bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of Medicaid reimbursement and eligibility policies on receipt of cancer screening.
Authors: Halpern Michael T. , Romaire Melissa A. , Haber Susan G. , Tangka Florence K. , Sabatino Susan A. , Howard David H. 
Published: March 2020

6514 Background: State Medicaid programs cover receipt of cancer screening services. However, coverage of cancer screening tests does not guarantee access to these services. Medicaid beneficiaries are less likely to be screened for cancer and more likely to present with advanced stage cancers. State-specific variations in Medicaid program eligibility requirements and reimbursements for medical services may affect cancer screening rates among Medicaid enrollees. This study examined how eligibility and reimbursement policies affected receipt of breast, cervical, colorectal, and prostate cancer screening. Methods: We examined 2007 Medicaid data for individuals age 21-64 enrolled in fee-for-service Medicaid for at least 4 months from 46 states and the District of Columbia. We examined the association of state-specific Medicaid cancer screening test and office visit reimbursements, income and financial asset eligibility requirements, physician copayments, and frequency of Medicaid eligibility renewal on receipt of cancer screening. Analyses used multivariate logistic regressions with generalized estimating equations to control for correlation between beneficiaries within a state. Results: Increased Medicaid screening test reimbursements were significantly associated with small increases in receipt of colonoscopy, mammograms, and PSA tests. Increased reimbursements for office visits were associated with increased receipt of colonoscopy, FOBT, Pap tests, and mammograms. Greater asset thresholds for Medicaid eligibility increased the likelihood of all screening tests except FOBT. Beneficiaries in states requiring more frequent (<12 month) renewal of Medicaid eligibility were more likely to receive FOBT, PSA, or mammograms, but less likely to receive Pap tests. Conclusions: Increasing Medicaid reimbursement rates and asset policies was generally associated with increases in cancer screening. As proposed Medicaid eligibility expansions will almost certainly increase the number of enrollees in this program, it is crucial to provide adequate reimbursements and develop eligibility policies to promote cancer screening and thereby increase early cancer detection among this underserved population.
When using patient-reported outcomes in clinical practice, the measure matters: Results from an RCT.
Authors: Snyder Claire Frances , Herman Joseph M. , Blackford Amanda L. , Carducci Michael Anthony , Wu Albert W. 
Published: March 2020

6519 Background: Patient-reported outcomes (PRO) assess patients' perspectives on the impact of diseases and treatments. There is increasing interest in having patients complete PRO questionnaires and using the data clinically to identify and address patients' issues. There are many different PRO questionnaires, and this study investigated whether one PRO is more appropriate than others for clinical use. Methods: This controlled trial randomly assigned patients to complete 1 of 3 PRO questionnaires: six domains from the Patient Reported Outcomes Measurement Information System (PROMIS), the EORTC QLQ-C30, or the Supportive Care Needs Survey-Short Form (SCNS). Breast or prostate cancer patients, >=21 years old, undergoing treatment, with oncologist visits at least monthly were eligible. Patients completed their assigned PRO questionnaire via computer either in the clinic or via the web prior to their clinic visits for the duration of active treatment. The results were provided to their clinicians for use during visits. After treatment ended, patients completed a 13-item feedback form to assess the impact of the questionnaire on their care (e.g., easy to complete, promoted communication, improved care quality). We hypothesized that there would be no difference in the proportion of patients who strongly agreed/agreed to all 13 items in the feedback form by questionnaire arm. Results: Of 294 eligible patients approached, 224(76%) enrolled (mean age 66, 78% white, 28% breast, 72% prostate). Of these, 181 patients (81%) responded to the feedback form, with 116 patients (52%) completing all 13 items. Of the 116 patients with complete data, subjects in the QLQ-C30 arm were most likely to strongly agree/agree to all items (82%), followed by PROMIS (62%), and SCNS (56%) [p=.05]. Among the 181 patients with at least partial data, the proportions strongly agreeing/agreeing to all items were 74% for QLQ-C30, 61% for PROMIS, and 52% for SCNS [p=.03]. Conclusions: In a randomized trial comparing the benefits of PROs applied in clinical practice, we found significant differences among the 3 PRO questionnaires. Future applications of PROs for patient care should select the most appropriate PRO measures for the purpose and setting.
Does biomarker information impact patients’ preferences for therapy?
Authors: Partridge Ann H. , Sepucha Karen , O'Neill Anne , Miller Kathy , Baker Emily , Dang Chau T. , Northfelt Donald W. , Sledge George W. , Schneider Bryan P. 
Published: March 2020

