bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patterns of disparities in breast cancer care.
Authors: Hassett Michael J. , Schrag Deborah , Chen Kun , Roohan Patrick R. , Boscoe Francis P. , Schymura Maria J. 
Published: March 2020

6565 Background: Studies have documented disparities in breast cancer care for decades, but disparities in outcomes have not improved. Previous disparity investigations included relatively small, potentially biased samples of disadvantaged populations, or focused only on selected aspects of care. We sought to describe the relative importance of race/ethnicity versus Medicaid insurance status as determinants of suboptimal quality across the spectrum of care using two population-based samples of women with non-metastatic breast cancer. Methods: From two state registry datasets (NY and CA), we identified adult women diagnosed with stage 0-III breast cancer from 2004-2009. To these data, we merged enrollment and claims files from Medicaid and Medicare. Quality was assessed relative to 35 underuse and overuse measures derived from clinical practice guidelines. We compared measures across race/ethnic and Medicaid enrollment groups, and used logistic regression models to assess the relationships between race/ethnicity, Medicaid status, and quality relative to surgery, chemotherapy, radiation, and endocrine measures. Analyses were conducted in parallel for NY and CA, and for women <65 and ≥65 years old. Results: The sample, which comprised 80,079 from NY and 121,098 from CA, included 14%/6% blacks, 8%/15% Hispanics, 5%/12% API’s, and 19%/14% Medicaid enrollees, respectively from NY/CA. There was moderate-high correlation in measure performance across states and race/ethnic groups. Multivariable models demonstrated that blacks had lower odds of receiving recommended surgery versus whites, and whites had lower odds of receiving chemotherapy, whether recommended or not, versus other race/ethnic groups. Medicaid status was associated with lower odds of receiving recommended surgery, radiation therapy, and anti-estrogen therapy, but not chemotherapy, for patients <65 and ≥65. Conclusions: Medicaid status, a surrogate for socio-economic status, was associated with lower odds of receiving recommended care across a broad spectrum of breast cancer treatments. Understanding patterns of disparities will facilitate efforts to design and disseminate real world solutions that foster improvements in outcomes for the most disadvantaged populations.
Survival rates of male breast cancer compared to female: A Surveillance, Epidemiology, and End Results (SEER) database analysis.
Authors: Mushtaq Rao , Shaik Mohammed , Mistry Shams , Alkharabsheh Omar Abed , Shaqfeh Mahmoud , Afsharimani Seyedamirhossein , Ahmad Delshad , Habte-Gabr Eyassu , Katato Khalil , Tamkus Deimante 
Published: March 2020

6567 Background: Breast cancer (BC) is rare in males (M) compared to females (F). There were 2,190 new cases of MBC out of total 226,870 BC cases diagnosed in 2012. Recently, the incidence of MBC is rising but mortality is decreasing in both MBC and FBC. Therefore we want to evaluate survival difference between MBC and FBC. Methods: Using SEER database we analyzed 4,192 MBC compared to 591,268 FBC diagnosed between 1983-2009. Data including age, sex, tumor size, grade, stage, and ER/PR status was used in analysis. Overall five year survival (OS) and Disease specific survival (DSS) rates were calculated using Kaplan-Meier (KM). We further analyzed the data based on race (Black vs White) and calculated 5yr-OS and 5yr-DSS using KM. Results: The majority of MBC were diagnosed at later stages (49.2% vs 35.3%), with greater number of +veLN (44% vs33.5%), and higher percentage of positive ER/PR(95% vs79%) compared to FBC. When analyzed stage-by-stage, males had significantly lower 5-yrOS in all stages except in the stage with distant metastasis (mets) (Table1a). There was no significant difference in 5-yr DSS survival in both sex. Based on race, black males had worse 5-yrOS and 5yr-DSS, followed by white males, black females, and white females (p= 0.0001)(Table1b). Conclusions: Even though MBC presents with advanced disease at diagnosis, our analysis shows there is no difference in DSS when analyzed stage-by-stage. White females had better prognosis compared to others, and black males had worse prognosis. Prospective studies needed to be done to evaluate the prognosis of male breast cancer. [Table: see text] [Table: see text]
Racial disparity in diffuse large B-cell lymphoma survival.
Authors: Han Xuesong , Jemal Ahmedin , Ward Elizabeth M. 
Published: March 2020

