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Window of opportunity trials (WOT) are increasingly common in oncology research. In WOT participants receive a drug between diagnosis and anti-cancer treatment, usually for the purpose of investigating that drugs effect on cancer biology. This qualitative study aimed to understand patient perspectives on WOT.We recruited adults diagnosed with early-stage breast cancer awaiting definitive therapy at a single-academic medical center to participate in semi-structured interviews. Thematic and content analyses were performed to identify attitudes and factors that would influence decisions about WOT participation.We interviewed 25 women diagnosed with early-stage breast cancer. The most common positive attitudes toward trial participation were a desire to contribute to research and a hope for personal benefit, while the most common concerns were the potential for side effects and how they might impact fitness for planned treatment. Participants indicated family would be an important normative factor in decision-making and, during the COVID-19 pandemic, deemed the absence of family members during clinic visits a barrier to enrollment. Factors that could hinder participation included delay in standard treatment and the requirement for additional visits or procedures. Ultimately, most interviewees stated they would participate in a WOT if offered (N = 17/25).In this qualitative study, interviewees weighed altruism and hypothetical personal benefit against the possibility of side effect from a WOT. In-person family presence during trial discussion, challenging during COVID-19, was important for many. Our results may inform trial design and communication approaches in future window of opportunity efforts.

PURPOSE: The financial toxicity of cancer care is a source of significant distress for patients with cancer. The purpose of this study is to understand factors associated with financial toxicity in three distinct care systems. METHODS: We conducted a cross-sectional survey of patients in three care systems, Stanford Cancer Institute (SCI), VA Palo Alto Health Care System (VAPAHCS), and Santa Clara Valley Medical Center (SCVMC), from October 2017 to May 2019. We assessed demographic factors, employment status, and out-of-pocket costs (OOPCs) and administered the validated COmprehensive Score for financial Toxicity tool. We calculated descriptive statistics and conducted linear regression models to analyze factors associated with financial toxicity. RESULTS: Four hundred forty-four of 578 patients (77%) completed the entire COmprehensive Score for financial Toxicity tool and were included in the analysis. Most respondents at SCI were White, with annual household income (AHI) > $50,000 USD and Medicare insurance. At the VAPAHCS, most were White, with AHI ≤ $50,000 USD and insured by the Veterans Administration. At SCVMC, most were Asian and/or Pacific Islander, with AHI ≤ $25,000 USD and Medicaid insurance. Low AHI ( P < .0001), high OOPCs ( P = .003), and employment changes as a result of cancer diagnosis ( P < .0001) were associated with financial toxicity in the pooled analysis. There was variation in factors associated with financial toxicity by site, with employment changes significant at SCI, OOPCs at SCVMC, and no significant factors at the VAPAHCS. CONCLUSION: Low AHI, high OOPCs, and employment changes contribute to financial toxicity; however, there are variations based on site of care. Future studies should tailor financial toxicity interventions within care delivery systems.

Globally, cancer care delivery is marked by inequalities, where some economic, demographic, and sociocultural groups have worse outcomes than others. In this review, we sought to identify patient-facing interventions designed to reduce disparities in cancer care in both high- and low-income countries. We found two broad categories of interventions that have been studied in the current literature: Patient navigation and telehealth. Navigation has the strongest evidence base for reducing disparities, primarily in cancer screening. Improved outcomes with navigation interventions have been seen in both high- and low-income countries. Telehealth interventions remain an active area of exploration, primarily in high income countries, with the best evidence being for the remote delivery of palliative care. Ongoing research is needed to identify the most efficacious, cost-effective, and scalable interventions to reduce barriers to the receipt of cancer care globally.

Despite advances in testing for heritable cancer susceptibility gene mutations, health disparities persist. We review racial/ethnic and socioeconomic factors that affect access to genetic counseling and testing, which may influence the validity of results among diverse populations and the clinical utility of genetic testing. Differential access to genetic testing among racial/ethnic minorities including Hispanics and blacks compared with whites drives disparities in the clinical validity of results: specifically, variants of unknown significance (VUS) are notably more prevalent in minorities. Deficiencies in results interpretation by patients and providers are common with VUS, which may engender disparities in clinical utility. There is evidence of racial/ethnic disparities in genetic testing access and the clinical validity of results, which are threats to the clinical utility of testing for all populations. Concerted efforts are needed to decrease disparities in germline cancer genetic testing and results’ interpretation and management.

PURPOSE: The discovery of driver oncogenes, such as ROS1, has led to the development of targeted therapies. Despite clinical advancements, gaps remain in our understanding of characteristics of patients with ROS1-positive ( ROS1+) cancers. The purpose of this study was to comprehensively assess demographic, clinical, and environmental characteristics associated with ROS1+ cancers worldwide. METHODS: In collaboration with a panel of patients with ROS1+ cancer, we designed and conducted a 204-question online assessment regarding the demographic, clinical, and environmental factors of patients with ROS1+ cancers. We invited patients with ROS1+ cancers to participate in the study from May 2016 to December 2018. RESULTS: A total of 277 patients from 18 countries worldwide responded and completed at least 90% of the survey. The majority of respondents were female (n = 191; 69%), non-Hispanic white (n = 202; 73%), never-smokers (n = 180/240; 75%). Most were diagnosed with lung cancer (n = 261/277; 94%) and stage IV disease (n = 201/277; 76%). The majority received chemotherapy in first (n = 137/199; 69%) and second (n = 103/199; 52%) lines of therapy. For patients diagnosed with lung cancer after the availability of crizotinib (n = 199), only a minority (n = 55/199; 28%) reported receiving crizotinib in the first line of therapy. CONCLUSION: This study is the first global, patient-designed approach, to our knowledge, to comprehensively assess demographic, clinical, and environmental characteristics associated with ROS1+ cancers. Future efforts include assessing these characteristics as well as patient-reported outcomes and treatment responses longitudinally.

