Cost-utility analysis of trastuzumab deruxtecan versus trastuzumab emtansine in the second-line treatment for HER2-positive metastatic breast cancer / 中国药房

OBJECTIVE To evaluate the cost-effectiveness of trastuzumab deruxtecan（T-DXd） versus trastuzumab emtansine （T-DM1） in the second-line treatment of HER2-positive metastatic breast cancer， and to provide a basis for the selection of clinical medication regimen and medical and health decisions. METHODS Based on the clinical trial DESTINY-Breast03， a partitioned survival model was constructed， with a cycle of 3 weeks as the simulation of patients’ lifetime. The incremental cost-effectiveness ratio （ICER） was calculated by using quality-adjusted life years （QALY） as output indicators， and sensitivity analysis was used to verify the robustness of the basic analysis results； the cost-effectiveness of the second-line treatment for HER2-positive metastatic breast cancer was compared between T-DXd and T-DM1. RESULTS Under the premise of taking 3 times China’s per capita gross domestic product （GDP） in 2022 as the willingness-to-pay threshold （257 094 yuan/QALY）， the T-DXd group also needed to pay more cost compared with T-DM1 group while obtaining incremental utility （0.69 QALYs）， and the ICER value was 1 850 478.40 yuan/QALY. The results of univariate sensitivity analysis showed that progression-free survival state utility value， T-DXd price， cost discount rate were factors that had a great influence on ICER value， but these parameters could not flip the basic analysis results within a reasonable range. In the probability sensitivity analysis， when the threshold of willingness-to-pay rose to 1 500 400 yuan/QALY， the probability of economic activity was 50% in the T-DXd regimen. The results of the scenario analysis also verified the robustness of the original research results. CONCLUSIONS Under the premise of 3 times China’s per capita GDP as the WTP threshold， compared with T-DM1， T-DXd is not cost-effective in the second-line treatment of HER2-positive metastatic breast cancer.

Complete response in metastatic breast cancer with visceral crisis using a combination of cyclin-dependent kinase 4/6 inhibitor and aromatase inhibitor: A case report from the eastern region of India

Patients with metastatic breast cancer (MBC) in visceral crisis require systemic chemotherapy. However, a coexisting cardiac failure that contradicts the use of systemic chemotherapy often demands an alternative treatment. Here, we report a case of hormone-receptor-positive MBC with cardiological comorbidities. She was treated with a combination treatment of tablet Ribociclib (600 mg once daily for 21 days followed by 7 days gap) and tablet Letrozole (2.5 mg once daily). The patient had a complete metabolic response in 18-Fluorodeoxyglucose Positron Emission tomography-Computed Tomography (18F-FDG PET/CT), after 6 months of treatment. Combination treatment with Ribociclib and Letrozole is beneficial in postmenopausal females with hormone receptor-positive and human epidermal growth factor receptor 2 neu-negative MBC in visceral crisis who have a contraindication to chemotherapy.

Comparison of adverse effects of trastuzumab with other drug combinations for the treatment of breast cancer: A review

OBJECTIVES: This study compares the adverse effects (AEs) associated with trastuzumab in the treatment of human epidermal growth factor receptor 2-positive breast cancer (HER-2 + BC) when used alone or in combination with chemotherapy or with tyrosine kinase inhibitors, so as to aid in rational treatment choices. MATERIALS AND METHODS: An electronic search was conducted on PubMed using the Mesh terms ‘BC’, ‘HER-2 positive’, ‘metastasis BC, ‘trastuzumab’, and ‘safety’. Data from 32 studies regarding AEs were extracted and categorised as trastuzumab + chemotherapy (T+C), trastuzumab biosimilar (Tb), trastuzumab + tyrosine kinase inhibitors+ chemotherapy (T+TKi+C), and trastuzumab + tyrosine kinase inhibitors (T+TKi). The data are presented as the mean percentage of AEs. The statistical comparison was represented by a box and whisker plot of the interquartile range value of AEs. RESULTS: AEs related to the gastrointestinal tract, skin, nervous, blood, and lymph were reported to be the most common in T+C, T+TKi+C, and T+TKi. Nausea, vomiting, diarrhoea, constipation, neuropathy peripheral, alopecia, rash, anaemia, leucopenia, raised aspartate transaminase and alanine transaminase were the most common complaints. AEs such as myalgia, nasopharyngitis, hypertension, and ejection fraction decrease was reported to be the most common in Tb. CONCLUSION: This study concluded that biosimilar of trastuzumab is safest for the treatment of HER-2-positive BC. Cardiovascular disorder is often reported in the biosimilar group, but this group has fewer AEs reported as compared with chemotherapy, and tyrosine kinase inhibitors groups related to other systems such as digestive, nervous, and respiratory. The choice of combination is depending on the type of BC and the condition of the patients. The patients must monitor for cardiotoxicity when the biosimilar of trastuzumab is used.

