Moving Toward Equal Ground: Engaging the Capacity of Youth, Families, and Communities to Improve Treatment Services and Outcomes in the Juvenile Justice System

Outlines RWJF's Reclaiming Futures project, describes successful programs at ten sites, and shares lessons learned about the importance of involving families and communities in improving the juvenile justice system's drug and alcohol treatment programs

Association of objectively assessed physical activity with total and central body fat in Spanish adolescents: the HELENA study

Objectives: To examine the association of objectively assessed physical activity (PA) with markers of total and central body fat in adolescents, and to determine whether meeting the current PA recommendations (>= 60 min day(-1) of at least moderate intensity PA) is associated with reduced levels of total and central body fat. Subjects/Methods: A total of 365 Spanish adolescents aged 12.5-17.5 years participated in this cross-sectional study. PA was assessed by accelerometry and expressed as average PA ( counts per minute), and min day(-1) of light, moderate, moderate to vigorous (MVPA) and vigorous PA. MVPA was dichotomized into = 60. Total body fat was measured by DXA, BodPod and the sum of six skinfolds. Central body fat was measured by DXA at three regions (R1, R2 and R3), and waist circumference. Results: All markers of central body fat were negatively associated with vigorous PA (P < 0.01) after controlling for sex, age and pubertal status. Abdominal adiposity measured at R1, R2 and R3 was also negatively associated with MVPA (P <= 0.001), and with average PA (P < 0.01). All markers of total body fat were negatively associated with vigorous PA (P < 0.01), MVPA (P < 0.01) and average PA (P < 0.05). Adolescents engaged on at least 60 min day(-1) MVPA presented lower levels of total (P < 0.05) and central body fat (P <= 0.01). Conclusions: The results suggest that vigorous PA may have a greater effect on preventing obesity in adolescents than does PA of lower intensity, whereas both average PA and at least moderate PA may have an impact on total and central body fat in youth

A phase 2 study of the efficacy and safety of INCMGA00012 in advanced penile squamous cell carcinoma (PSqCC): ORPHEUS.

TPS8 Background: PSqCC is a rare tumor with poor prognosis and limited therapeutic options. The current standard of care for advanced disease has been palliative platinum-based chemotherapy, with only marginal survival benefit. Recent data has shown that the majority of PSqCC patients present high levels of programmed death-ligand 1 (PD-L1). The ORPHEUS trial is evaluating the efficacy and safety of INCMGA00012 –a programmed cell death 1 (PD-1) antagonist– in patients with unresectable, locally advanced or metastatic PSqCC. Methods: ORPHEUS is an international, multicenter, open-label, single-arm, phase 2 clinical trial. Eligible patients are male aged ≥18 years with locally advanced or metastatic PSqCC, ECOG performance status of 0-1, adequate organ function, a life expectancy of ≥12 weeks, and with no prior treatment with PD-1 or PD-L1/2 agents. A total of 18 patients will be enrolled to receive INCMGA00012 500 mg administered intravenously on day 1 of each 28-day cycle. Treatment will continue until progressive disease or unacceptable toxicity. Tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune-related RECIST will be performed approximately every 8 weeks for the first 6 months and every 12 weeks thereafter until progressive disease. The primary endpoint is objective response rate. Secondary objectives include additional efficacy outcomes (clinical benefit rate, progression-free survival (PFS), 6-month PFS, duration of response, time to progression, overall survival, and maximum tumor shrinkage) and safety evaluated as per NCI-CTCAE 5.0. Exploratory objectives will evaluate efficacy based on immune-related RECIST; predictive and prognostic biomarkers; impact of INCMGA00012 on human immunodeficiency virus (HIV) control in patients known to be HIV-positive. The sample size calculation is based on an exact binomial test. At least 4 responders (22.2%) among 18 patients will be adequate to justify further investigation of this strategy. The analyses were designed to attain an 80% power, with a 10% dropout rate assumption, at a nominal one-sided α level of 5%. The response probabilities for null (H0) and alternative hypotheses (H1) were H0: ≤ 5% and H1: ≥ 25%, respectively. All 18 planned patients have been enrolled since the trial began in March 2020. Clinical trial information: NCT04231981. </jats:p