bluuebunny/crossref_metadata_2025_split huggingface dataset:
Potential impact of clinical trial (CT) participation on survival of patients with metastatic non-small cell lung cancer (NSCLC).
Authors: Merkhofer Cristina , Eaton Keith D. , Martins Renato G. , Ramsey Scott David , Goulart Bernardo H. L. 
Published: October 2019

137 Background: Evidence is conflicting as to whether enrollment in therapeutic drug trials confers a survival benefit for NSCLC patients. We assessed the effect of CT participation on overall survival in a cohort of metastatic NSCLC patients treated at a single large academic center. Methods: We retrospectively revised medical records of patients with metastatic NSCLC diagnosed between 1/1/2007 and 12/31/2015 that received treatment at the Seattle Cancer Care Alliance. Eligibility criteria included receipt of ≥ 1 anti-cancer drug within 180 days of M1 diagnosis, no active second malignancy, and 60 day minimum survival. We abstracted patient sociodemographic characteristics, smoking history, ECOG score, tumor histology, EGFR and ALK status, presence of brain metastases, systemic treatment history up to 5 lines, drug trial enrollment, and trial characteristics. We obtained death dates from the Washington State cancer registry complemented by medical records, censoring patients that were alive at end of follow-up (3/7/2019). We used multivariate Cox regression to test whether enrollment in ≥ 1 CT was associated with overall survival. Results: Of 371 eligible patients (median age 63.9 years, 47% male, 94% non-squamous histology, 30% never-smokers, 58% ECOG 0-1, 20% EGFR positive and 8% ALK positive, and 27% brain metastases), 118 (32%) enrolled in ≥ 1 CT. Of CT enrollees: 19% enrolled in > 1 CT, 89% in phase I/II trials, 15% in phase III trials, 26% in randomized trials, and 51% in trials of drugs later approved by the FDA. Median survival in CT enrollees was 838 days (95% CI 688, 1,021), as compared to 454 days in non-enrollees (95% CI 378, 511). After adjusting for sex, ECOG score, smoking, histology, EGFR and ALK status, and presence of brain metastases, CT enrollees had a 47% lower risk of death relative to non-enrollees (HR 0.53; 95% CI 0.13, 0.92; P = 0.002). Conclusions: Participation in therapeutic drug trials is associated with longer overall survival in advanced NSCLC. Besides supporting drug development, CT participation may directly benefit NSCLC patients by providing access to promising agents and/or enhanced supportive care.
Level of scientific evidence supporting NCCN guidelines: Is there evidence of progress?
Authors: Desai Aakash , Go Ronald S. , Poonacha Thejaswi 
Published: October 2019

14 Background: National Comprehensive Cancer Network (NCCN) guidelines are the most comprehensive and widely used standard for clinical care in oncology by clinicians and payors in the US. The level of scientific evidence in NCCN guidelines has not been studied since it’s last review in 2010. We describe the categories of evidence and consensus (EC) among the 10 most common cancers in the US as of 2019 and compare them with 2010 guidelines. Methods: We obtained the 2019 version of NCCN guidelines. The definitions for various categories of EC used were: Category 1 (high level evidence such as randomized controlled trials with uniform consensus), 2A (lower level of evidence with uniform consensus), 2B (lower level of evidence without a uniform consensus but with no major disagreement) and 3 (any level of evidence but with major disagreement). We compared our results with previously published results from 2010 guidelines. Results: Total recommendations increased by 77% from 1023 (2010) to 1818 (2019). Of the 1818 recommendations, Category 1, 2A, 2B and 3 EC were 7%, 87%, 6% and 0% while in 2010 they were 5%, 85%, 9% and 1% respectively. Recommendations with category 1 EC were found in lung (13%), prostate (11%), melanoma (8%), breast (7%), NHL (5%), kidney (2%), bladder (2%) and colorectal (2%) guidelines. Pancreatic and uterine cancer guidelines had no recommendations with category 1 EC. 19% of therapeutic recommendations were category 1 EC with the majority (65%) pertaining to initial therapy. Guidelines with highest proportions of therapeutic recommendations with category 1 EC were breast (30%), lung (10%), and kidney (10%) cancers. No category 1 EC recommendations existed in screening or surveillance. Although we found an increase in the total number of recommendations, the distribution of different types of categories of EC are largely similar to 2010. Conclusions: Recommendations in 2019 NCCN guidelines are largely derived from lower levels of evidence with uniform expert opinion. Despite the major advances in oncology in the past decade, this is largely unchanged. Our study underscores the urgent need and available opportunities to expand the current evidence base in oncology which forms the platform for clinical practice guidelines.
Racial/ethnic disparities in childhood cancer survival in the United States: Mediation effects of health insurance coverage and area-level social deprivation.
Authors: Zhao Jingxuan , Han Xuesong , Zheng Zhiyuan , Nogueira Leticia Maciel , Nathan Paul C. , Lu Amy , Yabroff K Robin 
Published: October 2019