Research progress in endocrine clinical treatment of HR +/HER2 - metastatic breast cancer / 国际生物医学工程杂志

Breast cancer, as a heterogeneous disease, has different molecular subtypes. The most common molecular subtype is hormone receptor positive (HR +). Endocrine therapy is the predominant treatment for this subtype. The main treatment modality for HR +/human epidermal growth factor receptor 2-negative (HER2 -) metastatic breast cancer (MBC) is novel targeted agents combined with endocrine therapy. In this review, researches in endocrine clinical treatment of HR +/HER2 - MBC was reviewed to provide a new targeted therapy, including CDK4/6 inhibitors combined with endocrine therapy, the debate between CDK4/6 inhibitors combined with endocrine therapy and chemotherapy, new directions of CDK4/6 inhibitor combination, exploration of multiple treatment strategies after CDK4/6 inhibitor therapy progresses, histone deacetylase inhibitor combined with endocrine therapy, PI3K/Akt/mTOR pathway targeting drugs in combination with endocrine therapy, polyadenosine diphosphate ribose polymerase (PARP) inhibitors for gBRCA1/2 mutated breast cancer, novel targeted drugs, and multi-target/multi-combination therapy model.

Incidence of central nervous system metastases in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer treated with trastuzumab: A meta-analysis

This study aimed to estimate the incidence of central nervous system (CNS) metastases in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) treated with trastuzumab. Studies were identified through a literature search of electronic databases. Random-effects meta-analyses were performed to estimate the incidence rate of CNS metastases, trastuzumab therapy duration, and time from trastuzumab therapy to CNS metastasis diagnosis. A meta-analysis of odds ratios was performed to evaluate the significance of a difference in CNS metastasis incidence between patients with and without trastuzumab treatment. Thirty studies (8121 trastuzumab-treated and 3972 control patients) were included. The follow-up duration was 18.9 months (95% confidence interval [CI]: 13.8, 24.1). The trastuzumab treatment duration was 9.0 months (95% CI: 7.0, 11.0). The median interval between the start of trastuzumab therapy and CNS metastasis diagnosis was 12.2 months (95% CI: 9.5, 14.7). The incidence of CNS metastasis after the start of trastuzumab therapy was 22% (95% CI: 16, 27). The incidence of CNS metastases was significantly higher in trastuzumab-treated than in non-trastuzumab-treated patients (odds ratio: 1.39 [95% CI: 1.06, 1.82], p=0.02). The survival time from the start of the study was 23.4 months (95% CI: 19.7, 27.1) in trastuzumab-treated patients and 18.4 months (95% CI: 12.7, 24.1) in patients treated with control regimens. The survival time after the development of CNS metastases in trastuzumab-treated patients was 19.2 months (95% CI: 15.6, 25.9). Approximately 22% of patients with HER2-positive MBC who were treated with trastuzumab developed CNS metastases. However, trastuzumab-treated patients had a longer survival than patients who were not treated with trastuzumab.

A randomized controlled Phase II trial of vinorelbine plus capecitabine versus docetaxel plus capecitabine in anthracycline-pretreated women with metastatic breast cancer

Background: Previous studies have shown that vinorelbine/capecitabine (NX) and docetaxel/capecitabine (TX) chemotherapy has a certain effect in advanced breast cancer. However, there are few clinical studies directly comparing TX and NX regimen chemotherapy, especially in patients with advanced breast cancer previously treated with anthracycline and taxane. The purpose of this Phase II study was to compare survival and side effects between patients with anthracycline- and taxane-resistant advanced breast cancer treated with NX and those treated with TX chemotherapy. Patients and Methods: From February 2012 to March 2014, a total number of 97 patients were randomly assigned to NX (n = 55) or TX (n = 42). Baseline characteristics were relatively well-balanced in the two treatment arms. The clinical trial registration number (clincaltrials.gov) is NCT01635465. Results: After a median follow-up of 46.0 months, there was no significant difference between the NX and TX arms in objective response rate (17.9% vs. 21.1%; P = 0.686) and progression-free survival (6 months vs. 7 months; P = 0.560). The overall survival period of the TX arm was longer than that of the NX arm (32 months vs. 27 months) but without statistical significance. Both regimens were well-tolerated. The main toxicities were neutropenia, leukopenia, and anemia. In the TX arm, hand-foot syndrome occurred more frequently than in the NX arm (P < 0.01), but frequencies of other minor adverse effects were similar between the two arms. Conclusion: NX and TX regimens are both alternative treatments for patients with anthracycline- and taxane-resistant advanced breast cancer, but the safety profile was more favorable and manageable with the NX regimen. Trial Registrations: ClinicalTrials.gov NCT01635465. Registered 09 July 2012

