bluuebunny/crossref_metadata_2025 huggingface dataset:
Machine learning guided adjuvant treatment of head and neck cancer.
Authors: Howard Frederick , Kochanny Sara , Koshy Matthew , Spiotto Michael T. , Pearson Alexander T.
Published: May 2020

6567

Background: A combined analysis of the EORTC 22931 and RTOG 95-01 trials confirmed that patients (pts) with head and neck squamous cell carcinoma (HNSCC) and positive margins or extracapsular extension (ECE) benefit from adjuvant chemoradiotherapy (CRT), but the best treatment of pts with other risk factors is unclear. We hypothesized that deep learning models could identify the margin/ECE negative pts who benefit from CRT. Methods: We abstracted pts from the NCDB diagnosed from 2004-2016 with resected HNSCC who received radiotherapy (RT). We reserved 20% of pts for validation and used the remaining 80% for feature selection and model training. Features were chosen based on independent significance in a Cox proportional hazards model, and included demographics, tumor stage, site, grade, RT dose, and receipt of chemotherapy. HPV status was included, and imputed when unknown. We generated survival predictions with DeepSurv (DS), random survival forest (RSF), and neural network multitask (NNM) models. We consider CRT to be recommended by a model if predicted survival is longer with CRT than RT. We calculated the median overall survival (mOS) difference and hazard ratio (HR) for receipt of treatment in line with model recommendations. This was repeated with inverse probability of treatment weighting (IPTW) to account for confounding. As a comparator, we used the intermediate risk factors in the EORTC (T3-4 except T3N0 larynx, N2-3, LVI, deep nodes with oral / oropharynx cancer) and RTOG (2 involved nodes) trials as decision rules. Results: 36,831 pts from the NCDB met the inclusion criteria. 92% had T3-4 or node positive disease, and 40% received CRT. RTOG, EORTC, DS, NNM, and RSF models recommend CRT for 32%, 74%, 63%, 61%, and 35% of pts. The concordance index in the validation set was 0.696, 0.692, and 0.699 for DS, NNM, and RSF. Treatment according to model recommendations in the validation cohort was associated with a mOS benefit of 18.4 months (7.6 to 29.3, 95% CI) for DS, 20.5 months (8.8 to 32.2, 95% CI) for NNM, and 5.8 months (-6.6 to 18.3, 95% CI) for RSF. Similar results were seen with IPTW. Conclusions: Machine learning models can predict benefit from CRT in margin/ECE negative pts, and outperform treatment according to EORTC or RTOG inclusion criteria in this cohort. External validation of these models is warranted. [Table: see text]
Prospective, longitudinal digital activity monitoring before and after treatment of low-risk oropharyngeal squamous cell carcinoma: A feasibility study.
Authors: Gunn Gary Brandon , Ferrarotto Renata , Johnson Faye M. , Bell Diana , Cardoso Richard , Johnson Jason Michael , Rubin M. Laura , Yuan Ying , Frank Steven J. , Fuller Clifton David , Rosenthal David Ira , Kupferman Michael Elliot , Goepfert Ryan , Hessel Amy Clark , Hutcheson Kate A. , Gross Neil D.
Published: May 2020

6578

Background: Given the expected excellent prognosis of low-risk oropharyngeal squamous cell carcinoma (OPSCC), consideration of long-term toxicity and functional outcomes has become increasingly important. Activity monitors (e.g. FITBIT) are imperfect but have been shown to have reasonable validity in healthy adults. Here we aimed to test the feasibility of using medical grade longitudinal digital activity monitoring to better define objective functional outcomes after treatment of low-risk OPSCC. Methods: This prospective, observational parallel cohort study included patients with previously untreated stage I-III (AJCC 7) OPSCC eligible for standard of care single-modality treatment with either Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS). Objective Actigraph accelerometer data (Actigraph, Pensacola, FL) were collected continuously for 1 week at baseline, 3, 6 and 12 months after treatment along with subjective patient-reported outcome (PRO) measures. Results: Forty-four patients (34M, 10F) enrolled with median age 59 years (range: 42-78). Baseline, 3 and 6 month activity data were available for 40 patients (91%): 16 IMPT and 24 TORS. There was a significant decrease in mean percent of day performing moderate to vigorous physical activity (MVPA) (-0.78, 0.021) mean number of steps/minute (-1.1, p = 0.035), and mean kcals/day (-115.9, p < 0.001) from baseline to 3 months after treatment for the overall cohort. A significant decrease in mean kcals/day (-82.2, p = 0.004) persisted for the overall cohort at 6 months with no significant difference between groups. Conclusions: Longitudinal digital activity monitoring is feasible before and after treatment of low-risk OPSCC. This approach may offer objective functional endpoints for future de-escalation trials. Similar short-term decreases in objective activity measurements were observed after IMPT and TORS. Long-term (12 month) activity data and correlations to subjective PRO measures will be available at the time of presentation. Clinical trial information: 02663583 .
RAS-mutated sporadic medullary thyroid cancer: A single-center experience.
Authors: Brown Spandana , Gruschkus Stephen K. , Waguespack Steven G. , Dadu Ramona , Zafereo Mark , Cabanillas Maria E. , Grubbs Elizabeth Gardner , Sherman Steven I. , Hu Mimi I-Nan
Published: May 2020

