bluuebunny/crossref_metadata_2025_split huggingface dataset:
What does the general population think about chemotherapy shortages?
Authors: Frosch Zachary Ak , Cronin Angel M. , Joshua Gagne J. , Teschke Maxwell P. , Gray Stacy W. , Abel Gregory A. 
Published: September 2018

6530 Background: Chemotherapy shortages have been increasingly recognized, and most oncologists report their patients have been at least intermittently affected. Despite their potential impact, little is known about the perspectives of the general population regarding shortages. Methods: In October 2016, we conducted a survey using the GfK KnowledgePanel, an online probability-based sample representative of adults in the United States. We assessed awareness of shortages, and provided vignettes in which a substitute chemotherapy drug had either a major or minor difference in side effects or effectiveness. We asked respondents whether they would want to be informed of a substitution, and, if the original drug were available elsewhere, would transfer care to receive it. We also asked if cancer centers were to publish drugs in shortage at their center, if such data would affect decisions about where to seek care. Analyses applied post-stratification sampling weights to draw national inferences. Results: Of 737 potential participants, 420 (57%) responded; 16% had heard of chemotherapy shortages. Respondents with a personal history of cancer were more likely to have heard of shortages (31% vs 14%, p = 0.03), as were those with greater education (p = 0.01) and those who reported more sources of health information (p = 0.01). Most desired to be informed about a chemotherapy substitution in the setting of both major (87%) and minor (83%) differences in side effects, as well as both major (87%) and minor (82%) differences in effectiveness. In contrast, only 61% reported they would transfer care if a substitute drug had major differences in side effects, and even fewer (40%) for minor differences. Similarly, 72% and 46% reported they would transfer care if a substitute had major or minor differences in effectiveness respectively. Finally, 57% reported that publically-reported shortage data would be a “big factor” in deciding where to be treated. Conclusions: Our data suggest that the general population is largely unaware of chemotherapy shortages. Moreover, in the setting of even minor changes in effectiveness or side effects, respondents wanted to be made aware of substitutions. With major differences, many would seek care elsewhere.
Enrollment of high-risk patients with diffuse large B-cell lymphoma in clinical trials.
Authors: Loh Kah Poh , Baran Andrea , Hu John , Casulo Carla , Barr Paul M. , Friedberg Jonathan W. , Reagan Patrick Michael 
Published: September 2018

6536 Background: Contemporary precision medicine trials in DLBCL often require real-time central pathology review for enrollment. Central review may lead to treatment delays and prevent high risk patients (pts) with aggressive presentations from enrolling onto clinical trials. We explored reasons pts with DLBCL were not enrolled on trials and the implication of non-enrollment on trial design and interpretation. Methods: We retrospectively analyzed all pts with histologic diagnosis of DLBCL or HGBL from 4/14 to 6/16 at the University of Rochester. Therapeutic trials open during this time included 3 sponsored and 2 NCTN studies. The Kaplan-Meier method was used to estimate the distribution of progression-free survival (PFS; time from start of treatment until progression/death or until the last date the patient was known to be progression free) and overall survival (OS). Results: 140 pts were identified; 22% enrolled on a trial. Reasons for non-enrollment included: 1) Protocol ineligibility (n=58); (2) Physician choice (n=24) and; 3) Patient choice (n=20). Reasons were unclear in 8 pts. Of the 24 pts who were not enrolled due to physician choice, 21 required urgent treatment secondary to symptoms or rapid progression. Compared to pts treated on trial, pts with rapid progression had higher risk clinical features (table). There was a trend towards a lower 1-year PFS rate in pts who required urgent treatment compared to those on trial (72.1% vs. 56.1%; p=0.08). There was no statistical difference in OS. Conclusions: At our institution, for patients with DLBCL meeting trial eligibility criteria, 42% required urgent chemotherapy and failed to enroll. Exclusion of these high risk patients in precision medicine trials has important implications in the interpretation and generalizability of clinical trials in DLBCL. In this curable malignancy, excluding high risk patients from trials limits the event rate, and associated power to demonstrate impact of novel therapies. [Table: see text]
A patient navigation program to enhance access to care for undeserved patients with a suspicion or diagnosis of cancer in Mexico City.
Authors: Bukowski Alexandra , Soto Perez De Celis Enrique , Ramos-López Wendy A , Rojo-Castillo Patricia , Sanchez- Gonzalez Jesus Armando , Sánchez-Gutiérrez Oscar , Viramontes-Aguilar Lorena , Davila-Davila Bernardo , Ahumada Tamayo Samuel , San Miguel Sandra , Alcalde-Castro Jacqueline , Goss Paul E. , Chavarri Guerra Yanin 
Published: September 2018