6527 Background: Biomarker information can risk stratify patients based on potential for benefits/toxicity from therapy. Ideally, a biomarker will identify those who benefit with limited toxicity. However, the impact of biomarkers is unclear when indicting individuals with greatest benefit are also at increased risk for toxicity. Methods: We surveyed participants at 18 month follow-up in the Decision-Making/Quality of Life (DM-QOL) component of ECOG5103, a RCT where patients were randomized to receive adjuvant chemotherapy for breast cancer with either placebo or bevacizumab (in 2 schedules). We asked patients for the preferred treatment in two hypothetical scenarios: 1) preference for chemo A or chemo A + B without biomarker information; 2) preference for chemo A or chemo A+B when participants tested positive for a “B-receptor” which increased both the benefit and toxicity of chemo A+B. McNemar’s test was used to examine changes in preferences. Results: 439 patients completed both scenarios on 18-month survey. The Table shows the treatment preferences in each scenario. The positive biomarker information in scenario 2 led 60/439 (14%) participants to switch their preference. The main reason for treatment preference in scenario 2 was greater benefits of chemo A+B (64%), the lower risks with chemo A (20%) and positive biomarker (10%). Among participants who changed preference, those randomized to receive bevacizumab were more likely to switch to chemo A in scenario 2. Conclusions: Information about a positive biomarker, indicating increased benefit and increased risk from additional chemo, did not significantly change participants’ preferred treatment. All participants were involved in a large placebo controlled double blind trial and the majority (70%) preferred the most aggressive course of treatment in both scenarios. Whether patients not enrolled in the trial would be more sensitive to the increased risk information is unclear. [Table: see text]
Racial/ethnic differences in end-of-life (EoL) treatment preferences: The role of religious beliefs about care.
Authors: Balboni Tracy A. , Maciejewski Paul K , Balboni Michael J. , Enzinger Andrea Catherine , Paulk M. Elizabeth , Munoz Francisco , Rivera Lorna , Mutchler Jan , Finlay Esme , Marr Lisa , McCorkle Ruth , Temel Jennifer S. , Weeks Jane C. , Vanderweele Tyler J. , Prigerson Holly Gwen 
Published: March 2020

6529 Background: Racial/ethnic minorities and patients who turn to religion to cope receive more aggressive EOL care. Beliefs underlying these associations are unknown. Methods: Coping with Cancer is an ongoing, multi-site, NCI-funded study examining factors influencing racial/ethnic EoL disparities. From 11/2010-10/2012, 133 advanced cancer patients underwent baseline interviews, including 7 items assessing religious beliefs about EoL care (RBEC). Univariate analyses assessed racial/ethnic differences in RBEC and EoL treatment preferences. Multivariable analyses (MVA) modeled mean RBEC score as a function of race/ethnicity, controlling for confounders, and assessed the relationship of race/ethnicity and RBEC to treatment preferences. Results: Religious beliefs about EoL care are common and more often held by racial/ethnic minorities (Table); racial/ethnic differences persisted in MVA (p<.0001). Black patients were more likely than Whites to prefer aggressive EOL care (OR=5.03, p=.02), whereas Latino’s EOL preferences did not differ from Whites (p=.87). In MVA including race and RBEC score, Black race was not related to EOL care preferences (OR 1.61, p=0.55), whereas greater RBEC score was associated with greater preference for aggressive care (OR 2.48, p=0.003). Conclusions: Religious beliefs about EoL care are common and significantly more so among racial/ethnic minorities. Preliminary data suggest these beliefs mediate the relationship between race/ethnicity and EoL treatment preferences. [Table: see text]
Perceptions regarding prostate cancer (CaP) treatment options: Results from the North Carolina Prostate Cancer Comparative Effectiveness and Survivorship Study (NC ProCESS).
Authors: Chen Ronald C. , Nielsen Matthew Edward , Reeve Bryce B. , Hendrix Laura H. , Agans Robert P , Hoffmeyer Anna , Usinger Deborah , Strigo Tara , Jackman Anne , Godley Paul Alphonso 
Published: March 2020

