bluuebunny/crossref_metadata_2025 huggingface dataset:
Answering real-world questions using real-world data: Understanding dynamic treatment decisions and outcomes in metastatic colorectal cancer (mCRC).
Authors: Wong Hui-Li , Degeling Koen , Jalali Azim , Shapiro Jeremy David , Kosmider Suzanne , Wong Rachel , Lee Belinda , Burge Matthew E. , Tie Jeanne , Yip Desmond , Nott Louise M. , Khattak Muhammad Adnan , Lim Stephanie Hui-Su , Caird Susan , Ijzerman Maarten J , Gibbs Peter
Published: May 2019

e18061

Background: The wide range of possible combinations and sequences available for mCRC treatment presents a major challenge to clinicians, who need to determine the optimal approach for an individual patient or patient subset. In the absence of clinical trial evidence, real world data are an increasingly valuable resource that can be utilized not only to understand treatment patterns and outcomes in routine practice, but also to define an optimal treatment strategy for individual patients across multiple lines of therapy. Methods: Real world data from an Australian mCRC registry were used to develop an interactive data visualization tool that displays treatment variation, customizable to different levels of detail and specific patient subsets, based on patient and disease characteristics. Next, a discrete event simulation model was developed to predict progression-free (PFS) and overall survival (OS) for first line palliative treatment with doublet chemotherapy alone or with bevacizumab, based on data of 867 patients that were treated accordingly. Results: Of 2694 Australian patients enrolled, 2057 (76%) started 1st line treatment with chemotherapy and/or a biologic agent, 1087 (40%) and 428 (16%) received 2nd and 3rd line therapy, respectively. Combined, these 3 lines of treatment accounted for 733 unique sequences. After recoding treatment to the most intensive chemotherapy and the first exposed biologic, 472 unique sequences remained. In exploratory analyses, the simulation model estimated that median 1st line PFS (95% CI) of 219 (25%) patients could be improved from 175 (156, 199) to 269 days (247, 293) by targeting a different treatment. Conclusions: This was an initial exploration of the potential for data visualization and simulation modeling to inform understanding of practice in mCRC and to guide clinical decision making. Such tools allow clinicians and health system providers to define variation in practice patterns and to identify opportunities to improve care and outcomes. Ultimately, the aim is to improve the delivery of personalized cancer care, where other applications such as conditional survival and cost-effectiveness analyses may be useful.
Adoption and utilization of NGS-based molecular profiling in community-based oncology practices: Insights from Sarah Cannon.
Authors: McKenzie Andrew , Schlauch Daniel , Sharma Yasha , Spigel David R. , Burris Howard A. , Jones Suzanne Fields , Dilks Holli Hutcheson
Published: May 2019

e18064

Background: As the price of NGS-based sequencing technologies falls, adoption of those technologies is predicted to increase. To date, a survey of the adoption and utilization of NGS-based technologies as a part routine oncology clinical care has not been performed. Thus, a comprehensive analysis of physician adoption and utilization of commercial NGS testing in the community-setting between 2012 and 2018 was performed. Methods: Medical Oncologists in the Sarah Cannon Research Institute network ordered commercially-available NGS-based molecular profiling for their patients as standard of care. Data use agreements were initiated between SCRI, affiliated medical oncology practices, and commercial NGS testing providers, and patient NGS data were subsequently analyzed starting in 2012. Results: Community-based NGS testing rates within the Sarah Cannon network were 5.75/month in 2012 and 440/month in 2018. Plasma-based NGS testing began in 2014 and comprised 4.9% of total testing compared to 40.1% in 2018. The number of oncologists ordering molecular profiles increased from 11 in 2012 to 269 in 2018. Physician test utilization grew from an average of 6 tests/physician to 22 tests/physician in 2012 and 2018, respectively. NGS tests were performed on 34 different tumor types and biopsies were taken from both primary (~40%) and metastatic (~60%) sites . Tissue-based tests averaged 14 mutations/sample while plasma-based tests averaged 4 mutations/sample. There was a 74% decrease in median time between biopsy collection and NGS test results between 2012 and 2018 (131 and 34 days, respectively), indicating a shift toward the use of fresh – non-archival – tissue in recent years. Conclusions: These data establish NGS-based testing trends in community oncology practices and show that NGS-based tumor testing utilization has increased in the community-setting between 2012 and 2018. NGS testing is performed on a wide array of tumor types and oncologists utilize fresher biopsies.
Automating incidental findings in radiology reports using natural language processing and machine learning to identify and classify pulmonary nodules.
Authors: French Christi , Makowski Maciek , Terker Samantha , Clark Paul Alexander
Published: May 2019