524 Background: The immune-responsive nature of bladder cancer has made it an active area of interest for novel applications of immune checkpoint inhibitors (ICIs), with multiple ICI agents approved in the metastatic setting and ongoing perioperative trials. Variant histology urothelial carcinoma is a rare, heterogenous, and aggressive disease category associated with poor prognosis and response to standard therapies. This investigator-initiated phase 2 trial explored the addition of durvalumab to neoadjuvant chemotherapy (NAC) in the setting of variant histology MIBC. Methods: Patients with cT2-T4a, N0-N1, M0 histologically-confirmed bladder cancer of variant histology who were candidates for platinum-based NAC and radical cystectomy were eligible for the study. Enrolled patients received durvalumab with each cycle of investigator’s choice of platinum NAC (ddMVAC, cisplatin/gemcitabine, or carboplatin/gemcitabine). The primary objective was to determine the safety and tolerability of each study treatment as assessed by the total number of adverse events of grade 3 or higher, judged by the investigator as probably or definitely related to durvalumab. Secondary objective was to determine the percent of subjects post neoadjuvant chemo immunotherapy who achieve tumor stage of pT2N0M0 or better at cystectomy. Target accrual was 24 patients. Results: Six patients were enrolled (the study closed early due to low accrual). Median age was 72 years, 17% were women, 67% were white, 33% were Asian. 50% received ddMVAC and 50% received carboplatin/gemcitabine. All patients completed the planned cycles of NAC and durvalumab (4 cycles) and 5/6 proceeded to radical cystectomy (one patient declined cystectomy). Three patients experienced a Grade 3 AE that was assessed by the investigator to be related to treatment (table). One patient with sarcomatoid and glandular histology had pathological complete response and one patient with papillary and 10% squamous had pT2N0 at cystectomy. Conclusions: The addition of durvalumab to platinum NAC for patients with variant-histology muscle invasive bladder cancer demonstrates a reasonable safety and tolerability profile. Further investigation into this combination is warranted in larger scale trials. Clinical trial information: NCT03912818 . [Table: see text]

Earlier studies on the cost of muscle-invasive bladder cancer treatments are limited to short-term costs of care. We determined the 2- and 5-year costs associated with trimodal therapy (TMT) vs. radical cystectomy (RC).We performed a retrospective cohort study using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Total Medicare costs at 2 and 5 years following RC vs. TMT were compared using inverse probability of treatment-weighted propensity score models.A total of 2,537 patients aged 66 to 85 years were diagnosed with clinical stage T2-4a muscle-invasive bladder cancer. Total median costs for patients that received no definitive treatment(s) were $73,780 and $88,275 at 2-and 5-years. Costs were significantly higher for TMT than RC at 2-years ($372,839 vs. $191,363, Median Difference $127,815, Hodges-Lehmann Estimate (H-L) 95% Confidence Interval (CI), $112,663-$142,966) and 5-years ($424,570 vs. $253,651, Median Difference $124,466, H-L 95% CI, $105,711-$143,221). TMT had higher outpatient costs than RC (2-years: $318,221 vs. $100,900; 5-years: $367,092 vs. $146,561) with significantly higher costs with radiology, medications, pathology/laboratory, and other professional services. RC had higher inpatient costs than TMT (2-years: $62,240 vs. $33,631, Median Difference $-29,174, H-L 95% CI, $-32,364-$-25,984; 5-years: $75,499 vs. $45,223, Median Difference $-29,843, H-L 95% CI, $-33,905-$-25,781).The excess spending associated with trimodal therapy vs. radical cystectomy was largely driven by outpatient expenditures. The relatively high long-term trimodal therapy costs are prime targets for cost containment strategies to optimize future value-based care.

BACKGROUND: Financial toxicity describes the financial burden imposed onto patients by a cancer diagnosis and is a growing concern. Many clinicians do not currently address financial toxicity despite patients’ desire for them to do so. Current literature explores physicians’ perspectives but does not clearly define an actionable role clinicians can take to address financial toxicity. We sought to fill this gap by first assessing clinicians’ perspective on their role in alleviating financial toxicity at our institution. We subsequently aimed to identify current barriers to mitigating financial toxicity and to garner feedback on clinician-oriented interventions to address this growing problem. METHODS: We developed an 18-item electronic, anonymous survey through Redcap. We invited all oncology clinicians including attending physicians, advance practice providers, and trainees at our institution to participate. RESULTS: A total of 72 clinicians (30%) completed the survey. The majority agreed that clinicians have a role in addressing cost. The top three barriers to discussing cost with patients were knowledge of out of pocket costs, time, and awareness of resources. Less than half of respondents used an existing comparative cost tool to incorporate cost consciousness into treatment decisions. The most desired intervention was an institutional resource guide. In open-ended comments, the most common barrier described was transparency of out of pocket costs, and the most common solution proposed was a multi-disciplinary approach to addressing financial concerns patient face. DISCUSSION: Improving price transparency, incorporating existing resources into clinical practice, and streamlining multi-disciplinary support may help overcome barriers to addressing financial toxicity.

