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Background: Breast cancer is the most common cancer in women worldwide, with a great diversity in outcomes among individual patients. The ability to accurately predict a breast cancer outcome is important to patients, physicians, researchers, and policy makers. Many models have been developed and tested in different settings. We systematically reviewed the prognostic models developed and/or validated for patients with breast cancer.Methods: We conducted a systematic search in four electronic databases and some oncology websites, and a manual search in the bibliographies of the included studies. We identified original studies that were published prior to 1st January 2017, and presented the development and/or validation of models based mainly on clinico-pathological factors to predict mortality and/or recurrence in female breast cancer patients.Results: From the 96 articles selected from 4095 citations found, we identified 58 models, which predicted mortality (n = 28), recurrence (n = 23), or both (n = 7). The most frequently used predictors were nodal status (n = 49), tumour size (n = 42), tumour grade (n = 29), age at diagnosis (n = 24), and oestrogen receptor status (n = 21). Models were developed in Europe (n = 25), Asia (n = 13), North America (n = 12), and Australia (n = 1) between 1982 and 2016. Models were validated in the development cohorts (n = 43) and/or independent populations (n = 17), by comparing the predicted outcomes with the observed outcomes (n = 55) and/or with the outcomes estimated by other models (n = 32), or the outcomes estimated by individual prognostic factors (n = 8). The most commonly used methods were: Cox proportional hazards regression for model development (n = 32); the absolute differences between the predicted and observed outcomes (n = 30) for calibration; and C-index/AUC (n = 44) for discrimination. Overall, the models performed well in the development cohorts but less accurately in some independent populations, particularly in patients with high risk and young and elderly patients. An exception is the Nottingham Prognostic Index, which retains its predicting ability in most independent populations.Conclusions: Many prognostic models have been developed for breast cancer, but only a few have been validated widely in different settings. Importantly, their performance was suboptimal in independent populations, particularly in patients with high risk and in young and elderly patients. [ABSTRACT FROM AUTHOR]

Background: Postmastectomy radiotherapy in patients with four or more positive axillary nodes reduces breast cancer mortality, but its role in patients with one to three involved nodes is controversial. We assessed the effects of postmastectomy radiotherapy on quality of life (QOL) in women with intermediate-risk breast cancer.Methods: SUPREMO is an open-label, international, parallel-group, randomised, controlled trial. Women aged 18 years or older with intermediate-risk breast cancer (defined as pT1-2N1; pT3N0; or pT2N0 if also grade III or with lymphovascular invasion) who had undergone mastectomy and, if node positive, axillary surgery, were randomly assigned (1:1) to receive chest wall radiotherapy (50 Gy in 25 fractions or a radiobiologically equivalent dose of 45 Gy in 20 fractions or 40 Gy in 15 fractions) or no radiotherapy. Randomisation was done with permuted blocks of varying block length, and stratified by centre, without masking of patients or investigators. The primary endpoint is 10-year overall survival. Here, we present 2-year results of QOL (a prespecified secondary endpoint). The QOL substudy, open to all UK patients, consists of questionnaires (European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR23, Body Image Scale, Hospital Anxiety and Depression Scale [HADS], and EQ-5D-3L) completed before randomisation, and at 1, 2, 5, and 10 years. The prespecified primary outcomes within this QOL substudy were global QOL, fatigue, physical function, chest wall symptoms, shoulder and arm symptoms, body image, and anxiety and depression. Data were analysed by intention to treat, using repeated mixed-effects methods. This trial is registered with the ISRCTN registry, number ISRCTN61145589.Findings: Between Aug 4, 2006, and April 29, 2013, 1688 patients were enrolled internationally and randomly assigned to receive chest wall radiotherapy (n=853) or not (n=835). 989 (79%) of 1258 patients from 111 UK centres consented to participate in the QOL substudy (487 in the radiotherapy group and 502 in the no radiotherapy group), of whom 947 (96%) returned the baseline questionnaires and were included in the analysis (radiotherapy, n=471; no radiotherapy, n=476). At up to 2 years, chest wall symptoms were worse in the radiotherapy group than in the no radiotherapy group (mean score 14·1 [SD 15·8] in the radiotherapy group vs 11·6 [14·6] in the no radiotherapy group; effect estimate 2·17, 95% CI 0·40-3·94; p=0·016); however, there was an improvement in both groups between years 1 and 2 (visit effect -1·34, 95% CI -2·36 to -0·31; p=0·010). No differences were seen between treatment groups in arm and shoulder symptoms, body image, fatigue, overall QOL, physical function, or anxiety or depression scores.Interpretation: Postmastectomy radiotherapy led to more local (chest wall) symptoms up to 2 years postrandomisation compared with no radiotherapy, but the difference between groups was small. These data will inform shared decision making while we await survival (trial primary endpoint) results.Funding: Medical Research Council, European Organisation for Research and Treatment of Cancer, Cancer Australia, Dutch Cancer Society, Trustees of Hong Kong and Shanghai Banking Corporation. [ABSTRACT FROM AUTHOR]