143 Background: Childhood cancer survival varies by race/ethnicity in the United States. This study evaluated the impact of potentially modifiable characteristics - health insurance and area-level social deprivation - on racial/ethnic disparities in childhood cancer survival nationwide. Methods: We identified 65,113 childhood cancer patients aged < 18 years newly diagnosed with any of 10 common cancer types (e.g. central nervous system (CNS) neoplasms, acute lymphoblastic leukemia (ALL), Hodgkin lymphoma) from the 2004-2014 National Cancer Database. Cox proportional hazard models were used to compare survival probabilities by race and ethnicity (non-Hispanic white (NHW) vs non-Hispanic black (NHB), Hispanic, and non-Hispanic other (NH other)) for each cancer type. We conducted mediation analyses by the mma R package to evaluate the racial/ethnic survival disparities mediated by health insurance (private, Medicaid, and uninsured) and social deprivation index (SDI) quartile. SDI is a composite measure of deprivation based on seven characteristics (e.g. income, education, employment). Results: Compared to NHW, worse survival were observed for NHB (HR (hazard ratio): 1.4, 95% CI: 1.3-1.5), Hispanic (HR: 1.2, 95% CI: 1.1-1.2), and NH other (HR: 1.2, 95% CI: 1.1-1.3) for all cancer sites combined after adjusting for sociodemographic characteristics other than health insurance and SDI. Health insurance explained 20% of the survival disparities and SDI explained 19% of the disparity between NHB vs NHW; health insurance explained 48% of the survival disparities and SDI explained 45% of the disparity between Hispanic vs NHW. For ALL, health insurance significantly explained 15% and 18% of the survival disparities between NHB and Hispanic vs NHW, respectively. SDI significantly explained 19% and 31% of the disparities, respectively. Conclusions: Health insurance and SDI mediated racial/ethnic survival disparities for several childhood cancers. Expanding insurance coverage and improving healthcare access in disadvantaged areas may effectively reduce disparities for these cancer sites.
Barriers to minority recruitment in a multicenter clinical trial (PRO-TECT [AFT-39]): Research staff insights.
Authors: Charlot Marjory , Henson Sydney , Spears Patty , Schrag Deborah , Stover Angela M. , Basch Ethan M. 
Published: October 2019

145 Background: Rates of minority enrollment in U.S. cancer clinical trials, including supportive care trials, are disproportionately low. Clinical research associates (CRAs) are the linchpin for successful accrual and often help screen and approach patients to discuss research studies. We sought to understand clinic-level factors that influence recruitment of African American patients (AA) in an ongoing U.S. multicenter, cluster- randomized controlled trial (PRO-TECT: Patient-Reported Outcomes to Enhance Cancer Treatment; NCT03249090 AFT-39]). Notably, partway through this trial, a purposeful enrollment strategy was initiated where sites were asked to focus on minority recruitment. Methods: A subset of community oncology practices participating in PRO-TECT was identified with: 1) overall patient populations ≥20% AA; or 2) <20% AA but trial enrollment ≥20% AA. Semi-structured phone interviews were conducted with CRAs at each site to elicit perceived barriers and facilitators in identifying and approaching AA patients for this trial. Results: Among 13 identified community practices out of a potential 50 randomized sites, 3 had populations <20% AA but enrollment >20% AA; 3 had populations ≥20% AA but enrollment <20% AA; and 7 had populations ≥20% AA and enrollment >20% AA. All sites identified participants through review of clinic visit lists with clinicians. Eleven out of 13 sites felt they experienced no barriers to identifying, approaching, or enrolling minority patients. One site CRA felt minority patients are often “too sick to participate”. One CRA felt awkward about the request to purposefully approach minority patients. Conclusions: Site CRAs generally did not perceive barriers to minority recruitment, even when their population demographics were underrepresented in accrual. Results of efforts in this trial to increase minority participation through a purposeful enrollment strategy will be reported elsewhere.
Bias and stereotyping among research and clinical professionals: Perspectives on minority recruitment for oncology clinical trials.
Authors: Niranjan Soumya J. , Martin Michelle Y. , Fouad Mona N , Vickers Selwyn M. , Wenzel Jennifer , Cook Elise D. , Konety Badrinath R. , Durant Raegan W 
Published: October 2019