6544 Background: High cancer mortality rates in developing nations are partially driven by advanced stages at diagnosis and limited access to care. In Mexico, the interval from problem identification to start of treatment can be up to 7 months, mostly due to healthcare system delays. We implemented a patient navigation (PN) program aimed at reducing time to referral to cancer centers for patients (pts) with a suspicion or a diagnosis of cancer seen at a public general hospital in Mexico City. Methods: Pts age > 18 seen at Hospital General Ajusco Medio in Mexico City who required referral to a cancer center were enrolled. Baseline demographic, economic and psychosocial data were collected. A Patient Navigator assisted pts with scheduling; paperwork; obtaining results in a timely manner; transportation; and with other cultural barriers. The goal of the PN program was for at least 70% of enrolled patients to obtain a specialized appointment at a cancer center within the first 3 months from enrollment. Results: 53 pts (median age 54, range 19-80; 51% female) were included between 01/16 and 12/16. 19% (n = 10) had breast/GYN, 19% (n = 10) GU, 19% (n = 10) endocrine, 19% GI (n = 10) and 14% (n = 13) other tumors. All the pts were uninsured, 59% (n = 30) had less than middle school education, 80% (n = 41) were unemployed and 96% (n = 49) had a monthly household income of < $360 USD. 54% (n = 28) reported deprivation in at least one basic living need (education, running water, toilet, electricity or flooring). The most commonly identified barriers to healthcare access were financial (73%, N = 37), lack of transportation (47%, N = 24), fear (37%, N = 19) and poor communication with healthcare workers (35%, N = 18). Mean time to referral was 11 days (range 0–46, SD 11.2) and mean time to cancer specialist appointment 26 days (range 1–94, SD 21.18). 92% of pts successfully obtained appointments at a cancer center in < 3 months. Conclusions: Compared with previously reported data, this PN program shortened time to referral to a cancer center for pts with a suspicion or diagnosis of cancer in Mexico City. PN represents a potential solution to overcome barriers to healthcare access for underserved pts with cancer in developing countries.
Minority patient reported attitudes regarding tissue donation and participation in cancer research.
Authors: Sohal Davendra , Raska Paola , Abraksia Samir , Wilson Sherry , Griggs Jennifer J. , Khorana Alok A. 
Published: September 2018

6558 Background: Minority populations are underrepresented in biospecimen banks created for cancer research, which has implications for future therapeutic approaches. Patients’ reluctance to donate biospecimens is perceived to be a potential barrier but is poorly studied. We present interim analyses of a survey to assess attitudes in a patient cohort comprised of racial/ethnic minorities. Methods: Patients filled out a validated 23-item survey [ J Cancer Educ, 2014. 29: p. 580-7] for this prospective cohort study approved by the Cleveland Clinic IRB. Surveys were provided in the outpatient oncology clinic of a Cleveland Clinic community hospital. Eligibility requirements included tissue diagnosis of any solid tumor malignancy in non-curative setting; age ≥ 18 years, ECOG PS 0-2, self-reported race/ethnicity as any other than non-Hispanic White, undergoing cancer therapy in the next 30 days. Data are presented for the first 90 patients surveyed in 2015-2016. Results: Median age was 69 years (range, 35-92). Only 24 (27%, 1 missing) had been asked to donate samples in the past; of those, 20 (83%) had donated. The majority (n = 60, 67%) were willing to donate samples. A higher proportion (75%) responded as being likely to donate samples if they learned more about the research and reasons for sample donation. A smaller proportion was likely to donate samples if they received money (30%) or health services (40%) in return. Many (55-73%) disagreed with negative statements such as, “I will be treated as a guinea pig,” and only (3-4%) disagreed with trust statements such as, “I trust sample banks/medical researchers/procedures.” However, 42% endorsed being “concerned that something like the Tuskegee study could happen again.” Conclusions: The majority of racial and ethnic minority patients in this study were willing to donate biospecimens for research, with an even greater likelihood of participation if appropriate rationales were provided. While systemic mistrust persists, the vast majority trusted medical researchers and procedures. Our findings suggest that underrepresentation of minorities in cancer biospecimen repositories, not likely attributable to patient reluctance, must be addressed to achieve health equity.
The Affordable Care Act Dependent Coverage Expansion (ACA-DCE): Disparities in impact in young adult oncology patients.
Authors: Alvarez Elysia Marie , Keegan Theresa , Johnston Emily E. , Haile Robert , Sanders Lee , Wise Paul , Saynina Olga , Chamberlain Lisa J 
Published: September 2018