EUSOBI and 30 national breast radiology bodies support mammography for population-based screening, demonstrated to reduce breast cancer (BC) mortality and treatment impact. According to the International Agency for Research on Cancer, the reduction in mortality is 40 % for women aged 50-69 years taking up the invitation while the probability of false-positive needle biopsy is <1 % per round and overdiagnosis is only 1-10 % for a 20-year screening. Mortality reduction was also observed for the age groups 40-49 years and 70-74 years, although with "limited evidence". Thus, we firstly recommend biennial screening mammography for average-risk women aged 50-69 years; extension up to 73 or 75 years, biennially, is a second priority, from 40-45 to 49 years, annually, a third priority. Screening with thermography or other optical tools as alternatives to mammography is discouraged. Preference should be given to population screening programmes on a territorial basis, with double reading. Adoption of digital mammography (not film-screen or phosphor-plate computer radiography) is a priority, which also improves sensitivity in dense breasts. Radiologists qualified as screening readers should be involved in programmes. Digital breast tomosynthesis is also set to become "routine mammography" in the screening setting in the next future. Dedicated pathways for high-risk women offering breast MRI according to national or international guidelines and recommendations are encouraged.Key Points: • EUSOBI and 30 national breast radiology bodies support screening mammography. • A first priority is double-reading biennial mammography for women aged 50-69 years. • Extension to 73-75 and from 40-45 to 49 years is also encouraged. • Digital mammography (not film-screen or computer radiography) should be used. • DBT is set to become "routine mammography" in the screening setting in the next future. [ABSTRACT FROM AUTHOR]

Aim: To assess the burden of disease associated with advanced breast cancer (ABC) treated with oral (VinO) or intravenous vinorelbine (VinIV) from the perspective of patients and caregivers in five European countries.Methods: This was an observational, prospective, international, multicenter study. Patients were included in the study at the beginning of their second cycle of chemotherapy with vinorelbine and categorized into two groups depending on whether they received VinO or VinIV. At baseline (V0) and at the end of the second cycle of chemotherapy (V1), patients and caregivers were asked to complete self-administered questionnaires: SF-12 and burden of disease.Results: At baseline, the two groups were well balanced in demographic and clinical characteristics. However, while HER2+ (human epidermal growth factor receptor 2) disease was significantly more frequent in patients receiving VinIV, patients receiving VinO were predominantly treated with single-agent therapy and were older than those treated with VinIV (67.1 years versus 57.7 years [p = 0.05]). As measured with SF-12, patients with VinO had, at end of cycle 1 and end of cycle 2, significantly more favorable outcomes in physical summary score, role physical, role emotional and mental health (all p < 0.05) than those treated with VinIV. Trends for a better caregiver mental score and social functioning were also observed with VinO (cycle 1 and 2; p < 0.10). From a patient perspective, no major difference was reported on the burden of disease between the two groups, however, a trend for a better" overall impact on daily life" was observed in VinO patients. Major significant differences, showing a lower burden of disease with VinO, were also reported from caregivers. In addition, in patients treated with VinO, mental score was almost similar to the one of the general population.Conclusion: VinO showed benefits over VinIV for both patients and caregivers, particularly in health related quality of life and burden of disease. Because of its observational design, results are only informative. [ABSTRACT FROM AUTHOR]