6584

Background: Activating RAS mutations are recognized as important drivers in sporadic medullary thyroid cancer (sMTC), with a reported prevalence between 0-43%. However, few studies have looked at correlations between RAS-mutated sMTC and clinicopathologic features. Methods: Patients with sMTC diagnosed between 1992 – 2019 with NGS testing for RET and RAS mutations seen at a tertiary cancer center were retrospectively evaluated. The objective was to analyze demographic and clinical features among patients with RAS-mutated sMTC and to evaluate associations between these features and overall survival (OS). Analyses were performed to correlate patient demographics and pathologic staging with treatment characteristics, disease course, and OS. Results: We identified 42 patients (50% female) with RAS-mutated sMTC out of 218 pts with sMTC. Median age at diagnosis was 50 years (range 24-78 years). 26 (62%) patients had stage IV disease at time of diagnosis. 28 (67%) of patients had HRAS mutations and 14 (33%) had KRAS mutations. HRAS Q61R was the most common HRAS mutation type (n = 19, 45%). Median follow-up time was 64 months (range 23-274 months) during which 11 (26%) patients died. The median OS was 16.2 years, with 5- and 10- year OS of 88% and 73% respectively. Of the 20 (48%) patients who received systemic therapy, 79% had stage IV disease and tended to be older (median age 54). Median time from diagnosis to initiation of systemic therapy was 33 months. Factors associated with worse OS included distant metastases at diagnosis, shorter time interval between diagnosis and treatment, and Ctn/CEA doubling times < 6 months. HRAS Q61R mutations were associated with a better prognosis, with 100% 10-year OS compared with 10-year OS of 39% and 51% (p = 0.02) for other HRAS and KRAS mutations respectively. Conclusions: At a tertiary cancer center, patients with RAS-mutated sMTC had a 10-year OS rate of 73%, with significantly worse OS in patients with HRAS/KRAS mutations other than HRAS Q61R. In comparison, prior studies have reported 10-year OS rates between ~71-90% in sMTC and 10-year OS rates as low as 56% for more aggressive RET M918T sMTC mutations. The findings here are consistent with other studies that have suggested patients with RAS-mutated sMTC are at intermediate risk for aggressive disease, though there are limited data on OS rates in RAS or RAS-/RET- sMTC. Future research comparing outcomes between various RAS mutations and in comparison to RET+ and RAS-/RET- patients is needed, especially as systemic therapy use in RAS-mutated sMTC evolves.
The oncology hospital at home: Health care utilization outcomes from the huntsman at home trial.
Authors: Mooney Kathi , Titchener Karen , Haaland Benjamin , Coombs Lorinda Adaire , O Neil Brock , Nelson Richard , McPherson Jordan P. , Kirchhoff Anne C. , Ameloot Karen , Beck Anna Catherine , Ward John Harris
Published: May 2020

7000

Background: Unplanned hospitalizations and emergency department (ED) visits are common during cancer care. Providing acute hospital level care at home may add value by decreasing hospital and ED use. We conducted the first evaluation of an oncology Hospital-at-Home program, Huntsman at Home (H@H). Methods: The Huntsman Cancer Institute began H@H services in 2018 and accepts referral of cancer patients for acute-medical or post-surgical care at home. Patients are admitted who require continued acute level medical care after hospitalization or have emergent unstable symptoms related to treatment or disease progression that would otherwise require ED evaluation or hospitalization. Prospectively, patients referred to H@H from 8/2018 through 10/2019 were compared to a usual care comparison group (UC) drawn concurrently from patients living within the Salt Lake City metropolitan area who qualified for admission to H@H, but lived outside the service zip codes. Probability of H@H enrollment propensity scores were constructed via random forest from patient descriptors and health care utilization at admission. We used an intent-to-treat approach for analysis. Primary outcomes were hospitalizations, length of stay (LOS), ED visits and cumulative charges over 30 and 90 days post admission to either group. Comparisons were made by generalized linear models, stratified by tertiles of H@H vs. UC propensity score. Results: 367 patients, 169 H@H and 198 UC, were evaluated. The average age was 62 yrs, 85% were Caucasian, and 77% had stage IV cancer. Propensity score distributions were overlapping, demonstrating group comparability. A variety of cancers were represented; the most common being colon, gynecologic, prostate and lung cancers. Compared to UC, H@H patients were more likely to be female (61% vs 43%) and during the month prior to admission, showed a trend towards longer LOS if hospitalized (6.7 vs 5.5 days). During the first 30 days after admission, propensity stratified comparisons showed H@H patients with lower hospital LOS (mean reduction 1.19 days, p=0.022), 56% lower odds of unplanned hospitalizations (OR 0.44, p=0.001), 45% lower odds of ED visits (OR 0.55, p=0.037) and 50% lower cumulative charges (mean ratio 0.50, p<0.001) compared to UC. Results over 90 days were similarly robust. Conclusions: In the first reported trial of an adult oncology Hospital at Home program, there was strong evidence for reduced hospitalizations, ED visits, and cost. Oncology Hospital at Home programs show promise for increased patient-centered care while simultaneously improving value.
Early discontinuation to adjuvant endocrine therapy in the ECOG-ACRIN TAILORx Trial.
Authors: Yanez Betina , Gray Robert James , Sparano Joseph A. , Carlos Ruth , Sadigh Gelareh , Garcia Sofia F. , Gareen Ilana F , Whelan Timothy Joseph , Sledge George W. , Cella David , Wagner Lynne I.
Published: May 2020

