bluuebunny/crossref_metadata_2025_split huggingface dataset:
Racial differences in treatment for breast cancer among black and white women in Atlanta
Authors: Lund M. J. , Brawley O. W. , Eley J. W. , Ward K. C. , Young J. L. , Liff J. M. 
Published: March 2020

603 Background: Among women with breast cancer, Black women experience a disproportionate excess in mortality, a reflection of their marked poorer survival, which persists even within stage and age groups. Adherence to first course treatment guidelines for breast cancer may not be uniform across racial/ethnic groups and could be a major contributing factor to racial disparities in outcome. In this population-based study, we assessed racial differences in initial treatment of primary invasive breast cancer. Methods: All data were obtained from the Surveillance, Epidemiology, and End Results (SEER) program. The study population included all invasive breast cancers diagnosed during 2000–2001 among Black (n=877) and White (n=2437) female residents of the five Atlanta SEER counties, an area whose population is 36% Black and where several large teaching hospitals are located. Outcome factors included delay in first course treatment, type of treatment, performance of cancer directed surgery, type of surgery, and receipt of chemotherapy, radiotherapy, or hormonal therapy. Racial differences in treatment were analyzed according to their basis for treatment; stage or age at diagnosis and tumor factors. Analyses utilized frequency distributions, χ2 tests of independence, and Cochran-Mantel-Haenszel statistics in and across strata. Results: Black women were more likely to experience delays in treatment, regardless of stage at diagnosis, and 4–5 fold more likely to experience delays greater than 60 days (p<0.001). For local-regional disease, more Black women did not receive cancer directed surgery (14.2% vs. 2.9% of white women, p<0.001), but did receive breast conserving surgery (BCS) equivalently. However, only 61% of Black vs. 72% of White women received radiation with BCS (p<0.001). Black women eligible for hormonal therapy were less likely to receive it (p<0.001). Conclusions: Our findings suggest treatment standards are not adequately or equivalently implemented among Black and White women, even in a metropolitan area where teaching hospitals provide a substantial portion of breast cancer care. Treatment differences can adversely affect outcome and reasons for the differences need to be addressed. No significant financial relationships to disclose.
Chemotherapy ordering in a computerized physician order entry (CPOE) environment: A longitudinal analysis of defects from oncologist to patient
Authors: Mertens W. C. , Cassells L. J. , Brown D. E. , Koertge V. , Cabana L. , Parisi R. , Naglieri-Prescod D. , Higby D. J. 
Published: March 2020

6040 Background: While published data suggest low chemotherapy error rates, the rate of chemotherapy ordering process defects and who detects them remains uncertain. Methods: Outpatient treatment plans/orders were prospectively evaluated by pharmacy prior to preparation, then by nursing prior to administration. Data collected included the nature of defects, how detected, utility of regimen-specific care sets (facilitating antineoplastic dose calculation and adjunct agent selection), and patient impact. Results: Pharmacy recognized problems with 36% of orders (comprising 1,082 cycles/4,600 drugs), with 34% incomplete (absent orders 17%; missing cycle number 12.5%; other items 4%). Pharmacy identified incorrect orders in 6% (dose calculation 2%; cycle number 1.5%; other items 2.5%). Incomplete orders were more likely to have incorrect items (11.6% v. 3.5% if complete, p < .001). Care set use (76% of cycles) was associated with fewer overall problems and incomplete orders (both p < .001), with reduced absent orders and missing antiemetics, but not antineoplastics. Care set orders exhibited a trend for fewer incorrect items (p=.06). Nursing recognized problems with 14.6% of orders, again most commonly incomplete orders (10%; absent orders 7%; missing antiemetic or antineoplastic drug 4.6%); fewer missing items resulted from care set use (p < .001). Nursing detected fewer orders with problems and missing items but more instances of missing antineoplastic and antiemetic agents (all p < .001) despite prior pharmacy review. Nursing identified incorrect orders in 5% (wrong dosage 3.4%; wrong drug 2.5%) and classified 4% of cycles as having an error (“near miss” 3.3%; more serious error reaching the patient 0.6%). Conclusions: Defects in chemotherapy orders are common despite the relatively low error rate. The predominant defects–incomplete orders–are associated with incorrect items. Both care sets and pharmacy review reduce but do not eliminate incomplete orders; the effect on incorrect orders is smaller. Even with CPOE, sequential pharmacy and nursing review remain critical to reducing order defects; additional software enhancements are needed to further reduce defects. No significant financial relationships to disclose.
Economic evaluation of adjuvant chemotherapy in Stage III (SIII) colon cancer: Capecitabine versus 5FU/LV
Authors: Virik K. , Skedgel C. , Younis T. 
Published: March 2020

