially for clinical problems that can′t be randomized. In recent years, real-world research in the field of breast cancer has gradually became a boom. Existing research results have begun to assist in the epidemiological analysis of breast cancer, promote the approval of rare diseases diagnosis and indication, and promote the analysis of real-world treatment status and evaluation of curative effects. Chinese scholars have also established databases and carried out relevant real-world research, providing real-world evidence for clinical practice in China. But domestic research is still in its infancy. The number of real-world research literature published by domestic scholars is relatively small, and there is a lack of pragmatic randomized clinical trial and real-world research for decision-making. In the future, we need to take advantage of the abundant diagnosis and treatment resources, further improve the database, and carry out real-world study on drug development based on population data in China.
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In the past two decades, with the introduction of NCCN guidelines, the establishment of a standardized diagnosis and treatment system for breast cancer had begun. The Chinese version of the NCCN guidelines, which combines international standards and Chinese characteristics, was then developed to guide clinical practice. Since 2011, Chinese experts have entered St. Gallen International Expert Consensus Group, and to introduce the latest therapy concepts. On this basis, the Chinese Society of Clinical Oncology has developed guidelines for diagnosis and treatment in line with product accessibility and expert opinions to help clinicians choose the best treatment option. The latest Chinese Society of Clinical Oncology Breast Cancer Guideline will further contribute to the establishment of a standardized diagnosis and treatment system for breast cancer.
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Artificial intelligence clinical decision-support system is an important direction of artificial intelligence in the medical field. Both international and domestic researchers are exploring the application value of intelligent decision-making system in the field of cancer. But at the same time of the craze, there are still some problems in the intelligent decision-making system. Combining the work of the research groups in this field, this paper explores the current confusions and solutions, and hopes to help clinicians better understand intelligent decision-making. It is believed that with the deepening of the concept and the advancement of technology, intelligent decision-making will become a good help for doctors in the future.
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The rigorous randomized clinical trials and qualified real world evidence have improved the domestic standardized diagnosis and therapy. Meanwhile, the recent consensus and guideline integrated with Chinese realities have also promoted the breast cancer therapy. To expound our views and to provide suggestions for the revision of breast cancer guideline of Chinese Society of Clinical Oncology, we select ten hot issues to discuss with our experience.
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Malignant tumor is the most heterogeneous human disease, and it has been gradually reached the consensus in clinical oncology that the personalized treatment of tumor patients should be directed by molecular diagnostics. However, the ever-changing characteristic of tumor in heterogeneity and the fact that tissue samples are usually unavailable highlight the function and significant of liquid biopsy. The material that could be used in liquid biopsy are mainly the circulating tumor DNA, circulating tumor cells and extracellular vesicles, which though have their own advantages and disadvantages, but could complement to each other, thus accurately and comprehensively reflecting the characteristic of the tumor and gave the best direction for patient′s individualized therapy. This article reviewed the recent advances of liquid biopsy and explained its importance in tumor precision medicine.
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In the past two years, researchers have been exploring the precision medicine. Thanks to the development of sequence industry and clinical study, the big data about the precision medicine have been more and more sufficient. However, how to deal with the precision data is still a question for clinicians. We focus on the hot issues that disturb clinicians most, wanting to help them to make suitable decisions between the traditional and precision medicine of breast cancer. We believe the precision medicine is on the way.
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Triple-negative breast cancer (TNBC) is a heterogeneous disease. Recently, the development of a gene expression profile fa-cilitated the re-classification of TNBC into six new subtypes, which show varied sensitivities to different therapies. In the era of preci-sion medicine, precision therapy may be directed at various potentially actionable molecular mutations in different subtypes of TNBC.
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With the development of the next generation sequencing technology, considerable attention has been paid to the utility of circulating tumor DNA (ctDNA) detection in breast cancer. There are many clinical trials showed the ctDNA detection is a potential biomarker for the diagnosis, management and prognosis of breast cancer. ctDNA detection can provide a more accurate diagnosis for patients to guide clinical treatment in precision medicine era.
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Endocrine therapy is one of the main treatment for hormone receptor positive breast cancer. In recent years, some of the critical results of clinical studies have been published, triggering a heat discussion. Guidelines and expert consensus have made appropriate updates based on some results. However, the selection and duration of the endocrine therapy for premenopausal women, the judgment of the menstrual conditions, the application of ovarian function suppression and the choice of endocrine drug combining with ovarian function suppress, and monitoring the endometrial thickness and hormone levels during therapy, as well as the endocrine therapy for postmenopausal patients and metastatic cancer are still controversial. Based on the evidence from study and clinical experience, this article will focus and discuss the ten hot issues.