7004

Background: The TAILORx study demonstrated women with an intermediate Oncotype DX score receive the same benefit with endocrine therapy (ET) compared to chemoendocrine therapy (CET). However, early discontinuation of adjuvant ET is problematic among breast cancer survivors, with previous studies suggesting that up to 50% of women do not adhere to the full 5 years of recommended ET treatment. The aim of this study was to identify patient-level risk factors associated with early discontinuation of ET in the TAILORx study. Methods: TAILORx was coordinated by the ECOG-ACRIN Cancer Research Group. Participants were a subgroup of 954 women who completed additional measures on health-related quality of life (HRQoL) including endocrine symptoms (ES) physical well-being (PWB) and social well-being (SWB) prior to initiating ET, which categorized into three groups by tertile for analysis. All participants were diagnosed with hormone-receptor–positive, human epidermal growth factor receptor 2–negative, axillary node–negative breast cancer who started ET within a year of study entry. Early discontinuation of ET, defined as discontinuation less than 4 years from initiation for reasons other than death or recurrence, was assessed by clinician report. Rate of discontinuation was calculated using Kaplan-Meier estimates, and Cox-proportional hazards joint models were used to analyze the association between rates of adherence to ET with patient-level factors. Results: In a joint model, receipt of CET therapy (vs receipt of ET only; HR = .59, 95% CI .38-.94, p = .02) and age above 40 (versus age < = 40; HR = .30, 95% CI .14-.66, p = .003) were associated with a lower probability of early discontinuation of ET. Adjusted for these factors, a history of depression compared to no history of depression (HR 1.82, 95% CI 1.19-2.77, p = 0.005), worse ES compared to better ES (HR 1.70, 95% CI 1.06-2.74, p = 0.03), worse PWB compared to better PWB (HR 2.12, 95% CI 1.30-3.45,p = 0.003), and worse SWB compared to better SWB (HR 1.94, 95% CI 1.20-3.13, p = 0.007) were individually and significantly associated with a higher probability of early discontinuation of ET, although none reached statistical significance when all were included in a joint model. Conclusions: Younger women are at risk for early discontinuation and modifiable characteristics such as HRQoL and history of depression are potential risk factors for early discontinuation of ET. These results support systematic screening for HRQoL and depressive symptoms to identify women at risk for discontinuation of ET. Clinical trial information: NCT00310180 .
U.S. trends and racial/ethnic disparities in opioid access among patients with poor prognosis cancer at the end of life (EOL).
Authors: Enzinger Andrea Catherine , Ghosh Kaushik , Keating Nancy Lynn , Cutler David M , Landrum Mary Beth , Wright Alexi A.
Published: May 2020

7005

Background: Heightened US opioid regulations may limit advanced cancer patients’ access to effective pain management, particularly for racial/ethnic minority and other vulnerable populations. We examined trends in opioid access, disparities in access, and pain-related emergency department (ED) visits among cancer patients near end of life (EOL). Methods: Using a 20% random sample of Medicare FFS beneficiaries, we identified 243,124 patients with poor prognosis cancers who died between 2007-2016. We examined trends in outpatient opioid prescription fills and pain-related ED visits near EOL (30 days prior to death or hospice enrollment), for the overall cohort and by race (white, black, other). Per-capita opioid supply by state was obtained from the federal Drug Enforcement Agency ARCOS database. Geographic fixed-effects models examined predictors of opioid use near EOL, opioid dose in morphine milligram equivalents (MMEs), and pain-related ED visits, adjusted for patient demographic and clinical characteristics, state, opioid supply, and year. Results: From 2007-2016 the proportion of patients with poor prognosis cancers filling an opioid prescription near EOL fell from 41.7% to 35.7%, with greater decrements among blacks (39.3% to 29.8%) than whites (42.2% to 36.5%) and other races (38.2% to 32.4%). The proportion of patients receiving long-acting opioids near EOL fell from 17% to 12% overall (15% to 9% among blacks). Among patients receiving EOL opioids, the median daily dose fell from 40MMEs (IQR 16.5-98.0) to 30MMEs (IQR 15.0–78.8). In adjusted analyses, blacks were less likely than whites to receive EOL opioids (AOR 0.85; 95% CI, 0.80 to 0.91) and on average received 10MMEs less per day (b -9.9; 95% CI -15.7 to -4.2). Patients of other race were also less likely to receive EOL opioids (AOR 0.92; 95% CI, 0.85-0.95), although their dose did not differ significantly from whites. Rates of pain-related ED visits near EOL increased from 13.2% to 18.8% over the study period. In adjusted analyses, blacks were more likely than whites to have pain-related ED visits (AOR 1.29, 95% CI, 1.16-1.37) near death, as were those of other races (AOR 1.30; 95% CI, 1.17-1.37). Conclusions: While lawmakers have sought to mitigate the impact of opioid regulations upon cancer patients, access to EOL opioids have decreased substantially over time with concomitant increases in pain-related ED visits. There are significant racial/ethnic disparities in opioid access, with blacks receiving fewer opioids at lower doses and having more ED-based care for pain near EOL.
Reassessing the net health benefit (NHB) of FDA approved cancer drugs with evolution of evidence using the American Society of Clinical Oncology Value Framework (ASCO-VF).
Authors: Delos Santos Seanthel , Witzke Noah , Arciero Vanessa Sarah , Rahmadian Amanda Putri , Everest Louis , Chan Kelvin K.
Published: May 2020