6569 Background: Although blacks have a lower risk of non-Hodgkin lymphoma (NHL) compared to whites, black non-Hodgkin lymphoma (NHL) patients experience worse survival than white patients. This study aims to examine in patients with diffuse large B-cell lymphoma (DLBCL), the most common subtype of NHL, how much of the racial disparity in survival can be explained by differences in certain demographic (age, sex and area-level education) and access-to-care-related (stage, treatment, health insurance status) factors. Methods: Our cohort included 3716 non-Hispanic white or black DLBCL patients aged 18-64, diagnosed in 2004-2005 from the National Cancer Database (NCDB), a nationwide, hospital-based cancer registry. The analysis included only HIV/AIDS-negative patients. Kaplan-Meier survival curves were drawn for blacks and whites. Cox proportional hazards model was fitted to estimate hazard ratios (HR) and the 95% confidence intervals (CI) for race with and without controlling for demographic factors (age, sex and area-level education), stage, treatment and health insurance status. Results: Black patients had a worse survival than white patients (5-year survival rate 66.6% in blacks vs. 73.3% in whites, log-rank test p-value = 0.0006). Without adjusting for other factors, blacks had a 34% higher risk of death compared to whites (crude HR=1.34, 95% CI =1.13-1.58). After adjusting for demographic factors including age, sex and area-level education, the HR reduced to 1.27 (95% CI=1.06-1.51). After further adjustment for stage, treatment and insurance status, the association disappeared (HR=1.03, 95% CI= 0.86-1.23). Conclusions: Demographic factors and access-to-care-related factors including stage, treatment and health insurance status fully explained the black-white racial disparity in DLBCL survival in this cohort. Our findings suggest that improvements towards timely diagnosis, appropriate treatment and other adequate access to health care measures could potentially eliminate the survival disparity between black and white DLBCL patients.
A new design for phase II single-arm clinical trials: Bayesian predictive sample size selection design.
Authors: Teramukai Satoshi , Daimon Takashi , Zohar Sarah 
Published: March 2020

6576 Background: The aim of phase II trials is to determine if a new treatment is promising for further testing in confirmatory clinical trials. Most phase II clinical trials are designed as single-arm trials using a binary outcome with or without interim monitoring for early stopping. In this context, we propose a Bayesian adaptive design denoted as PSSD, predictive sample size selection design (Statistics in Medicine 2012;31:4243-4254). Methods: The design allows for sample size selection followed by any planned interim analyses for early stopping of a trial, together with sample size determination before starting the trial. In the PSSD, we determined the sample size using the predictive probability criterion with two kinds of prior distributions, that is, an ‘analysis prior’ used to compute posterior probabilities and a ‘design prior’ used to obtain prior predictive distributions. In the sample size determination, we provide two sample sizes, that is, N and Nmax, using two types of design priors. At each interim analysis, we calculate the predictive probability of achieving a successful result at the end of the trial using analysis prior in order to stop the trial in case of low or high efficacy, and we select an optimal sample size, that is, either N or Nmax as needed, on the basis of the predictive probabilities. Results: We investigated the operating characteristics through simulation studies, and the PSSD retrospectively applies to a lung cancer clinical trial. As the number of interim looks increases, the probability of type I errors slightly decreases, and that of type II errors increases. The type I error probabilities of the probabilities of the proposed PSSD are almost similar to those of the non-adaptive design. The type II error probabilities in the PSSD are between those of the two fixed sample size (N or Nmax) designs. Conclusions: From a practical standpoint, the proposed design could be useful in phase II single-arm clinical trials with a binary endpoint. In the near future, this approach will be implemented in actual clinical trials to assess its usefulness and to extend it to more complicated clinical trials.
The importance of early treatment to decrease therapy-related complications in Burkitt lymphoma (BL), Burkitt-like leukemia/lymphoma (BLL), and acute lymphocytic leukemia (ALL) treated with disease-specific systemic therapy.
Authors: Muslimani Alaa , Fawole Adewale , Daw Hamed , Spiro Timothy Peter , Ye Hong , Jaiyesimi Ishmael A. 
Published: March 2020