Introduction: The use of menopausal hormone therapy (MHT) has decreased in many countries in the past 10 years. This is a consequence of the initial publication of the results of the Women's Health Initiative (WHI) randomized trial of estrogen plus progestin. In various countries, further studies then analyzed the incidence of breast cancer (BC) in relation to changes in MHT use. Some reported a decreased BC incidence following cessation of MHT, but others did not. This may reflect differences in BC incidence, in MHT use or in confounding factors, but also in study methodology.Aim: To analyze the changes in BC incidence and MHT use, using the same methodology, in 11 European countries.Materials& Method: We limited the study to women between the ages of 45 and 69. BC incidence data were provided from cancer registries. MHT sales data were extracted from health sales databases for the years 2003-2013. The association between BC incidence and the rate of MHT use during the past year in Europe was assessed using linear mixed models.Results: A drop in MHT sales was consistent in all countries for the whole period of follow-up. This was not the case for BC incidence. We found no evidence of a relation between BC incidence and MHT sales in the past year, except for sales of tibolone.Conclusions: The longer observation period did not confirm the results of studies that had a shorter follow-up, except in relation to tibolone. The role of confounding factors needs to be clarified. [ABSTRACT FROM AUTHOR]

Background:There is a need for interventions to promote uptake of breast screening throughout Europe.Methods:We performed a single-blind randomised controlled trial to test whether text-message reminders were effective. Two thousand two hundred and forty women receiving their first breast screening invitation were included in the study and randomly assigned in a 1 : 1 ratio to receive either a normal invitation only (n=1118) or a normal invitation plus a text-message reminder 48 h before their appointment (n=1122).Findings:In the intention-to-treat analysis, uptake of breast screening was 59.1% among women in the normal invitation group and 64.4% in the text-message reminder group (χ2=6.47, odds ratio (OR): 1.26, 95% confidence intervals (CI): 1.05-1.48, P=0.01). Of the 1122 women assigned to the text-message reminder group, only 456 (41%) had a mobile number recorded by their GP and were thereby sent a text. In the per-protocol analysis, uptake by those in the control group who had a mobile number recorded on the GP system was 59.77% and by those in the intervention group who were sent a reminder 71.7% (χ2=14.12, OR=1.71, 95% CI=1.29-2.26, P<0.01).Interpretation:Sending women a text-message reminder before their first routine breast screening appointment significantly increased attendance. This information can be used to allocate resources efficiently to improve uptake without exacerbating social inequalities. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: Breast cancer is the second cause of death in women in Europe and North America. The mortality of this disease can be reduced with effective therapy and regular follow up to detect early recurrence. Tumor markers are sensitive in detecting recurrent or residual disease but imaging is required to customize the therapeutic option. Rising tumor markers and negative conventional imaging (US, X-mammography, CT and MR) poses a management problem. Our aim is to assess the role of 18F-FDG-PET/CT in the management of post-therapy patients with rising markers but negative conventional imaging. Materials and methods: In the period from January 2008 to September 2009, 89 female patients with breast cancer who developed post-therapy rising markers (serum Ca 15-3 levels=64.8±16.3U/mL) but negative clinical examination and conventional imaging were investigated with 18F-FDG-PET/CT. Results: Tumor deposits were detected in 40/89 patients in chest wall, internal mammary nodes, lungs, liver and skeleton. The mean SUVmax value calculated in these lesions was 6.6±1.7 (range 3.1–12.8). In 23/40 patients solitary small lesion were amenable to radical therapy. In 7 out of these 23 patients a complete disease remission lasting more than 1 year was observed. Conclusions: 18F-FDG-PET/CT may have a potential role in asymptomatic patients with rising markers and negative conventional imaging. Our findings agree with other studies in promoting regular investigations such as tumor markers and 18F-FDG-PET/CT rather than awaiting the developments of physical symptoms as suggested by current guidelines since the timely detection of early recurrence may have a major impact on therapy and survival. [Copyright &y& Elsevier]

Summary: In general, rates of breast cancer are lower in low-income and middle-income countries (LMCs) than they are in more industrialised countries of North America and Europe. This lower incidence means that screening programmes aimed at early detection in asymptomatic women would have a lower yield—ie, substantially more women would need to be examined to find a true case of breast cancer. Because the average age of breast cancer is generally younger in LMCs, it has been suggested that breast-cancer screening programmes begin at an earlier age in these settings. However, the younger average age of breast cancer is mainly driven by the age distribution of the population, and fewer older women with breast cancer, rather than by higher age-specific incidence rates in younger women. Resources in LMCs might be better used to raise awareness and encourage more women with palpable breast lumps to seek and receive treatment in a timely manner. [ABSTRACT FROM AUTHOR]