Purpose As genetic testing expands, patients are increasingly found to carry pathogenic variants in cancer susceptibility genes that are less familiar to most clinicians, specifically genes other than those causing hereditary breast ovarian cancer syndrome ( BRCA1 and BRCA2) and Lynch syndrome. Little is known about the subsequent behaviors of such patients in terms of managing cancer risks and informing relatives. Methods All adult patients who were counseled and tested at the Stanford Cancer Genetics Clinic from January 2013 to July 2015 and had a pathogenic variant in a non- BRCA1/2, non–Lynch syndrome gene were invited to participate in a telephone interview about adherence to risk-reducing recommendations, genetic testing by relatives, and new cancer incidence. Results Fifty-seven (40%) of 142 eligible patients were successfully contacted, and all 57 patients participated; median follow-up was 677 days (range, 247 to 1,401 days). Most patients (82%; 95% CI, 70% to 90%) recalled that a risk-reducing intervention (screening, medication, or surgery) was recommended, and most patients (85%; 95% CI, 72% to 93%) adhered to the recommendation. Nearly all patients (91%; 95% CI, 81% to 97%) shared results with relatives, and most patients (78%; 95% CI, 64% to 88%) reported that a relative was subsequently tested. During the follow-up period, 9% of patients (95% CI, 3% to 19%) developed second cancers, and in 14% of patients (95% CI, 7% to 26%), a first-degree relative developed cancer, some of which were detected by recommended screening. Conclusion Patients with a pathogenic variant in a less familiar cancer susceptibility gene report high adherence to risk-reducing interventions. Furthermore, in the 57 carriers and subsequently tested relatives with two years of follow-up, a total of three cancers (one in a proband and two in relatives) were detected through interventions recommended on the basis of the pathogenic variant. These results suggest a potential benefit of genetic counseling and testing for pathogenic variants in less familiar genes.

8 Background: Patients with metastatic cancer benefit from advance care planning (ACP) conversations. Despite initiatives which train providers to have ACP conversations using the serious illness care program (SICP) conversation guide, few patients have a documented prognosis discussion due to busy clinic schedules and difficulty in deciding the right times to have such conversations. We designed an intervention to improve ACP by incorporating a validated computer model to identify patients at high risk for mortality in combination with lay care coaches. We investigated whether this would improve end of life quality measures. Methods: Four Stanford clinics were included in this pilot; all received SICP training. Two clinics (thoracic and genitourinary) underwent the intervention (computer model + care coach), and two clinics (sarcoma and cutaneous) served as the control. For providers in the intervention, an email was sent every Sunday listing the metastatic cancer patients who would be seen in clinic the following week and a predicted prognosis generated by the model. A lay care coach contacted patients with a predicted survival ≤2 years to have an ACP conversation with them. After, the care coach notified the provider to suggest discussion regarding prognosis with the patient. Criteria for a patient visit to be included in the analysis were: age ≥18, established patient, has sufficient EMR data for computer model, and no prior prognosis documentation. The primary outcome was documentation of prognosis in the ACP form by the end of the week following the clinic visit. Results: 5330 visits in 1298 unique patients met the inclusion criteria. Median age was 67 (range 19-97); 790 male, 508 female. 1970 visits were with patients with ≤2 year predicted survival. Prognosis discussion was documented by providers in the ACP form for 8.1% of intervention visits compared to 0.07% of control visits (p=0.001 in mixed effects model). Of the 1298 unique patients, 84 were deceased by December 2020. 41.7% died in the hospital. 59.5% were enrolled in hospice prior to death, and 19.0% were hospitalized in the ICU ≤14 days prior to death. Of deceased patients with ACP form prognosis documentation, 5.0% had ≥2 hospitalizations in the 30 days before death compared to 23.4% of deceased patients with no prognosis documented (p=0.10). For ≥ 2 ER visits in the 30 days before death, the proportions were 5.0% and 20.3% (p=0.17). Conclusions: This pilot study supports that our intervention is associated with higher rates of prognosis discussions and documentation. There was a trend towards better quality of end of life care as noted by higher rates of hospice enrollment and less intensive care at end of life. These results merit further investigation as a means to improve goal-concordant care and ensure appropriate care for cancer patients at the end of life.