7011

Background: Regulatory approval of oncology drugs are often based on data presented in the primary publication of clinical trials (CT). However, clinically relevant data, such as long-term overall survival (OS) and quality of life (QOL), are often reported in subsequent publications. Therefore, this study aimed to evaluate the ASCO-VF NHB at the time of drug approval and over time as further evidence is published. Methods: All FDA approved oncology drug indications from 01/06-12/16 were reviewed to identify CTs that were scorable using the ASCO-VF version 2. Subsequent publications of included CTs relevant for scoring were identified from Web of Science with a follow-up time of 3 years from approval. Using ASCO-defined threshold scores of ≤40 for low benefit and ≥45 for substantial benefit, changes in classification of benefit were assessed at 3-years post-FDA approval. Results: We identified 57 FDA approved indications (40.4% OS, 59.6% progression-free survival (PFS) as primary endpoints) with scorable ASCO-VF CTs. Among those 57 indications, 36.8% at the time of FDA approval demonstrated substantial benefit, 10.5% demonstrated intermediate benefit, and 52.6% demonstrated low benefit. We then identified 96 subsequent publications relevant to scoring within 3-years of FDA approval, consisting of primary endpoint updates (29.2%; 14.6% OS, 12.5% PFS), secondary endpoint updates (44.8%; 16.7% OS, 7.3% PFS), new reporting of secondary endpoint (4.2% OS), safety updates (28.1%), and QOL reporting (43.8%). Upon reassessment of the NHB in subsequent publications, there was an overall change from initial classification of benefit in 36.8% of trials (17.5% became substantial, 8.8% became low, and 10.5% became intermediate). Changes in scores were mainly the result of an updated hazard ratio (35.1%), change in scoring endpoints from PFS to OS as per ASCO-VF endpoint hierarchy (8.8%), toxicity updates (57.9%), new tail of the curve bonus (12.3%), palliation bonus (14.0%), or QOL bonus (22.8%). Overall, at reassessment at 3 years post-FDA approval, 42.1% were substantial, 10.5% were intermediate, and 47.3% were low benefit. Conclusions: Only a modest proportion of FDA approved drugs have demonstrated substantial NHB at time of approval. As further evidence was published, a substantial proportion of indications have a change in classification of NHB, resulting in a small increase in the overall proportion of indications being deemed to have substantial benefit at 3 years post-approval.
Impact of utilization management policy on uptake of hypofractionated radiation in early-stage breast cancer.
Authors: Chi Winnie , Parikh Ravi Bharat , Fishman Ezra , Zimmerman Robert Paul , Gupta Atul , Barron John , Sylwestrzak Gosia , Bekelman Justin E.
Published: May 2020

7015

Background: While hypofractionated radiation (HFR) after breast-conserving surgery is a cost-effective, patient-centered treatment in early-stage breast cancer (ESBC), less than 40% of eligible women received it in 2013. In 2016, a large commercial payer implemented a utilization management policy to encourage HFR for eligible women through denying reimbursement for extended-course radiation. We assessed the impact of the policy on HFR use and associated spending. Methods: We conducted a retrospective, adjusted difference-in-differences analysis using administrative claims of women continuously enrolled in 14 geographically diverse commercial health plans covering 6.9% of US adult women. The study population included women aged 18 or older with ESBC who were eligible for HFR according to 2011 guidelines from the American Society for Radiation Oncology. Women who received mastectomy, brachytherapy, or < 11 or > 40 external beam fractions were excluded. We compared HFR use and associated spending between women in fully-insured and Medicare Advantage (fully-insured) plans for whom the policy applied vs. self-insured or Medicare supplemental insurance (self-insured) plans for whom the policy did not apply. We adjusted for age, comorbidity, region, Medicare enrollment, and prior chemotherapy. Results: Among 10,540 eligible women, 3,619 (34%) were in fully insured plans and thus subject to the policy. There were no meaningful differences in mean age (63.8 vs. 65.0), Charlson comorbidity index (3.0 vs. 3.2), or practice setting between the fully-insured and self-insured groups. The policy was associated with an increase in HFR (4.2 adjusted percentage point difference-in-difference [ppd], 95% CI 0.0 to 8.4, p = 0.051) and a non-significant decrease in radiotherapy-associated expenditures (-$2,275, p = 0.09). Spillover analyses revealed significantly higher uptake of HFR among self-insured patients who were indirectly exposed to the policy through seeing the providers who also treated fulled insured women (8.5 adjusted ppd, 95% CI 3.6 to 13.5, p = 0.001), compared to those who were not exposed. Conclusions: A payer’s utilization management policy was associated with direct and spillover increases in HFR use, even after accounting for a strong secular trend towards increased hypofractionation use. However, policymakers must balance the impact of this and similar policies against their additional administrative costs.
Composite grading algorithm for National Cancer Institute’s PRO-CTCAE.
Authors: Dueck Amylou C. , Becker Claus C. , Rogak Lauren J. , Schrag Deborah , Reeve Bryce , Spears Patricia , Smith Mary Lou , Gounder Mrinal M. , Mahoney Michelle R. , Schwartz Gary K. , Bennett Antonia Vickery , Mendoza Tito R. , Cleeland Charles S. , Sloan Jeff A. , Bruner Deborah , Schwab Gisela , Atkinson Thomas Michael , Thanarajasingam Gita , Bertagnolli Monica M. , Basch Ethan M.
Published: May 2020