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Humans , Breast NeoplasmsABSTRACT
With development of molecular biology,breast cancer has entered an era of molecular classifi-cation,thus making biomarker based personalized medicine is the trend of breast cancer treatment.HER2-posi-tive breast cancer of high invasiveness and bad prognosis accounts for 20%~30%.Targeting HER2,trastuzumab is the first humanized monoclonal antibody which can improve the prognosis of HER2-positive patients and it is recommended by guidelines and expert consensus at home and abroad for anti-HER2 therapy in any stage.How-ever,the cardiotoxicity,de novo resistance and acquired resistance of trastuzumab make the clinician to explore the second line anti-HER2 therapy.Lapatinib is the first FDA approved and HER1,HER2 double-targeting tyrosine kinase inhibitor which can be a better choice after failure with trastuzumab.This article reviews the appli-cation,some clinical and mechanism of drug resistance researches of Lapatinib.
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Breast cancer is the most common malignant tumor in women, bone related events (SREs), such as bone pain, pathological fracture and so on, can affect seriously the quality of life.Experts in Chinese Anti-Cancer Association, Committee of Breast Cancer Society (CACA-CBCS) discussed the Consensus on the Diagnosis and Treatment of Bone Metastasis and Skeletal Related Diseases in Breast Cancer (2014 version), here reflections on several hot issues were explored.
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<p><b>BACKGROUND</b>This multicenter prospective study aimed to assess the utility of dynamic enhanced magnetic resonance imaging (MRI) prior to breast-conserving surgery for breast cancer.</p><p><b>METHODS</b>The research subjects were drawn from patients with primary early resectable breast cancer treated in the breast disease centers of six three-level hospitals in Beijing from 1 January 2010 to 31 December 2012. The participants were allocated to a breast-conserving surgery group (breast-conserving group) or a total mastectomy group (total mastectomy group). Enhanced MRI was used to measure breast volume, longest diameter of tumor and tumor volume. The correlations between these measurements and those derived from histopathologic findings were assessed. The relationships between the success rate of breast-conserving surgery and MRI- and pathology-based measurement results were statistically analyzed in the breast-conserving group.</p><p><b>RESULTS</b>The study included 461 cases in the total mastectomy group and 195 in the breast-conserving group. Allocation to these groups was based on clinical indications and patient preferences. The cut-off for concurrence between MRI- and pathology-based measurements of the longest diameter of tumor was set at 0.3 cm. In the total mastectomy group, the confidence interval for 95% concurrence of these measurements was 35.41%-44.63%. Correlation coefficients for MRI and histopathology-based measurements of breast volume, tumor volume and tumor volume/breast volume ratio were r = 0.861, 0.569, and 0.600, respectively (all P < 0.001). In the breast-conserving group, with 0.30 cm taken as the cut-off for concurrence, the 95% confidence interval for MRI and pathology-based measurements of the longest diameter of tumor was 29.98%-44.01%. The subjective and objective success rates for breast-conserving surgery were 100% and 88.54%, respectively.</p><p><b>CONCLUSIONS</b>There were significant correlations between dynamic enhanced MRI- and histopathology-based measurements of the longest diameter of breast lesions, breast and tumor volumes, and breast volume/tumor volume ratios. Preoperative MRI examination improves the success rate of breast-conserving surgery.</p>
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Adult , Female , Humans , Middle Aged , Breast Neoplasms , General Surgery , Magnetic Resonance Imaging , Methods , Prospective StudiesABSTRACT
PURPOSE: In the present study, we investigated the incidence of cardiotoxicity within 5 years of trastuzumab treatment and evaluated potential risk factors in clinical practice. METHODS: The study cohort included 415 patients diagnosed with early breast cancer (EBC). Cardiotoxicity incidence was evaluated in patients receiving trastuzumab and those who did not. Multivariate Cox proportional hazards regression models were used to estimate hazard ratios and 95% confidence intervals of potential risk factors for trastuzumab-related cardiotoxicity after appropriate adjustments. RESULTS: Incidence of cardiotoxicity in patients treated with trastuzumab was significantly higher than that in controls (23.7% vs. 10.8%, p<0.001). This result was adjusted for factors that might increase the risk of cardiotoxicity, such as history of coronary artery diseases or the use of anthracyclines for more than four cycles. CONCLUSION: Our findings indicated that treatment with trastuzumab was strongly associated with cardiotoxicity in EBC patients.
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Humans , Anthracyclines , Breast Neoplasms , Cohort Studies , Coronary Artery Disease , Incidence , Observational Study , Prospective Studies , Risk Factors , TrastuzumabABSTRACT
Circulating tumor markers have been paid more attention in the application of the treatment for breast cancer, the level of which has extended from protein to gene, including traditional tumor markers, HER-2 extracellular domain, circulating tumor cells, circulating tumor DNA (ctDNA), circulating RNA (ctRNA) and so on. As “liquid detection”, the detection of circulating tumor markers with real-time dynamic, easy operation, good reproducibility and other advantages are widely used in aiding early diagnosis, determining prognosis, prospectively predicting response or resistance to speciifc therapies, surveillance after primary surgery, and monitoring therapy in patients with advanced disease, The further study of circulating tumor markers may contribute to patient’s individual treatment.
