bluuebunny/crossref_metadata_2025_split huggingface dataset:
Real-world effectiveness of prophylactic granulocyte colony-stimulating factor (G-CSF) early (week 1) and late (weeks 2-3) in the cycle for the prevention of febrile neutropenia (FN) among patients (pts) with breast cancer (BC) after high FN–risk chemotherapy (chemo).
Authors: Blayney Douglas W. , Cummings Joyner Alice Kate , Jarvis John , Nunag Dominic , Wells Jasmine , Huang Lan , Mohanlal Ramon W. 
Published: June 2022

599 Background: G-CSF mitigates chemotherapy-induced neutropenia (CIN) and reduces FN risk. G-CSF moves the nadir of absolute neutrophil count (ANC) earlier (to week 1) in the chemo cycle and shortens nadir duration (Crawford, NEJM 1991), suggesting the potential for suboptimal CIN protection early (week 1) in the chemo cycle. The relative FN risk in week 1 vs. weeks 2-3 of the cycle with G-CSF is unknown and was analyzed compared with no G-CSF in the real-world setting with high FN risk chemo. Methods: Using a database of administrative claims representing 100% of fee-for-service Medicare, we analyzed BC pts who initiated docetaxel (T), doxorubicin (A), or cyclophosphamide (C) monotherapy or combination therapy between 01/01/2015 – 12/31/2019. Sample pts included adults aged ≥ 65 years with continuous coverage in Medicare Parts A, B, and D for 6 months before and 20 days after chemo initiation. Pts were categorized as receiving vs. not receiving G-CSF therapy within 3 days after chemo. Rate of FN events starting in week 1 vs. weeks 2-3 in cycle 1 was calculated. We defined FN as an inpatient admission with a primary or secondary diagnosis of neutropenia and measured the interval between chemo initiation and FN admission. Results: Among 18,788 Medicare beneficiaries with BC treated with T, A, and/or C, 72% received G-CSF therapy. More pts receiving G-CSF were treated with ≥ 2 of T, A, and/or C compared to pts who did not receive G-CSF (71% vs. 51%). Overall FN incidence in cycle 1 was significantly lower among pts receiving G-CSF (4.0%; n=546) compared to pts not receiving G-CSF (8.8%; n=462) (p<0.0001). In pts with G-CSF, 81% (440/546) of all 1st-cycle FN events started in week 1 vs. 19% (106/546) in weeks 2-3. In pts not receiving G-CSF, the start of 1st-cycle FN events was more equally distributed: 41% (190/462) started in week 1 vs. 59% (272/462) in weeks 2-3. Results were robust to sensitivity analyses restricted to pts receiving ≥ 2 of T, A, and/or C. The rates of 1st-cycle FN events starting in weeks 1 and 2-3 with and without G-CSF following chemo initiation is shown below. Conclusions: Prophylactic G-CSF was highly effective for the prevention of FN in weeks 2-3, but relatively ineffective in week 1 of cycle 1 in the real-world setting, leaving pts largely unprotected during the first week. This represents an unmet medical need in week 1 of the cycle, despite use of G-CSF. Clinical trial information: NCT03294577. [Table: see text]
Impact of high-deductible health plans on delays in metastatic cancer diagnosis.
Authors: Trad Nicolas Karim , Hassett Michael J. , Zhang Fang , Wharam J. Frank 
Published: June 2022