Impacto econômico da adoção de denosumabe em pacientes com metástases ósseas ou mieloma múltiplo sob a perspectiva do sistema de saúde privado brasileiro / Economic impact of denosumab adoption in cancer patients with bone metastases or multiple myeloma from the Brazilian private healthcare system's perspective

Objetivo: Estimar o custo por evento relacionado ao esqueleto (ERE) e o impacto econômico anual da adoção de denosumabe em pacientes com metástases ósseas secundárias ao câncer de mama, próstata e outros tumores sólidos ou mieloma múltiplo sob a perspectiva do sistema de saúde privado brasileiro. Métodos: Um modelo econômico foi desenvolvido para comparar os custos relacionados com denosumabe versus ácido zoledrônico na prevenção de EREs. O modelo incluiu os seguintes custos: medicamento, administração, monitoramento e manejo de ERE. O custo anual foi apresentado em reais (BRL) para 100 pacientes. Os custos do manejo de ERE [fratura vertebral (FV), fratura não vertebral (FNV), radiação óssea (RO), cirurgia óssea (CO) e compressão da medula espinhal (CME)] foram estimados a partir dos recursos e procedimentos coletados da revisão de literatura, bases de dados e painel Delphi. Dados coletados dos estudos clínicos randomizados relacionados com cada tipo de tumor na análise e de um estudo prospectivo observacional foram utilizados para estimar a eficácia clínica de denosumabe versus ácido zoledrônico. Resultados: O custo por cada tipo de ERE variou de BRL 27.246 a BRL 28.035 para FV, BRL 18.023 a BRL 18.811 para FNV, BRL 42.750 a BRL 43.538 para RO, BRL 18.023 a BRL 18.811 para CO e BRL 12.472 a BRL 13.260 para CME. A introdução de denosumabe foi estimada em economia anual por 100 pacientes de até BRL 1.072.043,14 para câncer de mama, BRL 1.212.822,79 para outros tumores sólidos, BRL 1.929.660,67 para câncer de próstata e BRL 77.965,07 para mieloma múltiplo. Conclusão: Esta análise sugere que EREs adicionam custos substanciais no manejo de pacientes com metástases ósseas. Dessa forma, o uso de denosumabe pode prevenir e retardar EREs em pacientes com câncer e pode possivelmente levar à redução do impacto econômico associado aos EREs sob a perspectiva dos pagadores de saúde privada brasileira.

Objective: To estimate the cost per SRE and annual economic impact of denosumab adoption in patients with bone metastases (BM) secondary to breast cancer, prostate cancer, other solid tumors or multiple myeloma from the Brazilian private healthcare system's perspective. Methods: An economic model was developed to compare the cost outcomes associated with denosumab instead of zoledronic acid for SRE prevention. The model included the following costs: drug, administration, monitoring and SRE management. Annual costs per 100 patients were reported in 2019 Brazilian currency (BRL). The SRE management costs (vertebral fracture (VF), non-vertebral fracture (NVF), radiation to bone (RB), surgery to bone (SB) and spinal cord compression (SCC)) were estimated from the resources and procedures collected from literature review, official database, and a Delphi panel. Data collected from randomized clinical trials related to each tumor type in the analysis and from a prospective observational study was used to estimate the clinical efficacy of denosumab vs zoledronic acid. Results: The cost per each type of SREs across all tumors ranged BRL 27,246 ­ BRL 28,035 for VF, BRL 18,023 ­ BRL 18,811 for NVF, BRL 42,750 ­ BRL 43,538 for RB, BRL 18,023 ­ BRL 18,811 for SB and BRL 12,472 ­ BRL 13,260 for SCC. The introduction of denosumab was estimated to result in annual savings per 100 patients of up to BRL 1,072,043.14 for breast cancer, BRL 1,212,822.79 for other solid tumors, BRL 1,929,660.67 for prostate cancer and BRL 77,965.07 for multiple myeloma. Conclusion: This analysis suggests that SREs add substantial costs to the management of patients with bone metastases. In this way, the use of denosumab would prevent and delay SREs in cancer patients and might possibly lead to reduce the economic burden associated with SREs, borne by Brazilian private healthcare payers.