152 Background: Extensive attention has been paid in recent years to the possibility that bias among health care professionals contributes to health disparities. In its 2003 report, Unequal Treatment, the Institute of Medicine concluded that bias against racial minorities may affect communication or care offered. However, the role of bias in the context of recruitment of racial minorities in cancer clinical trials has not been explored. Therefore, we assessed clinical and research personnel’s experiences related to factors influencing recruitment of racial and ethnic minorities for cancer clinical trials. Methods: Ninety-one qualitative interviews were conducted at 5 U.S. cancer centers among 4 stakeholder groups: cancer center leaders, principal investigators, referring clinicians and research staff. Data analysis was conducted using a content analysis approach to generate themes from the transcribed interviews. Results: Five prominent themes emerged. 1) Recruitment interactions with potential minority participants were perceived to be challenging. 2) Potential minority participants were not perceived to be ideal study candidates. 3) A combination of clinic level barriers and negative perceptions of minority study participants led to providers withholding clinical trial opportunities from potential minority participants. 4) When clinical trial recruitment practices were tailored to minority patients, addressing research misconceptions to build trust was a common strategy. 5) For some respondents, race was perceived as irrelevant when screening and recruiting potential minority participants for clinical trials. Conclusions: Not only did some respondents view racial and ethnic minorities as less promising participants, some respondents reported withholding trial opportunities to minorities based on these perceptions. Some providers endorsed using tailored recruitment strategies while others eschewed race as a factor in trial recruitment. The presence of bias and stereotyping among clinical and research professionals recruiting for cancer clinical trials, should be considered when designing interventions to increase minority enrollment.
ENRICH: Validating a multidimensional patient-reported financial toxicity measure.
Authors: Smith Grace L. , Volk Robert Joseph , Lowenstein Lisa M , Peterson Susan K. , Rieber Alyssa G. , Checka Cristina , Christopherson Kaitlin M. , Jagsi Reshma , Giordano Sharon H. , Mendoza Tito R. 
Published: October 2019