6503 Background: High-deductible health plans (HDHPs) have grown rapidly in recent years, and now cover over one-half of U.S. workers. Patients in HDHPs are liable for the costs of all cancer-related care until their annual deductible is met, with the exception of screening tests such as colonoscopy and mammography. Due to increased out-of-pocket obligations, patients may postpone presenting for concerning symptoms or diagnostic testing, leading to delayed diagnosis. We therefore assessed the impacts of HDHPs on the timing of metastatic cancer detection. Methods: Using a nationally representative cohort of privately insured members in a national commercial and Medicare Advantage database (2003-2017), we studied 345,401 individuals age 18-64 years whose employers mandated a switch from a low-deductible (≤$500) plan to a high-deductible (≥$1,000) plan. Our control group consisted of 1,654,775 contemporaneous individuals whose employers offered only low-deductible plans. Both groups had a 1-year baseline period when all members were enrolled in low-deductible plans, and we followed members for a maximum of 13.5 years. Participants were matched with respect to age, gender, race/ethnicity, morbidity (ACG) score, poverty level, geographic region, employer size, baseline primary cancer, baseline medical and pharmacy costs, and follow-up duration. We used a validated claims-based algorithm to detect incident metastatic cancer diagnoses. We assessed time to metastatic cancer diagnosis in the baseline period (pre-HDHP switch) and follow-up period (post-HDHP switch) using a weighted Cox proportional hazards model. Results: After matching, there were no systematic differences between the HDHP and control groups with regard to observable baseline characteristics (standardized differences < 0.1). The mean age of participants was 42 years and the mean ACG score was 0.75. 49% were female, 48% lived in low-income neighborhoods, and 62% were White. We detected 1,668 metastatic events over a mean follow-up period of 38 months. There were no differences in time to metastatic diagnosis in the baseline year, prior to the HDHP switch (HR 0.96, p = 0.67). After employer-mandated HDHP switch, HDHP participants had lower odds of metastatic cancer diagnosis (HR 0.88, p = 0.01), indicative of delayed detection relative to the control group. Conclusions: Compared with conventional health plans, HDHPs are associated with delayed detection of metastatic cancer. These findings imply that patients postpone seeking care for concerning symptoms or defer diagnostic testing when exposed to high cost-sharing. Given recent advances that have improved survival of patients with advanced-stage cancers, future research efforts should investigate the impacts of HDHPs on quality of life, engagement in palliative care, and use of treatments in this patient population.
Growing financial burden from targeted oral anticancer medicines among Medicare beneficiaries with cancer.
Authors: Li Meng , Liao Kai-Ping Eric , Pan I-Wen , Shih Ya-Chen Tina 
Published: June 2022

6504 Background: The rapidly rising costs of targeted oral anticancer medicines (TOAMs) raise concerns over their affordability. Our goal was to examine recent trends in the uptake of TOAMs among cancer patients with Medicare Part D, the share of TOAM users who reached catastrophic coverage, and the annual spending on TOAMs in the catastrophic phase. Methods: Using the 5% SEER-Medicare, we included patients aged 65 and older who had one primary cancer diagnosis between 2011 and 2016. We included person-years where patients were enrolled in a Part D plan for the entire year, did not receive the Low-Income Subsidy (LIS) at any time of the year, and received anticancer systemic therapies. We estimated the trends in the share of patients who used TOAMs, the percentage of TOAM users reaching catastrophic coverage, and the total and patient out-of-pocket spending on TOAMs in the catastrophic phase in a year. Results: From 2011 to 2016, the uptake of TOAMs among our study population increased from 3.6% to 8.9%. The percentage of non-LIS TOAM users who reached catastrophic coverage increased from 54.6% to 60.3%. Among those who reached the catastrophic phase, mean total gross spending on TOAMs in the catastrophic phase increased from $16,074 to $64,233 and mean patient out-of-pocket spending from $596 to $2,549. The mean 30-day total spending increased from $4,011 to $8,857, and the mean 30-day out-of-pocket spending from $154 to $328. Conclusions: The high and growing burden from TOAMs highlighted the need for reining in drug prices and capping out-of-pocket spending.
Validity and efficiency of progression-free survival (PFS)-2 as a surrogate endpoint for overall survival (OS) in advanced cancer.
Authors: Woodford Rachel , Zhou Deborah , Kok Peey-Sei , Lord Sally , Friedlander Michael , Marschner Ian , Simes John , Lee Chee Khoon 
Published: June 2022