Evaluation of cytotoxic profile of hydroalcoholic extract of fruit rinds of Garcinia pedunculata on human embryonic kidney and breast carcinoma cells

Background: The fruit rinds of Garcinia pedunculata has potential medicinal properties and used in many chronic ailments. It has been demonstrated that cytoprotective effects in various experimental research works. But its cytotoxic effect has not been evaluated. The present study was aimed to screen its relative cytotoxic effect on normal and cancer cell lines.Methods: In the present study, the cytotoxic effect of hydro alcoholic extract of Garcinia pedunculata was evaluated on normal human embryonic kidney (HEK-293) and M.D. Anderson metastatic breast cancer cell lines (MDA-MB 231) using 3-(4, 5-dimethylthiazol-2-yl)-2, 5-diphenyltetrazolium bromide (MTT) assay.Results: Higher dose level of hydro alcoholic extract of Garcinia pedunculata (HAGP) (500 ?g/ml) has shown considerable increase (112.503) in the percentage viability of HEK-29 whereas; there is a remarkable decrease in the viable cell population (77.490) in MDA-MB 231.Conclusions: Based on the observed results we could conclude that HAGP has potential cytotoxic effect on the cancer cell line without altering the normal cell growth and proliferation. Thus it has potential to develop as a safer chemotherapeutic agent. Further detailed exploration is required to confirm its therapeutic efficacy in different cancer cell lines.

Orbital Metastasis as The Initial Presentation of Breast Cancer

@#Breast cancer is the most common cancer among the female population of Malaysia, with an average lifetime risk of 31.1%.1 Typical sites for metastasis of the breast carcinoma include the bones, liver, lungs, skin, and brain. In most cases, breast cancer is diagnosed first, but in 12- 31% of the cases like in this case, the metastasis appear first as the initial presentation. In this case, we reported a case of a healthy young woman who presented with orbital metastasis as the initial presentation of breast cancer.

Biomarcadores mamarios en procesos metastásicos en mujeres ecuatorianas / Breast biomarkers in metastatic processes in Ecuadorian women

Resumen Introducción: Los biomarcadores tumorales CA 15-3 y CEA son predictores de metástasis en el cáncer de mama; no obstante, existe división de criterios de las ventajas de determinarlos de forma individual o conjunta. Objetivo: Evaluar la asociación de los biomarcadores tumorales CA 15-3 y CEA, por separado y en conjunto, en relación a la enfermedad metastásica en mujeres ecuatorianas con cáncer de mama. Métodos: Se realizó un estudio de prevalencia, en base a la información obtenida de las historias clínicas de 90 mujeres con cáncer de mama. Se identificaron los marcadores (CA 15-3, CEA y el conjunto de los dos (CA 15-3 ­ CEA) y se buscó la asociación con presencia o no de metástasis mediante prueba exacta de Fisher e índice Kappa de Cohen. Además, se determinó la sensibilidad, especificidad y valores predictivos positivos y negativos de cada marcador tumoral y en conjunto. Resultados: La prevalencia de carcinoma ductal invasivo en etapas localmente avanzadas de IIB a IIIC fue 77.8%. El sistema óseo y pulmonar fueron lugares frecuentes de invasión. De manera individual y conjunta existe una relación estadísticamente significativa (P <0.05) entre el valor de los biomarcadores y la presencia de procesos metastásicos, siendo CA15-3 y CA15-3-CEA los de mayor concordancia. CA15-3 presentó sensibilidad (S) 55% y especificidad (E) 91%. CEA tuvo (S) 30%; (E) 96%. En conjunto presentaron (S) 40%; (E) 100%. Conclusiones: La presencia de metástasis y mayor carga tumoral se correlacionan con la positividad de los biomarcadores tumorales CA 15-3-CEA, lo cual refuerza la utilidad clínica de evaluar los dos biomarcadores en conjunto.