6577 Background: BL, BLL and ALL are highly aggressive malignancies. We conducted a study to determine the relationship between the time to start of disease-specific systemic therapy and the frequency of various complications during treatment. Methods: A multi-center chart review was conducted for a total of 175 patients (pts) from Cleveland Clinic and Beaumont Health System, who received thearapy between Jan 2000 and Oct 2012. Pts were classified into two groups based on time to start of disease-specific systemic therapy. The first group started therapy within 1 week of the presenting symptoms and the second group started therapy in ≥ 1 week. Pts characteristics, stage of disease, incidence of acute renal failure (ARF) [Am J Med. 1983;74(2):243], Tumor lysis syndrome (TLS) [Cairo-Bishop definition], major bleeding [requiring transfusion, drop in hemoglobin > 2 g/dL, or bleeding in critical sites], venous thrombotic events (VTEs) [documented by imaging], neutropenic fever (NF) [Clin Infect Dis. 2011;52(4):e56], and mortality rate were retrieved from the records. Results: Of 175 pts (66 BL, 13 BLL, 96 ALL), 67 % were males, 92.6 % had stages III or IV disease. Chi-Square test analysis showed pts treated with disease specific systemic therapy within 1 week as compared to those whose treatment began ≥ 1 week after symptoms onset had less incidence of ARF (16.7% vs 38.5% p=0.001), less TLS (3.6% vs 16.5% p=0.006), less VTEs (8.3% vs 16.6% p=0.007), less NF (3.6% vs 24.2% p=0.001) and most importantly had a lower mortality rate during the therapy (1.2% vs 8.8% p=0.036). Further analysis of the data showed no significant difference in the incidence of major bleeding between the two groups (9.5% vs 17.8 p=0.129), although there was a trend toward fewer episodes in pts started on therapy within 1 week. Conclusions: This study confirmed an increased risk of therapy related complications including higher mortality in pts with BL, BLL and ALL when the therapy was initiated ≥ 1 week after symptoms onset. These findings indicate that clinicians should start disease specific therapy within 1 week.
Prognosis, diagnostic delay, and patient characteristics associated with diagnostic delay among Kaposi sarcoma (KS) patients in Uganda.
Authors: De Boer Christopher , Niyonzima Nixon , Orem Jackson , Bartlett John , Zafar Yousuf 
Published: March 2020

6578 Background: The incidence and mortality of KS remain high in sub-Saharan Africa. Delaying treatment might explain poor outcomes, but no study has measured the association between delay, characteristics associated with delay, and prognosis for KS patients in low- and middle-income countries. Methods: This is a prospective, cross-sectional study conducted from June-October 2012 at the Uganda Cancer Institute (UCI) in Kampala, Uganda among HIV-infected adults with histologically confirmed KS. The aim was to measure the association between delay and overall KS stage risk at diagnosis. Standardized interviews were conducted in English or Luganda to measure delay, and medical records were abstracted to obtain KS stage at admission to UCI. Multivariable logistic regression was used to assess the relationship between diagnostic delay and poor-risk stage at diagnosis. Results: 161 patients were enrolled; 68.9% were men, mean age was 34.0 years (SD 7.7), 58.1% had income < $2 per day, and 49.4% had ≥primary education. 25.8% had been seen in an HIV clinic within 3 months, 71.6% were on antiretroviral therapy (ART), and 25.5% had visited a traditional healer prior to being seen at UCI. 45.3% delayed seeking care at UCI for ≥3 months from onset of symptoms. Among those who delayed, 35.6% waited 6 months, and 24.7% waited 12 months. The most common reasons for delay were lack of pain (47.9%), no money (31.5%), and distance to UCI (8.2%). In adjusted analysis patients who experienced diagnostic delay were more likely to have poor-risk stage compared to those who did not delay (OR 3.41, p=0.002, 95%CI: 1.46-7.45). After adjusting for patient characteristics, HIV clinic attendance, and ability to pay out-of-pocket costs, visiting a traditional healer was the only characteristic associated with greater likelihood of delay (OR 2.69, p=0.020, 95%CI: 1.17-6.17). Conclusions: Diagnostic delay was independently associated with poor-risk stage at diagnosis, and visiting a traditional healer was the only patient characteristic independently associated with delay. The relationship between traditional and Western medicine presents a critical point of intervention to improve KS outcomes in Uganda.
Integration of patient-reported adverse events into a phase II chemotherapy treatment trial.
Authors: Basch Ethan M. , Pietanza Maria Catherine , Kris Mark G. , Shaw Mary , Sima Camelia S. , Rogak Lauren J. , Schrag Deborah 
Published: March 2020

