Entinostat, a class I selective histone deacetylase inhibitor, plus exemestane for Chinese patients with hormone receptor-positive advanced breast cancer: A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial

Entinostat plus exemestane in hormone receptor-positive (HR+) advanced breast cancer (ABC) previously showed encouraging outcomes. This multicenter phase 3 trial evaluated the efficacy and safety of entinostat plus exemestane in Chinese patients with HR + ABC that relapsed/progressed after ≥1 endocrine therapy. Patients were randomized (2:1) to oral exemestane 25 mg/day plus entinostat (n = 235) or placebo (n = 119) 5 mg/week in 28-day cycles. The primary endpoint was the independent radiographic committee (IRC)-assessed progression-free survival (PFS). The median age was 52 (range, 28-75) years and 222 (62.7%) patients were postmenopausal. CDK4/6 inhibitors and fulvestrant were previously used in 23 (6.5%) and 92 (26.0%) patients, respectively. The baseline characteristics were comparable between the entinostat and placebo groups. The median PFS was 6.32 (95% CI, 5.30-9.11) and 3.72 (95% CI, 1.91-5.49) months in the entinostat and placebo groups (HR, 0.76; 95% CI, 0.58-0.98; P = 0.046), respectively. Grade ≥3 adverse events (AEs) occurred in 154 (65.5%) patients in the entinostat group versus 23 (19.3%) in the placebo group, and the most common grade ≥3 treatment-related AEs were neutropenia [103 (43.8%)], thrombocytopenia [20 (8.5%)], and leucopenia [15 (6.4%)]. Entinostat plus exemestane significantly improved PFS compared with exemestane, with generally manageable toxicities in HR + ABC (ClinicalTrials.gov #NCT03538171).

Self-assembled multifunctional nanotheranostics against circulating tumor clusters in metastatic breast cancer

Circulating tumor clusters (CTC) disseminating from the primary tumor are responsible for secondary tumor formation where the conventional treatments such as chemotherapy and radiotherapy does not prevent the metastasis at locally advanced stage of breast cancer. In this study, a smart nanotheranostic system has been developed to track and eliminate the CTCs before it can colonize at a new site, which would reduce metastatic progression and increase the five-year survival rate of the breast cancer patients. Targeted multiresponsive (magnetic hyperthermia and pH) nanomicelles incorporated with NIR fluorescent superparamagnetic iron oxide nanoparticles were developed based on self-assembly for dual modal imaging and dual toxicity for spontaneous killing of CTCs in blood stream. A heterogenous tumor clusters model was developed to mimic the CTCs isolated from breast cancer patients. The nanotheranostic system was further evaluated for the targeting property, drug release kinetics, hyperthermia and cytotoxicity against developed CTC model in vitro. In vivo model in BALB/c mice equivalent to stage III and IV human metastatic breast cancer was developed to evaluate the biodistribution and therapeutic efficacy of micellar nanotheranostic system. Reduced CTCs in blood stream and low distant organ metastasis after treatment with the nanotheranostic system demonstrates its potential to capture and kill the CTCs that minimize the secondary tumor formation at distant sites.

Pharmacoeconomic evaluation of pyrotinib combined with capecitabine in the second-line treatment of HER- 2 positive patients with advanced breast cancer / 中国药房