Background: CA 15-3 and CEA tumor markers are metastasis predictors in breast cancer; however, criteria of the advantages in determining them in an individual or joint way are still not consensual. Objective: To evaluate the association of CA 15-3 and CEA tumor markers, in individual or joint way, in Ecuadorian patients diagnosed with metastatic breast cancer. Methods: A prevalence study was carried out, based on the information obtained from the medical records of 90 women with breast cancer. The markers CA 15-3, CEA were identified individually and together (CA 15-3 - CEA) and the association between the presence or absence of metastasis was established by using Fisher's exact test and Cohen's Kappa index. In addition, the sensitivity, specificity, positive and negative predictive values of each tumor marker as individual element and as a whole were determined Results: The prevalence of invasive ductal carcinoma in locally advanced stages from IIB to IIIC was 77.8%. The bone and lung system were frequent sites of cancer spread. There was a statistically significant relation (p<0.05) between the individual or whole biomarkers values and the presence of metastatic processes, being CA 15-3 and CA 15-3-CEA the ones with the highest concordance. CA 15-3 presented 55% sensitivity and 91% specificity. CEA presented 30% sensitivity and 96% specificity. As a whole, those have 40% sensitivity and 100% specificity. Conclusions: A higher tumor burden and metastatic development correlate with CA15-3-CEA biomarker positivity as a set, reinforcing the clinical benefit of evaluating both biomarkers simultaneously

Randomized Open Label Phase III Trial of Irinotecan Plus Capecitabine versus Capecitabine Monotherapy in Patients with Metastatic Breast Cancer Previously Treated with Anthracycline and Taxane: PROCEED Trial (KCSG BR 11-01) / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: We investigated whether irinotecan plus capecitabine improved progression-free survival (PFS) compared with capecitabine alone in patients with human epidermal growth factor 2 (HER2) negative and anthracycline and taxane pretreated metastatic breast cancer (MBC). MATERIALS AND METHODS: A total of 221 patients were randomly assigned to irinotecan (80 mg/m2, days 1 and 8) and capecitabine (1,000 mg/m2 twice a day, days 1-14) or capecitabine alone (1,250 mg/m2 twice a day, days 1-14) every 3 weeks. The primary endpoint was PFS. RESULTS: There was no significant difference in PFS between the combination and monotherapy arm (median, 6.4 months vs. 4.7 months; hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.63 to 1.11; p=0.84). In patients with triple-negative breast cancer (TNBC, n=90), the combination significantly improved PFS (median, 4.7 months vs. 2.5 months; HR, 0.58; 95% CI, 0.37 to 0.91; p=0.02). Objective response rate was numerically higher in the combination arm, though it failed to reach statistical significance (44.4% vs. 33.3%, p=0.30). Overall survival did not differ between arms (median, 20.4 months vs. 24.0 months; p=0.63). While grade 3 or 4 neutropenia was more common in the combination arm (39.6% vs. 9.0%), hand-foot syndrome was more often observed in capecitabine arm. Quality of life measurements in global health status was similar. However, patients in the combination arm showed significantly worse symptom scales especially in nausea/vomiting and diarrhea. CONCLUSION: Irinotecan plus capecitabine did not prove clinically superior to single-agent capecitabine in anthracycline- and taxane-pretreated HER2 negative MBC patients. Toxicity profiles of the two groups differed but were manageable. The role of added irinotecan in patients with TNBC remains to be elucidated.

Clinical study of docetaxel in the treatment of metastatic breast cancer in different age groups / 实用肿瘤学杂志

Objective The aim of this study was to evaluate the clinical efficacy and hematologic toxicity of docetaxel in the treatment of metastatic breast cancer patients in different age groups. Methods The clinical data of three groups of single-agent do-cetaxel in the treatment of metastatic breast cancer patients were retrospectively analyzed. The clinical efficacy of docetaxel was ana-lyzed statistically. Results The objective response rate(ORR) and clinical beneficial rate( CBR) in the group of age < =45 year group were 30. 6% and 38. 7% ,and the ORR and CBR in the 46~59 age were 27. 5% and 35. 7% ,while ORR and CBR in the≥60 age group were 20. 0% and 27. 5% . The median progress free survival( PFS) in three groups was 6. 0(2. 9 ~9. 1) months,5. 0 (2. 9~7. 1)months and 4. 0(3. 3~4. 7) months,respectively. There was no statistical difference in three different age groups(P=0. 477,0. 492 and 0. 460,respectively). Cox regression analysis showed that the docetaxel rescue treatment of PFS had not associated with clinical stage,pathological type,ipsilateral axillary lymph node metastasis,disease free survival,unit dose of body surface area dose,number of rescue treatment lines,number of recurrence and metastasis,etc. in three different age groups of patients with meta-static breast cancer. Hematological toxicity was mainly manifested by a decrease in white blood cells and neutrophils,and docetaxel has less effect on hemoglobin and platelets. Conclusion The clinical efficacy and hematologic toxicity of docetaxel have a certain de-gree of correlation with ages. With the increase of age,the clinical curative effect is reduced and the blood toxicity is aggravated.