6583 Background: It has been shown that patient reporting of symptomatic adverse events (AEs) is feasible during routine chemotherapy, and that patients report AEs that clinicians otherwise miss. It is not known if this approach is feasible in a treatment trial; whether clinicians will agree or disagree with patent-reported AE grades; or if clinicians will take actions based on patients' AE reports. Methods: Patients with advanced non-small cell lung cancer enrolling in a single-arm phase 2 trial of paclitaxel, pemetrexed, and bevacizumab at Memorial Sloan-Kettering Cancer Center (NCT00807573) reported 13 validated plain language questions adapted from the NCI's Common Terminology Criteria for Adverse Events (CTCAE), via iPads in waiting areas before each visit. Patients’ grades were transmitted to an investigator web page via which clinicians could agree or reassign each of the CTCAE grades, which were then transmitted to the institutional database as the official reported AEs for the trial. The proportion of patients and clinicians reporting AEs at each visit was tabulated with an a priori average compliance threshold set at 75% to conclude feasibility of the approach. The rate of clinician agreement with patient grades was computed. The frequency of clinical actions in response to patient-reported grade 3/4 AEs was calculated (ie, chemotherapy dose modification, ER referral, supportive medication). Results: 44 patients were enrolled between 1/09-9/11 (mean age 59; 50% female; 93% white), encompassing 721 total clinic visits (median 10; range 1-65). Patients reported AEs at visits 99.6% of the time and clinicians 98.7% of the time. Median time between patient self-reports and clinician reviews was 1 hour (range 0.2-18). Across symptoms, clinicians agreed with patients 93% of the time (weighted kappas .83 to .92), increasing the grade 5% of the time and decreasing it 2%. Clinical actions were taken in response to 67% of patient-reported grade 3/4 AEs. 71% of clinicians stated patient reporting informed their toxicity grading. Conclusions: Collection of patient-reported AEs at clinic visits via computer is feasible in a chemotherapy trial. Clinicians agree with patients’ self-reported AE grades and act on this information.
One-year survival and physical functioning with surgery compared to no surgery in early-stage lung cancer.
Authors: Walker Paul R. , Cykert Sam , McGuire Franklin , Edwards Lloyd , Dilworth-Anderson Peggye 
Published: March 2020

6584 Background: Medical co-morbidities in patients with lung cancer frequently impact a treatment decision out of fear of doing harm without a benefit. A prospective study looking at racial disparity factors associated with surgery decisions in early lung cancer identified > 2 co-morbidities with an Odds Ratio (OR) of 0.04 of going to surgery for African Americans (AA) patients, yet a 10-fold higher likelihood of Caucasians (C) going to surgery with an OR 0.45. (Cykert et al JAMA 2010: 303: 2368). Methods: 386 out of the original437 patients with early stage lung cancer and no absolute contraindications to surgery were evaluated at multiple institutions for relative co-morbidities and with an initial Short Form 12 (SF-12) to assess physical functional status at enrollment and one year after enrollment. One year mortality and physical functional status was assessed. Results: 66% of C underwent surgery compared to 55% of AA (p = .048). One year mortality was not different between the AA (15%) and C (15.4%) populations (p=0.9); however not powered for a survival difference between surgery and no surgery. One year mortality in the overall surgical group was 10.8% compared to 22.8% in the non-surgical group; OR 0.50 (p<0.001). Patients with > 2 co-morbidities at diagnosis had a 27.5% one year mortality compared to 13.5% with < 2 co-morbidities; OR 1.7 (p=0.01). Combined analysis of co-morbidities and surgery revealed those with < 2 co-morbidities having surgery experienced a 10% one year mortality and those with > 2 co-morbidities 19%; without surgery one year mortality was 20% and 31% respectively. Despite > 2 co-morbidities, there was a 12% absolute mortality reduction with surgery. Regression analysis controlling for age and co-morbidities identified no physical functioning decline with surgery compared to the non-surgical group. Conclusions: One year mortality was doubled in patients with early lung cancer who declined surgery compared to those treated with surgery. There was no increased physical functioning decline in patients treated with surgery compared to no surgery. Treatment decisions in early lung cancer should be based on the survival benefit and not a perceived concern of physical functioning decline.
Validation of a cancer-specific Oncological-Multidimensional Prognostic Index (Onco-MPI) for mortality prediction in older cancer patients.
Authors: Brunello Antonella , Fontana Andrea , Zafferri Valeria , Chiarini Ramona , Fiduccia Pasquale , Basso Umberto , Copetti Massimiliano , Lonardi Sara , Falci Cristina , Monfardini Silvio , Pilotto Alberto , Zagonel Vittorina 
Published: March 2020

