Effectiveness of post-trastuzumab deruxtecan treatments and incidence of interstitial lung disease in HER2-positive metastatic breast cancer: a real-world, observational cohort study.

Background: Trastuzumab deruxtecan (T-DXd) is recommended in the second-line or later setting for patients with human epidermal growth factor receptor 2 (HER2)-positive recurrent or metastatic breast cancer (mBC). However, clinical evidence for optimal post-T-DXd treatment is lacking. The EN-SEMBLE study examined the distribution of post-T-DXd treatment regimens, their effectiveness, and the incidence of interstitial lung disease (ILD) in the real-world setting.

Analytical and clinical validation of PATHWAY HER2 (4B5) assay for assessment of HER2-low/HER2-ultralow status and eligibility for trastuzumab deruxtecan in DESTINY-Breast06.

Background: The DESTINY-Breast06 study demonstrated a statistically significant and clinically meaningful improvement in progression-free survival benefit with trastuzumab deruxtecan (T-DXd) versus chemotherapy treatment of physician's choice in patients with hormone receptor-positive metastatic breast cancer (mBC) whose tumors were scored as human epidermal growth factor receptor 2 (HER2)-low [immunohistochemistry (IHC) 1+, or IHC 2+/in situ hybridization (ISH)-negative] and who had received one or more lines of endocrine therapy and no previous chemotherapy in the metastatic setting. An exploratory analysis consistently showed a benefit for patients with HER2-low and HER2-ultralow (IHC 0 with membrane staining) expression.

Materials And Methods: Analytical validation of the PATHWAY HER2 (4B5) assay (Roche HER2 4B5 assay; Roche Diagnostic Solutions) at the HER2-ultralow cut-off was carried out, including intermediate precision, inter-reader precision, and inter-laboratory reproducibility.

Patient-reported outcomes with trastuzumab deruxtecan in hormone receptor-positive, HER2-low or HER2-ultralow metastatic breast cancer: results from the randomized DESTINY-Breast06 trial.

Background: The randomized phase III DESTINY-Breast06 trial (NCT04494425) demonstrated superior efficacy with trastuzumab deruxtecan (T-DXd) versus chemotherapy treatment of physician's choice (TPC) and no new safety signals in patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-low [immunohistochemistry (IHC) 1+, IHC 2+/in situ hybridization-negative], and HER2-ultralow (IHC 0 with membrane staining) metastatic breast cancer (mBC). Here, we report the patient-reported outcome (PRO) endpoints in the intent-to-treat (ITT; HER2-low/-ultralow) and HER2-low populations.

Patients And Methods: Patients with progressive disease (PD) after one or more prior lines of endocrine-based therapy and no prior chemotherapy for mBC were assigned 1 : 1 to T-DXd 5.

Linking Adherence to Effectiveness in Family-Based Adolescent ADHD Academic Training and Medication Decision-Making Protocols.

Objective: Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA) and Medication Integration Protocol (MIP) are two family-based behavioral protocols designed to promote family solutions to academic problems and medication decision-making. Building on a randomized control trial examining these protocols, the current study examined how protocol dose, an indicator of treatment adherence, was associated with treatment outcomes.

Method: The sample consisted of 145 adolescent clients (M age = 14.

Analytical and clinical validation of PATHWAY Anti-HER-2/neu (4B5) antibody to assess HER2-low status for trastuzumab deruxtecan treatment in breast cancer.

In DESTINY-Breast04 (DB-04), safety and efficacy of HER2-targeted antibody-drug conjugate (ADC) trastuzumab deruxtecan (T-DXd) in previously treated HER2-low unresectable/metastatic breast cancer were established. This manuscript describes the analytical validation of PATHWAY Anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY HER2 (4B5)) to assess HER2-low status and its clinical performance in DB-04. Preanalytical processing and tissue staining parameters were evaluated to determine their impact on HER2 scoring.

Haitian and Haitian American experiences of racism and socioethnic discrimination in Miami-Dade county: At-risk and court-involved youth.

We examine how juvenile justice-involved youth of Haitian descent in Miami-Dade County cope with structural racism and its impact on their mental health. Drawing on longitudinal ethnography, psychosocial assessment data, and a family-based clinical intervention funded by the National Institute on Drug Abuse, this article explores youth narratives of discrimination prior to and during the COVID-19 pandemic. We use critical race theory and theory of practice to understand youths' perceptions as racialized bodies and stigmatized selves, highlighting the experiences and perspectives of a particular black immigrant group, ethnic beings caught up in the everyday practices of racialization, sociocultural marginalization, and racism.

First-in-man-proof of concept study with molidustat: a novel selective oral HIF-prolyl hydroxylase inhibitor for the treatment of renal anaemia.

Aims: Insufficient erythropoietin (EPO) synthesis is a relevant cause of renal anaemia in patients with chronic kidney disease. Molidustat, a selective hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, increases endogenous EPO levels dose dependently in preclinical models. We examined the pharmacokinetics, safety, tolerability and effect on EPO levels of single oral doses of molidustat in healthy male volunteers.

Process Evaluation Results From an Intergenerational Physical Activity Intervention for Grandparents Raising Grandchildren.

Background: Grandparents and the grandchildren they raise may experience stress related to their caregiving relationship that negatively impacts their health. Thus, there is a need to develop intergenerational health promotion interventions for these kinship families.

Methods: An 8-week intergenerational physical activity intervention for kinship families was developed and implemented.