2 Background: In our prior work, community or lay health worker-led goals of care interventions improved goals of care documentation by clinicians and decreased health care use at the end of life. Other studies have demonstrated improvements in provider-patient communication and goals of care documentation using the Serious Illness Care Program. The objective of this study was to determine whether the combination of these two interventions could improve goals of care documentation among patients with advanced stages of genitourinary cancers at an academic center. Methods: A randomized controlled trial was conducted from April 3, 2019, through October 30, 2019, among patients with metastatic or recurrent cancer on at least second line therapy in the urologic oncology clinics at Stanford Cancer Center. Patients were randomized to usual care or the intervention with a lay navigator trained to assist patients with establishing end-of-life care preferences using the Serious Illness Conversation Guide. The primary outcome was goals of care documentation by the primary oncologist. We used intent to treat analyses, descriptive statistics to compare demographic and clinical factors, and a logistic regression adjusting for imbalance to determine the effect on the primary outcome. Results: Two-hundred participants were randomized and included in the intent to treat analysis. Median age was 72 years, majority were male (n=175, 87.5%) and self-identified as non-Hispanic white (n=123, 61.5%). The majority had prostate cancer (n=110, 53.5%), followed by kidney cancer (n=51, 25.5%), and urothelial cancer (n=29, 14.5%) and most had stage IV disease at diagnosis (n=186, 93%). There were no significant differences in demographic or clinical factors except for gender; there were more females on the control arm (n=8 vs n=17, p=0.01) thus analysis of the primary outcome was adjusted for gender. The adjusted analysis showed that at 12 months post-enrollment, the intervention significantly increased goals of care documentation by the primary oncologist as compared to the control group (53.7% vs 32.6%, p=0.002). Conclusions: The CAREPlan program increased goals of care documentation by the primary oncologist at this single academic medical center. Clinical trial information: NCT03856463.

e18609 Background: The COVID-19 pandemic prompted rapid changes in cancer care delivery. We sought to examine oncology provider perspectives on clinical decisions and care delivery during the pandemic and to compare provider views early versus late in the pandemic. Methods: We invited oncology providers, including attendings, trainees and advanced practice providers, to complete a cross-sectional online survey using a variety of outreach methods including social media (Twitter), email contacts, word of mouth and provider list-serves. We surveyed providers at two time points during the pandemic when the number of COVID-19 cases was rising in the United States, early (March 2020) and late (January 2021). The survey responses were analyzed using descriptive statistics and Chi-squared tests to evaluate differences in early versus late provider responses. Results: A total of 132 providers completed the survey and most were white (n = 73/132, 55%) and younger than 49 years (n = 88/132, 67%). Respondents were attendings in medical, surgical or radiation oncology (n = 61/132, 46%), advanced practice providers (n = 48/132, 36%) and oncology fellows (n = 16/132, 12%) who predominantly practiced in an academic medical center (n = 120/132, 91%). The majority of providers agreed patients with cancer are at higher risk than other patients to be affected by COVID-19 (n = 121/132, 92%). However, there was a significant difference in the proportion of early versus late providers who thought delays in cancer care were needed. Early in the pandemic, providers were more likely to recommend delays in curative surgery or radiation for early-stage cancer (p < 0.001), delays in adjuvant chemotherapy after curative surgery (p = 0.002), or delays in surveillance imaging for metastatic cancer (p < 0.001). The majority of providers early in the pandemic responded that “reducing risk of a complication from a COVID-19 infection to patients with cancer” was the primary reason for recommending delays in care (n = 52/76, 68%). Late in the pandemic, however, providers were more likely to agree that “any practice change would have a negative impact on patient outcomes” (p = 0.003). At both time points, the majority of providers agreed with the need for other care delivery changes, including screening patients for infectious symptoms (n = 128/132, 98%) and the use of telemedicine (n = 114/132, 86%) during the pandemic. Conclusions: We found significant differences in provider perspectives of delays in cancer care early versus late in the pandemic which reflects the swiftly evolving oncology practice during the COVID-19 pandemic. Future studies are needed to determine the impact of changes in treatment and care delivery on outcomes for patients with cancer.

170 Background: Financial toxicity, or the financial burden related to cancer care, is a source of distress for urologic oncology patients. This study aimed to address financial toxicity among prostate, kidney and bladder cancer patients and test the feasibility of a lay-health worker (LHW) and social work (SW) driven intervention. Methods: LHW assessed financial burden in urologic oncology patients with advanced cancer who presented for return visits at a single academic center. The LHW collected responses to three statements on a Likert scale – “I worry about the financial problems I will have in the future because of my illness or treatment”, “My cancer or treatment has reduced satisfaction with my present financial situation”, and “I feel financially stressed”. Patients who responded, “Very much” (4) or “Quite a bit” (3) to all statements were offered a one-on-one consultation with a trained SW. The SW provided personalized recommendations after review of patients' financial information, insurance status, and out of pocket costs. SW referred patients to appropriate support services including those offered by the hospital, government, nonprofits and private corporations. Pre-specified outcomes included pre/post-intervention financial toxicity and patient satisfaction with the intervention. Results: 145 patients (67%) agreed to be screened for financial toxicity by the LHW. Most participants were White (n = 100, 69%), male (n = 130, 90%), married (n = 104, 72%) and with incomes > $100,000 (n = 111, 77%). The majority had prostate cancer (n = 87, 60%), followed by kidney cancer (n = 36, 25%) and bladder cancer (n = 22, 15%). 12% (n = 26) responded “I worry about the financial problems I will have in the future because of my illness or treatment”, “Very much” or “Quite a bit”. 14% (n = 20) responded “My cancer or treatment has reduced satisfaction with my present financial situation”, “Very much” or “Quite a bit”. 12% (n = 17) reported “I feel financially stressed”, “Very much” or “Quite a bit”. A total of 14 patients were eligible for the intervention and were referred for a one-on-one SW consultation. Post-intervention results indicated excellent patient satisfaction with the intervention and a significant improvement in financial toxicity. 100% of patients reported the SW “provided financial resources that were beneficial to me”, and 78% (n = 11) had a decrease in financial toxicity score post-intervention (average decrease = -1, p = 0.05038). Conclusions: In this single institution study of prostate, kidney and bladder cancer patients with overall low baseline financial burden a LHW and SW driven intervention was feasible and effective in reducing financial toxicity.