OBJECTIVE To evaluate the cost-effectiveness of pyrotinib combined with capecitabine in the second-line treatment of human epidermal growth factor receptor- 2（HER-2）positive advanced breast cancer from the point of view of medical and health system ，and to provide reference for the selection of clinical therapy plan and national health decision. METHODS The dynamic Markov model was constructed on the basis of a multicenter ，open，randomized controlled phase Ⅲ clinical trial in 29 centers in China. The simulation time limit was 8 years，and the cycle was 21 days. The cost-effectiveness of pyrotinib combined with capecitabine （observation group ）were compared with that of lapatinib combined with capecitabine （control group ）in the second-line treatment of HER- 2 positive advanced breast cancer. The incremental cost-utility ratio （ICER）was calculated by using quality-adjusted life year （QALY）as output indicators ，and the sensitivity analysis was carried out to validate the robustness of the results of basic analysis. RESULTS The results of basic analysis showed that compared with control group ，the incremental cost per capita and incremental utility per capita of observation group were 67 953.82 yuan and 0.40 QALYs；ICER was 168 861.89 yuan/QALY，which was lower than the willing to pay （WTP）threshold（217 500 yuan/QALY）represented by 3 times of China ’s per capita GDP in 2020，indicating the treatment plan of the observation group is more cost-effective. The results of single factor sensitivity analysis showed that the proportion of patients treated with trastuzumab or pyrotinib after entering disease progression （PD）status in the control group ，the proportion of patients treated with lapatinib or trastuzumab after entering PD status in the observation group ，the cost of capecitabine and other parameters showed great impact on ICER ，but those parameters didn ’t cause the reverse of basis analysis results. The results of probabilistic sensitivity analysis showed that when the WTP threshold was 217 500 yuan/QALY，the probability that the treatment plan in the observation group was cost-effective was 94.10％. The results of partition survival model analysis were consistent with those of dynamic Markov model. CONCLUSIONS On the premise of taking 3 times of China ’s per capita GDP in 2020 as the WTP lin- threshold， the second-line treatment of HER- 2 positive wang9805@163.com advanced breast cancer with pyrotinib combined with capecitabine is more cost-effective than that with lapatinib combined with capecitabine.

Clinicopathologic profile of breast cancer patients treated with neoadjuvant chemotherapy at HUCFF/UFRJ

Introduction: The objective of this study is to describe the profile of patients from a public institution, submitted to neoadjuvant chemotherapy (NACT), comparing the verified pathological response with literature data. Methods: Observational retrospective cohort study on breast cancer patients diagnosed between September 2001 and October 2018 and treated with NACT at Hospital Universitário Clementino Fraga Filho (HUCFF/UFRJ), located in Rio de Janeiro, Brazil. The adopted neoadjuvant chemotherapy regimen was based on anthracycline and docetaxel. Results: A total of 133 patients were evaluated. The average age in this group was 54 years (28-86), 49 women (37%) were under 50 years old. The following distribution by molecular subtype was observed: overexpression or amplification of the human epidermal growth factor receptor 2 (HER2+) (13 women, 26.6%), Luminal (19 women, 38.8%), and Triple-negative (TN) (17 women, 34.6%). The HER2+ and TN subtypes had a higher incidence of cases between 40-49 years and 50-59 years. As for the initial staging, 34% were IIIA; 26%, IIB; and 19%, IIIB. Only one patient did not undergo surgery after NACT, 33 (24.8%) underwent conservative surgery, and 99 patients (74.4%) underwent mastectomy. Regarding the axillary approach, 41 (31%) underwent sentinel lymph node biopsy and 88 (66%) had an indication for lymphadenectomy. In the anatomopathological evaluation of the surgery, 12 (9.1%) patients obtained a pathologic complete response (pCR) and 113 (84.9%), partial or no response to chemotherapy. Conclusion: This research enabled the identification of clinicopathologic characteristics and outcome of patients who received neoadjuvant chemotherapy in a public university service. The predominance of advanced tumors was observed, stressing the need for public health policies for the screening of breast cancer as well as the guarantee of timely treatment for diagnosed cases. The data somewhat reflect the difficulty that the public sector encounters to carry out the most appropriate treatment. The authors expect that this article, by analyzing the profile and the adopted treatment in real-life cases and in a public university institution, can contribute to the improvement of breast cancer treatment in Brazil.

