Objectives Lung cancer is strongly associated with venous thromboembolism (VTE), but primary prevention against VTE is not a validated management strategy. Risk assessment models will be necessary for efficient implementation of preventative strategies. Materials and methods Utilizing a prospectively collected lung cancer database, we aimed to validate the Khorana Risk Score (KRS) in the prediction of VTE among patients with lung cancer. VTE events were retrospectively identified by reviewers unaware of the clinical prediction score calculation. The association between KRS and the risk of VTE was examined using cumulative incidence function with competing risks models. Mortality prediction was evaluated as secondary outcome. Results We included 719 patients in our review. The patients were predominantly older males with NSCLC and 40% had metastatic disease at inception. The median follow up was 15.2 months. There were 83 VTEs (11.5%) and 568 (78.8%) patients died. A high KRS (Cumulative Incidence 12.4%, 95% Confidence Interval 6.4-20.5%) was not associated with VTE compared to an intermediate score (Cumulative Incidence 12.1%, 95% Confidence Interval 9.5-15.0%)) in both univariate and multivariable analyses. However, a high KRS was a predictor of mortality (HR 1.7 95% CI 1.4 - 2.2). Conclusions Among patients with lung cancer the KRS did not stratify the patients at the highest risk of VTE. Improved risk stratification methods are needed for this group of patients prior to implementing a primary prevention strategy.

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BackgroundExtremely premature (birth weight < 1250 g) infants are at high risk for acquiring late-onset sepsis and necrotizing enterocolitis, which are associated with significant mortality and morbidity. Own mother's milk contains protective (immune and trophic) biofactors which provide antimicrobial, anti-inflammatory, antioxidant, and immunomodulatory functions, enhance intestinal microbiota, and promote intestinal maturation. Many of these biofactors are most highly concentrated in the milk expressed by mothers of extremely premature infants. However, since extremely premature infants do not receive oral milk feeds until 32 weeks post-conceptional age, they lack the potential benefit provided by milk (biofactor) exposure to oropharyngeal immunocompetent cells, and this deficiency could contribute to late-onset sepsis and necrotizing enterocolitis. Therefore, oropharyngeal administration of own mother's milk may improve the health outcomes of these infants.ObjectivesTo compare the effects of oropharyngeal administration of mother’s milk to a placebo, for important clinical outcomes, including (1A) reducing the incidence of late-onset sepsis (primary outcome) and (1B) necrotizing enterocolitis and death (secondary outcomes). To identify the biomechanisms responsible for the beneficial effects of oropharyngeal mother’s milk for extremely premature infants, including; (2A) enhancement of gastrointestinal (fecal) microbiota (2B) improvement in antioxidant defense maturation or reduction of pro-oxidant status, and (2C) maturation of immunostimulatory effects as measured by changes in urinary lactoferrin.Methods/DesignA 5-year, multi-center, double-blind, randomized controlled trial designed to evaluate the safety and efficacy of oropharyngeal mother’s milk to reduce the incidence of (1A) late-onset sepsis and (1B) necrotizing enterocolitis and death in a large cohort of extremely premature infants (n = 622; total patients enrolled). Enrolled infants are randomly assigned to one of 2 groups: Group A infants receive 0.2 mL of own mother's milk, via oropharyngeal administration, every 2 hours for 48 hours, then every 3 hours until 32 weeks corrected-gestational age. Group B infants receive a placebo (0.2 mL sterile water) following the same protocol. Milk, urine, oral mucosal swab, and stool samples are collected at various time points, before, during and after the treatment periods. Health outcome and safety data are collected throughout the infant’s stay.Trial registrationClinicalTrials.gov identifier: NCT02116699 on 11 April 2014. Last updated: 26 May 2015

Objective• To determine the importance of perineural invasion (PNI) on diagnostic biopsy in men enrolled in active surveillance (AS). Patients and Methods• Eligibility criteria for AS included clinical stage ≤ T2a and Gleason score ≤6, ≤3 cores positive, maximum single core involvement <50%, and total tumour volume ≤5% on diagnostic biopsy.• All men received 12-core confirmation biopsy at ≤6 months.• AS 'failure' on confirmatory biopsy was defined as failure to meet one or more eligibility criteria.• Risk of AS failure was compared in men with and without PNI. Results• For the 165 men comprising the study population, the mean (SD) age was 66.9 (6.5) years and the median (interquartile, IQR) PSA level of men at study entry was 4.4 (3.2-6.0) ng/mL. The median (IQR) follow-up was 5.5 (1.1-9.9) months.• In all, 8.5% (14/165 men) had PNI on diagnostic biopsy.• Compared with those without PNI, men with PNI tended to have more cores involved with cancer, at a mean (SD) of 2.0 (0.7) vs 1.6 (0.8) cores (P = 0.08) but did not have significantly a greater mean (SD) total tumour length on diagnostic biopsy, at 3.0 (2.1) vs 2.3 (3.6) mm (P = 0.27).• Men with PNI on diagnostic biopsy were significantly more likely to meet criteria for disease progression on confirmatory biopsy (57% [8/14] vs 21% [32/151]; P = 0.006).• PNI remained a significant predictor for AS failure after adjustment for number of positive cores, maximum percentage core involvement, and total tumour length (odds ratio 4.4, 95% confidence interval 1.4-14.2). Conclusions• PNI on diagnostic biopsy is associated with disease progression on confirmatory biopsy.• The presence of PNI should factor into appropriate patient selection and counselling in AS.

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The use of therapeutic NSM is increasing dramatically in the United States, despite recommendations that the procedure be used with caution. As NSM becomes increasingly common, efforts are needed to monitor its long-term oncologic outcomes and to ensure equitable access to it.

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