Purpose: To assess the association of tumor mutational burden (TMB) with clinical outcomes, other biomarkers and patient/disease characteristics in patients receiving therapy for lung cancer. Results: In total, 4,303 publications were identified; 81 publications were included. The majority of publications assessing clinical efficacy of immunotherapy reported an association with high TMB, particularly when assessing progression-free survival and objective response rate. High TMB was consistently associated with TP53 alterations, and negatively associated with EGFR mutations. High TMB was also associated with smoking, squamous cell non-small cell lung carcinoma, and being male. Methods: A systematic literature review based upon an a priori protocol was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Cochrane methodologies. Searches were conducted in EMBASE, SCOPUS, Ovid MEDLINE®, and Emcare (from January 2012 until April 2018) and in two clinical trial registries. Conference abstracts were identified in EMBASE, and in targeted searches of recent major conference proceedings (from January 2016 until April 2018). Publications reporting data in patients receiving therapy for lung cancer that reported TMB and its association with clinical efficacy, or with other biomarkers or patient/disease characteristics, were included. Results are presented descriptively. Conclusion: This systematic literature review identified several clinical outcomes, biomarkers, and patient/disease characteristics associated with high TMB, and highlights the need for standardized definitions and testing practices. Further studies using standardized methodology are required to inform treatment decisions.

Background Glioblastoma is an incurable disease with a poor prognosis. For caregivers of people with glioblastoma, the burden of care can be high. Patients often present with different clinical characteristics, which may impact caregiver burden in different ways. This study aimed to evaluate associations between patient clinical characteristics and caregiver burden/quality of life (QoL). Methods Caregiver–patient dyads were enrolled at 7 academic cancer centers in the United States. Eligible caregiver participants were self-reported as the primary caregiver of an adult living with glioblastoma and completed a caregiver burden survey. Eligible patients were age ≥ 18 years at glioblastoma diagnosis and alive when their respective caregiver entered the study, with the presence of cognitive dysfunction confirmed by the caregiver. Data were analyzed with descriptive statistics and multivariable analyses. Results The final cohort included 167 dyads. Poor patient performance status resulted in patient difficulty with mental tasks, more caregiving tasks, and increased caregiving time. Language problems were reported in patients with left-sided lesions. Patient confusion was negatively associated with all caregiver domains: emotional health, social health, general health, ability to work, confidence in finances, and overall QoL. Better caregiver QoL was observed in patients with frontal lobe lesions versus non-frontal lobe lesions. Conclusion This study reinforced that patient performance status is a critical clinical factor that significantly affects caregiver burden, caregiving tasks, and caregiver time. Additionally, patient confusion affects multiple facets of caregiver burden/QoL. These results could be used to support guided intervention for caregiver support, customized to the patient experience.

16 Background: GBM is a largely incurable, highly aggressive cancer with high incidence of CD. Caregivers face heightened stress with loved one’s limited life expectancy and additional duties. To better understand this unique group, a survey tool was developed to examine effect of CD on caregiver burden. Methods: Four of 10 planned academic centers are enrolling towards achieving 200+ completed surveys. The survey was developed step-wise: 1) literature review of primary brain tumors, Alzheimer’s disease, and dementia to identify domains; 2) focus groups with neurooncologists and American Brain Tumor Association advocates to narrow domains; 3) caregiver interviews to verify selected domains; 4) single-site pilot study to confirm content (n=20). Dyads with caregiver survey and respective patient’s clinical data are created as possible. Results: Complete data from 31 caregivers and 28 dyads enrolled at Huntsman Cancer Institute, University of Utah and University of California, Los Angeles are currently available. Response rate was 88% for caregivers and 90% for patients. Among caregivers, 87% were patient spouse/partner, 84% female, average age 56 years, 42% currently employed, 32% have no additional help, and 26% are primary caregivers for others. Patients were male (74%), average age 59 years, not working (84%), and being treated for initial diagnosis (67%). Proportion of caregivers performing ≥ 1 caregiving task, i.e. meal preparation, doubled from before to after diagnosis (48% vs. 97%). The majority of caregivers (90%) perceived memory problems in a loved one over last 14 days. Trouble remembering recent events or things interfered with 71% of caregivers’ daily life "somewhat", "quite a bit", or "very much". When ranking effect of CD on caregiver’s general quality of life on a scale of 0 (none) to 10 (significant), 60% and 23% of caregivers indicated ≥ 5 and ≥ 8, respectively. Caregivers’ responses to survey satisfaction questions showed only 23% feel enough is being done to understand caregiving in GBM and 76% were satisfied overall with the survey. Conclusions: Caregivers are affected daily and significantly by GBM-related CD. Results will be updated at time of presentation.

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Background Digital Health Technologies (DHTs) have shown potential to improve health outcomes through improved medication adherence in different disease states1,2. Cystic Fibrosis (CF) requires care coordination across pharmacies, patients, and providers3,4. DHTs can potentially support patients, providers, and pharmacists in diseases like CF, where high medication burden can negatively impact patient quality of life and outcomes. Methods In this prospective cohort study, a CF-specific mobile application (Phlo) was distributed to adults with CF who received care at the University of Utah Cystic Fibrosis Center, used an iPhone, and filled prescriptions through the University of Utah Specialty Pharmacy services. Participants were asked to use Phlo for 90 days with an optional 90-day extension period. Participants completed four surveys at baseline and after 90 days. Changes in patient-reported outcomes, adherence, clinical outcomes, and healthcare resource utilization from baseline to 90 days were tracked. Results Phlo allowed users to track daily regimen activities, contact their care team, receive medication delivery reminders, and share progress with their healthcare team. A web-based dashboard allowed the care team to review reported performance scores from the app. Most patients (67%) said the app improved confidence in and motivation for continuing their regimen. The most important reported benefit of Phlo was having a single location to manage their whole routine. Inpatient hospital admissions decreased from 12 during the baseline period to 7 after the 90-day study period. Conclusions: Phlo is a mobile health technology designed to help patients with CF manage their treatment regimen and improve patient-provider communication.

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