Zahrieh, David

Abstract Current therapies for breast cancer prevention only prevent estrogen receptor positive (ER+) disease and toxicity limits use of these agents. Vitamin D is a potential prevention therapy for both ER+ and ER− disease and is safe with few side effects. This study evaluates the effect of 1-year of vitamin D supplementation on mammographic density (MD), a biomarker of breast cancer risk in a multicenter randomized controlled trial. Premenopausal women with ≥25% MD and no history of cancer were randomly assigned to 2,000 international units (IU) of vitamin D or placebo orally daily for 1 year. Change in percent MD was evaluated using Cumulus software after all participants completed treatment. Three hundred women enrolled between January 2011 and December 2013 with a mean age of 43 and diverse ethnicity [14% Hispanic, 12% African American (AA)]. Supplementation significantly increased vitamin D levels compared with placebo (14.5 ng/mL vs. −1.6 ng/mL; P < 0.0001) with all participants on the vitamin D arm achieving vitamin D sufficiency at 12 months. Vitamin D was safe and well tolerated. After adjustment for baseline MD, the mean between-arm difference (vitamin D vs. placebo) at 1 year was −0.75 (−0.26, 1.76; P = 0.56). A greater effect was seen for women with ≥50% MD and AA women, although neither reached significance. This randomized controlled trial demonstrated significant improvement in vitamin D levels with 2,000 IU for 1 year, with 100% of supplemented women achieving sufficiency. However, a null effect was seen regarding change in MD for premenopausal women (the primary outcome of the study). Prevention Relevance: Current therapies for breast cancer prevention only prevent estrogen receptor positive (ER+) disease and are underutilized due to toxicity and side effects. Vitamin D is a potential prevention therapy for both ER+ and ER− disease and is safe with few side effects.

e24086 Background: Nasal vestibulitis has been infrequently described as a side effect of cancer-directed therapy; however, a preliminary study reported that 71% of patients undergoing taxane chemotherapy experienced nasal vestibulitis symptoms. This natural history trial describes the incidence, characteristics, and severity of nasal vestibulitis symptoms among patients undergoing paclitaxel, docetaxel, and non-taxane chemotherapy. Methods: Eligible participants who reported baseline (prior to starting chemotherapy) nasal symptoms ≤ 2 on a 10-point scale were enrolled in this trial upon initiation of a new treatment regimen, involving paclitaxel or docetaxel, or non-taxane chemotherapy. Participants completed nasal symptom logs each time they received a dose of therapy until either the regimen was stopped or four months had passed. The proportion of patients reporting new nasal symptoms was estimated within each cohort with the 95% exact confidence interval (CI). A cumulative incidence model was utilized to quantify the incidence of treatment-emergent nasal symptoms within each cohort, while controlling for age, sex, smoking history, and history of asthma or allergies. Results: Thirty-five participants received paclitaxel, 21 received docetaxel, and 25 received other types of chemotherapy. 86.4% of participants were female, mean age was 60.2 ± 11.2 years; 93.8% of participants completed 2 or more surveys. A higher percentage of participants in the paclitaxel cohort experienced new nasal vestibulitis symptoms than participants in the other two cohorts. The percentage (95% CI) of participants with nasal symptoms, for patients receiving paclitaxel, docetaxel, and non-taxane chemotherapy were 74.3% (56.7%, 87.5%), 47.6% (25.7%, 70.2%), and 44.0% (24.4%, 65.1%), respectively. Epistaxis was reported by 60% of participants in the paclitaxel cohort. Paclitaxel-receiving participants also reported nasal dryness (48.6%), scabbing (40.0%), and pain (20.0%). Nearly half of participants reported moderate symptoms (4-7 out of a 10-point scale), with 8.6% reporting symptoms as severe (8-10 on a 10-point scale). Conclusions: Nasal vestibulitis is a common side effect of chemotherapy, especially paclitaxel chemotherapy.