e18093

Background: Pulmonary nodule incidental findings challenge providers to balance resource efficiency and high clinical quality. Incidental findings tend to be undertreated with studies reporting appropriate follow-up rates as low as 29%. Ensuring appropriate follow-up on all incidental findings is labor-intensive; requires the clinical reading and classification of radiology reports to identify high-risk lung nodules. We tested the feasibility of automating this process with natural language processing (NLP) and machine learning (ML). Methods: In cooperation with Sarah Cannon Research Institute (SCRI), we conducted a series of data science experiments utilizing NLP and ML computing techniques on 8,879 free-text, narrative CT (computerized tomography) radiology reports. Reports used were dated from Dec 8, 2015 - April 23, 2017, came from SCRI-affiliated Emergency Department, Inpatient, and Outpatient facilities and were a representative, random sample of the patient populations. Reports were divided into a development set for model training and validation, and a test set to evaluate model performance. Two models were developed - a “Nodule Model” was trained to detect the reported presence of a pulmonary nodule and a rules-based “Sizing Model” was developed to extract the size of the nodule in millimeters. Reports were bucketed into three prediction groups: > = 6 mm, < 6 mm, and no size indicated. Nodules were considered positives and placed in a queue for follow-up if the nodule was predicted > = 6 mm, or if the nodule had no size indicated and the radiology report contained the word “mass.” The Fleischner Society Guidelines and clinical review informed these definitions. Results: Precision and recall metrics were calculated for multiple model thresholds. A threshold was selected based on the validation set calculations and a success criterion of 90% queue precision was selected to minimize false positives. On the test dataset, the F1 measure of the entire pipeline (lung nodule classification model and size extraction model) was 72.9%, recall was 60.3%, and queue precision was 90.2%, exceeding success criteria. Conclusions: The experiments demonstrate the feasibility of NLP and ML technology to automate the detection and classification of pulmonary nodule incidental findings in radiology reports. This approach promises to improve healthcare quality by increasing the rate of appropriate lung nodule incidental finding follow-up and treatment without excessive labor or risking overutilization.
The impact of race and socioeconomic status on outcomes for HPV-associated squamous cell carcinoma of the head and neck.
Authors: Pike Luke Roy George , Royce Trevor Joseph , Mahal Amandeep R , Kim Daniel W. , Hwang William L. , Mahal Brandon Arvin Virgil , Sanford Nina Niu
Published: May 2019

e18103

Background: The socioeconomic factors affecting outcomes of human papillomavirus (HPV)-associated squamous cell carcinoma of the head and neck (SCCHN) are poorly characterized. Methods: A custom Surveillance, Epidemiology, and End Results (SEER) database identified adult patients with primary non-metastatic SCCHN and known HPV status diagnosed between 2013-14. Multivariable logistic regression defined associations between patient characteristics and HPV status, with adjusted odds ratios (AORs) and 95% confidence intervals (CIs) reported. Fine-Gray competing risks regression estimated adjusted hazard ratios (AHRs) and 95% CIs for cancer-specific mortality (CSM), including a disease subsite*HPV status*race interaction term. Results: 4735 patients with non-metastatic SCCHN and known HPV status were identified. HPV-associated SCCHN was positively associated with oropharyngeal primary, male sex and higher education and negatively associated with uninsured status, single marital status, and non-white race (p≤0.001 for all). For HPV-positive oropharyngeal SCCHN, white race was associated with lower CSM (AHR 0.55, 95%CI 0.34-0.88, p = 0.01) and uninsured status was associated with higher CSM (AHR 3.12, 95%CI 1.19-8.13, p = 0.02). These associations were not observed in HPV-negative or non-oropharynx SCCHN. Accordingly, there was a statistically significant disease subsite*HPV status*race interaction (pint< 0.001). Conclusions: Non-white race and uninsured status were associated with worse CSM in HPV-positive oropharyngeal SCCHN, while no such associations were observed in HPV-negative or non-oropharyngeal SCCHN. These results suggest that, despite having clinically favorable disease, non-white patients with HPV-positive oropharyngeal SCCHN have worse outcomes than their white peers. Further work is needed to understand and reduce socioeconomic disparities in SCCHN.
Examining predictors of female cancer treatment delay in Appalachian women.
Authors: Balkrishnan Rajesh , Batten George P , Desai Raj Piyush , Daniels Zachary H , Novruzov Lydia , Mole Susan J , Stepanov Nonna J , Roger Anderson
Published: May 2019

e18107

Background: Appalachian women have a higher burden of both morbidity and mortality from female cancers of the breast, ovary and cervix, and have documented treatment delay and poor adherence. The environmental and sociobehavioral risk factors that could contribute towards these issues such as patient non adherence and treatment delay have not been studied. Methods: We conducted a detailed survey of women seeking cancer related preventative care in a tertiary care cancer center in the Appalachian region of Virginia. Survey questions included health behaviors, financial issues, and past health history. The survey was administered to 200 women and a total of 158 complete responses (42 in women with cancer in the recent past) were obtained. Results: There were significant differences between women with and without female cancers with the cancer group being older, less likely to be married, be unemployed and more likely to have received mammograms (All p < 0.05). In multivariate analyses , the major risk factor associated with delaying treatment was the lack of health insurance in the previous year (RR: 0.25, 95% CI: 0.082-0.73). Conclusions: Women in Appalachia face significant barriers in receiving diagnoses and treatment for female cancer including lack of employment, health care insurance and social support. These factors need to be considered while designing interventions to improve access and adherence to cancer treatments in this population.
Disparities in the receipt of palliative care (PC) in metastatic renal cell carcinoma (mRCC).
Authors: Tella Sri Harsha , Kommalapati Anuhya , Tandra Pavan Kumar
Published: May 2019