153 Background: Financial toxicity is a patient-reported outcome reflecting burdens of cancer treatment costs. There is a need to assess financial toxicity in cancer care, as its unique domains—upstream factors like direct medical costs or downstream economic impact like bankruptcy—predict worse QOL, adherence, and mortality. Socioeconomically disadvantaged patients bear disparate financial toxicity burdens. We thus developed and report performance of a new measure, the Economic StraiN and Resilience in Cancer (ENRICh), to assess all financial toxicity domains in economically diverse patients. Methods: We studied 238 patients with Stage I-IV cancer from a tertiary academic comprehensive cancer center (MDA) and county safety-net hospital serving socioeconomically disadvantaged patients (LBJ). Financial toxicity domains and corresponding subscales were developed from qualitative/cognitive (n = 104) interviews. ENRICh and Comprehensive Score for Financial Toxicity (COST) questions were administered (n = 127; MDA = 71, LBJ = 56). To demonstrate known-group validity, we compared ENRICh scores between centers; for concurrent validity, we correlated ENRICh and COST; for reliability, we calculated Cronbach's coefficient α for ENRICh subscales (range 0, none, to 10, high burden). Results: There were 4 distinct, valid financial toxicity domains/subscales: 1) Burden of cost; 2) Disruption of financial stability; 3) Depletion of financial coping; 4) Depletion of instrumental coping. Patients from the 2 centers significantly differed in subscale and overall ENRICh scores. Socioeconomically disadvantaged patients had worse mean scores (4.9 vs 2.1, 95%CI -3.6,-2.1, effect size 1.4, P < .001). ENRICh significantly correlated with COST (r = -0.82, 95%CI -0.87,-0.77, P < .001). Subscales were reliable with excellent internal consistency (Cronbach α = 0.78 to 0.94). The 4 ENRICh domains collectively had synergistic impact on overall financial toxicity burden. Conclusions: ENRICh is valid, reliable, and identifies and 4 novel domains of financial toxicity. Future utility of this tool is to guide assessment/interventions targeting financial toxicity domains affecting diverse cancer patients, to mitigate disparities.
Examining Oncotype DX testing among a diverse patient population in North Carolina.
Authors: Marsh Katie , Benefield Thad , Lee Sheila , Henderson Louise 
Published: October 2019

154 Background: The Oncotype DX (ODX) is a 21-gene assay that quantifies the risk of breast cancer recurrence and predicts chemotherapy benefit among early stage, hormone-receptor positive patients. Most major insurance carriers now cover testing. We sought to determine factors associated with ODX testing in a diverse patient population. Methods: Data from the Carolina Mammography Registry (CMR), a breast imaging registry in North Carolina (NC) was used for this analysis. We included women ages 18 and over diagnosed with breast cancer from 2010-2017 who had a breast imaging exam at a CMR facility with no personal history of breast cancer. ODX testing was obtained through linkage with the NC Central Cancer Registry. Using a backwards elimination selection strategy, we explored the association of patient residence (urban versus rural), age, race, breast density, and family history of breast cancer on receipt of ODX testing. Results: Our population included 12,329 breast cancers among women that were 24.2% non-white with a median age of 64 years (11.2% < 50 years at time of diagnosis). The majority of our sample had dense breasts (52.0%), no family history of breast cancer (80.9%), and lived in urban areas (66.3%). Use of ODX testing increased from 15.7% in 2010 to 24.8% in 2017 (p-value for time trend < 0.00001). Compared with white women, black women were less likely to receive ODX testing (aOR = 0.57; 95% CI: 0.51-0.65), as were women of other races (aOR = 0.68; 95% CI: 0.51-0.90). We found that for every year age increased, the likelihood of receiving ODX testing decreased (aOR = 0.98, 95% CI: 0.97-0.98). Patient residence and breast density influenced the association of ODX testing. Among women in urban areas, women with dense versus non-dense breasts were more likely to receive ODX testing (aOR = 1.13; 95% CI: 1.01-1.27). Among women in rural areas, density was not associated with ODX testing (aOR = 0.91; 95% CI: 0.78-1.06). Conclusions: In our cohort, ODX testing was more common among younger white women with dense breast tissue living in urban areas of NC. Additional research to understand differences in testing by rural/urban areas are warranted to ensure that all appropriate patients receive this genetic assay.
Assessing time to treatment initiation and care delivery among patients with cancer and co-occurring Alzheimer's disease and related dementia using claims data.
Authors: Schiaffino Melody K 
Published: October 2019