6046 Background: Adjuvant chemotherapy for SIII colon cancer is an accepted standard of care. Oral Capecitabine (C) has been shown to be at least equivalent and possibly superior to 5FU/LV (F) with a superior relapse free survival (RFS). This new option is associated with a higher drug cost. An economic analysis was undertaken to compare these two alternatives. Methods: A cost minimisation analysis was performed in Canadian $ ($) using C and F given as per the X-ACT (X) trial. The direct costs including chemotherapy drug acquisition, supportive medications, laboratory investigation and health resources utilisation were examined based in Nova Scotia. Indirect costs included travel and opportunity cost based on the average provincial wage and participation rates. Complete drug delivery was assumed. A direct payer perspective was used. A cost-effectiveness (CE) model was also constructed to estimate the required lower risk of cancer recurrence for C to be cost effective compared to F at a commonly used CE threshold. The Markov model developed used a hypothetical cohort of 1,000 patients with SIII colon cancer and projected costs and outcomes over 5 years (discounted 3% and in $2,005). All recurrences were modeled to death. Recurrence rates, median survival with recurrent disease, costs and utility scores were derived from the literature. Estimates of background mortality without recurrence were obtained from Canadian Life Tables. Sensitivity analysis (SA) was performed using a range of recurrence risk hazard ratios (HR) including that reported in the X trial. Results: Compared to F, C is associated with higher direct costs, principally reflecting the higher drug cost (difference: $5,589/patient) but less resources utilisation cost (difference: - $1,804/patient). The total indirect costs favour C (difference: - $2,464/patient). For C to be potentially CE compared to 5FU/LV, a ≥ 9% lower relative recurrence risk (HR = 0.91) with C would be required. At the reported RFS HR 0.86, the CE of C relative to F is $15,844 per disease free survival years gained and $22,097 per quality adjusted life years gained. Conclusions: C has more direct costs but has indirect cost savings. It has the potential to be cost effective as seen in the SA and is a CE alternative to F at the HR for RFS reported in the X trial. No significant financial relationships to disclose.
An analysis of deficiencies identified during investigational new drug (IND) application reviews by the Division of Drug Oncology Products (DDOP) of the US FDA
Authors: Mann B. S. , Kane R. , Brave M. , Ryan Q. , Hazarika M. , Rock E. , Senderowicz A. , Dagher R. , Johnson J. , Justice R. , Pazdur R. 
Published: March 2020

6052 Background: Regulations require IND application review by the FDA prior to initiation of the clinical study. Deficiencies identified in the study protocol require communication between the FDA reviewers and the Sponsor for resolution. If the deficiencies are not adequately resolved, clinical hold and subsequent delay in the start of the clinical study results. To identify and analyze the commonly encountered IND application deficiencies, data from recent reviews were collected. Methods: Eight clinical reviewers analyzed the deficiencies that had been identified in 268 IND applications reviewed in the DDOP FDA from January 2003 to June 2005. All of the study protocol deficiencies leading to a clinical hold, or requiring resolution prior to study initiation were categorized as deficiencies pertaining to: patient eligibility; starting drug dose; study conduct (toxicity management, dose adjustment, stopping criteria); statistical or endpoints; non-clinical; and other issues. Results: 268 IND applications reviewed over a 30-month period by eight medical officers were analyzed. One hundred and twelve (42%) of the applications had no deficiencies; however, 156 (58%) had one (31%) or multiple (69%) deficiencies. Deficiencies pertained to study conduct/scheme (65%), dose (48%), patient eligibility (46%), others (31%), statistics or endpoints (15%), and non-clinical (4%) issues. In 141 (90%) of the deficient applications the deficiencies were adequately addressed by FDA reviewer-Sponsor communication and the trials could start as scheduled. Fifteen (10%) deficient trials were placed on clinical hold. Fourteen (93%) of these trials had multiple deficiencies that pertained to patient eligibility in 12 (80%), starting drug dose in 12 (80%), study conduct in 11 (73%), other in 7 (47%), and non-clinical and statistical issues in 2 (13%) each. Conclusions: Deficiencies were identified in 58% of the reviewed IND applications: 90% of these were resolved by FDA-Sponsor communication. Only 10% of deficient studies were placed on clinical hold; all except one had multiple deficiencies. The most common deficiencies leading to clinical hold pertained to eligibility of study population and proposed starting drug dose. No significant financial relationships to disclose.
Examining the cost and cost-effectiveness of adding bevacizumab to carboplatin and paclitaxel in advanced non-small cell lung cancer
Authors: Grusenmeyer P. A. , Gralla R. J. 
Published: March 2020