e18108

Background: Early integration of PC has shown to improve quality of life and survival in some solid malignancies. In this study we sought to analyze the PC utilization in mRCC patients. Methods: Patients with mRCC reported to NCDB between 2004 & 2015 were extracted and we included the patients who died of mRCC. We classified the patients into three cohorts based on their length of survival ( < 6, 6-24, and > 24 months) to account for disease severity. Using SPSS, we performed multivariable logistic regression to determine the patient and institutional factors determining the PC use. Results: A total of 29,296 patients were analyzed. Overall, 20% (n = 5737) of the patients received PC. Among these, 7%,17%,7%, 53%, and 12% received pain management PC; palliative chemotherapy, surgery, radiation and combination therapies, respectively. On cox multivariate analysis, among patients that survived < 6 months, receipt of PC was associated with better overall survival (OS) [HR: 0.91 (CI:0.87-0.95), p < 0.01]. Patients who received PC were more likely to be of White race, non-Hispanic origin, treated at non-academic facilities, and had higher educational background (p < 0.01) (Table). Patients living in East, Central, and Mountain regions had higher odds of receiving PC than those in the Pacific coast. The odds of receiving PC were significantly higher in patients who survived for < 6 months as compared to that of > 24 months (23 vs 13%, p < 0.01). Conclusions: We noticed a significantly better OS in mRCC patients who received PC. Despite the benefits in OS and guidelines advocating the PC use, the overall PC utilization in mRCC is markedly low and plagued by race, facility type and geographic region. [Table: see text]
Insurance status and racial disparities in detection of early-stage breast cancer.
Authors: Ko Naomi , Hong Susan , Winn Robert , Calip Gregory Sampang
Published: May 2019

e18121

Background: Racial/ethnic minority women are diagnosed with later stage breast cancer. This study identifies the extent insurance can affect stage differences among a large, diverse population of breast cancer patients in the U.S. Methods: Retrospective, population-based study of women aged 40-64 years diagnosed with stages I-III breast cancer in the Surveillance, Epidemiology and End Results Program between 2010 and 2014. The primary outcome was risk of diagnosis with locally-advanced (stage III) versus early stage breast cancer (stages I-II). Causal mediation analyses were conducted to determine effects of race/ethnicity and proportion of observed differences mediated by health insurance status on earlier stage. Results: A total of 124,415 women (104,468 insured and 19,947 uninsured /Medicaid) were included. Among women with health insurance, a lower proportion was diagnosed with locally-advanced breast cancer compared to uninsured/Medicaid-covered women (11% versus 21%). In multivariable models, non-Hispanic Black (OR = 1.50, 95% CI 1.43-1.58), American Indian/Alaskan Native (OR = 1.38, 95% CI 1.11-1.72) and Hispanic (OR = 1.35, 95% CI 1.28-1.42) women had higher odds of being diagnosed with locally-advanced disease compared to non-Hispanic White women. When adjusting for health insurance and other socioeconomic factors, associations between race/ethnicity and risk of locally-advanced breast cancer were attenuated (non-Hispanic Black: OR = 1.30, 95% CI 1.23-1.37; American Indian/Alaskan Native: OR = 1.15, 95% CI 0.91-1.45; Hispanic: OR = 1.16, 95% CI 1.09-1.22). Approximately half (48% to 50%) of racial differences in risk of locally advanced disease were mediated by health insurance. Conclusions: We find that half of the observed racial/ethnic disparities in upstaging at diagnosis are mediated by health insurance coverage.
Improved hepatocellular carcinoma (HCC) outcomes in a public hospital setting with increased access to procedural-based therapy.
Authors: Ellent Elizabeth S. , Joshi Tejas V , McDaniel Lee S , Boulmay Brian C.
Published: May 2019

e18137

Background: HCC is the 2nd most common cause of cancer death in the world. We investigate if increased access to various treatment modalities improved outcomes in a public hospital setting. Access to procedural-based treatments improved with development of an in hospital interventional radiology program that resulted from increased public hospital funding starting in 2013 at University Medical Center in New Orleans (UMC). Methods: A retrospective chart review was conducted to analyze 124 patients (pts) diagnosed with HCC from 2013 to 2018 at UMC to determine effect of treatment modality on outcome. Comparative analysis and Fisher’s exact test was performed using a previous study analyzing a similar population (n = 107) from 2007-2013. Results: Pts with HCC treated with transarterial chemoembolization (TACE) had an overall survival (OS) of 82.55% and 54.84% at 1 and 3 years (yr). Pts not treated with TACE had OS of 60.69% and 38.49% at 1 and 3 yr. OS in the 2007-2013 cohort at 1 year was 29%. Progression free survival (PFS) in pts treated with TACE was 52.99% and 22.66% at 1 and 3 yr. PFS in patients not treated with TACE was 58.36% and 50.28% at 1 and 3 yr. Treatment with Sorafenib (S) with or without TACE had OS of 75.84% and 48.43% at 1 and 3 yr. Pts not receiving S had an OS of 69.17% and 48.47% at 1 and 3 yr. PFS was 37.27% and 10.57% in pts treated with S at 1 and 3 yr. PFS for pts not treated with S was 67.00% and 47.02% over 1 and 3 yr. There were 140 total IR procedures which averages to 1.13 IR procedures per pt. Compared to 2007-2013 cohort, more HCC pts had TACE (10% to 56%, p < 0.001) and received S (18% to 39%,p < 0.001). Conclusions: Although PFS was not better for those pts treated with TACE (p value = 0.218), OS was statistically better with TACE (p value = 0.003). Radiologic response rates do not appear to correlate with OS benefit, perhaps due to TACE effect on image interpretation. PFS was decreased in pts treated with S (p value = < 0.0001), possibly due to its use in pts who have progressed despite TACE. The 2013-2018 cohort has superior OS compared to the 2007-2013 cohort at 1 yr. Increased access to procedural- based, locoregional therapy and S positively impacts patient outcomes.
Investigating racial differences in treatment responses through analysis of real-world data (RWD).
Authors: Liu Zongzhi , Ma Meng , Grover Kartikey , Li Li , Goldsweig Howard , Yadav Kamlesh , Zhou Xiang , Mullaney Tommy , Redfern Arielle , Jappe Whitney , Zimmerman Michelle , Prentice Tony , Pan Qi , Oh William K. , Schadt Eric E. , Li Dan , Chen Rong
Published: May 2019