6530 Background: NC ProCESS is a population-based cohort of early (non-metastatic) CaP patients followed prospectively from diagnosis. Methods: Patients were identified through Rapid Case Ascertainment of the NC Cancer Registry from all NC counties in 2010-12. Phone survey assessed perceptions regarding treatment options and priorities in treatment selection. Results: 937 (59% of all eligible) completed this survey. Median age was 65; 72% were Caucasian. At time of survey, ~13 weeks from diagnosis, 98% had discussed options with a urologist, 49% with primary care, and 41% radiation oncologist. Many patients had concerns about potential effects of surgery and radiation on ability to perform daily activities, recovery time, and burden to family (Table). Open prostatectomy (ORP) and external beam radiation (RT) were deemed most likely to affect urinary and sexual function; fewer reported concern with robotic prostatectomy (RALP). Only 32% reported hormonal therapy would affect sexual function. Most reported surgery (especially RALP) had the best chance for cure, while 59% worried about recurrence with RT. In almost all questions, patients who consulted only with a urologist had significantly different perceptions about treatment options than those who also consulted with a radiation oncologist. In choosing treatment, 61% reported that cure was the highest priority, and 28% indicated preserving quality of life. Conclusions: Modern CaP patients often have misconceptions about treatment options inconsistent with published evidence, which are partially mitigated by multidisciplinary consultation. Most indicated cure as the highest priority, and surgery offers the best chance of cure. [Table: see text]
Use and impact of chemotherapy-free intervals in metastatic colorectal cancer in routine practice.
Authors: Kay Amin , Yun Lingsong , Taback Nathan , Krzyzanowska Monika K. 
Published: March 2020

6535 Background: Several randomized trials have shown that chemotherapy-free intervals (CFIs) may reduce toxicity without compromising survival in patients with metastatic colorectal cancer (mCRC) treated with non-curative intent. However, uptake and outcomes of this approach in routine practice are unknown. We performed a population-based study of the patterns of use of CFIs and their impact on survival and toxicity among patients treated with first-line intravenous (IV) chemotherapy in Ontario, Canada. Methods: The Ontario Cancer Registry was linked with several other administrative databases to identify patients with colorectal cancer who started first-line IV chemotherapy between 2007-2009. A patient was considered to have had a CFI if more than 56 days elapsed between two chemotherapy billing claims. Survival of patients who had at least one CFI was compared to those who did not using Cox regression stratified by duration of treatment and adjusted for age, sex and Charlson comorbidity score. Analysis was performed separately for each type of first line treatment: Irinotecan (IRI), Irinotecan plus Bevacizumab (IR+B), and Oxaliplatin (OX). Toxicity was estimated by calculating the rate of emergency department visits and hospitalizations (adjusted for time on treatment) between those who did and did not have chemo breaks. Results: Between 2007-2009, 1,989 patients started first-line chemotherapy for mCRC in Ontario (22.6% IRI, 47.9% IRI+B, 29.5% OX). 489 (24.6%) had at least one CFI (14.9% IRI, 33.2% IRI+B, 18.1% OX). The median duration of first line treatment was 205 days (IQR 107-366 days). The median duration of the first CFI was 127 days (IQR 90-234 days). In multivariate models stratified by duration of treatment, CFIs did not have a negative effect on survival in either of the 3 treatment groups (HR: 0.62 IRI, 0.90 IRI+B, 0.51 O). Toxicity was lower in patients who had at least one CFI (12.6 vs 16.8 ER visits or admissions per person-month, p=0.036). Conclusions: Chemo-free intervals are used in routine practice in Ontario, and are associated with lower toxicity, without any apparent evidence of negative impact on survival.
Cost-effectiveness of everolimus plus exemestane in post-menopausal hormone receptor positive metastatic breast cancer.
Authors: Zeichner Simon B. , Avancha Kiran Kumar Venkata Raja , Lopes Gilberto , Gluck Stefan , Montero Alberto J. 
Published: March 2020