7018

Background: Standard reporting of symptomatic adverse events (AEs) in oncology relies on clinicians to rate patient (pt) experience using CTCAE; each symptom is represented by a single graded item. To capture direct pt experience, NCI developed PRO-CTCAE to supplement CTCAE. In PRO-CTCAE, the pt answers up to 3 questions per AE about a symptom’s frequency, severity and interference with daily activities. To align PRO-CTCAE with CTCAE, we developed an algorithm for mapping sets of questions for an AE to a single composite numerical grade. Methods: We used a 5-step process. (1) All 187 possible PRO-CTCAE score permutations were presented to clinical investigators to subjectively map permutations to single numerical grades (range 0-3). (2) Permutations with < 75% agreement were presented to investigator committees at a National Clinical Trials Network meeting to gain majority consensus via anonymous voting. (3) The resulting algorithm was refined via graphical and tabular approaches to assure directional consistency. (4) Validity, reliability and sensitivity were assessed in a national study dataset. (5) Accuracy for delineating AEs between study arms was measured in 2 phase III clinical trials (Alliance for Clinical Trials in Oncology A091105 and Exelixis COMET-2). Results: (1) 12/187 score permutations had < 75% initial agreement. (2) Majority consensus was reached for all permutations. (3) 5 mappings were adjusted to assure directional consistency. (4) Composite grades for 46/59 (78%) AEs were higher in pts with ECOG performance status 2-4 vs 0-1 (median effect size 0.23 [range -0.49-0.73]; 32/59 effect size ≥0.2; 25/59 p< 0.05), similar to when conducting analysis on individual unmapped items. The test-retest reliability for 24 selected composite grades ranged from 0.57-0.96 (median intraclass correlation coefficient [ICC] 0.77) with 18/24 (75%) grades having ICC ≥0.7. Median (range) standardized response means in pts reporting worsening, no change, and improvement were 0.20 (0.03-0.34), -0.06 (-0.20-0.03) and -0.12 (-0.32-0.06). (5) Pattern, directionality and statistical significance of between-arm differences in both trials were preserved with composite grades as compared to individual unmapped items. Conclusions: A composite grading algorithm for PRO-CTCAE was rigorously developed and validated. PRO-CTCAE composite grades may be useful in analyses to provide a single metric for each pt-reported AE for trial and real-world reporting. Support: UG1CA189823; U01CA233046; HHSN261200800043C; Bayer (A091105); https://acknowledgments.alliancefound.org .
Predictive survival ability of patient-reported in comparison to physician-reported performance status in solid malignancies.
Authors: Al-Rashdan Abdulla , Sutradhar Rinku , Nezari-Rad Narges , Yao Cindy , Barbera Lisa Catherine
Published: May 2020

7019

Background: Performance status (PS) is an important prognostic tool in cancer management that is mainly generated by physicians. In oncology, the Eastern Cooperative Oncology Group (ECOG) measure is commonly used. Patient-reported functional status (PRFS) is an emerging method that allows patients to provide an estimate of their function; however, there is limited information about its prognostic significance in solid tumors. We explored the prognostic value of PRFS in comparison to ECOG on survival. Methods: 13,045 newly diagnosed cancer patients in Ontario, Canada, who had information from both PRFS and ECOG on the same day of an outpatient visit between March 2013 and March 2018 were included. The dataset were randomly divided into 60% training (n = 7,827) and 40% validation (n = 5,218) cohorts. Covariates were similar at baseline for both training and validation datasets. Survival was estimated by modeling clinical characteristics with PRFS, with ECOG, and alone. Results: PRFS and ECOG scores were statistically significant predictors of overall survival. Both higher PRFS and ECOG scores tended to be associated with inferior survival, hazard ratio (HR) = 1.71 (P < .0001), and HR = 1.90 (P < .0001) respectively. Models that included either PRFS or ECOG scores outperformed the model with baseline clinical characteristics only. C statistics were 0.836, 0.839, and 0.811 respectively. Conclusions: Patient-reported functional status adds to survival modeling and is equally predictive as the ECOG scale at various stages of solid malignancies. PRFS may be used instead of ECOG in clinical or research setting for survival estimation.
Videos improve patient understanding of misunderstood chemotherapy terms in a rural population.
Authors: Abernethy Eli Rowe , Campbell Gavin Paul , Hianik Rachel , Thomson Mary Catherine , Dixon Margie D , Switchenko Jeffrey M. , Pentz Rebecca D.
Published: May 2020

7022

Background: Rural communities can have low health literacy, which impacts the adequacy of informed consent, adherence to treatment, and outcomes. We had previously created and tested educational videos about basic chemotherapy terminology for use in an underserved population at our inner-city hospital. This study aimed to determine if these videos increased understanding of these terms in rural communities. Methods: Through patient and provider interviews in an underserved urban setting, 20 basic cancer treatment terms were identified as frequently misunderstood. As a pilot, 6 of these terms were explained in short, animated one-minute videos using VideoScribe (Sparkol).To determine if these videos improved understanding in the rural setting, 50 rural patients, specified as patients living in a county ranked 4-9 on the USDA Rural Urban Continuum Code (RUCC) scale, were asked to define each term before and after viewing the video. All answers were audiotaped and double coded for correctness of definition pre and post video screening, using the video definition as the correct definition. Before video and after video correct definition rates were calculated, along with 95% exact binomial confidence intervals using the Clopper-Pearson method. The videos for all 20 terms can be viewed on CancerQuest ( https://www.cancerquest.org/media-center/videos/cancer-treatment-terms ). Results: Participants were mostly white (79%), female (52%), resided in the more rural counties RUCC ranked 6-9 (62%), had < a high school degree (56%) and had a family income of <$40K (59%). Conclusions: Improving health literacy is a critical component in improving care. Our study establishes that a simple and easily disseminated intervention can significantly increase patient understanding of basic chemotherapy terminology in a rural setting. [Table: see text]
Impact of the affordable care act and early Medicaid expansion on head and neck cancer mortality in the United States.
Authors: Osazuwa-Peters Nosayaba , Barnes Justin M , Pannu Jaibir S , Simpson Matthew C , Challapalli Sai D , Rohde Rebecca L , Adjei Boakye Eric
Published: May 2020