e18141

Background: Clinical trials remain the most reliable means to evaluate drug efficacy and safety for evidence-based cancer care. However, there is a significant racial disparity among participants in clinical trials. For example, only 1-3% of the participants in registration trials of immune checkpoint inhibitors (CPIs) in advanced non-small cell lung cancers (aNSCLCs) were Black. RWD data enable assessment of whether clinical trial results can be generalized to broader populations. Methods: We analyzed clinical records of > 145,000 cancer patients treated at Mount Sinai hospitals. Therapeutic agents approved by FDA in recent years were assessed for responses across various race groups. Time to treatment discontinuation (TTD) was used as a surrogate clinical endpoint for outcomes. Results: Overall we did not observe significant differences in TTD among different race groups for the following drugs and indications we examined: palbociclib in metastatic breast cancer (mBC), EGFR tyrosine kinase inhibitors in aNSCLC, EGFR antibody cetuximab and panitumumab in metastatic colorectal cancer with wild type KRAS, abiraterone in metastatic castration-resistant prostate cancer (mCRPC), enzalutamide in mCRPC, sorafenib in unresectable hepatocellular carcinoma (HCC), CPIs in metastatic melanoma. For example, the median TTD of palbociclib in combination with fulvestrant or letrozole in post-menopausal women with HR+HER2- mBC was 181, 261, and 160 days in White (n = 114), Black (n = 55), other (n = 48) race groups, respectively (P = 0.61, log-rank test). Among patients with unresectable HCC treated with sorafenib, the median TTD was 64, 49, and 67 days in the White (n = 201), Black (n = 127) and other (n = 243) race groups, respectively (P = 0.70). However, when CPIs in aNSCLC were examined, we observed a significantly longer TTD in the Black group (median TTD not reached; n = 77) compare to the non-Black group (169 days, 95% CI 133-331; n = 211), P = 0.0049, median follow up 194 days. Conclusions: RWD showed there are no apparent differences of treatment response in various race groups for most new therapeutic agents. Preliminary results of CPIs in aNSCLC suggested a favorable response in the Black than the non-Black population.
Impact of a pilot patient navigator program on pediatric cancer outcomes in a low resource setting.
Authors: Schroeder Kristin , Alvi Fatima , Johnston Hartlee , Masalu Nestory Andrew , Chao Nelson Jen An
Published: May 2019

e18152

Background: Oncology patient navigation programs have been successfully implemented at hospitals throughout the U.S., enhancing the quality of canceer care. In low resource settings, the barriers to receiving cancer care are increased and a patient navigator in this setting has the potential to significantly impact outcomes. However, research on efficacy is limited. Methods: At Bugando Medical Centre (BMC) in Mwanza, Tanzania, semi-structured qualitative interviews of 15 key stakeholders in the oncology department and 15 families of patient with pediatric cancer diagnoses were completed to identify health system delivery and patient related barriers to timeliness of diagnosis, treatment initiation, and treatment completion. Based on identified barriers, a pilot patient navigation program was established to assist patients and their families with care coordination throughout the diagnosis and treatment process. A retrospective analysis of hospital records was conducted of all pediatric oncology patients seen at BMC from 2010-2016, separated by presentation date before or after establishment of navigation program. Collected data includes demographics, diagnosis, time from presentation to oncology evaluation and diagnosis, and treatment completion. Results: Identified patient related barriers included patient diagnosis and treatment knowledge, and complexity of care. Health system delivery barriers included limited provider capacity, and poor care coordination between the oncology providers, other health care services and patient families. A total of 238 patient files were reviewed, with 169 pre- and 69 post- program initiation. Patient groups did not differ by age or gender (p = 0.329 and 0.744), or diagnosis distribution. The average time to oncology evaluation decreased from 49.7 to 16.6 days (p = 0.015), and time to diagnosis decreased from 49.1 to 23.6 days (p = 0.07). Treatment abandonment decreased from 50% to 38% (p < 0.001). Conclusions: In pediatric oncology, early diagnosis is critical to the initiation of chemotherapy and improving outcomes. These data suggest that a patient navigation program is feasible in a LMIC and can impact both health system inefficiency and treatment abandonment, with the potential to improve pediatric cancer outcomes.
Cancer patients experiencing homelessness: What’s happening to them?
Authors: Bingham Brian Stewart , Facer Benjin , Ivey Camille , Osmundson Evan
Published: May 2019