6548 Background: Everolimus in combination with exemestane is approved for the treatment of postmenopausal women with hormone-receptor (HR) positive, HER2-negative metastatic breast cancer (MBC). The BOLERO-2, a randomized phase 3 trial, demonstrated a significantly improved progression free survival (PFS) with everolimus plus exemestane compared to exemestane alone in patients previously treated with non-steroidal aromatase inhibitors. In order to better inform U.S. policymakers, this study aimed to assess the cost-effectiveness, from a payer perspective, of everolimus in combination with exemestane. Methods: We created decision analytical and Markov models using published data from the BOLERO-2 trial. Utilities were derived from available literature. Costs were obtained from the Center for Medicare Services drug payment table and physician fee schedule and were represented in 2012 U.S. dollars. The quality-adjusted life-years (QALY) and incremental cost-effectiveness ratio (ICER) were calculated. One way and probabilistic sensitivity analyses were performed. Results: Everolimus added 0.42 years of progression-free survival (PFS) by central radiographic assessment with an incremental cost of $33,103, an overall cost of $62,751.54 per year of PFS gained, and an ICER of $79,376/QALY. By local assessment, everolimus added 0.29 years PFS years with an incremental cost of $31,873, an overall cost of $83,222 per year of PFS gained, and an ICER of $108,131/QALY. The results of the model were robust in sensitivity analyses. The primary drivers in this model were found to be: PFS duration, progression free probability on therapy, and overall everolimus cost. Conclusions: Everolimus plus exemestane appears to be cost-effective in the treatment of metastatic breast cancer. Based on efficacy and value, this newly approved combination should be considered to be a viable option in treating patients with HR+/HER2- MBC upon progression on non-steroidal aromatase inhibitors.
Simulating the cost-effectiveness of lung cancer screening by low-dose CT scan in Canada.
Authors: Goffin John R. , Flanagan William M , Miller Anthony , Liu Fei Fei , Cressman Sonya , Fitzgerald Natalie , Fung Sharon , Wolfson Michael , Evans William K. 
Published: March 2020

6550 Background: The National Lung Screening Trial (NLST) demonstrated that low-dose CT screening diminishes the risk of death among smokers. A cost-effectiveness analysis was undertaken in the context of the Canadian publically funded healthcare system. Methods: Microsimulation of CT screening was undertaken using the Cancer Risk Management Model, which incorporates demographic data, cancer risk factors, cancer registry data, diagnostic and treatment algorithms and health utilities. Simulations were performed at the individual level for a cohort incepted during the period 2012-2032. The criteria for the screen-eligible population, CT scan test characteristics, and screened cohort outcomes were derived from NLST and Canadian data. The baseline screening scenario was annual CT screening for ≥30 pack-year smokers, age 55 to 74. Simulation assumed 60% of the eligible population participates by 10 years, 70% adhere to the screening regimen, and smoking cessation rates are unchanged. One-way sensitivity analyses were performed. Costs and life-years lived were discounted at 3% annually. Results: Compared to no screening, annual screening results in incremental system costs of $2.97 billion (Cdn), 149,000 life-years saved (LYS) or 55,000 quality-adjusted life-years saved (QALYS), an incremental cost-effectiveness ratio (ICER) of $19,900/LYS, and $53,700/QALYS. With participation rates from 40% to 80%, ICER /QALYS remained within the range of $53,700 to $58,200. Increases in screening adherence from 50% through 90% increased the ICER /QALY from $50,400 to $58,800. Higher rates of smoking cessation led to improvements in ICER /QALY (150% of background cessation rate of 3.2-5.3%, $47,000; 200%, $41,500; 300%, $32,900). A system of biennial screening had a net cost of $1.81 billion, resulting in an ICER of $19,600 /LYS, and $54,800 /QALYS. Conclusions: Screening for lung cancer with low-dose CT scans could be cost-effective, but requires substantial system costs. The smoking cessation rate greatly impacts the ICER and a cessation program should be considered if screening is implemented. Compared to annual screening, biennial screening costs less and produces a similar ICER. Further analyses will be detailed.
NCIC CTG MAP.3: Symptoms and quality of life (QoL) among racial/ethnic minority women taking the aromatase inhibitor (AI) exemestane (EXE) for breast cancer risk reduction.
Authors: Moy Beverly , Tu Dongsheng , Richardson Harriet , Maunsell Elizabeth , Goss Paul E. 
Published: March 2020