Safety Results and Analysis of Eribulin Efficacy according to Previous Microtubules-Inhibitors Sensitivity in the French Prospective Expanded Access Program for Heavily Pre-treated Metastatic Breast Cancer / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: Eribulin is approved for advanced breast cancers refractory to anthracyclines and taxanes. Efficacy according to sensitivity to previous therapies has been poorly explored. MATERIALS AND METHODS: Safety data were collected prospectively and we retrospectively collected efficacy data from the five French centres that participated in the Eribulin E7389-G000-398 expanded access program. Our main objectives were exploration of safety and analysis of eribulin efficacy (progression-free survival [PFS] and overall survival [OS]) according to sensitivity to the last microtubule-inhibiting agent administered. RESULTS: Median eribulin treatment duration was 3.3 months for the 250 patients included in this prospective single-arm study. Two hundreds and thirty-nine patients (95.6%) experienced an adverse event (AE) related to treatment including 129 (51.6%) with grade ≥ 3 AEs. The most frequently observed toxicities were cytopenias (59.6% of included patients), gastro-intestinal disorders (59.2%), and asthenia (56.4%). The most frequent grade 3-4 AE was neutropenia (37.2% with 4.8% febrile neutropenia). Median PFS and OS were 4.6 and 11.8 months, respectively. Patients classified as responders to the last microtubule-inhibiting therapy had a longer OS (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.51 to 0.94; p=0.017), and tended to display a better PFS (HR, 0.78; 95% CI, 0.58 to 1.04; p=0.086). OS improvement was still significant in multivariate analysis (adjusted HR, 0.53; 95% CI, 0.35 to 0.79; p=0.002). CONCLUSION: This work based on a prospective study suggests that identification of patients likely to be more sensitive to eribulin could be based on their previous response to microtubules inhibitors.

Clinical effect of docetaxel combined with lobaplatin in the treatment of metastatic breast cancer / 中国基层医药

Objective To analyze the efficacy and safety of combination of docetaxel and lobaplatin in the treatment of metastatic breast cancer (MBC).Methods The clinical data of 46 patients with MBC who had been administered docetaxel and lobaplatin were retrospectively reviewed.Results All 46 patients were treated for 4 cycles,4 cases achieved complete remission (CR),25 cases achieved partial remission (PR),the effective rate was 63.0％ (29/46).The patients were followed up for 12 monthpatients,the progression-free survival time was (8.1 ±0.6) months,2 patients died due to tumor progression.The adverse reactions were mainly granulocyte,thrombocytopenia,anemic,gastrointestinal reaction,articular muscle soreness,mucosa,diarrhea and peripheral edema,mainly Ⅰ ～ Ⅱ degree.Conclusion Docetaxel combined with lobaplatin is well-tolerated and safe for MBC patients,and has less adverse reactions.

Efficacy and safety of trastuzumab combined with paclitaxel for treatment of human epidermal growth factor receptor-2 overexpressing metastatic breast cancer patients / 新乡医学院学报

Objective To evaluate the efficacy and safety of the second or third line usage of trastuzumab combined with paclitaxel for treatment of patients with human epidermal growth factor receptor-2(Her-2)overexpressing metastatic breast cancer. Methods A total of 58 patients with Her-2 overexpressing metastatic breast cancer who had been treated by the first and second-line treatment method were selected in the First People's Hospital of Xinxiang City from March 2012 to March 2015. All patients were treated with trastuzumab combined paclitaxel for 6 to 8 cycles,then the efficacy and adverse reactions were evaluated,and the efficacy and adverse reactions between patients with different clinical features were compared. The pa-tients were followed up for three years,and the survival rate was analysed. Results Of the 58 patients,53 patients completed the chemical treatment successfully,including 6 cases of complete remission,24 cases of partial remission,12 cases of stable dis-ease,11 cases of progressive disease,the effective rate was 56. 6％(30/ 53);the 3-year survival rate of patients was 28. 3％(15/53). The effective rate of patients who had not used taxanes was significantly higher than that who had used the taxanes(P <0. 05);the conditions of previous treatment,the estrogen and progesterone receptor and the number of the metastatic sites had no significant effect on the treatment effect(P >0. 05);the 3-year survival rate of patients who had used first-line chemotherapy was significantly higher than that who had used the second-line chemotherapy(P <0. 05);whether use of trastuzumab,the conditond of estrogen and progesterone receptor and the number of the metastatic sites had no significant effect on the 3-year survival rate (P >0. 05). The main adverse reactions of patients were neutrophilic granulocytopenia(75. 5％,40/ 53),anemia(71. 7％,38/53)and thrombocytopenia(50. 9％,27/ 53);there was no statistic difference in the incidence of main adverse reactions in pa-tients with different clinical characteristics(P > 0. 05). Conclusion The second or third-line usage of trastuzumab combined with paclitaxel for treatment of Her-2 overexpressing metastatic breast cancer patients is efficacy and safety. Patients who have not treated with trastuzumab and only received the first-line chemotherapy have a better therapeutic effect.