Overcoming resistance to endocrine therapy in hormone receptor-positive human epidermal growth factor receptor 2-negative (HR / 医学前沿

New targeted therapies have been developed to overcome resistance to endocrine therapy (ET) and improve the outcome of HR

Clinico-pathological study of locally advanced breast cancer and their hormone receptor analysis

Background: Breast carcinoma is one of the most common malignant tumor of women. Determination of estrogen receptors (ER) and progesterone receptors (PR) status, prior to therapeutic intervention has become standard practice. Survival and response to hormone therapy are most favorable among women who are receptor positive. The aim of this study is to assess the hormone receptor status in locally advanced breast carcinomas and correlate this reactivity pattern with tumor stage, clinical stage and lymph node metastasis. Objective of the study was to co-relate the locally advanced breast cancer and their hormone receptor analysis.Methods: Patients who visited Department of General Surgery, Hamidia Hospital, Bhopal were assessed clinically, radiologically and histopathologically and then ER and PR study was done, for a total of 50 cases were done.Results: In our study majority of the cases were locally advanced breast cancer (50%) which may be due to the low socio economic status, late presentation, pain tolerance, illiteracy and availability of the resources. Majority of cases were in postmenopausal, clinical stage 3 and histological grade 2. ER positivity 50% and PR positivity 44% and it was found that hormone receptor positivity was high in locally advanced breast cancers 63.5%.Conclusions: Hormone receptor analysis should be an integral part of initial workup of carcinoma breast, as the percentage of hormone receptor positivity is increasing in our population in locally advanced breast cancer. So locally advanced breast cancer can be diagnosed at an early stage by screening and conducting breast awareness programs.

To Compare the Effects of Adjuvant and Neoadjuvant Chemotherapy on Outcome of Stage III Carcinoma Breast.

At present, the ideal treatment of patients diagnosed to have carcinoma breast includes multimodal treatment therapy. However, the sequence of various modalities in the treatment of breast cancer varies according to the stage of the tumour at the time of presentation. Early breast cancer cases first undergo surgical treatment modality before systemic therapies, while advanced cases should undergo systemic therapies first followed by surgical interventions if possible. However, treatment of stage IIIA and IIIB patients (locally advanced disease) but having an operable lump poses a dilemma of whether to go for surgery first or systemic therapy first. We wanted to compare the outcome in terms of metastasis/recurrence between adjuvant and neo-adjuvant chemotherapy in selected cases of stage IIIA and stage IIIB carcinoma breast for a follow-up period of 1 year at a tertiary care hospital in central India.METHODSThis is a comparative observational study conducted at Acharya Vinoba Bhave Rural Hospital (AVBRH) of Jawaharlal Nehru Medical College from October 2017 to Sept 2019, which included patients of TNM stage IIIA and IIIB breast carcinoma, half of whom were treated with adjuvant chemotherapy and other half treated with neoadjuvant chemotherapy along with standard surgical procedure like MRM/toilet mastectomy.RESULTSDistribution of patients according to presence of lymphovascular Invasion was done which was statistically non-significant. However, when disease recurrence or disease metastasis/mortality was compared with lymphovascular invasion in neo-adjuvant group, it was found to be statistically significant (p value=0.022) In the adjuvant group 90 % of patients belonged to stage IIIA while in neo-adjuvant group only 50 % patients belonged to stage IIIA. Rest patients in both group belonged to stage IIIB. This difference in adjuvant and neo-adjuvant group was statistically significant. (p=0.022) In comparison of outcome in both adjuvant and neo-adjuvant chemotherapy, 5% patients of adjuvant group developed metastasis and died succumbing to it while another 5 % developed recurrence during follow up. In the neo-adjuvant group 35% patients developed distant metastasis or died due to disease while another 5 % patient developed local recurrence in axilla for the disease. This difference in the outcome of two groups was statistically significant with p value of 0.013.CONCLUSIONSIn our study we found that for a locally advanced breast cancer patient (stage IIIA &B) with an operable breast lump, adjuvant chemotherapy is superior than neo-adjuvant chemotherapy with a significant p value of 0.013. Superior in terms of lesser distant metastasis/recurrence when we followed up the patient for 1 year after the completion of treatment.

