Elacestrant in women with estrogen receptor-positive and HER2-negative early breast cancer: results from the preoperative window-of-opportunity ELIPSE trial.

Introduction: Elacestrant has shown significantly prolonged progression-free survival compared to standard-of-care endocrine therapy in estrogen receptor-positive (ER-positive), HER2-negative metastatic breast cancer (BC), while potential benefit in early-stage disease requires further exploration. The SOLTI-ELIPSE window-of-opportunity trial investigated the biological changes induced by a short course of preoperative elacestrant in postmenopausal women with early BC.

Methods: Eligible patients with untreated T1c (≥1.

Patritumab deruxtecan in HER2-negative breast cancer: part B results of the window-of-opportunity SOLTI-1805 TOT-HER3 trial and biological determinants of early response.

Patritumab deruxtecan (HER3-DXd) exhibits promising efficacy in breast cancer, with its activity not directly correlated to baseline ERBB3/HER3 levels. This research investigates the genetic factors affecting HER3-DXd's response in women with early-stage hormone receptor-positive and HER2-negative (HR+/HER2-) breast cancer. In the SOLTI-1805 TOT-HER3 trial, a single HER3-DXd dose was administered to 98 patients across two parts: 78 patients received 6.

Patritumab deruxtecan in untreated hormone receptor-positive/HER2-negative early breast cancer: final results from part A of the window-of-opportunity SOLTI TOT-HER3 pre-operative study.

Background: Patritumab deruxtecan (HER3-DXd) is a human epidermal growth factor receptor 3 (HER3)-directed antibody-drug conjugate composed of a fully human anti-HER3 monoclonal antibody (patritumab) covalently linked to a topoisomerase I inhibitor payload via a stable, tumor-selective, tetrapeptide-based cleavable linker. TOT-HER3 is a window-of-opportunity study designed to assess the biological activity, measured by CelTIL score [= -0.8 × tumor cellularity (in %)  +  1.

Prognostic value of intrinsic subtypes in hormone-receptor-positive metastatic breast cancer: systematic review and meta-analysis.

Background: In hormone receptor-positive (HoR+) breast cancer (BC), gene expression analysis identifies luminal A (LumA), luminal B (LumB), human epidermal growth factor receptor 2 (HER2)-enriched (HER2-E), basal-like (BL) intrinsic subtypes and a normal-like group. This classification has an established prognostic value in early-stage HoR+ BC. Here, we carried out a trial-level meta-analysis to determine the prognostic ability of subtypes in metastatic BC (MBC).

Clinical implications of the intrinsic molecular subtypes in hormone receptor-positive and HER2-negative metastatic breast cancer.

Traditionally, the classification of breast cancer relies on the expression of immunohistochemical (IHC) biomarkers readily available in clinical practice. Using highly standardized and reproducible assays across patient cohorts, intrinsic molecular subtypes of breast cancer - also called "intrinsic subtypes" (IS) - have been identified based on the expression of 50 genes. Although IHC-based subgroups and IS moderately correlate to each other, they are not superimposable.

Pre-operative ribociclib plus letrozole versus chemotherapy: Health-related quality of life outcomes from the SOLTI CORALLEEN trial.

Introduction: In the phase II CORALLEEN trial, patients with PAM50 luminal B early breast cancer (EBC) were randomised to neoadjuvant ribociclib plus letrozole (R + L) or chemotherapy based on anthracyclines and taxanes. Results from the primary efficacy analysis showed a similar proportion of patients with response at surgery in both groups. How health-related quality of life (HRQoL) outcomes with R + L compare with chemotherapy in EBC setting is still unknown.

Oncolytic viruses: A new immunotherapeutic approach for breast cancer treatment?

Immunotherapy has revolutionized the oncology field during the last years, mainly with the introduction of immune checkpoint inhibitors in the clinical routine. Despite the recent approval of these drugs for the treatment of triple-negative breast cancer, most breast cancer patients cannot benefit from immunotherapy as most tumors are not considered immunoreactive. Therefore, new strategies must be developed to bring immunotherapy closer to breast cancer patients.

Minimally important differences for the EORTC QLQ-C30 in prostate cancer clinical trials.

Background: The aim of the study was to estimate the minimally important difference (MID) for interpreting group-level change over time, both within a group and between groups, for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scores in patients with prostate cancer.

Methods: We used data from two published EORTC trials. Clinical anchors were selected by strength of correlations with QLQ-C30 scales.

Formation and validation of an acute care clinical pharmacist productivity model: Part 2.

Purpose: The purpose of the project described here was to use the work outputs identified in part 1 of a 2-part research initiative to build and validate an acute care clinical pharmacist productivity model.

Methods: Following the identification of work outputs in part 1 of the project, relative weighting was assigned to all outputs based on the time intensity and complexity of each task. The number of pharmacists verifying an inpatient medication order each day was selected to represent the labor input.

Decision-making framework for an acute care clinical pharmacist productivity model: Part 1.

Purpose: Clinical pharmacist productivity assessment has long been challenging, as a standard definition does not exist. A multistep project was undertaken with the intent to develop, validate, and implement an acute care clinical pharmacist productivity model. The initial step of the project was designed to identify, define, prioritize, and weight a comprehensive list of daily pharmacist responsibilities stratified by relative time spent on each function via consensus.