7035

Background: Medicaid expansion has been associated with increased access to care and earlier stage at diagnosis among patients with head and neck cancer (HNC). However, it is unclear whether Medicaid expansion has impacted HNC mortality rates. We examined the associations between early Medicaid expansions (2010-2011) with mortality rates for HNC in the United States. Methods: Data were obtained from the Surveillance, Epidemiology, and End Results (SEER) program. SEER*Stat was utilized to obtain mortality rates for early expansion (CA, CT, DC, MN, NJ, and WA) and non-early expansion states (all others) in the year ranges as available in SEER: 2005-2007 (pre-expansion) and 2012-2016 (post-expansion). Deaths in 2008-2011 were excluded as a phase-in/washout period. Difference-in-differences analyses were utilized to compare mortality rates pre- and post-early expansion in early expansion vs. non-early expansion states. The parallel trends assumption was tested comparing changes in HNC mortality rates between early expansion and non-early expansion states from 2002-2004 to 2005-2007 and from 2005-2007 to 2008-2011. Results: There were 6882 and 35459 deaths due to HNC in early expansion and non-early expansion states, respectively. HNC mortality rates (deaths per 100,000) decreased from 2005-2007 to 2012-2016 in both early expansion (2.17 to 1.85, difference = -0.32, 95% CI = -0.42 to -0.22) and non-expansion states (2.59 to 2.43, difference = -0.16, 95% CI = -0.22 to -0.11). Relative to non-expansion states, there was a reduction of 0.16 deaths per 100,000 (95% CI = 0.05 to 0.27, p = 0.007) after early Medicaid expansion in expansion states. However, in parallel trends testing, there was no difference in the change in mortality rates between early expansion and non-expansion states from 2002-2011 (p > 0.37). Conclusions: In this quasi-experimental analysis, there was an association between early Medicaid expansion with decreased HNC mortality. Thus, Medicaid expansion might help decrease disparities associated with access to care among HNC survivors. As longer-term data emerges, additional follow-up will be necessary to understand the mechanisms that underlie the HNC mortality benefits seen in early Medicaid expansion.
Patient-reported health literacy and numeracy among new patients seeking consultation at a comprehensive cancer center.
Authors: McCleary Nadine Jackson , Cleveland Jessica , Zhang Sunyi , Lepisto Eva M. , Lee Sherry , Hassett Michael J. , Schrag Deborah
Published: May 2020

7038

Background: Health literacy and numeracy are essential for patients to make informed cancer treatment decisions. Oncologists do not typically evaluate literacy and numeracy and vary in their ability to adapt health discussions to meet patients’ needs. Systematic ascertainment of literacy and numeracy may provide oncologists with useful information to help guide initial oncology consultations. Methods: We deploy an electronic new patient intake questionnaire (NPIQ) that includes health literacy and numeracy, basic demographics and cancer risk screening. Patients are considered to have limited health literacy and/or numeracy if they respond with either “somewhat”, “a little bit” or “not at all” to a single question: “How confident are you filling out medical forms?” or “How confident are you in understanding medical statistics?” respectively. Results: Between January 2018 and August 2019, 8418 (24.6%) of patients presenting for a new patient consultation responded to the NPIQ. Among respondents with non-missing data, limited health literacy was reported by 19.4% respondents with 13.9% reporting “not at all” and 33.1% reporting “not at all” or only “a little bit” of confidence completing medical forms. Limited health numeracy was reported by 33.2% respondents with 9.1% reporting “not at all”. Nearly 20% of respondents reported both limited health literacy and numeracy. Patients reporting lack of confidence completing medical forms or understanding medical statistics were older (20.3%, 30.7% ³ 70 years old), male (20.2%, 30.1%), and non-white (21.3%, 32.1%). Conclusions: A substantial proportion of cancer patients report lack of confidence in their ability to complete medical forms or understand medical statistics, potentially limiting the ability to actively engage in shared decision-making. Prospective identification of these social determinants of health prior to consultations may provide oncologists with information necessary to tailor health discussions and to provide materials that promote understanding and informed decision-making. [Table: see text]
NSCLC: Integrating the “Yale model shared decision-making solution” into the practice setting.
Authors: Adelson Kerin B. , Herbst Roy S. , Peterson Patricia , Ingram Michele , Oliver Brant J. , Agrawal Tarjani , Davies Marianne , Rudell Elaine
Published: May 2020

7054

Background: Lung cancer patients are faced with treatment choices that involve complex decisions that can be preference-sensitive. In 2017 the National Quality Forum initiated a “Call to Action” to integrate shared decision-making (SDM) processes into practice in which clinicians and patients work together to make healthcare decisions that align with what matters most to patients. Projects In Knowledge, @Point of Care, Dartmouth and Yale collaborated to develop a pilot educational initiative to address and improve patient-centered care and SDM processes in the institutional cancer-care setting. Methods: Training materials co-developed for the Yale NSCLC team members (oncologists, nurses/NPs, social worker) address SDM, Checkpoint Inhibitor Therapy in NSCLC, and clinician-patient role play methods for implementing SDM in treatment discussions/decisions. Qualitative interview and observational methods were used to assess improved SDM performance by the multidisciplinary Yale NSCLC team by comparing baseline pre-intervention to post-intervention interviews and rating observed performance on case study role-play scenarios. Following the training and assessments, a focus group that included all team members was conducted to assess the acceptability, feasibility, and repeatability of the program and to inform future education. Results: Training empowered all Yale NSCLC team members to show pre- to post-education improvement in SDM (34% to 88%). Areas of greatest improvement: 1) providing reasonable treatment options to patients (+58%); 2) determining decision style preference – to what extent a patient wants to participate in the treatment decision process with their clinician (+76%); 3) determining patients’ risk tolerance regarding treatments that may be more efficacious but may have more side effects (+77); and 4) determining patients’ goals/preferences (+88%). Conclusions: Educational training improved SDM skills by all Yale NSCLC team members, which can lead to improved clinician-patient decision-making and patient-centric care. The training process also facilitated team building and encouraged ongoing participation in SDM.
iStopCancer: A database of 6,016 low pass whole genome sequencing of minimal invasive samples from 21 cancer types of Chinese population.
Authors: Yuan Min , Ziliang Qian , Fang Juemin , Zhu Zhongzheng , Wu Jianguo , Guo Xianling , Liu Weixing , Qian Hong , Xu Qing
Published: May 2020