Role of neoadjuvant chemotherapy in downstaging locally advanced breast carcinoma, selection of surgical procedure and its outcome

Background: In clinical practice all cases of locally advanced breast carcinoma (LABC) warrant chemotherapy followed by multimodality care. Neoadjuvant chemotherapy (NACT) has been the mainstay in the management of LABC. The main aim of NACT is to downstage and prevent systemic micrometastasis early.Methods: This was a prospective study conducted on 36 diagnosed cases of stage III locally advanced breast cancer coming to the Dept. of Surgery, Dr. D. Y. Patil Medical College and hospital, Pune for a period of 2 years from 2017-2019. The effectiveness of neoadjuvant chemotherapy was assessed based on clinical, pathological and radiological response.Results: Among 36 LABC cases, maximum number of patients fell in the 41-50 years (41.6%) and presented in the Infiltrating ductal carcinoma group with a clinical stage IIIA disease. The response to NACT showed that a total of 12 patients (33.3%) showed complete clinical response and 30 patients were downstaged after neoadjuvant chemotherapy which was statistically significant. Only 4 out of the total 12 complete clinical responders went for Breast conservative surgery. Seroma formation was found to be the most common post-operative complication.Conclusions: LABC subjected to neoadjuvant chemotherapy based on taxanes/Anthracyclines show good clinical and radiological response. Patients preferred modified radical mastectomy due to the lack of awareness and low socioeconomic strata.The type of surgery did not increase  the chance of recurrence in the follow up period.

Two-weekly docetaxel in treatment of advanced breast cancer: A preliminary study

@#Objective: Three-weekly docetaxel causes a high rate of febrile neutropenia, especially in the Asian population. Two-weekly docetaxel has been shown to reduce rate of febrile neutropenia in castrate-resistant prostate cancer patients. We conducted a preliminary study to investigate the safety of two-weekly docetaxel in advanced breast cancer patients. Methods: We recruited 10 patients with advanced breast cancer with ECOG (Eastern Cooperative Oncology Group) performance status score of zero to two, who needed chemotherapy in the first or second-line setting to receive two-weekly docetaxel for 8 cycles. The primary endpoint was safety and secondary endpoints were response rate and progression free survival. Results: The most reported adverse events were haematological (anaemia 100% and neutropenia 90%). The febrile neutropenia rate was 10%. The overall response rate was 20%. The median progression free survival was 5.0 months. Conclusion: Two-weekly docetaxel may be a reasonable alternative treatment regimen for patients with advanced breast cancer in the first or second-line setting. This regimen is yet to be compared with standard 3-weekly schedule in a phase 3 randomised clinical trial.

A Case of Paraneoplastic Stiff-person Syndrome with Advanced Breast Cancer

Stiff-person syndrome (SPS) is an extremely rare disease that is characterised by progressive rigidity and muscle spasms affecting the axial and limb muscles and is difficult to diagnose. In SPS, autoantibodies such as anti-GAD antibody or anti-amphiphysin antibody may be proved, and it is speculated that SPS is GABAergic neurons disorder with the central nervous system due to these antibodies. We report a case of advanced breast cancer with a paraneoplastic SPS. Case: A 52-year-old woman was diagnosed with advanced breast cancer with bilateral multiple lung metastases, bilateral cancerous pleurisy, multiple liver metastases, cancerous peritonitis, and bilateral ovarian metastases. Anti-cancer treatment was not indicated due to poor condition, and oxygenation and pleural drainage and ascites drainage were performed in the palliative care unit. A series of symptoms due to muscle rigidity progressed rapidly which initially manifested as dysphagia, then stiffness of the upper extremities and locomotive disability. So she was diagnosed as paraneoplastic SPS by a neurologist. Despite the partial efficacy of diazepam, it was difficult to increase dosage due to sedation.