181 Background: In “window of opportunity” (WOO) clinical trials, people with newly diagnosed early-stage cancer are exposed to an experimental drug during the period of time between diagnosis and definitive anti-cancer treatment. These trials allow investigators to study drug efficacy in untreated disease, which can expedite drug development. However, for trial participants, the WOO approach requires them to decide about an altruistic clinical trial during an intense time immediately after cancer diagnosis. This qualitative study aimed to understand patient perspectives on WOO clinical trials. Methods: We recruited adults newly diagnosed with early-stage breast cancer who were awaiting definitive therapy at a single academic medical center. We developed an interview guide grounded in the theoretical framework, the Theory of Planned Behavior (TPB). TBP is a well-validated decision-making model with three domains that guide behavior: (1) attitudes (2) normative factors and (3) perceived difficulty of a behavior. We conducted one-on-one semi-structured interviews that were audio-recorded and transcribed. Transcripts were analyzed to ensure interrater reliability and content analysis was performed to assess themes that emerged. Results: We interviewed 15 women (age 32-72) with early-stage breast cancer, and the majority were White (n = 12, 80%) and at least college educated (n = 12, 80%). Key themes that emerged included favorable attitudes towards participating in a WOO trial that were altruistic, including the desire to contribute to science (n = 10, 67%) and to help future breast cancer patients (n = 5, 33%). Several individuals also identified a potential benefit to themselves (n = 10, 67%), including access to a targeted drug (n = 4, 27%) and adding meaning to their diagnosis (n = 3, 20%). However, most interviewees reported concerns about drug side effects (n = 12, 80%) and whether side effects would impact other planned treatments (n = 10, 67%). Interviewees also expressed family would be an important normative factor in decision-making (n = 8, 53%). A key theme that emerged as a difficulty was the potential delay in standard treatment (n = 14, 93%). Despite this concern, at the end of the interviews, most interviewees stated they would participate in a WOO trial if offered (n = 10, 67%). Conclusions: WOO trials are becoming increasingly common in oncology research. In this qualitative study, interviewees weighed altruism against the possibility delaying or impacting other treatments. Our results may inform trial design and communication approaches in future WOO efforts.

82 Background: Characterizing the oncology provider’s role in addressing the growing epidemic of financial toxicity faced by cancer patients is of increasing importance. Advance practice providers (APPs) increasingly serve as primary providers for many cancer patients, but no studies to date have examined their perspectives and practices in addressing financial toxicity, nor compared them to that of attending physicians. Methods: We developed an 18-question electronic, anonymous survey informed by an extensive literature search regarding perspectives on the provider’s role and current practices in addressing financial toxicity. We emailed the survey to 75 attending physicians and 117 APPs at our institution’s cancer center. Responses during the study period 12/12/2018-1/31/2019 were analyzed. Results: 32 attending physicians and 28 APPs completed the survey. Response rates were higher among attending physicians (42%) compared to APPs (24%). Attending physicians were more likely than APPs to agree that providers should openly discuss cost (75% vs. 36%, p = 0.002). APPs were more likely to agree that providers should defer cost conversations to a third party (57% vs. 31%, p = 0.04) and make the same treatment recommendation regardless of cost (50% vs. 25%, p = 0.022). Use of cost-effectiveness (CE) guidelines was higher among APPs compared to attending physicians (71% vs. 31%, p = 0.0019). Awareness of out of pocket costs, frequency of referrals to financial counselors, and ranking of top barriers to cost conversations (price transparency, knowledge of resources, and time) were similar between attending physicians and APPs. Conclusions: While APPs and attending physicians differed considerably in their perspectives on the role oncology providers should take in mitigating financial toxicity, they were more consistent in current practices and identification of barriers to cost conversations. APPs were interestingly more likely to use CE guidelines than attending physicians. Higher response rates among attending physicians may reflect inherently stronger opinions regarding the provider’s role in addressing financial toxicity. Future studies should explore these differences to better inform provider-level interventions to reduce financial toxicity.

e19392 Background: The treatment landscape for advanced renal cell carcinoma (RCC) has transformed in the past two years. Both Nivolumab plus Ipilimumab and Pembrolizumab plus Axitinib are approved regimens for first-line treatment of intermediate to poor-risk patients with advanced RCC. The choice between these immunotherapy-based combinations for first-line therapy is highly debated; no prior study has evaluated the cost-effectiveness of both combinations compared to Sunitinib. Methods: We used a decision analytic Markov model informed by the recent Checkmate-214 and Keynote-426 phase 3 randomized controlled clinical trials to evaluate costs and effectiveness of Nivolumab plus Ipilimumab, Pembrolizumab plus Axitinib, and Sunitinib in the first-line treatment of advanced RCC from a US health payer perspective. We used the model to extrapolate survival beyond the closure of the trials and examined the robustness of our findings with sensitivity analyses. Main outcomes were life expectancy, quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratios, all discounted at 3% annually. Results: Nivolumab plus Ipilimumab increased life expectancy by 0.58 years at cost of approximately $190,000 per QALY gained compared to Sunitinib. Pembrolizumab plus Axitinib increased life expectancy by 0.39 years at a cost of approximately $861,000 per QALY gained compared to Nivolumab plus Ipilimumab. The results were not sensitive to reasonable changes in drug costs and quality of life estimates. Both combinations cost more than the traditional willingness-to-pay threshold (WTP) of $150,000 per QALY gained. A 20% price reduction is required for Nivolumab and Ipilimumab to be cost-effective and a 48% price reduction is required for Pembrolizumab plus Axitinib to be cost-effective. Conclusions: Both Nivolumab plus Ipilumumab and Pembrolizumab plus Axitinib provide increased longevity and reduced morbidity relative to Sunitinib. However, the prolonged duration of treatment and doublet-drug pricing results in high-costs. Price reductions are required for both of the immunotherapy-based combinations to be cost-effective. [Table: see text]