6057 Background: Two-drug platinum-containing regimens are considered the standard of care in advanced non-small cell lung cancer. A recent randomized trial (ECOG 4599) compared carboplatin + paclitaxel (PC) with PC + bevacizumab (PCB). PCB was found to result in a modest improvement in survival (12.5 months vs 10.2 months with PC, p = .007). This finding was exceptional in showing a survival benefit with the addition of a molecularly targeted agent to chemotherapy in a largely unselected population, and doing so in this most common cause of malignant death in the US. Additionally, new therapies can have a major impact on health care costs. Using the known survival data and costs, we analyzed the cost-effectiveness of the addition of bevacizumab to this chemotherapy regimen. Methods: Medicare reimbursement (cost) of the two regimens was developed using the CMS Drug Payment Table and Physician Fee Schedule for January, 2005. Incremental cost effectiveness was calculated. Results: Carboplatin and paclitaxel regimen costs $14,073 for 6 cycles (the number of cycles planned in the clinical trial.) The addition of bevacizumab increases cost by $66,270 to $80,343. Given an increase of 2.3 months in median overall survival over chemotherapy alone, the addition of bevacizumab to chemotherapy costs $345,762 per year of life gained. Conclusions: Adding bevacizumab to chemotherapy is not cost effective even at the $100,000 per Year of Life Gained (YLG) threshold. To be cost effective at the $100,000/YLG level, bevacizumab reimbursement would have to be reduced to $14.70/10 mg. ($1,764/cycle) or 26% of 2005 Medicare reimbursement of $57.08/10 mg. ($6,849/cycle). Prior analyses have examined the impact of chemotherapy on survival and cost-effectiveness. Several factors beneficially influence survival in NSCLC, as shown in meta-analyses, including: chemotherapy vs supportive care, two-agents vs one, and the choice of which platinum agent to use. While all of these may increase costs, some are cost-effective, while others are not. The addition of bevacizumab is the most costly and least cost-effective of any of these interventions. [Table: see text]
Cost-effectiveness of MRI compared to mammography for breast cancer screening in a high risk population
Authors: Moore S. G. , Tumeh J. , Flowers C. R. 
Published: March 2020

6060 Background: Breast magnetic resonance imaging (MRI) is a sensitive method of breast imaging virtually uninfluenced by breast density. Because of the improved sensitivity, breast MRI is increasingly being used for detection of breast cancer among high risk young women. However, the specificity of breast MRI is variable and costs are high. The purpose of this study was to determine if breast MRI is a cost-effective approach for the detection of breast cancer among young women at high risk. Methods: A Markov model was created to compare annual breast cancer screening over 25 years with either breast MRI or mammography among young women at high risk. Data from published studies provided probabilities for the model including sensitivity and specificity of each screening strategy. Costs were based on Medicare reimbursement rates for hospital and physician services while medication costs were obtained from the Federal Supply Scale. Utilities from the literature were applied to each health outcome in the model including a disutility for the temporary health state following breast biopsy for a false positive test result. The analysis was performed from the payer perspective with results reported in 2005 U.S. dollars. Univariate and probabilistic sensitivity analyses addressed uncertainty in all model parameters. Results: Breast MRI provided 23.287 quality-adjusted life-years (QALYs) at a cost of $30,317 while mammography provided 23.141 QALYs at a cost of $7,895 over 25 years of screening. The cost-effectiveness ratios for the two strategies were $1302 and $341, respectively. The incremental cost-effectiveness ratio of breast MRI compared to mammography was $131,376/QALY. In univariate analysis, breast MRI screening became <$50,000/QALY when the cost of the MRI was <$405. In the probabilistic sensitivity analysis, MRI screening produced a net benefit of +0.146 QALYs (95% central range: -0.825 QALYs to +1.378 QALYs). However, breast MRI screening was superior in <1%, <$50,000/QALY in 27%, >$50,000/QALY in 32%, and inferior in 41% of 10,000 probabilistic Monte Carlo simulations. Conclusions: Breast MRI provides a net benefit when compared to mammographic screening for high risk women, however, this approach does not appear to be cost-effective at this time. No significant financial relationships to disclose.
Quality indicators for end-of-life breast cancer care: Testing the use of administrative databases
Authors: Lethbridge L. , Grunfeld E. , Dewar R. , Johnston G. , McIntyre P. , Lawson B. , Burge F. , Dent S. , Paszat L. , Earle C. 
Published: March 2020