Pattern and predictors of locoregional failure in locally advanced breast cancer following neoadjuvant chemotherapy and modified radical mastectomy with or without radiotherapy: Retrospective cohort analysis of patients in a Tertiary Hospital Breast Center

Objective@#The study aimed to identify the pattern and clinicopathologic factors associated with locoregional failure (LRF) in locally-advanced breast cancer (LABC) patients who received neoadjuvant chemotherapy (NAC) and modified radical mastectomy (MRM) with or without adjuvant radiotherapy (RT).@*Methods@#Retrospective cohort analysis of LABC patients who developed LRF following NAC and MRM with or without RT in the Breast Care Center, Philippine General Hospital from 2007-2010 was done. Clinicopathologic and treatment factors were compared between patients who developed and did not develop recurrence using Student's t-tests and Chi-square tests and logistic regression analysis, with p values ≤0.05 considered significant.@*Results@#A total of 63 patients were included, 34 with locoregional recurrence (LR) and 29 without. Two-year locoregional recurrence rate (LRR) was 54% with mean time to recurrence at 263 days and chest wall as most common site. Simple logistic regression analysis showed age distribution, pathologic nodal status (pN), percentage positive pathologic lymph nodes, pathologic stage, lymphovascular invasion, and adjuvant RT to be predictors of LR. Furthermore, pN (OR 1.31, CI 1.07-1.59, p=0.01) and adjuvant RT (OR 0.14, CI 0.04-0.53, p=0.004) were independent predictors of LR on multiple logistic regression analysis. In the subset of patients without adjuvant RT, no independent predictor of LR was found on multiple logistic regression analysis.@*Conclusion@#Among patients with LABC who received NAC and MRM, locoregional recurrence occurred frequently, usually in the chest wall and within a year of treatment. The absence of adjuvant radiotherapy and increased number of positive pathologic lymph nodes were predictive of locoregional recurrence.

Assessment of Clinical Response to Multimodality Approach in Advanced Carcinoma Breast

Cases of carcinoma breast with TNM stage 3 are considered as locally advanced breast cancer. This study was done to demonstrate the effect of multimodal treatment approach in cases of stage 3 technically inoperable breast cancer. Its effect on clinical response was studied. Methods: This prospective study was carried out in department of general surgery, government Medical College, Amritsar, Punjab. Main part of multimodal approach is neoadjuvant chemotherapy, so in collaboration with department of radiotherapy, relevant data was collected. 25 cases of locally advanced breast carcinoma were studied. These patients were studied on treatment with FAC regimen (as neoadjuvant chemotherapy), then underwent surgical excision (MRM) followed by chemotherapy, radiotherapy and hormonal therapy wherever indicated, and response was assessed. Results: Initially assessment of lump was done after 3 cycle of chemotherapy. 2 patients (8%) have reduction <50%, 22 patients (88%) have reduction in size which ranges between 51- 75% of the initial, remaining 1 patient (4%) has reduction >75% of the initial. Thus making them operable therefore after this they all had undergone modified radical mastectomy. During follow up period no lump was detected clinically, ultrasonographically or radiologically. There was no any loco-regional recurrence in any case. Conclusion: The study demonstrated the effectiveness of neoadjuvant chemotherapy in down staging the tumor enabling definitive surgery with less morbidity.

Cardiac abnormalities among chronic hemodialysis patients

Objective: The annual mortality of cardiovascular diseases of dialysis patients is higher than the general population. The tranc-thoracic echocardiography allows the evaluation of the heart structure and function within the trated patients by hemodialysis in order to identify patients with cardiovascular high risk. Methods: This work is a descriptive retrospective study. The objective is to determine the major cardiac abnormalities diagnosed with echocardiography in patients with chronic hemodialysis and to list their epidemiological, clinical and biological characteristics at the time of the study. Results: The average age of our patients is of 50.2 ± 7 years with an average hemodialysis endurance of 12.1± 2.4 years. The main etiologies of the chronic renal failure were essentially the diabete type 2, the arterial hypertension and chronic nephritis tubule-interstitial. The most cardiac abnormalities was the left ventricular hypertrophy. The presence of a systolic or diastolic arterial hypertension has been noted as a significant factor fostering the LVH within the chronic hemodialysis (p=0.002).The anemia is not said to be associated to the development of the left ventricular hypertrophy(p=0.09). Conclusions: This study revealed the etiology leading to chronic renal failure insufficiency. Echocardiography accurately diagnosed cardiac abnormalities such as left ventricular hypertrophy. The study allowed to detect the factors involved in the development of this HVG especialy systolic arterial hypertension. This result permit us to act on these factors in order to prevent the cardiovascular events to which hemodialysis patients will be exposed.