e18153

Background: Over three million people in the United States of America (USA) experience homelessness each year. Homeless patients have high rates of cancer risk factors, later stage diagnoses, and increased rates of cancer death. Despite this, little is known about the treatment of homeless patients with cancer. General recognition exists that homelessness is accompanied by socioeconomic challenges, but their effect on cancer treatment is unknown. This analysis identifies published data on cancer care in homeless populations and evaluates the difference in information volume related to screening and treatment. Methods: A PubMed, MEDLINE, and Web of Science search was performed using combinations of: “homeless, homeless persons, homelessness, street people, neoplasm, neoplasia, tumor, malignancy, cancer, screening, early detection of cancer, treatment, and therapy”. Each result was reviewed to identify primary research articles (excluded case reports and review articles) reporting data about cancer screening and/or treatment for homeless patients. For each included study, information was recorded including publication year, country, study type, patient numbers, and relevance to screening and/or treatment. Results: From this search, 61 publications were identified of which 29 were excluded due to inappropriate scope and/or publication type. In total, 32 publications were included for analysis. Most (81%) reported data from the USA and all were published in 1998 or later. Thirty (94%) reported data about cancer screening in homeless patients. In contrast, only two (6%) reported data about treatment and outcomes. Combined, these studies report screening data from over 8,000 patients compared to treatment data from less than 100. Only one publication reported utilization rates of different treatment modalities. Conclusions: This analysis highlights a disparity in published data about cancer screening and treatment for homeless patients. Little data exists regarding treatment and outcomes of homeless patients following a cancer diagnosis, with even less data about modalities, side effects, and follow-up. Future studies on treatment and outcomes of homeless cancer patients will identify barriers unique to this population and contribute to more evidence-based practices.
Race as an independent factor for survival in breast cancer patients according to analysis of the National Cancer Database (NCDB).
Authors: Murray Drew Carl Drennan , Bhandari Shruti , Ngo Phuong , Mudra Sarah , Lele Rachana Shirish , Srivastava Sudhir , Wu Xiaoyong , Rai Shesh , Mandadi Mounika , Riley Elizabeth Carloss
Published: May 2019

e18155

Background: Black (B) women after early stage of diagnosis have been shown to have double the risk of white (W) women for failing to receive adjuvant chemotherapy. Despite lower incidence of breast cancer in B patients, they are more likely to die of the disease. Worse outcomes in B populations have been related to clinical and socioeconomic factors. However, the determination of improved access and its effects on survival in black patients remains uncertain. Methods: 1042844 patients diagnosed between 2004 and 2014 with stage I-III breast cancer were identified in the NCDB. Only W and B races were analyzed with established risk factors of age, stage, comorbidity score, and insurance status. Data was analyzed using univariable and multivariable logistic and Cox proportional hazards regression models. Odds Ratio (OR) for binary outcome, Hazard Ratio (HR) for time-to-event (survival) outcome along with 95% confidence interval (95% CI) are reported. Results: Among the total population 85.5% were W, 10.6% B, and 3.9% other. B were more likely to be uninsured (OR: 1.66; 95% CI: 1.59 - 1.72; p < 0.0001), or have Medicaid (OR: 2.01; 95% CI: 1.96 - 2.07; p < 0.0001). B were also diagnosed at later stage (stage 3 OR: 1.59; 95% CI: 1.57 - 1.63; p < 0.0001) with higher co-morbidities (OR: 2.49; 95% CI: 2.34 - 2.67; p < 0.0001) consistent with prior studies. B were more likely to experience delayed treatment (OR: 2.15; 95% CI: 2.10 - 2.20; p < 0.0001). B race remained an independent factor associated with higher likelihood of death compared to W patients (HR: 1.32; 95% CI: 1.3 - 1.34; p < 0.0001) in multivariable analysis. Conclusions: This large database study demonstrates that even when controlling for established risk factors such lack of insurance or Medicaid, higher comorbidities, and later stage at diagnosis, B patients were more likely to experience delays in treatment initiation and worse overall survival. This suggests race remains an independent risk factor for poor outcome even when clinical factors are matched. Further analysis including tumor biology should be examined to better understand this persistent disparity.
Barriers to clinical trial accrual: Clinical trialists' perspectives.
Authors: Kim Edward S. , Kurbegov Dax , Hurley Patricia A. , Waterhouse David Michael
Published: May 2019

e18156

Background: Oncology clinical trial participation rates remain at historic lows. There are many barriers that impede participation. Understanding those barriers, from the perspective of cancer clinical trialists, will help develop solutions to increase physician and site engagement, with the goal of improving accrual rates and advancing cancer treatment. Methods: Physician investigators and research staff from community-based and academic-based research sites were surveyed during ASCO’s Research Community Forum (RCF) Annual Meeting (N = 159) and through a pre-meeting survey (N = 124) in 2018. Findings and potential solutions were discussed during the meeting. Results: 84% of respondents (n = 84) reported that it took 6-8 months to open a trial and 86% (n = 81) reported that trials had unnecessary delays 70% of the time. The top 10 barriers to accrual identified were: insufficient staffing resources, restrictive eligibility criteria, physician buy-in, site access to trials, burdensome regulatory requirements, difficulty identifying patients, lack of suitable trials, sponsor and contract research organization requirements, patient barriers, and site cost-benefit. Respondents shared strategies to address these barriers. Conclusions: The current state of conducting clinical trials is not sustainable and hinders clinical trial participation. New strategies are needed to ensure patients and practices have access to trials, standardize and streamline processes, reduce inefficiencies, simplify trial activation, reduce regulatory burden, provide sufficient compensation to sites, engage the community and patients, educate the public, and increase collaborations. The ASCO RCF offers resources, available to the public, that offer practical strategies to overcome barriers to clinical trial accrual and has ongoing efforts to facilitate oncology practice participation in clinical trials.
Are racial differences in obesity and insulin resistance related to aggressive breast cancer?
Authors: Gallagher Emily , Leroith Derek , Feldman Sheldon M. , Port Elisa R. , Friedman Neil B , Boolbol Susan K , Killelea Brigid K. , Choi Lydia , Fei Kezhen , Franco Rebeca , Yagnik Radhi , Cruz Daliz , Bickell Nina A.
Published: May 2019