Shivani Khanna,1 Kristine N Kim,1 Muhammad M Qureshi,1 Ankit Agarwal,1 Divya Parikh,1 Naomi Y Ko,2 Alexander E Rand,1 Ariel E Hirsch1 1Department of Radiation Oncology, Boston Medical Center, Boston University School of Medicine, 2Department of Hematology Oncology, Boston Medical Center, Boston MA, USA Purpose and objective: The aim of this study was to examine the impact of patient demographics, tumor characteristics, and treatment type on time to treatment (TTT) in patients with breast cancer treated at a safety net medical center with a diverse patient population.Patients and methods: A total of 1,130 patients were diagnosed and treated for breast cancer between 2004 and 2014 at our institution. We retrospectively collected data on patient age at diagnosis, race/ethnicity, primary language spoken, marital status, insurance coverage, American Joint Committee on Cancer (AJCC) stage, hormone receptor status, and treatment dates. TTT was determined from the date of breast cancer biopsy to treatment start date. Nonparametric Mann–Whitney U-test (or Kruskal–Wallis test when appropriate) and multivariable quantile regression models were employed to assess for significant differences in TTT associated with each factor.Results: Longer median TTT was noted for Black (P=0.002) and single (P=0.002) patients. AJCC stage IV patients had shorter TTT (27.5days) compared to earlier AJCC patients (36, 35, 37, 37 days for stage 0, I, II, III, respectively), P=0.028. Age, primary language spoken, insurance coverage, and hormone receptor status had no significant impact on TTT. On multivariate analysis, race/ethnicity remained the only significant factor with Black reporting longer TTT, P=0.025. However, race was not a significant factor for time from first to second treatment. More Black patients were noted to be single (P

103 Background: Financial toxicity of cancer care has not previously been studied within the Veterans Health Administration (VHA). The VHA provides health care for veterans in VA hospitals across the United States (US). It is a single-payer system and the largest integrated health system in the US and in this study we sought to assess financial toxicity experienced by veterans at a VA hospital. Methods: We asked veterans with oncology clinic visits at the VA Palo Alto to complete a survey that included an 11-item validated questionnaire called the COST tool. The COST tool calculates a score 0-44 with higher scores suggestive of higher financial toxicity. We also assessed demographic factors including gender, education, race, income, and insurance status as well as monthly out of pocket costs (OOPC) and suggested resources to reduce burden. We coded responses and calculated descriptive statistics with proportions. Results: A total of 84 veterans completed the survey and demographic factors are depicted in Table. Veterans were predominantly male (96%), high school or less educated (46%), white (61%), with annual income less than $50,000 (81%), and VA insurance (95%). The mean COST score was 21. The majority of veterans (63%) reported less than $100 of monthly OOPC and many (56%) reported transportation as a major expense and requested transportation resources. Conclusions: Financial toxicity is an unmet concern among veterans. Despite low monthly OOPC in the VHA single-payer system, financial toxicity as measured by the COST score at a VA hospital was as high as a nearby academic center. Transportation was the most significant expense and future studies should evaluate interventions to reduce the financial burden of transportation for veterans. [Table: see text]

e18362 Background: Financial toxicity (FT) is a major cause of distress for cancer patients. We have previously reported that FT was high among patients at a county hospital and a tertiary academic center. In this study, we sought to compare factors associated with FT at these institutions. Methods: Patients with clinic visits were asked to fill out an 11-item validated FT survey, the COST tool, and demographic questions from 10/2017 - 2/2018 at the county hospital and 7/2015 - 10/2018 at the academic center. We used a logistic regression model to analyze demographic factors associated with FT. Results: Mean COST score was significantly higher at the county hospital (28.7) compared to the academic center (20.4) (p < 0.001). Distribution of cancer stage was similar between the institutions. Patients at the county hospital were more likely to have an annual household income (AHI) < $25K (p < 0.001), and be insured by Medi-cal (p < 0.001). Patients at the academic center were more likely to be White (p < 0.001). Monthly OOP spending was more likely to be > $500 at the academic center (p < 0.001). Conclusions: Overall, FT was higher at the county hospital as compared to the academic center. FT at both institutions was associated with higher OOP spending and lower AHI. However, variations in FT among other demographic factors may reflect differences in care delivery systems and patient populations. Our study demonstrates that demographic groups at risk for FT differs between institutions suggesting the factors that contribute financial toxicity are complex and variable. Thus local assessments of FT may be necessary for individual health systems to develop targeted interventions to improve FT among their patients.[Table: see text]