The detecting value of CTCs in peripheral venous blood of patients with advanced metastatic breast cancer / 实用医学杂志

Objective To detect the value of circulating tumor cells(CTCs)in peripheral venous blood in patients with metastatic breast cancer. Methods 50 female patients with advanced advanced metastatic breast can-cer hospitalized in our hospital from May 2016 to December 2016 were enrolled in the research. Patients were divid-ed into oligometastases group and extensive metastasis group through multi-department comprehensive analysis andimaging diagnosis. 10 cases with early stage breast cancer were selected randomly. 10 healthy female volunteers were recruited as control group. After obtaining written informed consent from research subjects ,7.5 mL peripheral blood was drew from patients and volunteers prior to starting a new line of chemotherapy ,surgery or other treat-ment. CTCs counts from Blood samples were detected density gradient centrifugation associate with flow cytometry. Results The base line was formulated as CTCs≥5/7.5 mL positive and CTCs<5/7.5 mL negative. By comparing the positive expression of CTCs in early and advanced metastatic breast cancer(Pa = 0.01,P < 0.05),positive CTCs was associated with advanced metastatic breast cancer. Comparision of the positive expression of CTCs between oligometastases group and the extensive transfer group showed significant difference in the CTCs count be-tween the two groups(Pb = 0.018,P < 0.05). In the corresponding period,no positive CTCs was detected in all healthy volunteers. Conclusion CTCs count was associated with metastatic breast cancer. There was a correlation between tumor metastasis and CTCs count (the more widely metastasis ,the higher the detection rate of CTCs). CTCs may be of relevant value in the diagnosis and treatment ,and prognosis evaluation of metastatic breast cancer.

Analysis of clinical features and prognosis of breast cancer with uncommon metastases / 肿瘤

Objective: To analyze the clinical pathological characteristics and prognosis of breast cancer patients with uncommon metastases. Methods: Clinical data of 68 cases of breast cancer with uncommon metastases from 2012 to 2015 was retrospectively analyzed. The definition of uncommon sites of metastases is the metastatic sites except for lymph node, chest wall, breast, bone, liver, lung, brain and peritoneal and pleural metastases. Results: Among the 68 patients, the uncommon metastatic sites included adrenal gland, ovary, pancreas, eyes, uterus, spleen, rectum, bladder, kidney, thyroid gland and parotid gland. The top three common metastatic sites were adrenal gland (44.1%, 30/68), ovary (41.2%, 28/68) and pancreas (11.8%, 8/68); 75.0% (51/68) of the patients had other common metastases. The median survival time after uncommon metastases was 23.5 months (range: 1.4-116.0 months). The univariate analysis showed that the patients without metastases outside the special sites had a better survival than those with common metastases (median survival time were 36.0 and 18.0 months, respectively; P = 0.007). Conclusion: Breast cancer metastasis is widespread, in addition to the common sites, the cancer can be transferred to many other sites. Patients with uncommon metastases from breast cancer may have a favorable prognosis if they do not accompany with other common metastases, and local treatment may improve the survival of some selected patients. Many ovarian metastases are found after the operation, and the possibility of ovarian metastasis should be considered in the selection of the method of ovarian ablation.

Progress on surgical resection of the primary diagnostic stageⅣbreast cancer / 中国肿瘤临床

Systemic therapy is usually the main treatment for patients with stageⅣbreast cancer at diagnosis. Surgical resection of the primary tumor is typically conducted for palliative reasons, and whether such treatment can benefit patients' survival outcome re-mains unclear. In our clinical practice, proper timing and indications for surgery of the primary tumor, as well as an appropriate surgi-cal technique, may increase the success of local treatment for stageⅣbreast cancer. This article reviews available literature and dis-cusses the role of surgical resection in the treatment of stageⅣbreast cancer at initial presentation.