Summary: Background: Treatment with adjuvant trastuzumab for 1 year improves disease-free survival and overall survival in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. We aimed to assess disease-free survival and overall survival after a median follow-up of 4 years for patients enrolled on the Herceptin Adjuvant (HERA) trial. Methods: The HERA trial is an international, multicentre, randomised, open-label, phase 3 trial comparing treatment with trastuzumab for 1 and 2 years with observation after standard neoadjuvant, adjuvant chemotherapy, or both in patients with HER2-positive early breast cancer. The primary endpoint was disease-free survival. After a positive first interim analysis at a median follow-up of 1 year for the comparison of treatment with trastuzumab for 1 year with observation, event-free patients in the observation group were allowed to cross over to receive trastuzumab. We report trial outcomes for the 1-year trastuzumab and observation groups at a median follow-up of 48·4 months (IQR 42·0–56·5) and assess the effect of the extensive crossover to trastuzumab. Our analysis was by intention-to-treat. The HERA trial is registered with the European Clinical Trials Database, number 2005-002385-11. Findings: The HERA trial population comprised 1698 patients randomly assigned to the observation group and 1703 to the 1-year trastuzumab group. Intention-to-treat analysis of disease-free survival showed a significant benefit in favour of patients in the 1-year trastuzumab group (4-year disease-free survival 78·6%) compared with the observation group (4-year disease-free survival 72·2%; hazard ratio [HR] 0·76; 95% CI 0·66–0·87; p<0·0001). Intention-to-treat analysis of overall survival showed no significant difference in the risk of death (4-year overall survival 89·3%vs 87·7%, respectively; HR 0·85; 95% CI 0·70–1·04; p=0·11). Overall, 885 patients (52%) of the 1698 patients in the observation group crossed over to receive trastuzumab, and began treatment at median 22·8 months (range 4·5–52·7) from randomisation. In a non-randomised comparison, patients in the selective-crossover cohort had fewer disease-free survival events than patients remaining in the observation group (adjusted HR 0·68; 95% CI 0·51–0·90; p=0·0077). Higher incidences of grade 3–4 and fatal adverse events were noted on 1-year trastuzumab than in the observation group. The most common grade 3 or 4 adverse events, each in less than 1% of patients, were congestive cardiac failure, hypertension, arthralgia, back pain, central-line infection, hot flush, headache, and diarrhoea. Interpretation: Treatment with adjuvant trastuzumab for 1 year after chemotherapy is associated with significant clinical benefit at 4-year median follow-up. The substantial selective crossover of patients in the observation group to trastuzumab was associated with improved outcomes for this cohort. Funding: F Hoffmann-La Roche, Michelangelo Foundation. [Copyright &y& Elsevier]

Ridaforolimus (AP23573; MK 8669) is an analog of sirolimus and a small molecule inhibitor of the mammalian target of rapamycin for the treatment of cancer. Both intravenous and oral formulations of the compound are being tested in clinical trials for the treatment of soft-tissue and bone sarcomas. It is in phase III development for sarcoma in the EU and US, and phase II for breast cancer, endometrial cancer, non-small cell lung cancer, and prostate cancer in the US and other markets in the world. This review discusses the key development milestones and therapeutic trials of this drug. [ABSTRACT FROM AUTHOR]

To define a set of quality indicators that should be routinely measured and evaluated to confirm that the clinical outcome reaches the requested standards, Eusoma has organised a workshop during which twenty four experts from different disciplines have reviewed the international literature and selected the main process and outcome indicators available for quality assurance of breast cancer care. A review of the literature for evidence-based recommendations have been performed by the steering committee. The experts have identified the quality indicators also taking into account the usability and feasibility. For each of them it has been reported: definition, minimum and target standard, motivation for selection and level of evidence (graded according to AHRO). In overall 17 main quality indicators have been identified, respectively, 7 on diagnosis, 4 on surgery and loco-regional treatment, 2 on systemic treatment and 4 on staging, counselling, follow-up and rehabilitation. Breast Units in Europe are invited to comply with these indicators and monitor them during their periodic audit meetings. [Copyright &y& Elsevier]

The article presents the recommendations by an international panel of oncologists, radiologists, pathologists, surgeons and epidemiologists from Europe and the U.S. on the locoregional treatment of primary breast cancer. It highlights the importance of core needle biopsy as an accurate method of breast cancer diagnosis, as well as appropriate breast-conserving therapies for breast cancer. It also emphasizes on the need for strict monitoring of the quality standards of locoregional treatment.