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The utility of circulating tumor cells in breast cancer has been paid more attention. There are many clinical trials all over the world which concerned the whole course of breast cancer. Although the value of detecting circulating tumor cells is different at each stage of breast cancer, the advantage is significant compared with traditional methods in monitoring and evaluating diseases status. Nowadays the treatments of breast cancer are classiifed and individualized, it is possible to ifnd the most timely and optimized regimens after detecting the amount and characteristics of circulating tumor cells.
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Objective To analyze the clinical value of chemotherapy combined with endocine therapy after standard treatment failure for advanced metastatic breast cancer.Methods 30 metastatic breast cancer patients after standard treatment failure were analyzed.Etoposide (75-100 mg/d) wasused on days 1-10,followed by 11 days of rest combined with medroxyprogesterone 0.5 g,twice per day,or megestrol 160 mg/d for 21 days.Clinical effects and life quility were analysed.Results The median treatment line of this therapy was 6 (range 3-9).The clinical benefit rate is 16.7 ％ (5/30),and the median progression free survival (PFS) was 4.0 months (range 1.0-13.0 months).Conclusion The combination of chemotherapy (etoposide) and endocrine therapy (progesterone) is a choice of treatment after standard drug failure for advanced mastatic breast cancer patients.
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Objective To evaluate the correlation of the clinical effects and prognosis in patients receiving medical ovarian suppression (goserelin)combined with anastrozole treatment with premenopausal metastatic breast cancer.Methods 44 hormone dependent mastatic breast cancer patients were treated by goserelin,3.6mg hypodermic injection every 28 days and anastrozole 1 mg were administered orally,clinical effects and prognosis were analysed.Results The clinical benefit rates of goserelin combination with anastrozole in patients with metastatic breast cancer were 52.4 ％(23/44),and the median progression free survival (PFS)was 8.3(5.3-11.2)months.In the analysis of whether to accept chemotherapy,the PFS of the not received chemotherapy group was better than received chemotherapy group (16.9 months vs 5.8 months P=0.048).Conclusion The combination of goserelin and anastrozole is an effective endocrine therapy regiment for patients with premenopausal metastatic breast cancer.It can be recommended for the premenopausal and hormone dependent mastatic breast cancer patients.
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Objective To analysis the relationships between bone markers, bone-specific alkaline phosphatase (BAP) and cross-linked telopeptide of type Ⅰ collage (ICTP), and bone metastasis of breast cancer.Methods A total of 217 patients' serum were collected.The 217 cases were divided into two groups:109 cases with bone metastasis, 108 cases without bone metastasis. Serum BAP and ICTP was measured by ELISA. The relationships between factors of bone metastasis and serum levels of BAP, ICTP were analyzed.Results The levels of serum BAP and ICTP in bone metastases group were significantly higher than those in non-bone metastasis group[BAP:24.8 μg/L(7.60-213.70 μg/L) vs 21.2 μg/L(7.3～68.8 μg/L),ICTP:7.0μg/L(1.4～32.4 μg/L) vs 4.1 μg/L(0.0～15.8 μg/L) (P=0.003,P=0.000)].The level of serum BAP and ICTP in patients with multiple bone metastasis was significantly higher than that in patients with single bone metastasis[BAP:32.3 μg/L(9.A～213.7 μg/L) vs 18.1 μg/L(7.6～60.0 μg/L),ICTP:7.6 μg/L(1.4～32.4 μg/L) vs 4.9 μg/L(1.8～10.5 μg/L),(P=0.001,P=0.010)].The sensibility of BAP and ICTP was 45.0 ％ (49/109)and 46.8 ％ (51/109),respectively.The specificity of ICTP and BAP was 83.3 ％ (90/108)and 84.3 ％ (91/108),respectively.Joint detection of BAP and ICTP had improved sensibility in the diagnosis of bone metastasis in breast cancer patients. Conclusion Joint detection of serum bone biochemical markers ICTP and BAP have a little values for diagnosing bone metastasis in breast cancer patients.
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Circulating tumor cells (CTCs) in breast cancer patients can be detected by Cell Search system. Results from recent studies suggested that CTCs level might serve as a prognostic marker and be used in the early assessment of therapeutic response in patients with metastatic breast cancer. However the role of CTCs in early stage breast cancer is not well established. Large prospective trials are needed to further understand its biological characteristics and to confirm its role as a predictive and prognostic marker.