7062

Background: Cancer is a group of genetic diseases that result from changes in the genome of cells in the body, leading them to grow uncontrollably. Recent researches suggest Chromosome instability (CIN), which is defined as an increased rate of chromosome gains and losses, manifests as cell-to-cell karyotypic heterogeneity and drives cancer initiation and evolution. Methods: In the past two years, we initiated iStopCancer project, and characterized 4515 ‘best available’ minimal-invasive samples from cancer patients and 1501 plasma samples from non-tumor diseases by using low-pass whole genome sequencing. DNA from ‘best available’ minimal-invasive samples, including peripheral plasma, urines, pancreatic juice, bile and effusions were analyzed by low coverage whole genome sequencing followed by the UCAD Bioinformatics workflow to characterize the CINs. In total, 32T bp nucleotide (coverage =1.7X for each sample) were collected. All the data can be visualized on website: http://www.istopcancer.net/pgweb/cn/istopcancer.jsp . Results: 3748(83%) of tumors present detectable CIN (CIN score>1000) in minimal-invasive samples. The missed cancer patients were majorly from patients with either tumor size less than 2cm or less-aggressive cancers, including thyroid cancer, low-grade urothelial carcinoma, lung cancer in-situ, et al. Of the 1501 non-tumor individuals, 30(2.0%) present detectable CIN (|Z|>=3) at the time of sample collection, 24(80.0%) was diagnosed as tumor patient in 3-6 months follow-up. There were 9 (0.59%) of non-cancer individuals without detectable CIN were also reported as tumor patients during 6-month following up. In summary, the positive and negative prediction value is 80.0% and 99.4% respectively. The false alarms were majorly from patients with EBV activations, which indicates virus may interference chromosome stability and drove virus-associated carcinogenesis. For the patient with repeated detections, plasma cfDNA CIN dynamics predicted clinical responses and disease recurrences. Quick clearance of plasma cfDNA CIN in 2-3 weeks was found in 153 (83.6%) patients. Meanwhile, no quick clearance was found in majority of SDs/PDs (73/88=83.0%). Furthermore, cfDNA CIN predicts clinical response 2-8 weeks ahead of traditional biomarkers (CEA, CA15-3, CA199, AFP et al). Conclusions: Large-scale low coverage whole genome sequencing data provides useful information for cancer detection and managements.
The economic impact of cancer-related premature mortality in Brazil: A human capital approach analysis.
Authors: De Camargo Cancela Marianna , Borges Lopes de Souza Leonardo , Leite Martins Luis Felipe , Souza Dyego , Barchuk Anton , Correa Schilithz Arthur , Hanly Paul , Sharp Linda , Pearce Alison , Soerjomataram Isabelle
Published: May 2020

7068

Background: One method of calculating indirect costs of cancer is the analysis of productivity loss. Using the human capital approach, we estimate how much cancer-related premature mortality indirectly impacts the economy. Given the diverse causes of cancer death and sociodemographic profiles in Brazil, we estimated lost productivity due to cancer by regions, providing evidence for local decision-makers. Methods: Data of all cancers deaths among working-age people (15-64 years for men and 15-60 for women) occurring in 2016 were extracted from the National Mortality System, by region, sex and age-group. Data on life expectancy, workforce participation, unemployment and wages were extracted from the Brazilian National Institute of Geographics and Statistics. Loss of productivity was calculated as the value of time between death and potential retirement age. Results: In total 536,827 (men) and 407,737 (women) years of potential productive life (YPPLL) were lost in 2016, corresponding to US$ 6,196,682,092 (PPP) for Brazil. The profile of YPPLL by cancer type varied by region. In the affluent South and Southeast regions, the cancers with higher impact in men were lung (12.4% and 9.9% of total YPPLL) and colorectal (9.6% and 10.4% of total YPPLL) while in the less affluent North and Northeast, stomach cancer was responsible for 17% and 12% of YPPLL, respectively. Among women, breast cancer had the highest impact in all regions (21.7%-26.2%), excepting the North, where cervical cancer was responsible for 31.3% of the YPPLL. Nationally, individual YPPLL was higher for testicular cancer in males (31.3 years) and Hodgkin’s disease in females (20.2). In the North and the Northeast, despite lower mortality rates, the economic impact of productivity loss was higher, representing 0.23 and 0.29% of the regional GDP. Conclusions: Our results show the indirect economic impact of premature cancer mortality in Brazil, at a total cost of US$ 6,196,682,092 in 2016, representing 0.2% of the entire country’s GDP. The regional patterns highlight the need for adaption of public policies, typical from a country in transition, with the impact of lifestyle and infection-related cancers simultaneously and differently affecting economically the regions.
Post-traumatic stress symptoms in hematopoietic stem cell transplant (HCT) recipients.
Authors: Griffith Sarah , Fenech Alyssa L. , Nelson Ashley , Greer Joseph A. , Temel Jennifer S. , El-Jawahri Areej
Published: May 2020