Interpretation of the latest progress of CDK4/6 inhibitors combining with endocrine therapy in advanced breast cancer at ASCO of 2018 / 中华内分泌外科杂志

Endocrine therapy is the main treatment of hormone receptor-positive advanced breast cancer.How to reverse the endocrine resistance and the new endocrine therapy have become the focus of attention in the tumor community.The study of cyclin dependent kinase (CDKs) has developed rapidly,and the selective cdk4/6 inhibitors can significantly extend the progression-free survival of patients with endocrine resistance to breast cancer,which has been approved for standard treatment for advanced breast cancer.

Surgical reconstruction of complex and huge defect after locally advanced breast cancer ablation / 中华整形外科杂志

Objective@#The purpose of this study is to review the single institutional experience in oncoplastic treatment of locally advanced breast cancer (LABC).@*Methods@#This is a retrospective analysis of 246 female patients who underwent breast and chest wall reconstruction after LABC ablation in the department from August 2007 to December 2015. The mean age of the patients is 43.7 years old, range from 34 to 70 years old. The soft tissue defect size ranged from 12 cm×6 cm to 32 cm×28 cm, different flaps were chosen for reconstruction, flap size ranged from 13 cm×6 cm to 33 cm×29 cm. Simple rib defects or sternum defects occurred in 65 cases, using mesh repair and flap reconstruction; simple soft tissue defects were noted in 112 cases, pedicled flap or free flap was used; in 69 cases complicated composite chest wall defects involving multiple layers (soft tissue, ribs/sternum, and intrathoracic organs) were repaired with methylmethacrylate/polypropylene mesh sandwich prostheses. The breast and chest wall soft tissue defects were repaired with pedicled or free flap.@*Results@#In 3 cases with pedicled rectus abdominis flap partial necrosis was noted, local flap was used after further debridement in 2 cases, in the third case with extensive defect left, free anterolateral thigh flap was transferred for reconstruction. In 2 cases with free deep inferior epigastric artery perforator flap, postoperative venous congestion occurred. The re-exploration procedure was carried out, edema was removed and the flap survived thoroughly. In 2 cases with free deep inferior epigastric artery perforator flap postoperative course margin dehiscence and chest wall basement partial necrosis was noted, free anterolateral thigh flap was transferred for reconstruction after thoroughly debridement, the wounds healed smoothly. All other wounds healed uneventfully, all flaps survived totally. The hospital stay time ranged from 12 days to 42 days, all patients received further therapy. The mean follow-up was 28.8±0.4 months, with a range from 9 to 96 months. 26 cases were lost for follow up, in the rest 220 cases, local tumor recurrence was noted in 52 cases, distant metastasis was noted in 42 cases, all other patients recovered well, the function and appearance of flaps were satisfactory, the life quality of patients improved notably.@*Conclusions@#Oncoplastic techniques are suitable and safe for LABC reconstruction, helpful for oncological local control, can improve patients life quality.

Cáncer de mama avanzado receptor de estrógeno positivo: manejo sistémico actual / Systemic therapy for estrogen receptor positive advanced breast cancer

El cáncer de mama es la primera causa de muerte por cáncer en mujeres chilenas. Mientras la mayoría de las personas logra curarse de esta enfermedad, un 5% de los casos se presenta inicialmente con enfermedad avanzada y hasta un 20-30% de pacientes con enfermedad localizada pueden sufrir recurrencias sistémicas. La mayoría de las neoplasias mamarias son dependientes del estímulo estrogénico, de allí que la deprivación de estrógenos es la principal estrategia terapéutica. Recientemente, el uso de terapias molecularmente dirigidas en combinación con la terapia endocrina ha logrado mejorar los resultados de sobrevida del cáncer de mama avanzado, con menos efectos colaterales que aquellos producidos por la quimioterapia convencional. El conocimiento de los mecanismos de acción de estas nuevas terapias, sus toxicidades, vías de resistencia y selección de pacientes para lograr los mejores beneficios terapéuticos son aspectos relevantes en el manejo de la enfermedad. Presentamos una revisión del estado actual del manejo del cáncer de mama metastásico hormonodependiente con enfásis en el uso de terapias endocrinas combinadas con terapias moleculares.