6066 Background: Defining, measuring and monitoring quality of care is a facet of health services research that is growing in importance. Breast cancer offers a disease model to examine quality end-of-life (EOL) care provided to women. Administrative data have the unique potential to provide population-based measures of quality of care. The objective of this study was to assess the feasibility of using routinely-collected administrative data to measure quality EOL care for breast cancer patients. Methods: A cohort of all women in Nova Scotia who died of breast cancer between 01/01/1998 and 31/12/2002 was assembled from the Cancer Registry and Vital Statistics data. The EOL study period was defined as the last 6 months of life. A total of 864 women met the eligibility criteria. After a literature review, an expert panel identified 19 indicators that were potentially measurable through administrative data. Physician billings, hospital discharge abstracts and seniors pharmacare data, supplemented by clinical datasets, were utilized to calculate the statistics with which to represent the indicators. Results: Benchmark measures of care across the cohort show 63.4% died in a hospital, a mean continuity of care index of 0.786, and the mean number of inpatient days in the last 30 was 9.9. Indicators of aggressive care include 9.3% had chemotherapy in the last 14 days, 5.6% had more than 1 emergency room visit in the last 30 days, and 29.1% had more than 14 inpatient days in the last 30 days. Conclusions: Weaknesses of using these data include: 1) fixed variables with an administrative rather than a clinical objective; 2) lack of comprehensiveness of various datasets; and 3) the use of billings data where increasingly physicians are paid through methods other than fee-for-service. Strengths of this approach are: 1) population-based cohort; 2) comprehensiveness of cohort selection through the provincial Vital Statistics file; and 3) accessibility of data. No significant financial relationships to disclose.
Potentially modifiable influences on cancer family history-taking among primary care physicians in Vermont and Massachusetts
Authors: Flynn B. S. , Wood M. E. , Dana G. S. , Ashikaga T. 
Published: March 2020

6067 Background. Taking a complete family history is key in identifying individuals at increased risk for cancer. The objectives of this study were to test hypothesized relationships between potentially modifiable factors and family history-taking by primary care physicians. Methods. Primary care physicians (family medicine, internal medicine, gynecology) were surveyed by mail in Vermont, urban and suburban Boston (n=880) using comprehensive rosters from employers or state-wide networks, with a response rate of 70%. Measures of family history-taking quality and factors that may influence this behavior were developed systematically and validated using factor analysis methods. The primary outcome variable was either extent of history-taking or age of cancer diagnoses. These dependent variables were regressed on scales measuring physician perceptions of the advantages and disadvantages of history-taking, confidence in taking cancer family histories, supportive resources, and knowledge of management for patients at high risk for breast and colon cancer; relevant factors controlled in these multiple regressions included type and location of practice. Results. Most physician perception factors hypothesized to influence quality of history taking were found to be significantly associated in the analysis. The strongest predictor of extent of family history-taking was perceived disadvantages of taking a cancer family history (p<.001). Reports of supportive resources ((p<.01); perceived advantages (p=.02); and confidence (p=.02) were also associated with this behavior. Gathering age of cancer diagnoses was significantly associated with perceived advantages, supportive resources and confidence (all p<.0001). Knowledge of high risk management was not associated with quality of family history-taking in either analysis. Conclusions. Potentially modifiable resource and perception factors were significantly associated with quality of family history in a large and diverse sample of primary care physicians. Improving family history quality for identification of high risk individuals among primary care providers will need to address multiple factors. No significant financial relationships to disclose.
Comparison of adjuvant chemotherapy use in African American women with breast cancer versus the rest of the adjuvant breast cancer population
Authors: Quigley J. M. , Bule W. , Runyun J. , Moseley A. 
Published: March 2020

6069 Background: Demographics, specifically race have been discussed as reasons for disparity of care in the breast cancer setting. Methods: We used a validated database with physician entered, de-identified patient data from a randomized sample of oncologists in the US. Physicians capture de-identified data on up to 20 patients per week using a clinically validated, software driven algorithm. We evaluated all female patient records with breast cancer that were receiving adjuvant chemotherapy for their disease, from January 2005 through November 2005. All data elements are required fields, allowing for a complete patient record with each entry, including race, age, stage, nodal status, hormone status, her 2 status and chemotherapy treatments. Results: During this 11 month period, 4465 adjuvant breast cancer records were received. All were included in this analysis. Of the 4465 patient records, 69%( n=3085) were Caucasian, 18% (n= 830) were African American, 9% (n=408) were Hispanic/Latino and 4% were ‘other, which included, Native American and Asian patients. The average age for Caucasian patients was 56 years; average age for African American patients was 55 years, average age for Hispanic/Latino patients 51 years, average for all other patients 55 years. 63% of the Caucasian patients had node + disease, 59% of African Americans had node + disease, 62% of Hispanic/Latinos had node + disease, and 61% of all others had node + disease. Top treatment regimens for Caucasian patients were AC followed by Taxol (dose dense), AC, AC followed by Taxotere (dose dense), ACT (Taxotere) and CMF. Top treatment regimens for African Americans were AC followed by Taxol (dose dense), AC, AC followed by Taxotere (dose dense), ACT (Taxotere) and FAC. Conclusions: In this clinically similar patient population there was no difference in adjuvant chemotherapy selected based upon race. Further evaluations of treatment selections, including, surgery, radiation and endocrine therapy by race are warranted. No significant financial relationships to disclose.