Mohracosta9211
Purpose The Comprehensive School Physical Activity Program (CSPAP) model has recently been adopted as a national framework for physical activity (PA) promotion in schools. As a result, there is a need to develop an instrument to help leaders of PA measure policies and practices across the five component areas of a CSPAP. To address this gap, our team systematically developed and assessed the psychometric properties of the CSPAP-Q, an instrument designed to assess school policies and practices related to the five components of CSPAP. Methods The instrument development process began by reviewing existing school health and PA surveys. The Delphi method was then used to evaluate face and content validity through expert feedback. Thirty-eight physical education teachers completed the CSPAP-Q twice over a 14-day period to further establish validity and to assess test-retest reliability. Results In total, 117 items were identified for the initial review. Upon completion of expert feedback, 22 items were eliminated and 66 items were revised. After reliability testing, three additional items were eliminated due to low test-retest agreement levels (Kappa less then .40; non-significant χ2). Ninety-two items were retained in the final version of the CSPAP-Q and kappa values indicated moderate to substantial agreement among items. Conclusions After validity and reliability testing, results suggest that the CSPAP-Q is a valid and reliable tool for assessing policies and practices related to CSPAP.PURPOSE Platinum compounds have activity in triple-negative breast cancer (TNBC) in germline BRCA mutation carriers (BRCA carriers). Limited data exist for estrogen receptor (ER)-positive (+) breast cancer among BRCA carriers. INFORM is a randomized, multicenter, phase II trial comparing pathologic complete response (pCR) rates (ypT0/is, N0) after neoadjuvant single-agent cisplatin (CDDP) versus doxorubicin-cyclophosphamide (AC) in BRCA carriers with stage I-III human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Secondary objectives included residual cancer burden scores (RCB) of 0 or 1 (combined) and toxicity. The goal was to determine whether pCR was ≥ 20% higher with CDDP than AC. PATIENTS AND METHODS BRCA carriers with cT1-3 (≥ 1.5 cm), cN0-3 HER2-negative breast cancer were randomly assigned to preoperative CDDP (75 mg/m2 every 3 weeks × 4 doses) or AC (doxorubicin 60 mg/m2; cyclophosphamide 600 mg/m2 every 2-3 weeks × 4 doses) followed by surgery. Pathologic responses were confirmed by central review. RESULTS A total of 118 patients were randomly assigned; 117 were included in outcome analyses. Mean age was 42 years (range, 24-73 years); 69% were BRCA1+, 30% were BRCA2+, and 2% had both mutations. Clinical stage was I for 19%, II for 63%, and III for 18%; 45% had nodal involvement at baseline. Seventy percent had TNBC. Clinical and tumor characteristics were well matched between treatment arms. The pCR rate was 18% with CDDP and 26% with AC, yielding a risk ratio (RR) of 0.70 (90% CI, 0.39 to 1.2). The risk of RCB 0 or 1 (RCB 0/1) was 33% with CDDP and 46% with AC (RR, 0.73; 90% CI, 0.50 to 1.1). Both regimens were generally well tolerated without unexpected toxicities. CONCLUSION pCR or RCB 0/1 is not significantly higher with CDDP than with AC in BRCA carriers with stage I-III HER2-negative breast cancer for both TNBC and ER+/HER2-negative disease.PURPOSE We hypothesized that bevacizumab will potentiate activity of pembrolizumab. We conducted a phase Ib/II, single-arm, multisite clinical trial of the combination in metastatic renal cell carcinoma (RCC). PATIENTS AND METHODS Patients with metastatic clear cell RCC who experienced progression after at least one systemic therapy (phase Ib) or were treatment naïve (phase II) were enrolled. In phase Ib, pembrolizumab (200 mg) and bevacizumab (10 or 15 mg/kg) were given intravenously every 3 weeks. The primary end point for phase II was overall response rate (ORR). With an 80% statistical power and a type I error probability of 0.1, 48 patients were to be accrued to detect an ORR of 42%. RESULTS Thirteen patients (ages 33-68 years; median, 55 years) were enrolled in the phase Ib study. No dose-limiting toxicities were reported. Pembrolizumab 200 mg and bevacizumab 15 mg/kg were chosen for phase II. Forty-eight patients (ages 42-84 years; median age, 61 years; 33 males) were accrued for the phase II study. The primary end point was met, with the ORR reaching 60.9% (95% CI, 45.4% to 74.9%), consisting of 1 complete response (CR), 2 CRs in target lesions, 25 partial responses, 18 responses of stable disease, 2 unevaluable responses. Median progression-free survival was 20.7 months (95% CI, 11.3 to 27.4 months). Median overall survival was not reached at the median follow-up of 28.3 months. The most common treatment-related grade 3 toxicities were hypertension and proteinuria. There were two grade 4 toxicities duodenal ulcer and hyponatremia. Presence of tumor-infiltrating T cells, but not programmed death-ligand 1 expression, in tumor tissue correlated with response. MSA-2 order CONCLUSION The combination of 200 mg of pembrolizumab and a 15 mg/kg dose of bevacizumab given every 3 weeks is safe and active in metastatic RCC.Purpose The purpose of this study was to examine narrative language samples of Spanish-speaking preschoolers to analyze changes in microstructural and macrostructural skills in their first language (L1) from fall to spring, relationships between narrative and vocabulary skills in L1, and the extent to which fall skills predict spring performance. Method Participants included 40 Spanish-speaking children who were enrolled in community-based preschool programs. Narrative language retells from the fall and spring were examined, and microstructural and macrostructural components were analyzed using the Narrative Assessment Protocol-Spanish and the Narrative Scoring Scheme, respectively. Participants also completed an assessment of expressive vocabulary in Spanish. Results The results indicated different degrees of change in microstructural and macrostructural elements, change from fall to spring in some but not all elements measured, shifting patterns of association between L1 vocabulary and narrative skills, and variable prediction of spring scores.