e18157

Background: Black women are more likely to die of breast cancer and develop more aggressive subtypes than white women. Black women are also more likely to be obese and have insulin resistance than white women. Insulin resistance has been associated with faster tumor growth but has not been studied as a potential mediator of racial disparities in women with breast cancer. We hypothesized that black women would present with more aggressive breast cancer and this would be associated with obesity and insulin resistance. Methods: We recruited 1017 (80% white, 20% black) women with new primary breast cancer, measured fasting blood glucose and insulin, body mass index (BMI), triple negative breast cancer (TNBC) & Nottingham prognostic index (NPI). We classified aggressive breast cancer as NPI > 4.4. We calculated insulin resistance scores (HOMA) and classified insulin resistance as HOMA > 2.8. Patients self-identified race. Results: Of 1017 women, average age was 58 years (SD = 12.0). 373 (37%) were stage 2+ at time of diagnosis; 19% had an NPI > 4.4. Black women presented with higher stage of cancer than white women (stage 2+: 45% vs 35%; p = 0.01), more TNBC than white women (10% vs 5%, p = 0.01), were more insulin resistant (24% vs 11%, p < .0001), had higher BMI (31.4kg/m2 vs 26.6 kg/m2; p < .0001) and NPI > 4.4 (29% vs. 17%, p = 0.0002) than white women. HOMA score was positively but not significantly associated with NPI score (r = 0.05; p = 0.1). Multivariate mediation regression model suggested that HOMA_IR does not mediate the effect from black race to higher NPI score (β = 0.01; 95%CI: -0.017 to 0.039). Conclusions: In women with newly diagnosed breast cancer, black women are more likely to be obese, have higher HOMA & NPI scores than white women. While these data are consistent with the hypothesized relationship of hyperinsulinemia promoting more aggressive breast cancer, to date, insulin resistance does not appear to mediate the effect of race and poor prognostic breast cancer.
The impact of ACA on medical financial hardship among cancer survivors.
Authors: Winn Aaron N , Knueppel Parker , Neuner Joan Marie
Published: May 2019

e18160

Background: Prior research has documented that privately insured cancer patients are exposed to significant financial burdens which can result in bankruptcy. A key provision of the Affordable Care Act (ACA) was to set limits on patients out-of-pocket (OOP) spending, which was implemented in 2014. This study aims to assess if OOP limits reduces financial hardship. Methods: Using the 2000-2017 National Health Interview Survey we identified cancer survivors under age 65. We performed a difference in difference analysis which compared financial hardship for low- or moderate-income individuals (LMII), family income under $50,000, to those with higher incomes before and after OOP limits were implemented for privately insured patients. Financial hardship was measured in the following ways: delayed medical care due to cost and the number of family members delayed medical care due to costs, could not afford a prescription, medical care or seeing a specialist, and problems paying medical bills. We used multivariate regression models adjusting for age, race, marital status, gender and size of family. All analyses accounted for the complex survey design and weights. Results: We identified 20,879 privately insured, cancer survivors age 65 or younger. The impact of the ACA resulted in lower financial hardships for LMII compared to higher income persons for most outcomes. The impact of the OOP limits on financial hardship for LMII was seen in any family member delaying care due to costs (difference-in-difference (DiD) = -3.6%; 95% CI = -5.9%, -1.5%; p-value = 0.002), number of family members delaying care due to costs (DiD = -0.048; 95% CI = -0.082, -0.135; p-value = 0.002), had problems paying medical bills (DiD = -3.3%; 95% CI = -6.3%, -0.4%; p-value = 0.028), could not afford prescription medication (DiD = -2.3%; 95% CI = -4.2%, -0.3%; p-value = 0.023), could not afford medical care (DiD = -1.9%; 95% CI = -3.5%, -0.3%; p-value = 0.021), but there was no statistically significant difference in the ability to afford seeing a specialist (DiD = -1.1%; 95% CI = -2.6%, -0.5%; p-value = 0.002). Conclusions: Little research has examined the impact of the ACA’s OOP spending limits. In this study we find that after the introduction of OOP spending limits, financial hardship measured in a variety of ways significantly decreased for LMII.
Building international partnerships to improve global oncological care: Perspective from Rutgers-CINJ Global Oncology Fellowship Program.
Authors: Chandar Ashwin , Kaur Sukhdeep , Toppmeyer Deborah , Ralefala Tlotlo Bathethi , Strair Roger , Philipp Claire , Marlink Richard , Antony Reena , DiGiacobbe Marilyn , Lebelonyane Refeletswe , Gaolathe Tendani , Mayer Tina M.
Published: May 2019

e18161

Background: With cancer accounting for 1 in every 7 deaths worldwide and 60-70% of cancer deaths occurring in low- and middle-income countries, any advancement in cancer care should include understanding to alleviate structural inequalities that produce these global oncologic disparities. Rutgers-Cancer Institute of New Jersey (R-CINJ) Oncology Fellowship program, through partnerships with Rutgers Global Health and University of Botswana (UB), established a global oncology program in 2018 to provide young oncologists in training with this educational opportunity. Aims included understanding challenges faced by cancer patients in Botswana, evaluating opportunities to improve oncology care at Princess Marina Hospital (PMH), scholarly collaborations, and exchange knowledge. Methods: In partnership with PMH, UB, and Ministry of Health and Wellness (MOHW), R-CINJ created a global oncology program consisting of a 1 month rotation at PMH in Gaborone, Botswana, as well as longitudinal research/quality improvement (QI) projects. Two 3rd year oncology fellows rotated with house officers and oncologist at PMH. Weekly video conferences facilitated communication during the elective. Projects continued throughout 3rd year of fellowship, in conjunction with programmatic meetings. Results: Fellows gained exposure to cancer care using limited resources. In working with PMH staff, mentorship was provided, QI ideas were shared, and organizational changes were implemented. Scholarly activity was undertaken to examine trends in chemotherapy utilization at PMH over a 12-month period to assess patterns of malignancy and issues with stock outs. Relationship between pathology at PMH, UB, R-CINJ, and Rutgers Biomedical Engineering was established to expand digital pathology services in Botswana. Conclusions: Our global oncology program is a successful start to an ongoing partnership to help improve cancer care in Botswana. Future directions include development of cancer guidelines and protocols in Botswana, helping limit medication shortages, and establishing telemedicine based collaboration to assist with diagnosis and improve pathology turnaround time.
Influence of timing of goals of care discussion on hospitalization outcomes in metastatic cancer patients.
Authors: Emiloju Oluwadunni , Djibo Djeneba Audrey , Ford Jean G
Published: May 2019