e18342 Background: Few studies have evaluated the perspectives and clinical practices of oncology providers in regards to assisting patients with financial toxicity. Our study sought to assess providers’ attitudes regarding their role in addressing patients’ financial concerns, understand practice patterns in discussing cost of care, and obtain feedback on potential interventions to help address existing barriers. Methods: We developed an 18-question electronic, anonymous survey informed by an extensive literature search and piloted with three physicians with health services research experience. We emailed the survey to 75 attending physicians in Medical Oncology, Hematology, and Radiation Oncology, 117 advance practice practitioners (APPs) and 46 trainees. Responses during the study period 12/12/2018-1/31/2019 were analyzed. Results: A total of 71 (response rate of 30%) participants completed the survey, including 31 attending physicians, 28 APPs, and 12 trainees. Sixty-two percent of participants agreed that oncology providers should openly discuss cost of care with patients. There was wide variation in opinion around whether providers should offer the same treatment recommendations to all patients regardless of cost, with one third stating they agreed, one third stating they disagreed, and one third stating they were neutral. Sixty-one percent of participants did not use any cost-effectiveness tools in decision making. Sixty-three percent of respondents stated that a gap in knowledge of out of pocket costs was the number one barrier to helping patients avoid financial toxicity. The highest ranked intervention of those listed was a guide on available resources for patients with financial needs, voted for by 70% of respondents. Conclusions: Providers identified many barriers at our institution to discussing cost of care, including lack of transparency of out of pocket costs and lack of awareness of available resources. Providers were overwhelmingly interested in incorporating institutional resources and cost-effectiveness tools into their clinical practices. These findings can inform provider-level interventions to better address the financial burden patients face with their cancer care.

76 Background: The rising costs of cancer care increasingly results in financial distress for patients and their families. Low-income patients face a greater burden of financial toxicity, but few studies have characterized what factors contribute to this, and what interventions can relieve toxicity. Methods: From October 2017 to December 2017, we used a validated COST survey tool to understand the extent of financial burden that patients with cancer experience. We surveyed patients who receive their oncology care in a medical system that serves predominantly minority and low-income patients in Santa Clara County. We collected demographic information including sex, education level, ethnicity, income, insurance status, monthly out of pocket costs (OOPC) and employment status prior to diagnosis. We used a multivariable linear regression to study the association between the patient factors and financial burden as demonstrated by the COST score. All data were analyzed using Stata 14. Results: Demographic information is presented in Table 1. A total of 152 patients completed all 11 items of the COST survey. In the multivariate model, there was no significant difference in COST score by sex, education level, or ethnicity. However, income ≤$25,000 was associated with higher COST scores (p = 0.019), as was higher monthly OOPC (p = 0.003). Medicare patients and patients who were employed prior to diagnosis tended to have higher COST scores although not quite statistically significant (p = 0.057, p = 0.083). Conclusions: Patient-reported financial toxicity is an unmet concern among patients in this single institution study with a high proportion of underinsured patients. Higher OOPC and low income was associated with a higher financial burden. These findings suggest that patients would benefit from targeted interventions to mediate out of pocket costs of cancer care.[Table: see text]

Objective. To examine the impact of patient demographics on mortality in breast cancer patients receiving care at a safety net academic medical center.Patients and Methods. 1128 patients were diagnosed with breast cancer at our institution between August 2004 and October 2011. Patient demographics were determined as follows: race/ethnicity, primary language, insurance type, age at diagnosis, marital status, income (determined by zip code), and AJCC tumor stage. Multivariate logistic regression analysis was performed to identify factors related to mortality at the end of follow-up in March 2012.Results. There was no significant difference in mortality by race/ethnicity, primary language, insurance type, or income in the multivariate adjusted model. An increased mortality was observed in patients who were single (OR = 2.36, CI = 1.28–4.37,p=0.006), age > 70 years (OR = 3.88, CI = 1.13–11.48,p=0.014), and AJCC stage IV (OR = 171.81, CI = 59.99–492.06,p<0.0001).Conclusions. In this retrospective study, breast cancer patients who were single, presented at a later stage, or were older had increased incidence of mortality. Unlike other large-scale studies, non-White race, non-English primary language, low income, or Medicaid insurance did not result in worse outcomes.

1528 Background: Next-generation sequencing technology enables more comprehensive germline genetic testing, including genes whose cancer risks are less well-characterized (particularly among patients with less striking family histories). Little is known about patient outcomes, particularly adherence to risk-reducing recommendations and family testing. Methods: We attempted a phone interview ≥3 times with each adult patient who had a germline pathogenic or likely pathogenic mutation found in an emerging cancer gene (defined as any gene other than BRCA1/2 or the Lynch Syndrome genes MLH1, MSH2/6, PMS2) at a single academic cancer genetics clinic from January 2013-July 2016. Results: Of 143 eligible patients, 53 (37%) were successfully contacted and all consented to participate. Median follow-up was 677 days (range 247–1401) and age was 52 years (21-82). Two-thirds (68%) had personal cancer history and 93% had a first-degree relative with cancer. Mutations in genes associated with named syndromes ( APC=5 , CDH1=3 , TP53=3, PTEN=2) were found in 23% (many of whom lacked family history typical of these syndromes) whereas 77% had mutations in less well-characterized genes ( MYH=10, CHEK2=10, ATM=6, PALB2=6 , NBN=3, RAD51C=2, RAD51D=2, SDHB=1, CDKN2A=1, MRE11A=1, RAD50=1, FLCN=1). Conclusions: Two years after panel testing, patients with germline mutations in less well-characterized genes reported high rates of adherence to recommendations, family communication and testing. Limitations include a relatively low response rate and a single academic center; this may bias toward a “best-case” scenario. Larger, population-based studies will be crucial to understand the real-world outcomes of germline multiple-gene panel testing and its contribution to precision oncology. [Table: see text]