7505

Background: Patients admitted for HCT, an intensive and potentially curative therapy for hematologic malignancies, experience a prolonged, isolating hospitalization and endure substantial physical and psychological symptom burden. However, data are limited regarding long-term post-traumatic stress (PTSD) in HCT survivors and its risk factors. Methods: We conducted a secondary analysis examining longitudinal data from 250 patients who underwent autologous and allogenic HCT. We used the Post-Traumatic Stress Checklist (PTSD-CL) to assess for PTSD symptoms at six months post-HCT. We used the Functional Assessment of Cancer Therapy—Bone Marrow Transplant (FACT-BMT), and the Hospital Anxiety and Depression Scale to assess quality of life (QOL), depression, and anxiety symptoms at the time of admission for HCT, at week-2 during hospitalization, and at six months post-HCT. We used multivariate regression models to assess factors associated with PTSD symptoms, modeling QOL, depression, and anxiety symptoms separately given their collinearity. Results: The mean age was 56.3 (SD = 13.3). The rate of clinically significant PTSD symptoms at six months post-HCT was 18.9% and these patients experienced hypervigilance (92.3%), avoidance (92.3%), and intrusion (76.9%) symptoms. Among patients without clinically significant PTSD symptoms, 24.5% and 13.7% had clinically significant hypervigilance and avoidance symptoms, respectively. Lower QOL at time of HCT admission (B = -0.04, P = 0.004), and being single (B = -3.35, P = 0.027) were associated with higher PTSD symptoms at six months post-HCT. Higher anxiety at time of HCT admission (B = 1.34, P < 0.001), change in anxiety during HCT hospitalization (B = 0.59, P = 0.006), and being single (B = -3.50, P = 0.017), were associated with higher PTSD symptoms at six months. In a separate model, younger age (B = -0.13, P = 0.017), being single (B = -3.58, P = 0.018), and higher baseline depression symptoms were also associated with higher PTSD symptoms at six months (B = 0.97, P < 0.001). Conclusions: Approximately one fifth of patients undergoing HCT experienced clinically significant PTSD symptoms at six months post-transplant. Patients’ baseline QOL and psychological symptoms emerged as important predictors of their risk for PTSD at six months post-HCT. Thus, interventions to prevent and treat PTSD symptoms in HCT recipients are clearly warranted.
Ten-day decitabine with venetoclax (DEC10-VEN) in AML and high-risk (HR) MDS.
Authors: Maiti Abhishek , Dinardo Courtney Denton , Pemmaraju Naveen , Kadia Tapan M. , Rausch Caitlin R , Naqvi Kiran , Daver Naval Guastad , Borthakur Gautam , Ohanian Maro , Issa Ghayas C. , Alvarado Yesid , Short Nicholas James , Andreeff Michael , Jabbour Elias , Pierce Sherry A. , Ravandi Farhad , Garcia-Manero Guillermo , Welch John Sutton , Kantarjian Hagop M. , Konopleva Marina ,   Department of Leukemia, MD Anderson Cancer Center
Published: May 2020

7519

Background: VEN-based low intensity regimens have shown promise in older pts with newly diagnosed (ND) AML. We hypothesized that adding VEN to 10-day (d) DEC may improve outcomes in AML and HR MDS. Methods: Pts received VEN 400 mg daily or equivalent with DEC 20 mg/m2 for 10d every 4-8 weeks for induction and DEC 5d with VEN for consolidation after CR/CRi. If cycle 1 day 21 bone marrow showed ≤5% blasts, VEN was held to enable count recovery. VEN duration could be further reduced for myelosuppression. FLT3 and IDH inhibitors were allowed for applicable pts. All pts received tumor lysis syndrome (TLS) prophylaxis. Primary objective was overall response rate (ORR). Secondary objectives were safety and overall survival (OS). Data cut-off date was February 6, 2020. Results: Between January 2018 and December 2019 we enrolled 184 pts with ND AML (>60 yrs), untreated secondary AML (sAML), treated sAML, relapsed/refractory (R/R) AML and HR MDS (Table). 58% pts were ≥70 yrs, 30% pts had ECOG PS ≥2, 67% pts had ELN adverse risk AML. Previously treated pts (n=96) had received a median of 1 prior therapy (range 1-8) including HMA (62), intensive chemotherapy (49) and stem cell transplantation (SCT, 27). 30d mortality was 3.3% and 60d mortality was 7.6%. 30d mortality in ND AML was 1.4%. Most common G3/4 adverse events were infections with G3/4 neutropenia (46%), febrile neutropenia (28%), infections with ANC ≥1x109/L (6%) and TLS (3%). Outcomes are shown in Table. 25 pts (14%) proceeded to SCT including treatment naive AML (ND+ untreated sAML, 12), previously treated AML (treated sAML + R/R, 11) and HR MDS (2). 100d post-SCT mortality was 4%. Median OS in treatment naïve AML pts undergoing SCT was not reached (1yr OS 100%) and for previously treated AML pts was 22.1 months (mo). After a median follow up of 15 mos, 25% PTS continue therapy. Additional analyses by molecular subgroups will be presented. Conclusions: DEC10-VEN is safe and highly effective in ND AML and can serve as an effective bridge to SCT in previously treated pts. Trial continues to accrue (NCT03404193). Clinical trial information: NCT03404193 . [Table: see text]