Comparison of Therapeutic Efficacy of Lobaplatin or Cisplatin Combined with Tegafur, Gimeracil and Oteracil Potassium in the Treatment of Advanced Metastatic Breast Cancer / 中国药房

OBJECTIVE:To compare therapeutic efficacy and safety of lobaplatin or cisplatin combined with tegafur,gimeracil and oteracil potassium in the treatment of advanced metastatic breast cancer.METHODS:A total of 160 patients with advanced metastatic breast cancer were randomly divided into observation group and control group,with 80 cases in each group.Control group was given Cisplatin injection 30 mg/m2 intravenously,every 3 weeks Tegafur,Gimeracil and Oteracil Potassium capsules 50 mg orally after meal,twice a day,for consecutive 14 days.Observation group was given Lobaplatin for injection 30 mg/m2 intravenously,every 3 weeks+Tegafur,Gimeracil and Oteracil Potassium capsules (same usage and dosage as control group),every 3 weeks.A treatment course lasted for 3 weeks,and both groups received 2 courses.Short-term efficacies (ORR、DCR),chemotherapy effects of lymph node,lung,bone and liver,ADR and long-term efficacy were compared between 2 groups.RESULTS:After treatment,ORR(67.50％ vs.46.25％),DCR(85.00％ vs.66.25％),ORR of lymph node metastasis (71.43％ vs.47.83％),ORR of lung metastasis (60.71％ vs.40.00％),DCR of lung metastasis (78.57％ vs.56.00％),ORR of bone metastasis (28.57％ vs.16.67％),1-year survival rates (75.00％ vs.52.50％) and 2-years survival rates (42.50％ vs.17.50％) of observation group were significantly higher than control group;the incidence of chemotherapy ADR in observation group was significantly lower than control group (43.75％ vs.70.00％),with statistical significance (P＜0.05).There was no statistical significance in lymph node metastasis DCR,bone tissue metastasis DCR,liver metastasis ORR and DCR,or half year sarvival rate between 2 groups (P＞0.05).CONCLUSIONS:Compared to cisplatin combined with tegafur,gimeracil and oteracil potassium,lobaplatin combined with tegafur,gimeracil and oteracil potassium show better short-term therapeutic efficacy,therapeutic efficacy of lymph node metastasis,bone metastasis and lung metastasis,more than 1-year long-term therapeutic efficacy and safety in the treatment of advanced metastatic breast cancer.

An Open-Label, Randomized, Parallel, Phase III Trial Evaluating the Efficacy and Safety of Polymeric Micelle-Formulated Paclitaxel Compared to Conventional Cremophor EL-Based Paclitaxel for Recurrent or Metastatic HER2-Negative Breast Cancer / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: Genexol-PM is a Cremophor EL–free formulation of low-molecular-weight, non-toxic, and biodegradable polymeric micelle-bound paclitaxel. We conducted a phase III study comparing the clinical efficacy and toxicity of Genexol-PM with conventional paclitaxel (Genexol). MATERIALS AND METHODS: Patients were randomly assigned (1:1) to receive Genexol-PM 260 mg/m² or Genexol 175 mg/m² intravenously every 3 weeks. The primary outcome was the objective response rate (ORR). RESULTS: The study enrolled 212 patients, of whom 105 were allocated to receive Genexol-PM. The mean received dose intensity of Genexol-PM was 246.8±21.3 mg/m² (95.0%), and that of Genexol was 168.3±10.6 mg/m² (96.2%). After a median follow-up of 24.5 months (range, 0.0 to 48.7 months), the ORR of Genexol-PM was 39.1% (95% confidence interval [CI], 31.2 to 46.9) and the ORR of Genexol was 24.3% (95% CI, 17.5 to 31.1) (p(non-inferiority)=0.021, p(superiority)=0.016). The two groups did not differ significantly in overall survival (28.8 months for Genexol-PM vs. 23.8 months for Genexol; p=0.52) or progression-free survival (8.0 months for Genexol-PM vs. 6.7 months for Genexol; p=0.26). In both groups, the most common toxicities were neutropenia, with 68.6% occurrence in the Genexol-PM group versus 40.2% in the Genexol group (p < 0.01). The incidences of peripheral neuropathy of greater than grade 2 did not differ significantly between study treatments. CONCLUSION: Compared with standard paclitaxel, Genexol-PM demonstrated non-inferior and even superior clinical efficacy with a manageable safety profile in patients with metastatic breast cancer.