Breast cancer is the leading cause of cancer death in Chilean women. While most patientes are cured, five percent of cases present with advanced disease initially and up to 20-30% of patients with localized disease may suffer systemic recurrences. The majority of breast neoplasms are dependent on the estrogenic stimulus, hence the deprivation of estrogen is the main therapeutic strategy. Recently, the use of molecular targeted therapies in combination with endocrine therapy has been successful in improving the survival outcomes of advanced breast cancer, with fewer side effects than those produced by conventional chemotherapy. Knowledge of the mechanisms of action of these new therapies, their toxicities, resistance pathways and patient selection to achieve the best therapeutic benefits are relevant aspects in the management of the disease. We present a review of the current state of management of hormone-dependent metastatic breast cancer with emphasis on the use of endocrine therapies combined with molecular therapies.

Efficacy and safety comparison of everolimus and fulvestrant in patients with estrogen receptor-positive advanced breast cancer progressed after endocrine therapy / 实用医学杂志

Objective To compare the efficacy and safety of everolimus combined with endocrine therapy and fulvestrant in patients with estrogen receptor-positive advanced breast cancer progressed after endocrine thera-py. Methods Ninety-three breast cancer patients were selected from January 2014 to February 2017. The primary end points were progression-free survival and clinical benefit rate and the secondary end points was tolerability. Re-sults The progression-free survival in fulvestrant group was slightly higher than that in the everolimus group(13.4 months vs 12.2 months,P = 0.297). The clinical benefit rates were 46.15% and 31.71% in fulvestrant group and everolimus group,respectively. Patients treated with fewer than 2 lines and endocrine resistant patients benefited more from fulvestrant but without statistical difference. The main adverse events related to everolimus were stomati-tis,with a prevalence rate of about 26% and a localized pneumonia with a prevalence rate of about 10%. The main adverse reaction of fulvestrant was the injection site reaction. Conclusions The efficacy of everolimus in combina-tion with endocrine therapy is not superior to that of fulvestrant for the treatment of advanced breast cancer pro-gressed after endocrine therapy. After weighing the clinical benefits and quality of life,fulvestrant may be better for patients treated with fewer than 2 lines and endocrine resistance.

Capecitabine combined with docetaxel on tumor marker levels in patients with advanced breast cancer / 国际检验医学杂志

Objective To explore the effects of combination of capecitabine and docetaxel for the treatment on advanced breast cancer and their influence on tumor biomarkers.Methods The 75 cases with advanced breast cancer were randomly recruited from December 2010 to December 2015 in our hospital,and they were divided into the observation group (38 cases) and control group (37 cases) according to the admission time,the patients in control group were treated with docetaxel,while patients in the observation group were treated with combination of capecitabine and docetaxel,the clinical efficacy before and after treatment was observed,and the changes of serum CEA,glucose CA125,CA15-3 and adverse reaction were compared between two groups.Results The effective rate (RR) of the control group was 40.54% (15/37),and the disease control rate (DCR) was 67.57% (25/37).The RR was 63.16% (24/38) and DCR was 86.84% (33/38)in the observation group.There was significant difference between the two groups (P0.05);After treatment,the levels of CEA,CA125 and CA15-3 in both two groups were significantly lower than those before treatment (P<0.05);Moreover,after treatment,the observation group of three tumor biomarkers were significantly lower than those of the control group (P<0.05).Conclusion Combination of capecitabine and docetaxel in the treatment of advanced breast cancer can reduce the serum tumor biomarkers significantly,attenuate the side effects,and the patients are in the good tolerance,it can be widely recommended in clinical use.