e18183

Background: Cancer patients often require acute hospitalizations, many of which are unplanned. These hospitalizations have been shown to increase in frequency near the end of life. The American College of Physicians recommends that goals of care (GOC) discussions be initiated early for metastatic cancers. We hypothesize that discussing GOC during hospitalization will help reduce readmissions and improve patient satisfaction, by helping to ensure that patients receive goal-congruent care. We aim to examine the association between the timing of GOC discussion and the patient's length of stay and the time to hospital readmission. Methods: We conducted a retrospective review of medical records of patients with stage IV solid tumors who were hospitalized acutely between August 2017 and July 2018 (N = 241). We assessed demographics, clinical information, timing of GOC discussion, use of palliative care services and hospital readmissions within 90 days. Chi-square tests were used to identify independent associations with having a GOC discussion; and anova was used for continuous variables. We used logistic regression to examine the association with a hospital readmission within 90 days, controlling for potential confounders. Results: The subjects were 26-92 years old and 40.6% were female. Only 43% (n = 106) of patients had a GOC discussion. Age, gender, tumor site, and presenting complaint were not independently associated with having a GOC discussion (p > 0.05). Overall, 34.4% (n = 83) had a palliative care encounter. Having a palliative care consult and being admitted to critical care were independently associated with having a GOC discussion. Early timing of GOC discussion was inversely associated with admission to critical care units (p < 0.05). Length of stay was positively correlated with having a GOC discussion. Thirty-seven percent (n = 91) had unplanned hospital readmission within 90 days. Having any GOC discussion reduced the odds of an unplanned hospital readmission within 90 days by 75% [OR = 0.25, 95% confidence interval (CI) 0.14-0.45]. Conclusions: Among hospitalized patients with stage IV cancer, performing an early GOC discussion is associated with better hospitalization outcomes. It is therefore important to perform GOC discussion early when such patients are acutely hospitalized.
Inpatient outcome of solid tumor associated tumor lysis syndrome.
Authors: Gong Zimu , Ali Faisal , Wang Yanting , Syed Sabah , Garcia Jessica Lee
Published: May 2019

e18185

Background: Tumor lysis syndrome (TLS) is a constellation of metabolic disturbances that can occur in virtually any malignancy, though it is more common in hematological malignancies given their high tumor burden and growth index. While TLS can occur in patients with solid tumors, the clinical behavior and outcome of solid tumor associated-TLS (STA-TLS) is not well characterized. Methods: We used the national inpatient sample to identify patients with STA-TLS (utilizing the ICD10 code E883; and ICD9 code 27788), from year 2010 through year 2016. Patients with both hematological malignancy and solid tumor, and patients without a cancer diagnosis were excluded. Results: A total of 11,733 patients were identified using the above criteria, of which 2117 (18.0%) had STA-TLS. The median age at admission was 63 years and 940 (44.4%) STA-TLS patients were females. The most common primary cancer sites were lung (26.8%), breast (4.2%), and colon (3.7%). Patients with STA-TLS were more likely to receive mechanical ventilation and less likely to receive red blood cell or platelet transfusion compared to those with hematological malignancies ( Table). STA-TLS was also associated with a significantly higher inpatient mortality rate and shorter length of stay than TLS in hematological malignancies ( P < 0.001). No statistically significant difference was found in the requirement of dialysis, transfusion of plasma, and cardiac arrest rates. Conclusions: STA-TLS is rare with an inferior outcome than TLS in hematological malignancies evident by a higher mechanical ventilation and mortality rate. Future studies should identify factors that impact management and outcome of STA-TLS. [Table: see text]
Vitamin D status and survival in patients with triple negative breast cancer.
Authors: Khoury John , Jinna Sruthi , Sahlieh Ali , Chacko Rebecca , Macari David , Jaiyesimi Ishmael A. , Huben Marianne T.
Published: May 2019

