Abstract Biomarkers play an essential role in the management of patients with invasive breast cancer. For selecting patients likely to respond to endocrine therapy, both oestrogen receptors (ERs) and ...progesterone receptors (PRs) should be measured on all newly diagnosed invasive breast cancers. On the other hand, for selecting likely response to all forms of anti-HER2 therapy (trastuzumab, pertuzumab, lapatinib or ado-trastuzumab emtansine), determination of HER2 expression or gene copy number is mandatory. Where feasible, measurement of ER, PR and HER2 should be performed on recurrent lesions and the primary invasive tumour. Although methodological problems exist in the determination of Ki67, because of its clearly established clinical value, wide availability and low costs relative to the available multianalyte signatures, Ki67 may be used for determining prognosis, especially if values are low or high. In oestrogen receptor (ER)-positive, HER2-negative, lymph node–negative patients, multianalyte tests such as urokinase plasminogen activator (uPA)-PAI-1, Oncotype DX, MammaPrint, EndoPredict, Breast Cancer Index (BCI) and Prosigna (PAM50) may be used to predict outcome and aid adjunct therapy decision-making. Oncotype DX, MammaPrint, EndoPredict and Prosigna may be similarly used in patients with 1–3 metastatic lymph nodes. All laboratories measuring biomarkers for patient management should use analytically and clinically validated assays, participate in external quality assurance programs, have established assay acceptance and rejection criteria, perform regular audits and be accredited by an appropriate organisation.
In the OlympiAD study, olaparib was shown to improve progression-free survival compared with chemotherapy treatment of physician’s choice (TPC) in patients with a germline BRCA1 and/or BRCA2 mutation ...(BRCAm) and human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (mBC). We now report the planned final overall survival (OS) results, and describe the most common adverse events (AEs) to better understand olaparib tolerability in this population.
OlympiAD, a Phase III, randomized, controlled, open-label study (NCT02000622), enrolled patients with a germline BRCAm and HER2-negative mBC who had received ≤2 lines of chemotherapy for mBC. Patients were randomized to olaparib tablets (300mg bid) or predeclared TPC (capecitabine, vinorelbine, or eribulin). OS and safety were secondary end points.
A total of 205 patients were randomized to olaparib and 97 to TPC. At 64% data maturity, median OS was 19.3months with olaparib versus 17.1months with TPC (HR 0.90, 95% CI 0.66–1.23; P = 0.513); median follow-up was 25.3 and 26.3months, respectively. HR for OS with olaparib versus TPC in prespecified subgroups were: prior chemotherapy for mBC no (first-line setting): 0.51, 95% CI 0.29–0.90; yes (second/third-line): 1.13, 0.79–1.64; receptor status (triple negative: 0.93, 0.62–1.43; hormone receptor positive: 0.86, 0.55–1.36); prior platinum (yes: 0.83, 0.49–1.45; no: 0.91, 0.64–1.33). Adverse events during olaparib treatment were generally low grade and manageable by supportive treatment or dose modification. There was a low rate of treatment discontinuation (4.9%), and the risk of developing anemia did not increase with extended olaparib exposure.
While there was no statistically significant improvement in OS with olaparib compared to TPC, there was the possibility of meaningful OS benefit among patients who had not received chemotherapy for metastatic disease. Olaparib was generally well-tolerated, with no evidence of cumulative toxicity during extended exposure.
It is imperative to accurately estimate whole body fat percentage (%fat) to understand the deleterious nature of excess adiposity on cardiometabolic disease risk. Cost and accessibility often ...preclude the use of advanced imaging methods like dual-energy X-ray absorptiometry (DXA) and magnetic resonance imaging (MRI). Relative fat mass (RFM) is an emerging estimator of whole body %fat based on waist circumference, height, and biological sex. The purpose of this ancillary study was to examine the relationship between RFM and gold-standard measures of adiposity among community-dwelling older adults with obesity and to evaluate if changes in RFM reflect changes in %fat following a 12-month lifestyle intervention (clinicaltrials.gov #NCT00955903).
Participants (N = 163, 37.4% male, 70.3 ± 4.7 years) were randomized to the exercise only group, exercise + nutrient-dense weight maintenance group, or exercise + nutrient-dense energy restriction of 500 kcal/d group. Total and regional adiposity assessed by DXA and MRI, as well as anthropometrics, were evaluated at baseline and 12 months.
RFM was significantly positively correlated with DXA whole body %fat and DXA trunk %fat at baseline. Equivalence testing revealed that RFM was considered equivalent to DXA whole body %fat for females only. Additionally, from baseline to 12 months, a significant reduction in RFM was observed among female participants in the exercise + energy restriction group only. Changes in RFM were significantly correlated with changes in DXA whole body %fat, DXA trunk fat, and total abdominal fat tissue determined by MRI.
Results support the use of RFM as an estimate of whole body %fat where advanced imaging techniques are not feasible. Furthermore, results suggest that this index is sensitive to changes in fat mass over 12 months in female older adults with obesity.
KEY MESSAGES
Relative fat mass (RFM), an emerging estimator of whole body %fat based on waist circumference, height, and biological sex, was intentionally developed to be a simple estimate of adiposity that overcomes limitations of measures like body mass index.
In the current study, results from correlations and agreement analyses support the use of RFM to estimate whole-body fat percentage in a community-dwelling older adult population with obesity when advanced methods, namely dual-energy X-ray absorptiometry, are not feasible.
Significant reductions in RFM were also observed over a 12-month period that was significantly correlated with changes in whole body fat percentage; thus, supporting the sensitivity of RFM to lifestyle changes.
The 4th International Consensus Conference for Breast Cancer in Young Women (BCY4) took place in October 2018, in Lugano, Switzerland, organized by the European School of Oncology (ESO) and the ...European Society of Medical Oncology (ESMO). Consensus recommendations for the management of breast cancer in young women were updated from BCY3 with incorporation of new evidence to inform the guidelines. Areas of research priorities were also identified. This article summarizes the ESO–ESMO international consensus recommendations, which are also endorsed by the European Society of Breast Specialists (EUSOMA).
•Breast cancer in young women should be treated based on stage and biology of disease.•Management of breast cancer in young women requires special considerations including psychological, reproductive and genetic.•Breast cancer in young women necessitates multi-disciplinary care at diagnosis, during treatment and during survivorship.