Patients With Invasive Breast Cancer Who Refuse Treatment: An Analysis of Associated Factors and Impact on Survival.

BACKGROUND: Completion of surgical resection and adjuvant/neoadjuvant treatments (chemotherapy, radiation, and endocrine therapy) is necessary to achieve optimal outcomes in invasive breast cancer. The objective of this study was to determine the characteristics of patients refusing treatment and to analyze the impact of refusal on survival. STUDY DESIGN: A retrospective cohort study of invasive breast cancer cases diagnosed 2004-2016 was performed utilizing the National Cancer Database. RESULTS: Of 2 058 568 cases comprising the study cohort, .6% refused recommended surgery, 14.1% refused chemotherapy, 5.5% refused radiation, and 6.3% refused endocrine therapy. Patients refusing therapy were older and more likely uninsured; they did not live farther from the treating hospital. Racial disparities were also associated with refusal. Surgery refusal had the highest hazard ratio for mortality (2.7; 95% CI: 2.5-3.0, P < .001) compared to chemotherapy (1.3; 95% CI: 1.3-1.4, P < .001), radiation (1.8; 95% CI: 1.7-1.9, P < .001), and endocrine therapy (1.5; 95% CI: 1.4-1.6, P < .001) independent of race, insurance, receptor status, and stage. CONCLUSION: This study demonstrates significant associations with refusal of breast cancer treatment and quantifies the impact on mortality, which may help to identify at-risk groups for whom interventions could prevent increases in mortality associated with declining treatment.

Differences in outcomes after emergency general surgery between Hispanic subgroups in the New Jersey State Inpatient Database (2009-2014): The Hispanic population is not monolithic.

BACKGROUND: Our aim was to examine differences in clinical outcomes between Hispanic subgroups who underwent emergency general surgery (EGS). METHODS: Retrospective cohort study of the HCUP State Inpatient Database from New Jersey (2009-2014), including Hispanic and non-Hispanic White (NHW) adult patients who underwent EGS. Multivariable analyses were performed on outcomes including 7-day readmission and length of stay (LOS). RESULTS: 125,874 patients underwent EGS operations. 22,971 were Hispanic (15,488 with subgroup defined: 7,331 - Central/South American; 4,254 - Puerto Rican; 3,170 - Mexican; 733 - Cuban). On multivariable analysis, patients in the Central/South American subgroup were more likely to be readmitted compared to the Mexican subgroup (OR 2.02; p < 0.001, respectively). Puerto Rican and Central/South American subgroups had significantly shorter LOS than Mexican patients (Puerto Rico -0.58 days; p < 0.001; Central/South American -0.30 days; p = 0.016). CONCLUSIONS: There are significant differences in EGS outcomes between Hispanic subgroups. These differences could be missed when data are aggregated at Hispanic ethnicity.

Safety and tolerability of Bifidobacterium longum subspecies infantis EVC001 supplementation in healthy term breastfed infants: a phase I clinical trial.

BACKGROUND: Historically, bifidobacteria were the dominant intestinal bacteria in breastfed infants. Still abundant in infants in developing nations, levels of intestinal bifidobacteria are low among infants in developed nations. Recent studies have described an intimate relationship between human milk and a specific subspecies of Bifidobacterium, B. longum subsp. infantis (B. infantis), yet supplementation of breastfed, healthy, term infants with this organism, has not been reported. The IMPRINT Study, a Phase I clinical trial, was initiated to determine the safety and tolerability of supplementing breastfed infants with B. infantis (EVC001). METHODS: Eighty mother-infant dyads were enrolled in either lactation support plus B. infantis supplementation (BiLS) or lactation support alone (LS). Starting with Day 7 postnatal, BiLS infants were fed 1.8-2.8 × 1010 CFU B. infantis EVC001 daily in breast milk for 21 days. Mothers collected fecal samples, filled out health questionnaires, and kept daily logs about their infants' feeding and gastrointestinal symptoms from birth until Day 61 postnatal. Safety and tolerability were determined from maternal reports. RESULTS: There were no differences in the mean gestational age at birth, weight 1 and 2 months postnatal, and breast milk intake between groups. The mean Log10 change in fecal Bifidobacterium from Day 6 to Day 28 was higher (p = 0.0002) for BiLS (6.6 ± 2.8 SD) than for LS infants (3.5 ± 3.5 SD). Daily stool number was higher (p < 0.005) for LS and lower (p < 0.05) for BiLS infants during supplementation than at Baseline. During supplementation, watery stools decreased and soft stools increased by 36% over baseline in BiLS infants (p < 0.05) with no significant changes in stool consistency for the LS infants. None of the safety and tolerability endpoints, including flatulence, bloody stool, body temperature, ratings of gastrointestinal symptoms, use of antibiotics or gas-relieving medications, infant colic, jaundice, number of illnesses, sick doctor visits, or diagnoses of eczema were different for the groups at any point. CONCLUSIONS: The B. infantis EVC001 supplement was safely consumed and well-tolerated. Stools were fewer and better formed in infants in the BiLS group compared with LS group. Adverse events were those expected in healthy infants and not different between groups. TRIAL REGISTRATION: ClinicalTrials.gov NCT02457338 . Registered May 27, 2015.