6593 Background: Recently, a Multidimensional Prognostic Index (MPI) based on a Comprehensive Geriatric Assessment (CGA) was developed and validated in independent cohorts of older patients (pts) demonstrating good accuracy in predicting 1-year mortality. Aim of the study was to validate a cancer-specific modified MPI (Onco-MPI) for mortality prediction in older cancer pts. Methods: 658 consecutive new cancer pts aged ≥70 years (mean age 77,1 years, 433 females, 65.8%) referred to the Geriatric Oncology Program from Sep 2004 to June 2011 were included. MPI was calculated according to a previously validated algorithm (derived from multivariate Cox regressions) as a weighted linear combination of the CGA domains: age, sex, basal and instrumental activities of daily living (ADL, IADL), Performance Status, Mini Mental State Examination, Body Mass Index, comorbidity by Cumulative Illness Rating Scale, number of drugs and presence of caregiver. To develop the Onco-MPI, cancer sites (breast 46.5%, colorectal 21.3%, lung 6.4%, prostate 5.5%, urinary tract 5.0%, other 15.3%) and cancer stages (I 37%, II 22%, III 19%, IV 22%) were also included in the model. Pts were followed for a median of 2,5 years and mortality was recorded. Three grades of severity of the onco-MPI (low 0.0-0.46, medium 0.47-0.63, high-risk 0.64-1.0 score) were calculated on the basis of estimated recursive partition and amalgamation method (RECPAM) cut-offs. Discriminatory power and calibration were further assessed. Results: Overall 1-year mortality incidence rate (events/person-years) was 17.4%. A significant difference in mortality rates was observed for Onco-MPI low-risk compared to medium- and high- risk pts (2.1% vs 17.7% vs 80.8%, p<0.0001). The discriminatory power of 1-year mortality prediction of the Onco-MPI was very good (survival C index 0.86, 95%CI 0.83-0.89). The Onco-MPI was well calibrated showing < 10% differences between predicted and observed mortality. Conclusions: The Onco-MPI is an accurate and well-calibrated predictive tool for 1-year mortality in older cancer pts and can be useful for clinical decision making in geriatric oncology.
Patient perceptions about potential side effects and benefits from chemotherapy agents.
Authors: Kuchuk Iryna , Bouganim Nathaniel , Beusterien Kathy , Grinspan Jessica , Vandermeer Lisa , Mazzarello Sasha , Crawly Freya , Gertler Stan Z. , Dent Susan Faye , Song Xinni , Segal Roanne , Dranitsaris George , Clemons Mark J. 
Published: March 2020

6595 Background: Little is known about how breast cancer patients (pts) perceive the relative side effects and benefits of different chemotherapy (CT) agents. The objective of this study was to better understand these preferences in pts receiving CT at a Canadian cancer center. Methods: Pts completed a Web survey. Grade I/II (mild to moderate) and III/IV (moderate to severe) descriptions of 9 common CT side effects were assigned preferences by: conjoint and standard gamble (SG). Conjoint involved making trade-offs among different risks of side effects, yielding preferences (utilities) for each side effect. SG involved choosing to stay in a selected side effect state or taking a gamble between full health (probability p) or being dead (1-p). For each side effect, p was varied until the patient was indifferent of the side effect. Pts were also asked to rate how much of detriment in quality of life they would endure for benefits in survival. Results: 102 women participated, mean age 54 + 11, stage 1 (21%), 2 (24%), 3 (38%) and 4 (18%). Among the grade I/II side effects, a 5% reduction in risk of sensory neuropathy, nausea, and motor neuropathy had the highest impact on preferences. Among grade III/IV side effects, motor neuropathy, nausea/vomiting, and mucositis made the most difference. SG preferences for side effects were lowest (i.e. least preferred) for grade III/IV nausea (0.624) followed by diarrhea (0.633), hand-foot syndrome (0.681), and highest for grade I/II sensory neuropathy (0.757), mucositis (0.756), and myalgia (0.750). Agree/disagree items revealed patients are willing to endure quality of life detriments for improvement in survival; this willingness increased as disease stage increased (p=0.01). Conclusions: Relatively small changes in the risks of some CT side effects may have substantial impacts on pt treatment preferences. Nevertheless, pts will endure significant toxicity for a potential gain in survival. The standard gamble utilities from this population may also be used to quality-adjust life expectancy in cost-effectiveness evaluations of breast cancer chemotherapies.