6561 Background: Private health insurance is associated with improved outcomes in cancer patients. We know little, however, about the impact of the ACA-DCE, which extended private insurance to young adults (up to age 26) beginning in 2010, on the insurance status of young adults with cancer. This study sought to determine the effect of the ACA-DCE on having private insurance coverage among hospitalized young adult oncology patients. Methods: We performed a retrospective, population-based analysis of hospitalized young adult oncology patients (22-30 years-old) in California during 2006-2014 (n = 11,062) using the Office of Statewide Health Planning and Development database. Multivariable regression analyses examined the social and clinical predictors of having private insurance. Results are presented as adjusted odds ratios (OR) and 95% confidence intervals (CIs). A difference-in-difference analysis examined the influence of the ACA-DCE on insurance coverage by race/ethnicity and zip code federal poverty level. Results: Multivariable regression demonstrated patients of black and Hispanic race/ethnicity were less likely to have private insurance both before and after the ACA-DCE, compared to non-Hispanic white patients. Younger age (22-25 years) was associated with having private insurance after the ACA-DCE implementation (OR 1.18, CI 1.05-1.33; reference, 27-30 years). In the difference-in-difference analysis, private insurance increased among non-Hispanic whites aged 22-25 living in medium- (2006-2009: 64.6% versus (vs) 2011-2014: 69.1%; p = 0.003) and high-income zip codes (80.4% vs 82%; p = 0.043) and among Asian patients aged 22-25 living in high-income zip codes (73.2 vs 85.7%; p = 0.022). Private insurance decreased for all Hispanic patients aged 22-25 between the two time periods. Conclusions: The ACA-DCE provision was an important first step in increasing coverage, but it was not universal and generated disparity in coverage as gains occurred for non-Hispanic white and Asian patients living in higher income zip codes. This policy change was shown to increase coverage for a traditionally underinsured population and attention should now focus on those remaining uninsured.
Feasibility of wearable physical activity monitors in cancer patients (PAMCaP).
Authors: Beg Muhammad Shaalan , Stewart Tyler , Gupta Arjun , Dong Ying , Rahimi Zain , Paul Tony , Crane Kimberli , Rethorst Chad 
Published: September 2018

6577 Background: Wearable physical activity monitors (PAMs) provide a degree of functional assessment not possible with prior clinical instruments. Subjective assessments of functional status are prone to inaccuracy and current objective assessment techniques are limited to the research setting. The relevance of physical activity monitors (PAMs) to measure functional status in cancer patients is unclear. The feasibility of using these devices in cancer patients is not known. Methods: This is a prospective pilot trial of a commercially available PAM in cancer patients. Patients with Eastern Cooperative Group performance status (ECOG PS) 0-2 receiving systemic therapy at an NCI Designated Comprehensive Cancer Center were enrolled. (NCT02583815). The primary objective was to determine feasibility of PAM use, defined as device use of more than 50% of the study observation period. Secondary objectives were to correlate PAM-reported measures: median, minimum and maximum steps/day, minutes of activity/day, (light/ fairly active/ very active); with 1) clinician assessed ECOG PS and 2) quality of life tool scores (FACT-G, QIDS, PQSI and BFI). Patient experience with wearable PAMs was assessed at the end of study. Results: We enrolled 32 patients: median age = 56 years (range 23-72), female = 67%, and white = 78%. Most patients had gastrointestinal (52%) and breast (19%) primaries. Clinician assessed PS was ECOG 0 in 56%, 1 in 37% and 2 in 7%. Majority of patients (81%) met the primary end point. Mean PAM measured steps for ECOG 0 was 5911 steps/d, ECOG 1 was 1890 steps/d and ECOG 2 was 845 steps/d (p = 0.002). Minimum steps/day correlated with BFI (r = -0.56, p < .01), FACT-G (r = 0.45, p 0.01) and QIDS (no vs mild vs moderate depression, p 0.01). Patients reported a positive experience with the devices (74%). Conclusions: Wearable PAMs are a feasible tool to measure physical activity in cancer patients receiving systemic therapy. PAM derived measures correlate with clinician assessments of performance status. Future work should develop methods to systematically incorporate PAMs in oncology clinical trials and practice. Clinical trial information: NCT02583815.
Possible mechanisms of serotonin and aprepitant actions in chemotherapy induced nausea and vomiting (CINV): Insights into the mechanisms of serotonin and aprepitant actions in CINV—According to recent multi-institutional double-blind randomized clinical research on the AC regimen.
Authors: Tsuneizumi Michiko , Saito Mitsue , Ogata Hideaki , Kutomi Goro , Hosoya Keiko , Kawai Yuko , Matsuoka Joe 
Published: September 2018