Compared with treatment options for early-stage breast cancer, few data exist regarding the optimal use of chemotherapy for metastatic breast cancer (MBC). The choice of using a combination of cytotoxic chemotherapies vs sequential single agents is controversial. At the 6th European Breast Cancer Conference, the European School of Oncology Metastatic Breast Cancer Task Force convened an open debate on the relative benefits of combination vs sequential therapy. Based on the available data, the Task Force recommends sequential monotherapy as the preferred choice in advanced disease, in the absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control. Patient- and disease-related factors should be used to choose between combination and sequential single-agent chemotherapy for MBC. Additional research is needed to determine the impact of therapy on patient-rated quality of life and to identify predictive factors that can be used to guide therapy. [ABSTRACT FROM PUBLISHER]

Background: Complete lymph node removal through conventional axillary dissection (ALND) has been standard treatment for breast cancer patients for almost a century. In the 1990s, however, and in parallel with the advent of the sentinel lymph node (SLN) procedure, ALND came under increasing scrutiny due to its association with significant patient morbidity. Several studies have since provided evidence to suggest omission of ALND, often in favor of axillary radiation, in selected clinically node-negative, SLN-positive patients, thus supporting the current trend in clinical practice. Clinically node-positive patients, by contrast, continue to undergo ALND in many cases, if only for the lack of studies re-assessing the indication for ALND in these patients. Hence, there is a need for a clinical trial to evaluate the optimal treatment for clinically node-positive breast cancer patients in terms of surgery and radiotherapy. The TAXIS trial is designed to fill this gap by examining in particular the value of tailored axillary surgery (TAS), a new technique for selectively removing positive lymph nodes.Methods: In this international, multicenter, phase-III, non-inferiority, randomized controlled trial (RCT), including 34 study sites from four different countries, we plan to randomize 1500 patients to either receive TAS followed by ALND and regional nodal irradiation excluding the dissected axilla, or receive TAS followed by regional nodal irradiation including the full axilla. All patients undergo adjuvant whole-breast irradiation after breast-conserving surgery and chest-wall irradiation after mastectomy. The main objective of the trial is to test the hypothesis that treatment with TAS and axillary radiotherapy is non-inferior to ALND in terms of disease-free survival of clinically node-positive breast cancer patients in the era of effective systemic therapy and extended regional nodal irradiation. The trial was activated on 31 July 2018 and the first patient was randomized on 7 August 2018.Discussion: Designed to test the hypothesis that TAS is non-inferior to ALND in terms of curing patients and preventing recurrences, yet is significantly superior in reducing patient morbidity, this trial may establish a new worldwide treatment standard in breast cancer surgery. If found to be non-inferior to standard treatment, TAS may significantly contribute to reduce morbidity in breast cancer patients by avoiding surgical overtreatment.Trial Registration: ClinicalTrials.gov, ID: NCT03513614. Registered on 1 May 2018. www.kofam.ch , ID: NCT03513614 . Registered on 17 June 2018. EudraCT No.: 2018-000372-14. [ABSTRACT FROM AUTHOR]

Explores the effectiveness of endoscopy in treating breast cancer. Technique described by Doctor Francois Suzanne at the San Antonio Breast Cancer Symposium in December 1998; Study conducted by Doctor Jonathann Sackier in the United States; Protocol being developed by researchers at the Stanford University.

Highlights the consensus development conference on the treatment of primary breast cancer in Europe. Side effects of radical mastectomy; Symptoms of the disorder; Forms of systemic treatment.

Reports on the quality of treatment provided to European women suffering from breast cancer. Variation in rates of breast-conserving surgery; Five-year survival rates; Data from the European Organisation for Research and Treatment of Cancer.

Offers news briefs related to medicine around the world as of November 2000. Reports of cases of Rift Valley Fever outside traditionally affected areas in North and sub-Saharan Africa; Call for European nations to establish accredited breast care programs by the Second European Breast Cancer Conference; Internet resource that will bring Russian-language information on the prevention and treatment of HIV/AIDS; Others.