Assessing Needs and Outcomes of Children and Youth Receiving Intensive Services

This study investigated whether children/youth in Ontario triaged to residential services showed a higher intensity of need than those referred to outpatient services, and whether residential treatment gains were sufficient for transition to community services. Participants included 2053 children/youth assessed at 23 diverse mental health agencies across Ontario using the interRAI™ Child and Youth Mental Health (ChYMH) instrument. Various presenting problems were examined utilizing scales including: Disruptive/Aggressive Behavior, Hyperactive/Distraction, Social Disengagement, Anxiety, and Sleep Difficulties. Analyses were conducted separately for boys and girls. Notable differences were found in the initial assessment, with residential boys scoring higher on all scales than outpatient boys, and residential girls scoring higher on the externalizing scales (Disruptive/Aggressive Behavior, Hyperactive/Distraction) than outpatient girls. Treatment gains at residential discharge included improvements in Anxiety, Social Disengagement, Hyperactive/Distraction and Sleep Difficulties for boys and girls to levels at or below the initial scores of outpatient peers. Disruptive/Aggressive Behavior is still a high need following residential services. The results highlight differences in severity of mental health presentation between children/youth receiving residential and outpatient services, and how multiple agencies in Ontario are providing services that successfully reduce the severity of mental health needs

Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03)

Purpose: The PALLAS study investigated whether the addition of palbociclib, an oral CDK4/6 inhibitor, to adjuvant endocrine therapy (ET) improves invasive disease-free survival (iDFS) in early hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In this analysis, we evaluated palbociclib exposure and discontinuation in PALLAS. Methods: Patients with stage II-III HR+, HER2- disease were randomly assigned to 2 years of palbociclib with adjuvant ET versus ET alone. The primary objective was to compare iDFS between arms. Continuous monitoring of toxicity, dose modifications, and early discontinuation was performed. Association of baseline covariates with time to palbociclib reduction and discontinuation was analyzed with multivariable competing risk models. Landmark and inverse probability weighted per-protocol analyses were performed to assess the impact of drug persistence and exposure on iDFS. Results: Of the 5,743 patient analysis population (2,840 initiating palbociclib), 1,199 (42.2%) stopped palbociclib before 2 years, the majority (772, 27.2%) for adverse effects, most commonly neutropenia and fatigue. Discontinuation of ET did not differ between arms. Discontinuations for non-protocol-defined reasons were greater in the first 3 months of palbociclib, and in the first calendar year of accrual, and declined over time. No significant relationship was seen between longer palbociclib duration or ≥ 70% exposure intensity and improved iDFS. In the weighted per-protocol analysis, no improvement in iDFS was observed in patients receiving palbociclib versus not (hazard ratio 0.89; 95% CI, 0.72 to 1.11). Conclusion: Despite observed rates of discontinuation in PALLAS, analyses suggest that the lack of significant iDFS difference between arms was not directly related to inadequate palbociclib exposure. However, the discontinuation rate illustrates the challenge of introducing novel adjuvant treatments, and the need for interventions to improve persistence with oral cancer therapies