6518 Background: PFS is used widely as a primary endpoint in oncology trials and as a surrogate for OS. PFS-2, defined as time from randomization to progression on second line therapy, is potentially a more reliable surrogate than PFS but requires additional follow-up time. We evaluated the validity and efficiency of PFS-2 as a surrogate endpoint for OS and compared its performance with PFS. Methods: We performed an electronic search to identify randomized trials of advanced solid tumors reporting on PFS, PFS-2 and OS as pre-specified endpoints. We compared the correlations in the relative treatment effect for OS with PFS and PFS-2. We extracted data from Kaplan-Meier survival curves to create individual patient data to estimate time to statistical significance (TSS), defined as logrank P < 0.05. We further computed the samples size (person-year follow-up) required to reach statistical significance and assessed for the effect of survival post-progression (SPP). If trials failed to reach statistical significance for a particular endpoint, the maximal follow-up time was used. Results: Our study consisted of 39 analysis units with 20714 patients. Correlations of the OS treatment effect with the PFS and PFS-2 treatment effects were r= 0.12 (95% CI 0.00-0.13) and r= 0.67 (95% CI 0.08-0.69) respectively. The median differences in TSS between OS with PFS, OS with PFS-2, and PFS2 with PFS were 8.7, 8.4, and 3.2 months respectively. For trials with a SPP < 12 months, smaller differences in the median TSS as compared to SPP ≥12 months were seen. The median differences in follow-up required to reach statistical significance were 329, 151 and 122 person-years (PY) respectively. These differences were equivalent to a median 18.3% increase in sample size required for PFS-2 over PFS. The median increase in sample sizes were 18.2% and 22.3% for trials with SPP < 12 and ≥12 months respectively. Conclusions: PFS-2 has a stronger correlation with OS benefit than PFS. When PFS-2 is used as primary endpoint, trials will require an additional median 3.2 months to achieve statistical significance, and an additional 18.3% increase of sample size over PFS. PFS-2 balances between improved correlation with OS but modest increase in follow-up time and sample size. PFS-2 should therefore be considered as a primary endpoint in future trials of advanced cancers.[Table: see text]
Feasibility of systematic screening for unmet social determinants of health (SDoH) needs and associated resource utilization in ambulatory oncology.
Authors: Odai-Afotey Ashley , Haakenstad Ellana , Neville Bridget A. , Lipsitz Stuart R. , Zhang Sunyi , McCleary Nadine Jackson 
Published: June 2022

6535 Background: Addressing unmet SDoH needs may reduce interruptions to cancer care caused by ED visits and hospitalizations (EDH). We aimed to determine feasibility of systematic screening for unmet patient-reported SDoH needs within a large tertiary academic comprehensive cancer center and association of unmet needs with EDH. Methods: We conducted a cross-sectional analysis of SDoH needs among new oncology patient (pts) consults from 5/15-9/21 at Dana-Farber Cancer Institute (DCFI). Pts completed an intake questionnaire including demographics, disease, and SDoH needs of financial distress, health literacy/numeracy, social isolation on a dichotomous or 5-point Likert scale. We ran bivariate and multivariable models on the association between demographics, SDoH and EDH within 30 days of consult using robust generalized estimating equations controlling for clustering by consult provider. Results: 125,997 unique new consults were seen from 5/15 – 9/21 of which 20,913 completed the intake questionnaire and were alive at 30 days after consult. Respondents were age 40-64 (50%), female (60%), non-Hispanic (84%), White (90%) and English speaking (97%), and 7% had an EDH within 30 days of consult. The most reported SDoH need was limited health numeracy (26%). In bivariate analysis, factors associated with ED visits were: non-English language, lung or GU/GYN cancer, living > 25 mi from DFCI and limited health literacy and numeracy (all p < 0.05). Demographics associated with hospitalizations included: White race and English as a primary language (EPL) (both p < 0.05). Multivariable analysis showed female gender (OR 1.53, p < 0.01), lung (OR 3.22*) and GU/GYN (OR 2.21*) (p < 0.05 for both) cancer, and living > 25 mi from DFCI (OR 2.50, p < 0.0001) were associated with increased likelihood of ED visit while EPL (OR 1.80, p < 0.05) and GU/GYN (OR 1.65, p < 0.01*) cancer were associated with increased likelihood of hospitalization. Conclusions: It is feasible to systematically screen for unmet SDoH which are associated with increased frequency of ED visits. Differences in characteristics associated with ED vs. hospitalization could indicate possible bias or suggest SDoH needs as a reason for avoidance of costly medical care. Further study will expand SDoH screening and measure impact of resource matching to reduce disruptions to cancer care. [Table: see text]
Theory-guided assessment of barriers and facilitators to adequate informed consent for childhood cancer clinical trials: Using the Exploration, Preparation, Implementation, Sustainment (EPIS) framework.
Authors: Aristizabal Paula , Vu Britney , Perdomo Bianca , Kaiser Bonnie N , Nodora Jesse , Thornburg Courtney D , Martinez Elena , Aarons Gregory A 
Published: June 2022