6587 Background: One of our interests has been whether palonosetron(P) would be superior to granisetron(G) when administering triplet antiemetic therapy for the prevention of CINV, since a prior trial demonstrated P to be superior to G for controlling CINV induced by highly emetogenic chemotherapy (HEC) in doublet therapy. In this study(TTT; trial for antiemetic therapy), we assessed the efficacies of P and G for use as triplet antiemetic therapy for AC, by monitoring CINV, focusing complete response (CR; no vomiting and no rescue medicine) in the delayed phase. The primary endpoint of TTT was a CR during the delayed phase with 5-HT3ra plus dexamethasone and aprepitant administration for AC.　The purpose of gaining insights into the possible mechanism of action of aprepitant and P was to obtain ideas for the next strategy against CINV. Methods: Between 2012 and 2015, 491 breast cancer receiving AC were recruited from 11 institutions, and randomly assigned to either single-dose P(0.75mg) or G(40μg/kg) prior to AC on day 1, both with dexamethasone (9.9 mg) and aprepitant (125mg) on day 1 followed by additional doses (80mg) on days 2 and 3. Age, institution and habitual alcohol intake were used as stratification factors. The primary endpoint was a CR. Results: All 491 patients were included in efficacy analyses: 246 patients in the group P and 245 in the group G. The difference in CR during the delayed phase, i.e. 24 hrs after the administration of AC, did not reach statistical significance, however, there was a remarkable difference between 48 and 72 hrs in the day-to-day analysis(p < 0.02). Conclusions: P showed better efficacy in controlling CINV between 48 to 72 hours after AC, than G as triplet antiemetic therapy for AC. We can reasonably speculate that the influence of serotonin has two peaks (0-24 hrs and 48-72 hrs). For controlling CINV in the delayed phase, not only an NK1 receptor antagonist but also administering a 5-HT3ra with long life should be considered until 72 hrs after HEC. Clinical trial information: UMIN 000007882.
Identifying determinants of quality of life in patients undergoing systemic therapy for solid tumors.
Authors: Lin Frank Po-Yen , Martin Chloe , Kocbek Simon , Joshua Anthony M. , Dear Rachel Fitz-Gerald , Lim Elgene , Chantrill Lorraine A. , Chin Venessa T. , Epstein Richard J 
Published: September 2018

6596 Background: Knowing which factors compromise quality of life (QoL) in patients undergoing cancer treatments can help oncologists provide more effective care. To identify these factors, we conducted a single-centered cross-sectional study examining the relationships between patient-reported QoL, adverse events (AE), and treatment characteristics. Methods: Consecutive patients attending an outpatient chemotherapy unit completed two questionnaires (EORTC QLQ-C30 and National Cancer Institute PRO-CTCAE) per visit to identify factors contributing to the lowest global QoL score [QLQ-C30 QL2, range 0 (worst)–100 (best)] over a 6-week period. QL2 was correlated to each PRO-CTCAE item and treatment characteristic (tumor type, drug class, number of cycles, and treatment intent) using multiple regression, adjusted for age, sex, and use of concurrent radiotherapy. To determine whether QoL can be reliably modeled by machine learning, ten algorithms were compared for performance in classifying patients into dichotomized QL2 subgroups. Results: One hundred and fifteen of 130 patients (157/244 visits) completed up to 6 sets of questionnaires (median QL2: 67, IQR: 50–83). No difference was found between QL2 and treatment characteristics (at α Bonferroni=5×10-4). However, QL2 was significantly associated with AE in gastrointestinal, respiratory, attention, pain, sleep/wake, and mood categories. Using AE as covariates, support vector machine with radial basis kernel was the best at classifying patients into QoL groups (mean bootstrapped area under ROC curve 0.812, 95% CI 0.700–0.925). Conclusions: Patient-reported QoL is associated with multiple AE, but not with characteristics of systemic therapy. Machine learning analysis suggests that a combined AE analysis may reliably characterize a patient’s QoL. [Table: see text]
Are surrogate endpoints unbiased metrics compared to hazard ratio for death? An evaluation of clinical benefit scores (CBS) in the American Society of Clinical Oncology (ASCO) value framework.
Authors: Qureshi Mahin Iqbal , Cheung Matthew C. , Cheng Sierra , Jiang Di Maria , McDonald Erica , Arciero Vanessa Sarah , Ezeife Doreen Anuli , Chambers Alexandra , Sabarre Kelley-Anne , Chan Kelvin K. 
Published: September 2018