161 Background: Colorectal cancer (CRC) is one of the most commonly diagnosed cancers in Americans. Prognosis for survival is better if cancer is detected at an early stage, the patient is from a majority racial/ethnic group, and not a member of an older age cohort ( > 65). Risk is also exacerbated when a patient is dealing with concurring condition such as Alzheimer's Disease or dementia (ADRD)which affects approximately 10% of older adults. Methods: A SEER-Medicare cohort of patient with CRC from 2004-2013 was obtained from the NCI. After appropriate criteria were applied, only cases with all data for cancer and ADRD and first cancer-related treatment were included for an analysis sample of N = 54, 357. Results: The prevalence of concurrent ADRD and CRC in our sample was 3.1%. Mean time to treatment initiation (TTI) was 34.99 days for all patients, and 35.19 days for patients in the CRC-only group vs ~ 27 days in the CRC+ADRD group. Most patients in either group were Stage II though TTI decreased as patient stage at diagnosis increased. Conclusions: Using claims data to assess TTI in cancer patients suggests that TTI is shorter for patients with concurrent ADRD. While this may be attributable to ADRD patients existing interactions with the care delivery systems and the role of caregivers it is evident that additional contextual research is necessary to consider these systems and non-clinical factors.
Do rural cancer patients receive lower quality cancer care? Assessing the impact of rurality on oncology practice performance measures.
Authors: Fedorenko Catherine R. , Panattoni Laura Elizabeth , Sun Qin , Li Li , Kreizenbeck Karma L. , Ramsey Scott David 
Published: October 2019

166 Background: Rural residents are diagnosed at later stages of cancer compared to urban residents, have poorer survival, and face distinct barriers to receiving quality cancer care. ASCO has developed policy initiatives to address rural cancer care; however, little is known about quality of cancer care among patients residing in rural areas. This study examined the impact of rurality on performance metrics, controlling for socioeconomic status and insurance type. Methods: We linked Washington state cancer registry records from 2015-2017 with claims records for two large commercial insurers, Medicare, and Medicaid. Using claims from this database, we generated eight nationally recognized quality measures. Rurality was measured by the Rural-Urban Commuting Area Codes (RUCAs) categorized into 4 levels (Metro, Metro with commute, Micropolitan, Small Town/Rural). Process and outcome measures were adjusted for age, sex, race, comorbidity score, stage, cancer type, marital status, the Area Deprivation Index, and treatment factors where appropriate. Results were stratified by payer type. Results: The table below lists the effect of a patient’s rurality on the quality metric where significant (p<0.05). Where rurality did not impact the performance measure, results are left blank. Conclusions: After controlling for socioeconomic status and payer type, quality of cancer care for rural cancer patients was not consistently poorer compared to urban patients. These results suggest that lower survival among rural patients may be due to factors beyond quality of care.[Table: see text]
The cancer care network clinical trials program: Rising from the camp fire ashes.
Authors: Vigil Ofilio Ramon , Little Dana Ann , Mensonides Kristin J. , Bold Richard J. 
Published: October 2019

168 Background: The UC Davis Health Cancer Care Network (CCN) in Sacramento improves quality through partnerships with community cancer centers and the UC Davis Comprehensive Cancer Center (UCDCCC). The UCDCCC, as an NCI Lead Academic Participating Site (LAPS) grant recipient, lists Adventist Health Rideout Cancer Center (RCC) in Marysville (42 miles north of Sacramento) as a component. The Adventist Health Feather River Cancer Center (FRCC) and the town of Paradise were devastated by the 2018 Camp Fire, forcing FRCC’s relocation to the city of Chico (49 miles north of Marysville). FRCC was forced to disband its local IRB and unable to continue clinical trials research operations during the aftermath of this natural disaster. The CCN established an affiliation with the FRCC in April 2019. Future plans include establishing an IRB agreement and adding FRCC as a LAPS component. The CCN identified strategies to facilitate the participation of FRCC patients in clinical trials. Methods: The CCN identified 13 NCTN clinical trials with 34 enrolled patients that were in need of appropriate research oversight. Four of these trials were previously never activated at the UCDCCC or its affiliates. CCN staff engaged leaders at the various institutions involved: Quality Assurance (QA) Managers at each NCTN research base, the CIRB, the local IRB, the CTSU, and other leaders within UC Davis and Adventist Health. Results: Stakeholders acknowledged the unusual and urgent nature of our requests and questions, while contributing to the development of a plan allowing patients to continue clinical trial participation. QA managers approved a plan transferring patients to the RCC, allowing research staff to collect and submit data while patients continue receiving care closer to home. Together we developed a notification letter to inform patients of this plan. Conclusions: The relocation of facilities and patients brought rare challenges while conducting clinical research in rural communities. We learned that the cooperation and flexibility of all parties involved was crucial in supporting the continued care for FRCC's clinical trial patients and research contributions.