e18323 Background: Many studies have shown that patients with cancer are at higher risk of financial difficulty than those without cancer. Given the rising cost of cancer therapy it is important to study the financial distress associated with cancer care. Therefore, we assessed patient reported financial toxicity at a large tertiary academic cancer institute. Methods: From July 2014 to August 2014, we asked 300 patients at the Stanford Cancer Center to participate in an 11-item questionnaire about costs incurred with cancer care. We calculated patient-reported financial toxicity using the COST score, validated at the University of Chicago (scores range from 0-44 with higher values indicating higher financial burden). We obtained demographic information including sex (male or female), education level (high school or less, associates/bachelors degree, or masters/professional degree), race (white or non-white) and annual household income ( < $49,999, $50,000-$99,999, or > $100,000) and used multivariable logistic regression to analyze the association between demographic factors and COST score. Results: Out of the 300 patients approached 254 patients (84.7%) participated in the survey. Nearly half (46%) responded that they “worry about the financial problems in the future as a result of illness or treatment“ quite a bit (4) or very much (5). More than half (52%) reported “I feel I have no choice about the amount of money I spend on care” quite a bit (4) or very much (5). Of patients without missing data (n = 184, 61.3%), the mean COST score was 21 (range 2-41). There were no significant differences in COST score by sex, education level, or race. However, there was a significant difference in COST score by annual household income with a higher degree of financial burden in the lowest income group (OR = 1.04, CI = 0.69-1.38, p < 0.001). Conclusions: Financial toxicity is an unmet concern among patients in our single institution study, with increased burden expressed by those in lower income groups. Our results demonstrate that financial toxicity is a critical concern despite our limited sample. Multicenter studies should be conducted to better characterize the risk factors and serve as a basis for interventions for patients at risk for financial toxicity.

We determined the attitudes toward and practices regarding soil-transmitted helminthes (STH) control among parents and school teachers to identify reasons behind attitudes and practices that do not promote STH control. Written knowledge, attitudes and practices surveys were distributed to parents (N = 531) and teachers (N = 105) of students at 11 elementary schools in Guimaras Province, the Philippines. The survey addressed attitudes about mass drug administration (MDA), knowledge about STH control, hygienic practices, and acceptability of distributing deworming tablets among teachers. More than 90% of parents and teachers held favorable attitudes towards MDA. Sixty-nine percent of parents and 75.5% of teachers believed stool exams were necessary before MDA. Thirty-seven percent of parents stated they would not allow teachers to administer deworming tablets and 91.5% of parents feared teachers would not detect side effects of the medication. Forty-eight percent of teachers felt they could safely give deworming tablets and 81.4% of teachers were afraid of managing the side effects of deworming tablets. Forty-seven point eight percent of parents and 42.2% of teachers stated defecation in the open occured in their community. Although attitudes toward STH control were largely favorable, misconceptions about the MDA strategy, lack of support for teachers giving deworming tablets, and the practice of open defecation still exist as barriers to STH control efforts. The next step to achieve effective STH control will be to clarify misconceptions in education campaigns, to train teachers about medication administration, campaign to improve sanitation and hygiene and begin targeted mass treatment in Guimaras, the Philippines.

Background Anaphylaxis to egg or severe egg allergy has been considered a contraindication to receiving trivalent seasonal influenza vaccine (TIV). Objective To evaluate the safety of TIV among severely egg allergic children. Methods A 2-phase, multicenter study at 7 sites was conducted between October 2010 and March 2012. Inclusion criteria included a history of a severe reaction, including anaphylaxis, to the ingestion of egg and a positive skin test result or evidence of serum specific IgE antibody to egg. Phase 1 consisted of a randomized, prospective, double-blind, placebo controlled trial of TIV administration to egg allergic children, using a 2-step approach; group A received 0.1 mL of influenza vaccine, followed in 30 minutes if no reaction with the remainder of an age-appropriate dose, whereas group B received an injection of normal saline followed in 30 minutes if no reaction with the full 100% of the age-appropriate dose. Phase 2 was a retrospective analysis of single dose vs split-dose administration of TIV in eligible study participants who declined participation in the randomized controlled trial. Results Thirty-one study participants were prospectively evaluated in the randomized controlled trial (group A, 14; group B, 17); 45.1% had a history of anaphylaxis after egg ingestion. A total of 112 participants were retrospectively evaluated (87 with the single dose and 25 with the split dose); 77.6% of participants had a history of anaphylaxis after egg ingestion. All participants in both phases received TIV without developing an allergic reaction. Conclusion TIV administration is safe even in children with histories of severe egg allergy. Use of 2-step split dosing appears unnecessary because a single dose was well tolerated.