e13617 Background: Breast cancer (BC) is the most prevalent cancer of women in the United States (US). The incidence rates for BC among American Indian and Alaska Native (AI/AN) women vary across the US. A novel application of Bayesian disease mapping was applied to quantify potential inequities in 10-year BC incidence in New Mexico (NM) in order to better inform health equity initiatives within the AI/AN at-risk population. Methods: Surveillance, Epidemiology, and End Results Program (SEER) data from 2005 to 2014 were used to identify new cases of BC within the 33 counties in NM. Initially, a Poisson-gamma model was applied to quantify the reduction in risk of BC within the at-risk AI/AN population compared with the general at-risk population. To account for spatial variation and to address the small area estimation problem inherent in these data by borrowing strength globally and locally in NM, we applied Bayesian disease mapping to the counts of county-level BC cases. We quantified the disparity effect, as measured by the rate ratio (95% credible interval [CI]), comparing the incidence of BC between at-risk AI/AN and non-AI/AN women, and assessed if the rate ratio differed between counties. Markov chain Monte Carlo sampling was used to estimate posterior quantities and the deviance information criterion was used for model selection. Results: In 2010, 1,041,758 women were at-risk for BC of which 107,656 (10.3%) were AI/AN women. During the 10-year study period, 12,974 new BC cases were recorded in the general at-risk population. In the at-risk AI/AN population, the expected number of new cases during the 10-year study period, therefore, was 1,340.74; however, 597 incidence cases of BC were diagnosed in the at-risk AI/AN population resulting in a posterior mean for the true relative risk of 0.445 (95% CI: 0.410, 0.482). Based on the selected model that accounted for over dispersion and spatial correlation among the 33 counties, the posterior mean of the overall adjusted rate ratio was 0.405 (95% CI: 0.336, 0.478). The adjusted rate of BC in AI/AN women was 0.40 times the corresponding adjusted rate for women who were non-AI/AN. Further, the adjusted rate ratios were similar for each county. Conclusions: The novel application of Bayesian disease mapping to these data provided substantial evidence of a significant overall disparity effect in BC incidence within NM between at-risk AI/AN and non-AI/AN women, which was more marked than previous reports. Targeted state-wide health equity initiatives may lead to reducing disparities in BC incidence in AI/AN at-risk women.

Introduction: What if you could only ask one question of the patient during a clinic visit? Further, suppose the patient’s biggest concern can pragmatically be incorporated into routine clinical care and clinical pathways that can address the patient’s single biggest concern can be identified. If the principal concern can be dealt with efficiently at each visit through key stakeholder case management, positive outcomes should result. Therefore, motivated by the need for patient-centered health care visits, the Beacon electronic patient-reported outcomes (PRO) quality of life (QOL) tool was developed. Methods: Central to the tool is that at each health care visit, the patient’s biggest concern is electronically communicated to the health care team. Therefore, the tool can help catalyze important discussions between the health care team and the patient, perhaps on topics that would not have been discussed otherwise at a routine visit. In recognition of the community of resources needed to provide comprehensive care, the tool generates clinical pathways or actions that can be pursued to address the patient’s biggest concern. The concern is efficiently triaged such that members of the health care community with appropriate expertise and resources are identified to address and manage that single biggest concern signaled by the patient. A report, which can be uploaded into the patient’s medical chart, is created and provides a list of resources for a case manager to assist the patient and contains graphical presentations of the patient’s QOL and a history of prior concerns. The report also labels potentially significant changes in QOL. Discussion: The tool, which has been applied successfully in several health conditions, acts as a beacon to health care providers so that a patient’s self-reported concern can be consistently and effectively integrated into their care. Key Points: It is impractical to try to deal with every patient concern in every visit. The key to the Beacon tool is that at each visit the patient’s biggest concern is identified, clinical pathways indicated, and resources efficiently matched to address the patient’s biggest concern.

Motivated by the paucity of high‐quality stillbirth surveillance data and the spatial analysis of such data, we describe the pattern of stillbirth events as a step toward increased understanding of risk factors which can better guide future measures to mitigate these events. A challenge in such an analysis is that some mothers experience stillbirth events from independent pregnancies within a defined study period. To account for these dependencies, we parameterize our model to include a maternal contextual effect and broaden the appeal of Bayesian Poisson point process modeling to quantify excess stillbirth risk while considering a form of a log‐Gaussian Cox process. In the presence of extra unobserved spatial variation in risk, we demonstrate a pragmatic methodologic strategy to model the risk surface in relation to covariates and that there is a variance‐bias trade‐off associated with the use of a maternal contextual effect. We applied our strategy to the spatial distribution of stillbirth in Iowa during the years 2005–2011 using data obtained from an active, statewide public health surveillance program. We identified areas of excess risk for further investigation based on model components that captured important features of the data.