6557 Background: Racial/ethnic minority postmenopausal women reported fewer side effects than whites on the aromatase inhibitor (AI) letrozole in MA.17. We present symptoms and QoL according to race and ethnicity in women taking EXE for BC prevention in MAP.3. Methods: Adjusted proportions ever experiencing symptoms or reporting worsened SF-36 domains (change scores from baseline decreased by ≥ -5 points) among racial minorities (M) and whites (W), and Hispanics (H) and non-Hispanics (non-H), were compared using logistic regression models adjusting for age, body mass index (BMI), country, marital status, education level and employment status. Results: Of 2285 women randomized to EXE, 2231 (97.6%) women had race information: 129 M (6.1%) and 2102 W (93.9%).Compared to W, M were significantly older, had higher BMI, had lower Gail scores, received more drugs for cardiovascular diseases, and were more likely to live in the United States.M women experienced fewer sweats (12% vs. 22%; p = 0.005) and less vaginal dryness (8% vs. 16%; p=0.03). No significant difference between W and M was seen in the proportion with worsened QoL on any SF-36 domain. Ethnicity was known for 2198 women on EXE (96.2%): 241 H (11.0%) and 1957 non-H (89%). The following were less frequent among H women: hot flashes (21% vs. 42%; p<0.0001); fatigue (14% vs. 24%; p=0.01); sweats (5% vs. 24%; p<0.0001); insomnia (6% vs. 11%; p=0.001); heartburn (5% vs. 16%; p=0.001); nausea (3% vs. 7%; p=0.02); arthritis (5% vs. 12%; p=0.02); depression (7% vs. 11%; p=0.005); back pain (2% vs. 10%; p=0.002); cough (4% vs. 11%; p=0.02); and vaginal dryness (4% vs. 17%; p<0.0001). Fewer H women reported worsening in SF-36 bodily pain (60 vs. 66%; p=0.02) but more reported worsening in SF-36 mental health (59% vs. 48%; p=0.02). Conclusions: Consistent with MA.17 findings, racial/ethnic minorities experienced fewer adverse events on AI. H women had less bodily pain but reported worsening mental health. These differences may be important for minority women contemplating EXE for BC prevention. Genotypic variations and pharmocogenomics that might account for these differences merit investigation.
Quality of reporting of phase II trials in oncology in highly ranked oncology journals.
Authors: Grellety Thomas , Petit-Monéger Aurelie , Diallo Abou , Mathoulin-Pelissier Simone , Italiano Antoine 
Published: March 2020

6582 Background: Phase II trials represent an essential step in the development of anti-cancer drugs. The aim of this study was to assess the quality of their reporting in highly-ranked oncology journals, to investigate predictive factors of quality and to develop better reporting guidelines for authors. Methods: We reviewed the tables of contents of 8 peer-reviewed oncology journals published between January 2011 and December 2011 and with a 2011 impact factor (IF) >4: Br J Cancer, Eur J Cancer, Oncologist, J Clin Oncol, Lancet Oncol, JNCI, Clin Cancer Res and Ann Oncol. Two reviewers assessed the quality of each report by using a 44-point overall quality score (OQS; range, 0 to 44 points) inspired from the revised Consolidated Standards of Reporting Trials statement. Primary endpoint definition, justification of sample size and definition of the evaluable population for each endpoint, were assessed separately because of their crucial methodological importance using a 3-point key methodological score (KMS; range, 0 to 3). Exploratory analyses were used to identify predictive factors associated with the different scores. Results: 156 articles were included. Agreement between the reviewers for each item was good (kappa coefficient range: 0.62-1). The median OQS was 28 (range: 9-35). OQS sub-score analysis showed that reporting of statistical methods was particularly low with a mean of 2.5 (6 items). The median KMS was 2 (range 0-3). Primary endpoint definition, justification of sample size and definition of the evaluable population were reported only in 107 (68.6%), 121 (77.6%), and 52 (33.3%) cases, respectively. On multivariate analysis, reporting of clinicaltrial.gov registration was associated with improved OQS, OR = 3.2 (95CI, 1.5 to 7.1). No predictive factor for KMS were identified. Conclusions: Phases II trials reporting is still poor even in journals with strict editorial policies. This may lead to biased interpretation of phase II trial results. We have developed a checklist for use by authors, reviewers, and editors to improve reporting of these studies. As well as using a checklist during the preparation of their manuscript, we recommend that authors provide reviewers and readers with the last version of the study’s protocol.