Development of an electronic trigger tool at a children's hospital within an academic medical center.

Purpose: To evaluate the validity and reliability of select recommended triggers, defined as flags found on review of the medical record that prompt further investigation to determine the presence or absence of an adverse drug event (ADE), selected from a list initially constructed based on severity, frequency, and detectability of triggers within a pediatric population.

Methods: This was a single-center, retrospective cohort analysis of pediatric patients admitted to University of North Carolina (UNC) Children's Hospital who received trigger-associated medications between January 2015 and December 2016. Patient-care areas of the emergency department, operating rooms, and post-anesthesia care units were excluded.

Evaluation of Targeted Pharmacist Interventions to Reduce Length of Stay in an Acute Care Practice Model.

Background: Despite widespread recognition of the need for innovative pharmacy practice approaches, the development and implementation of value-based outcomes remains difficult to achieve. Furthermore, gaps in the literature persist because the majority of available literature is retrospective in nature and describes only the clinical impact of pharmacists' interventions.

Objective: Length of stay (LOS) is a clinical outcome metric used to represent efficiency in health care.

Prognosis in patients diagnosed with loco-regional failure of breast cancer: 34 years longitudinal data from the Stockholm-Gotland cancer registry.

Rationale: Survival after loco-regional failure (LRF) of breast cancer was investigated at the population level.

Methods: Using the Stockholm cancer registry, 2698 patients diagnosed with LRF between 1980 and 2014 were identified and divided into three cohorts by year of LRF diagnosis. Post-relapse event-free survival (EFS) and overall survival (OS) were analyzed separately in local and loco-regional relapses and compared across the cohorts by Kaplan-Meier method.

Gene Expression Signatures and Immunohistochemical Subtypes Add Prognostic Value to Each Other in Breast Cancer Cohorts.

Gene signatures and Ki67 stratify the same breast tumor into opposing good/poor prognosis groups in approximately 20% of patients. Given this discrepancy, we hypothesized that the combination of a clinically relevant signature and IHC markers may provide more prognostic information than either classifier alone. We assessed Ki67 alone or combined with ER, PR and HER2 (forming IHC subtypes), and the research versions of the Genomic Grade Index, 70-gene, cell-cycle score, recurrence score (RS), and PAM50 signatures on matching TMA/whole tumor sections and microarray data in two Swedish breast cancer cohorts of 379 and 209 patients, with median follow-up of 12.

Persistent Gaps in Appropriate Use of Empiric Acyclovir in Neonates.

The use of empiric acyclovir for suspected neonatal herpes simplex virus (HSV) infection has been debated for years. To identify the gap in the decision to initiate empiric acyclovir, we performed a retrospective chart review and administered a survey to pediatricians to assess current practices regarding evaluation for possible HSV infection. Seventy infants received empiric acyclovir over a 1-year period; of these, 3 infants (4.

Intrinsic subtypes and genomic signatures of primary breast cancer and prognosis after systemic relapse.

Molecular subtypes and gene expression signatures are widely used in early breast cancer but their role in metastatic disease is less explored. Two hundred-twenty patients diagnosed with primary breast cancer and subsequent relapse in Stockholm, Sweden between 1997 and 2006 were identified and their primary tumor was assessed for immunohistochemistry (IHC)- and PAM50-based subtypes, risk of recurrence (ROR-S) score, 21-gene and 70-gene signatures using research-based microarray expression profiles. Clinical and pathological data were retrospectively collected.

A retrospective safety and efficacy analysis of the first patients treated with eribulin for metastatic breast cancer in Stockholm, Sweden.

Backgrounds: Eribulin is a non-taxane, microtubule dynamics inhibitor approved for the treatment of patients with metastatic breast cancer (MBC) in Europe in March 2011.

Material And Methods: For the purpose of an internal quality control, all patients with MBC treated with eribulin at Karolinska University Hospital were registered in a database. Clinical data were collected retrospectively for patients that were registered by August 2012 and safety and efficacy of eribulin were evaluated.

Ki67 measured in metastatic tissue and prognosis in patients with advanced breast cancer.

The purpose of this study is to determine the prognostic role of Ki67 evaluated in relapse biopsies from patients with metastatic breast cancer (MBC). Two hundred and ten patients diagnosed with MBC in Stockholm, Sweden between 1998 and 2009 and with Ki67 assessed at time of first systemic relapse (mKi67) were retrospectively identified and divided into two groups according to mKi67 fraction (low ≤20 %, high >20 %). Post-relapse survival was compared between the groups using Kaplan-Meier and Cox regression methods.

Molecular mechanism and clinical implications of endocrine therapy resistance in breast cancer.

Endocrine therapy, the first targeted therapy in oncology, is the most successful systemic therapy in the management of estrogen receptor (ER)-positive breast cancer. Approximately 50% of patients with advanced disease do not respond to first-line treatment with tamoxifen, and many women who receive tamoxifen as adjuvant therapy experience tumor relapse and die from their disease. Aromatase inhibitors are proving superior to tamoxifen, at least in certain patient subsets.