6539 Background: To participate in childhood cancer clinical trials, parents/legal guardians must provide informed consent (IC), which is a fundamental ethical right. However, barriers to achieving valid IC include: use of medical jargon, misunderstanding about clinical trials procedures, tremendous emotional distress surrounding the initial cancer diagnosis, and the complexity and length of the IC forms. There are scarce data on using theory to assess perspectives of parents of children with cancer on barriers and facilitators for adequate IC in diverse populations. Methods: Using implementation science theory and methods, we assessed parent-reported barriers and facilitators to adequate IC, in a convenience sample that included a significant number of Hispanics. Twelve qualitative semi-structured interviews and 224 open-ended surveys were conducted with 236 parents of children with newly-diagnosed cancer at Rady Children’s Hospital-San Diego, a large quaternary children’s hospital in California. Fifty-three percent of participants were Hispanic and 38% were monolingual Spanish-speakers. We utilized the Exploration, Preparation, Implementation, Sustainment (EPIS) Framework, specifically domains of outer context, inner context, bridging and innovation factors. Four main codes (IC concepts and delivery; desired clinical trial information; motivations and emotions related to clinical trial enrollment; and potential areas for interventions) were used as a coding guide for analysis. Interviews and surveys were transcribed and coded for thematic analysis by three independent coders to identify key barriers and facilitators. Results: Four main themes were identified as barriers: 1) Complexity of the IC forms and discussion (lengthy, confusing, not available in Spanish, and use of medical jargon); 2) parents feeling emotionally overwhelmed, anxious and pressured around the IC; 3) parents viewing the clinical trial as the only treatment option; and 4) mistrust and fear of clinical trial procedures. Four IC facilitators were identified: 1) simpler explanations of study procedures; 2) provider flexibility for accommodations when delivering the IC, including psychosocial support; 3) active promotion of voluntariness and trust; and 4) supplemental education in lay language, including request for peer-education, decision aids, and navigation to “bridge the provider-patient gap.” Conclusions: Our implementation science approach identified multiple barriers and facilitators to adequate IC in a diverse sample of parents. Findings can inform potential interventions to enhance IC for childhood cancer clinical trials, including the use of decision aids, peer-navigation, and interventions tailored to the language and culture of the individual.
Rural disparities in oncology patient portal enrollment and use.
Authors: Morris Bonny , Topaloglu Umit , Lesser Glenn Jay , Strowd Roy E. , Weaver Kathryn E. , Falk Derek Sean , Bell Ronny A. 
Published: June 2022

6557 Background: Patient portals support patient access, engagement, and care coordination, yet could also widen the digital divide and exacerbate disparities among vulnerable populations. There is emerging evidence that racial/ethnic minority patients are less likely to use portals, yet prior research has not examined potential rural differences. We identified sociodemographic factors associated with portal enrollment and use among a racially and geographically diverse population of cancer patients. Methods: We retrospectively examined portal enrollment and use at an NCI-designated comprehensive cancer center from January 2015 until February 2022 among patients 18+ years old with a neoplastic disease diagnosis (ICD-10-CM C00-D49). Potential predictors included gender, race/ethnicity, marital status, age, rural (Rural-Urban Continuum Codes [RUCC] 4-9) vs nonrural (RUCC 1-3) residence, residential distance from the cancer center, and time since diagnosis. We used multivariable logistic regression to generate odds ratios (ORs) for portal enrollment and having ever sent a portal message, and Poisson regression to determine incidence rate ratios (IRRs) for number of logins and number of healthcare team interactions (portal messages or appointment requests), controlling for ICD-10 diagnosis (SAS 9.4). Results: We identified 11,333 patients (average age 67 years, 59% female, 24% rural, 10% Non-Hispanic Black, 1% Hispanic, 20% non-melanoma skin cancer, 14% breast cancer, 9% lung cancer). 36% of patients had enrolled in the portal, and of these, 80% had sent at least one message. Patients logged in a median of 203.5 times and had a median of 19 portal interactions. Rural residents were less likely to enroll in the portal than urban patients (28% vs 38%, p < 0.0001). Non-Hispanic Black patients and Hispanic/Latinx patients were less likely to enroll in the portal compared with non-Hispanic White patients (22% and 27%, respectively, vs 38.5%, p < 0.0001). Women, younger patients, more recently diagnosed cancer patients, and patients who were married/ partnered were significantly more likely to enroll. In multivariable analysis controlling for cancer type, rural patients were half as likely to enroll in the portal (OR: 0.48 [0.43-0.54]). Among those enrolled, rural residents were 25% less likely to have ever sent a portal message (OR: 0.75 [(0.62-0.92]), and had nearly half the login and interaction rates (IRR: 0.66 [0.66-0.67]; IRR: 0.58 [0.58-0.59], respectively). Patients who were Non-Hispanic Black, Hispanic, or unmarried were also significantly less likely to enroll or engage in the portal. Conclusions: Patient portals remain underutilized among cancer patients, despite an increased reliance on virtual communications in the COVID era. Interventions to support portal engagement among rural residents and racial/ethnic minority patients are needed to avoid potentially exacerbating health disparities.
An examination of translated content on NCI-designated cancer websites with a focus on breast and colorectal cancer.
Authors: Aslanova Minira , Buckley Megan C , Karim Gres 
Published: June 2022