Shenmai injection for inhibition of hepatic and renal toxicity and leukocyte disorder during chemoradiotherapy in advanced breast cancer / 中国生化药物杂志

Objective To investigate the Shenmai injection for the inhibition of hepatic and renal toxicity and leukocyte disorder during chemoradiotherapy in the women with advanced breast cancer. Methods 58 cases of female breast cancer patients with stage Ⅳ were selected and randomly divided into 2 groups, 29 cases of each group, and patients were treated with 5-hydroxytryptamine (5-HT3) receptor antagonists and white blood cell growth hormone and other conventional therapy, the control group received gemcitabine plus cisplatin chemotherapy, 28d for 1 cycles, the treatment group received more with Shenmai injection, interval was 15d, 2 groups were treated for 3 cycles. Levels of peripheral blood T lymphocyte subsets, cytokine levels and liver and kidney function, quality of life and clinical efficacy were compared. Results Compared with before treatment, levels of CD3+, CD4+ and CD4+/CD8+ in control group decreased (P<0.05), levels of CD3+, CD4+ and CD4+/CD8+ in treatment group increased (P<0.05), levels of CD8+ decreased(P<0.05), levels of IFN-γ, IL-2 and TNF-α increased(P<0.05), levels of IL-6 decreased(P<0.05), scores of KPS increased(P<0.05), scores of FACT-B decreased(P<0.05), levels of ALT, AST, BUN increased(P<0.05), and levels of CCr, WBC counts decreased(P<0.05), and compared with the control group, levels of CD3+ , CD4+ and CD4+/CD8+ in the treatment group were higher(P<0.05), levels of CD8+ were lower(P<0.05), levels of IFN-γ, IL-2 and TNF-α were higher(P<0.05), levels of IL-6 were lower(P<0.05), and the total efficiency was higher(P<0.05), levels of ALT, AST, BUN were lower (P<0.05), and levels of CCr, WBC counts were higher (P<0.05). After treatment, the efficacy of treatment group was higher than that of control group(Z=-2.142,P=0.032<0.05). Conclusion Shenmai injection can improve the efficacy of radiotherapy and chemotherapy in patients with advanced breast cancer, and it can effectively inhibit the liver and kidney damage and leukocyte disorder.

Effect of neoadjuvant chemotherapy combined with anthracycline and taxane in early or locally advanced breast cancer and its effects on ER,PR and Her-2 / 中国生化药物杂志

Objective To research the effect of neoadjuvant chemotherapy with anthracycline and taxane in early or locally advanced breast cancer and its effects on ER, PR and Her-2.Methods 120 cases of early or locally advanced breast cancer patients were selected as the research objects, according to the order of admission, the patients were divided into the observation group and the control group.The control group were given conventional chemotherapy with EC regimen (epirubicin +cyclophosphamide), while the observation group were treated with anthracyclines and taxanes.The clinical efficacy and the expression of ER, PR and Her-2 receptor in the two groups after treatment were compared.Results The total effective rate of the observation group was 73.33%, which was higher than that of the control group (53.33%) (P<0.05).After treatment, the positive expression level (0~+++) of ER receptor in the observation group were 20.00%, 15.00%, 35.00%, 30.00%, respectively, the positive expression level(0~+++) of PR receptor were 26.67%, 20.00%, 23.33% and 30.00%, respectively, were significantly better than those of the control group ( ER:31.67%, 21.67%, 28.33%, 18.33%, PR:40.00%, 25.00%, 20.00%, 15.00%) (P<0.05).But there was no significant difference between the two groups in the expression of Her-2 receptor (25.00%, 11.67%, 30.00%, 33.33% and 31.67%, 21.67%, 16.67%, 30.00%, respectively).The incidence of adverse reactions in the observation group and the control group were 6.67% and 21.67%, respectively, and there was significant difference between the two groups ( P<0.05 ) .Conclusion In the treatment of early or late stage breast cancer , anthracycline combined with taxane neoadjuvant chemotherapy has a significant effect, which can effectively improve the expression of ER and PR receptors.In addition to improve the effect of clinical treatment, and reduce the incidence of adverse reactions in a certain extent,so it can be used as a new adjuvant chemotherapy in the clinical application of the best option.