e18210

Background: Although many studies have investigated the association of blood 25OH-vitamin D (vit-D) levels with breast cancer prognosis, the results have been mixed. It has been suggested that low vit-D concentrations were associated with advanced tumor stage and triple-negative (TNBC) subtype. We retrospectively investigated associations of serum vit-D levels with triple negative breast cancer outcome. Methods: Out of 797 cases of TNBC diagnosed at William Beaumont Hospital between 2006-2017, 163 patients had vit-D level available within 1 year prior to diagnosis. Analyses of vit-D levels was classified by 3 cut points (deficient, < 20.0 ng/mL; insufficient, 20.0-29.9 ng/mL; sufficient, ≥30.0 ng/mL). Primary outcomes are disease free survival (DFS) and overall survival (OS). SPSS statistics 25 software was used to analyze the data. Results: Median age of diagnosis of TNBC was 60. Of these patients 43.6% were diagnosed with stage I, 37.4% at stage II, 4.9% at stage III and 4.9% at stage IV. 47.2% of the patients had sufficient vit-D level prior to diagnosis, 28.2% with insufficient vit-D level and 24.5% with deficient vit-D. Vit-D deficiency was more prevalent in premenopausal than in postmenopausal women (33.3%, 41% and 25.6% in premenopausal women for deficient, insufficient and sufficient levels respectively vs 21.8%, 24.2% and 54% in postmenopausal women). Rates of Vit-D deficiency were not different between early disease and advanced disease (24.3% of patient with stage I-II vs 25% in patients with stage III-IV). Median OS and disease-free survival were not statistically different among the 3 different categories. 5-year OS was 91%, 91% and 85% for deficient, insufficient and sufficient levels respectively. 5-year DFS was 93%, 95% and 95% for deficient, insufficient and sufficient levels respectively. Multivariate COX regression analysis demonstrated that age and stage were associated with mortality, whereas vit-D level was not. Conclusions: The results from this study show that adequate vit-D level do not have an impact on OS and DFS in patients with triple negative breast cancer. Premenopausal women are more likely to have inadequate vit-D level. Identification and treatment of vitamin D deficiency is still important for musculoskeletal health and possibly extraskeletal health in general population and breast cancer survivors specifically.
Socioeconomic contributions to clinical outcome by HPV status in squamous cell carcinomas of the head and neck (SCCHN): An analysis of NCDB.
Authors: Marks Jennifer Aline , Switchenko Jeffrey M. , Steuer Conor Ernst , Herrin Sara , Ryan Martha A. , Patel Mihir , El-Deiry Mark , Beitler Jonathan Jay , Shin Dong Moon , Gillespie Theresa Wicklin , Saba Nabil F.
Published: May 2019

e18214

Background: HPV association remains one of the most important predictors of clinical outcome in SCCHN. We aimed to determine whether the relationship between HPV status and overall survival (OS) varied by certain socioeconomic factors. Methods: Data were obtained from the National Cancer Database (NCDB). We examined the relationship between OS and HPV status, controlling for demographics and socioeconomic variables (insurance, income, education, urban/rural, great circle distance, and/or distance to treatment facility of 0-10, 10-50, and > 50 miles). Results: HPV status modified the relationship between insurance status (p = 0.011), urban/rural residence (p = 0.041), and overall survival, controlling for age, race, sex, and clinical stage. Whereas for HPV- patients, government insurance conferred a lower risk of death compared to no insurance (HR: 0.86, 95% CI: 0.75-0.99, p = 0.038); this finding did not hold for patients with HPV related disease (HR: 0.97, 95% CI: 0.80-1.18, p = 0.781). For patients with HPV related SCCHN, those living in rural areas have significantly higher risk of death compared to those living in metro areas (HR: 1.55, 95% CI: 1.17-2.05, p = 0.002), which did not hold for patients with HPV unrelated SCCHN (HR: 0.94, 95% CI: 0.68-1.30, p = 0.703). Conclusions: Despite HPV’s prospective prognostication, patients with HPV + SCCHN who live in rural environments have a higher risk of death likely from lack of physical access to care. This finding did not hold for HPV negative population, presumably because of their worse outcomes at baseline, and their struggle for access to care regardless of physical location.
Impact of the addition of bevacizumab (Bev) to chemotherapy on survival in metastatic colorectal cancer (MCRC): A real-world population-based analysis.
Authors: Kannappan Sunand Nageswaran , Arora Rahul Krishan , Cheung Winson Y.
Published: May 2019

e18215

Background: The addition of bev to IFL chemotherapy in MCRC was shown to improve survival in clinical trials, but its benefit in the real-world where it is frequently used with other systemic therapy regimens has not been fully evaluated. We aimed to assess the impact of bev on MCRC outcomes in a population-based setting. Methods: We examined all patients diagnosed with MCRC from a large Canadian province between 2004 and 2016. We categorized cases based on receipt of bev. Predictors of bev use were examined with multivariate logistic regression models. We also determined correlates of overall survival (OS) and disease specific survival (DSS) using Kaplan-Meier methods and Cox regression models, adjusting for measured confounders. Results: In total, 1,324 MCRC patients received systemic therapy. Median age was 68 years and 728 (55.0%) were men. Among them, 310 (23.4%) received bev. Younger age and better Charlson comorbidity score were associated with a higher likelihood of bev treatment (all p < 0.05). In multivariate analysis, bevacizumab receipt did not correlate with OS or DSS for the entire cohort or for those who received bev with single agent chemotherapy (see Table). However, use of bev was correlated with improved outcomes for patients treated with oxaliplatin-based chemotherapy (HR for OS: 0.751 [0.571 – 0.987], p = 0.040; HR for DSS: 0.680 [0.502 – 0.920], p = 0.013), but worse outcomes for irinotecan-based chemotherapy (HR for OS: 1.327 [1.083 – 1.628], p = 0.006; HR for DSS: 1.309 [1.054 – 1.627], p = 0.015). Conclusions: Bev was only associated with improved survival when used with specific chemotherapy regimens. Table: Univariate and multivariate survival analysis for MCRC patients based on receipt of bevacizumab. m = median; (m) = months; HR = hazard ratio [Table: see text]