NRG Oncology/RTOG 0921: A phase 2 study of postoperative intensity-modulated radiotherapy with concurrent cisplatin and bevacizumab followed by carboplatin and paclitaxel for patients with endometrial cancer.

BACKGROUND: The current study was conducted to assess acute and late adverse events (AEs), overall survival (OS), pelvic failure, regional failure, distant failure, and disease-free survival in a prospective phase 2 clinical trial of bevacizumab and pelvic intensity-modulated radiotherapy (IMRT) with chemotherapy in patients with high-risk endometrial cancer. METHODS: Patients underwent a hysterectomy and lymph node removal, and had ≥1 of the following high-risk factors: grade 3 carcinoma with \u3e50% myometrial invasion, grade 2 or 3 disease with any cervical stromal invasion, or known extrauterine extension confined to the pelvis. Treatment included pelvic IMRT and concurrent cisplatin on days 1 and 29 of radiation and bevacizumab (at a dose of 5 mg/kg on days 1, 15, and 29 of radiation) followed by adjuvant carboplatin and paclitaxel for 4 cycles. The primary endpoint was grade ≥3 AEs occurring within the first 90 days (toxicity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]). RESULTS: A total of 34 patients were accrued from November 2009 through December 2011, 30 of whom were eligible and received study treatment. Seven of 30 patients (23.3%; 1-sided 95% confidence interval, 10.6%-36.0%) developed grade ≥3 treatment-related nonhematologic toxicities within 90 days; an additional 6 patients experienced grade ≥3 toxicities between 90 and 365 days after treatment. The 2-year OS rate was 96.7% and the disease-free survival rate was 79.1%. No patient developed a within-field pelvic failure and no patients with International Federation of Gynecology and Obstetrics stage I to IIIA disease developed disease recurrence after a median follow-up of 26 months. CONCLUSIONS: Postoperative bevacizumab added to chemotherapy and pelvic IMRT appears to be well tolerated and results in high OS rates at 2 years for patients with high-risk endometrial carcinoma

Effect of Education and Cardboard Bassinet Distribution on Newborn Bed-Sharing

Objective. This study sought to determine if infant sleep education plus a cardboard bassinet reduced bed-sharing, a risk factor for sudden infant death syndrome (SIDS) and sleep-related deaths (SRD), in the first week of life. Methods. Women delivered between 1/1/2015-11/15/2016 were interviewed by phone within 72 hours of discharge. Control 1 delivered through 10/31/2015 (previously reported); Control 2: 11/1/2015-2/7/2016; Intervention 1 received inpatient safe sleep education and delivered between 2/8/2016-5/4/2016; Intervention 2 also received a cardboard bassinet and delivered after 5/4/2016. Subjects self-reported bed-sharing, newborn sleep position, feeding method, and sleep environment; demographic data was obtained from medical records. Bayesian methodology compared bed-sharing rates between aggregated control and intervention groups; results were expressed as posterior rates, rate ratios, and 95% credible intervals (CredInt); the posterior probability that the rate ratio was > 1(Bayesian probability) was determined by calculation and simulation. Results. 5187 eligible subjects, 2763 (53%) completed the survey (Control 1: n=1264; Control 2: n=423; Intervention 1: n=391; Intervention 2: n=685). Bed-sharing rates: Control: 6.3% (5.2,7.4); Intervention: 4.7% (3.5,5.9). Rate ratio (Control/Intervention) was 1.36 (0.95,1.83) and the Bayesian probability that the rate ratio >1 was .96 and .97 by calculation and simulation, respectively. Bed-sharing rates for exclusively breastfed infants: Control: 11% (7.4, 14.6); Intervention: 5.9% (2.7, 9.2); Rate ratio was 2.00 (1.01, 3.15) and the Bayesian probability that the rate ratio >1 was .993. Conclusions. Infant sleep education plus a cardboard bassinet reduced the rate of bed-sharing in the first week of life, particularly among exclusively breastfeeding dyads

Kids Safe and Smokefree (KiSS) Multilevel Intervention to Reduce Child Tobacco Smoke Exposure: Long-Term Results of a Randomized Controlled Trial

Background: Pediatricians following clinical practice guidelines for tobacco intervention (“Ask, Advise, and Refer” [AAR]) can motivate parents to reduce child tobacco smoke exposure (TSE). However, brief clinic interventions are unable to provide the more intensive, evidence-based behavioral treatments that facilitate the knowledge, skills, and confidence that parents need to both reduce child TSE and quit smoking. We hypothesized that a multilevel treatment model integrating pediatric clinic-level AAR with individual-level, telephone counseling would promote greater long-term (12-month) child TSE reduction and parent smoking cessation than clinic-level AAR alone. Methods: Pediatricians were trained to implement AAR with parents during clinic visits and reminded via prompts embedded in electronic health records. Following AAR, parents were randomized to intervention (AAR + counseling) or nutrition education attention control (AAR + control). Child TSE and parent quit status were bioverified. Results: Participants (n = 327) were 83% female, 83% African American, and 79% below the poverty level. Child TSE (urine cotinine) declined significantly in both conditions from baseline to 12 months (p = 0.001), with no between-group differences. The intervention had a statistically significant effect on 12-month bioverified quit status (p = 0.029): those in the intervention group were 2.47 times more likely to quit smoking than those in the control. Child age was negatively associated with 12-month log-cotinine (p = 0.01), whereas nicotine dependence was positively associated with 12-month log-cotinine levels (p = 0.001) and negatively associated with bioverified quit status (p = 0.006). Conclusions: Pediatrician advice alone may be sufficient to increase parent protections of children from TSE. Integrating clinic-level intervention with more intensive individual-level smoking intervention is necessary to promote parent cessation