6576 Background: One unforeseen implication of the pandemic has been a greater reliance on health information sharing via the Internet. This is complicated by the fact that many healthcare websites and online resources fail to consider Limited English Proficiency (LEP) when designing websites that relay essential health information. We aimed to quantify the extent to which NCI-Designated Cancer Center websites provide language accessibility. Methods: Over the course of 2021, we performed a cross-sectional review of translation services and available languages on NCI-Designated Cancer Center websites. This study was particularly focused on both breast cancer and colorectal cancer portions of these websites. The primary out-comes were as follows: option of translated content, presence of more than one language, and method by which the translation was performed (written text vs. Google scholar). We referred to the 2015 US language map for the percentage of LEP by state. Results: Of the 71 NCI-Designated Cancer Centers, 56 (78.9%) were without translation, and 15 (21.1%) used either manual translation or displayed a link for Google translate. Of the 15 centers who offered translated content on their website, 15/15 (100%) had more than one language available in the drop down list. Spanish (100%) was the most common language available. In terms of Limited English Proficiency, 25 of 71 (35.21%) NCI-Designated Cancer Centers were located in states where greater than 10% of the population is defined as having LEP, and yet, only 5 of these centers (20.0%) had languages other than English featured. We observed no significant relationship between the state LEP percentile and the number of NCI-Designated Cancer Centers offering website translation services within that state. Additionally, no appreciable differences in language availability were observed between breast cancer and colorectal cancer. Conclusions: Overall, only a fraction of NCI-Designated Cancer Centers actually translate the content of their websites. In New York for example, despite having the highest percentage of residents with LEP at 19.345%, only one of ten NCI-Designated Cancer Centers within the state had a website with language translation. We believe this represents a missed opportunity as language inaccessibility may contribute to delays in care for non-English speaking patients, particularly in a post pandemic world, further exacerbating health care disparities among patient populations.
Longitudinal changes in financial burden in patients with colorectal cancer treated with curative intent: Primary results of EAQ162CD.
Authors: Kircher Sheetal Mehta , Duan Fenghai , Underwood Ellen , Gareen Ilana F. , Sicks Jorean , Sadigh Gelareh , Suga Jennifer Marie , Kehn Heather , Mehan Paul Tracy , Bajaj Rajesh , Hanson David Sam , Dalia Samir , Acoba Jared David , Taylor Michael A , Wagner Lynne I. , Carlos Ruth C 
Published: June 2022

6597 Background: We prospectively assessed financial burden (FB) due to treatment costs among patients with colorectal cancer (CRC) recruited by NCI Community Oncology Research Program (NCORP) sites. Methods: Patients with newly diagnosed CRC treated with curative intent enrolled through NCORP sites and completed the FACIT Comprehensive Score for Financial Toxicity (COST) instrument at 0-, 3, 6, and 12 months. Higher COST score (range 0-44) indicates greater financial well-being. Effects of demographic, clinical, self-efficacy and safety net affiliation on FB were assessed using linear mixed modeling with compound symmetry covariance structure to account for measurement correlation from the same subject. Results: In 450 patients (mean age 61, 47% female, 84% white, 64% colon, 31% rectal) attrition was comparable across demographics, clinical variables and baseline FB. Higher COST score was linearly correlated with time. Increasing age, income less than $60,000 (vs. less than $29,999), higher self-efficacy, and higher neighborhood socioeconomic status (nSES) predicted a higher COST score; these effects were not moderated by time. Chemotherapy receipt, insurance type, and treatment at a safety net hospital did not predict COST score. Conclusions: Among those with CRC treated with curative intent in community settings, FB improves over the 12 months post diagnosis. Individual and neighborhood level social determinants of health are protective from financial fragility.[Table: see text]