6600 Background: Clinical benefit scores (CBS) are a key element of the American Society of Clinical Oncology (ASCO) value framework's Net Health Benefit valuation of cancer therapies. CBS are assigned based on a hierarchy of efficacy endpoints, from hazard ratio for death (HR OS), to median overall survival (mOS), HR for disease progression (HR PFS), median progression-free survival (mPFS), and response rate (RR). When HR OS is unavailable, other endpoints in the hierarchy are used as "surrogates" to calculate CBS via their scaling factors. We aim to examine whether surrogate-derived CBS offer unbiased scoring of clinical benefit compared to HR OS-derived CBS. Methods: CBS for advanced-disease settings were computed for randomized clinical trials (RCTs) of oncology drug approvals by the Food and Drug Administration, European Medicines Agency, and Health Canada, between 2006 and August 2015. Spearman's correlation assessed association between CBS derived from surrogates and HR OS. Mean bias (surrogate-derived CBS minus HR OS-derived CBS) evaluated the tendency for surrogate-derived CBS to over- or under- estimate clinical benefit. Mean absolute error (MAE), a measure of average deviation, assessed precision of surrogate-derived CBS in relation to HR OS-derived CBS. Results: Scored RCTs (n=104) yielded 69, 93, 88, and 89 paired CBS between HR OS and mOS, HR PFS, mPFS, and RR, respectively. See table for results. Restricting to RCTs reporting all endpoints (n=59) and RCTs without OS as primary endpoint (n=68) showed similar results. Conclusions: Findings suggest HR PFS-, mPFS-, and RR-derived CBS are poor "surrogates" as they are imprecise and weakly correlated to HR OS-derived CBS. HR PFS and particularly mPFS exhibit bias to overestimate CBS. [Table: see text]
Delivery of meaningful cancer care: Evaluating benefit and cost of cancer therapies using ASCO and ESMO frameworks.
Authors: Del Paggio Joseph , Sullivan Richard , Schrag Deborah , Hopman Wilma M , Azariah Biju , Pramesh C S. , Tannock Ian , Booth Christopher M. 
Published: September 2018

6609 Background: ASCO and ESMO have developed frameworks to evaluate the benefit of cancer therapies. Here, we apply the frameworks to a cohort of contemporary randomized controlled trials (RCTs) to explore agreement and to evaluate the relationship between treatment benefit and cost. Methods: Characteristic and outcome data from RCTs evaluating systemic therapies in non-small cell lung cancer (NSCLC), breast cancer, colorectal cancer (CRC), and pancreatic cancer published and cited in PubMed between 2011-2015 were abstracted. Trial endpoints were evaluated using ASCO and ESMO frameworks. Cohen’s kappa statistic was calculated to determine agreement between the two frameworks, using the median ASCO score as a benefit threshold. Differences in monthly drug cost between RCT experimental and control arms were derived from 2016 average wholesale prices. Analyses included Pearson chi-square tests, Fisher’s Exact tests, independent samples t-tests, and Pearson correlation to assess the association between continuous variables. Results: Fifty percent (136/271) of published RCTs favoured the experimental arm; scoring rubrics were applicable to 109 RCTs (39% NSCLC, 33% breast, 23% CRC, 5% pancreas). ASCO scores ranged from 2 to 72; median score was 25. Thirty seven percent (40/109) of RCTs met benefit thresholds using the ESMO framework. Agreement between frameworks was fair at best (κ = 0.28, p = 0.002). When stratified by treatment intent (19 curative, 90 palliative RCTs), agreement remained poor (κ = 0.23, p = 0.115; κ = 0.34, p < 0.001). Major differences leading to limited agreement includes the relative weights each framework places on HR, endpoints, and toxicity/QOL analysis. Smaller RCT sample size was the only trial characteristic associated with higher ASCO scores (p = 0.015). Among the 100 RCTs for whom drug costing data were available, there was no association between ASCO benefit score and monthly drug costs (r = -0.12, p = 0.22); those meeting ESMO thresholds had a lower mean drug cost than those who did not (p = 0.046). Conclusions: There is only fair correlation between ASCO and ESMO clinical benefit frameworks. Drug costs are not associated with ESMO/ASCO measures of magnitude of clinical benefit.