bluuebunny/crossref_metadata_2025_split huggingface dataset:
The economic implications of rasburicase treatment in adult tumor lysis syndrome patients
Authors: Eaddy M. , O’Day K. , Tangirala K. M. , Seal B. 
Published: August 2020

e17503 Background: Rasburicase is a recombinant urate-oxidase enzyme used to reduce high levels of plasma uric acid (UA) resulting from tumor lysis syndrome (TLS). Rasburicase reduces UA levels within 4 hours of administration, minimizing risk of serious complications from TLS. Treatment pattern analyses indicate rasburicase is often used in combination with allopurinol; however, no studies have evaluated clinical and economic consequences of this pattern of care. The purpose of the study was to compare hospitalization costs, length of stay (LOS), and duration of critical care in patients receiving rasburicase with or without allopurinol. Methods: Patients in the Premier hospital database administered rasburicase or combination therapy within 2 days of hospital admission were eligible for study inclusion. Patients were excluded if they were <18 years of age or received hemodialysis on admission. Patients were propensity score matched to rasburicase patients based on gender, race, hospital type, provider type, payer type, admission source, use of electrolyte modification therapy, critical care admission, and comorbid diagnoses. Differences in health care costs, LOS, and duration of subsequent critical care were assessed using exponentially distributed generalized linear models with a log link function. Projection weights are used to produce national projected patient counts. Results: There were 280 rasburicase and 310 combination patients matched in the analysis. Mean age of the sample was 65.2, with 31% being female. There were no statistical differences in matched covariates across the cohorts. Rasburicase patients incurred an average total cost of $39,474 per hospitalization compared to $52,047 for combination patients (p = 0.0029). Rasburicase patients also had a lower LOS (10.5 days) compared to combination therapy (16.4 days, p < 0.0001). Duration of critical care was similar in both cohorts (rasburicase = 1.4 days vs 1.8 days, p = 0.1222). Conclusions: Combination therapy of rasburicase and allopurinol resulted in higher total hospitalization costs and longer LOS compared to rasburicase monotherapy. [Table: see text]
Initial results of a new clinical trial matching service to increase patient participation
Authors: Gansler T. , Comis R. , Sharpe K. , Tis L. , Jin M. , Dahlquist K. , Kepner J. , Hao Y. , Cressman G. , Naples K. 
Published: August 2020

e17504 Methods: Data from CTMS constituents and follow-up information describing enrollment status and barriers to trial participation are reviewed. Results: During 15 months of operation the CTMS provided information to 10,997 individuals; 7,521 (68.39%) used the website only, and 3,476 (31.61%) also contacted the ACS call center. Among 981 of the 3,476 (28.22% the basis of analyses below) who consented to and could be reached for follow-up and who answered the question on enrollment status, 119 (12.13%) enrolled in a CT. Trial phase was known for 74 enrollees (phase I: 17 [22.97%]; II: 36 [48.65%]; III: 21 [28.38%]; IV: 0 [0%]). Enrollment was negatively (p < 0.05) associated with poor ECOG functional status and black race, and was positively related to disease stage. Among the 757 individuals with available disease site and enrollment information, those with stomach cancer accounted for the most enrollments (25, 24.75% of all enrollments); followed by melanoma (12, 11.88%) and kidney, renal pelvis, bladder, ureter and urethra (also 12, 11.88%), and breast cancer (11, 10.89%). The highest enrollment rates (% enrollees among individuals with available follow-up) were for multiple myeloma/plasma cell disorders (4/14, 28.57%), melanoma (12/49, 24.49%), primary CNS malignancy (5/31, 16.13%), and soft tissue sarcoma (6/45, 13.33%). The following barriers were significantly associated with non-enrollment: ‘I cannot travel to clinical trial site,‘ ‘I cannot find a clinical trial using the modality or treatment I want,‘ ‘My physical activity level is too low,‘ and ‘I do not have measurable disease or am cancer-free.‘ Conclusions: 12% of CTMS participants with available follow-up data for enrollment status participated in a CT. Several determinants of CT participation were identified. Strategies for eliminating racial disparities, facilitating transportation, and increasing participation among patients with earlier stage disease and more common tumor types must be developed and implemented. No significant financial relationships to disclose.
Assessing compliance with practice treatment guidelines by treatment centers and the reasons for noncompliance
Authors: Biagi J. J. , Wong R. , Brierley J. , Rahal R. , Ross J. 
Published: August 2020

e17506 Background: Cancer Care Ontario (CCO) is the chief advisor on cancer care to the government of Ontario, a province with a population of more than 12 million. One of the many roles of CCO is to develop evidence based consensus-derived treatment practice guidelines for all major cancer types, through its Program in Evidence-based Care (PEBC). To determine province-wide compliance with these guidelines, a pilot project assessed the proportion of patients with stage III colon cancer (CC) treated in concordance with the corresponding treatment guideline. Initial results are made available to the regional cancer centers (RCC) in the province and to the public through web based Cancer Systems Quality Index (CSQI, http://www.cancercare.on.ca/qualityindex2007/ ). Methods: The guideline (http://www.cancercare.on.ca/pdf/pebc2–29s.pdf) states that patients with resected stage 3 CC will have adjuvant fluoropyrimidine-based chemotherapy within eight weeks of resection. Patients at each of 11 RCC who presented in 2007/2008 with stage III CC and the proportion treated according to the guidelines were identified. Individual charts of those patients who were not treated according to guideline were reviewed to determine the reason. Results: Across eight RCC with complete chart results to date 376 patients with stage 3 CC were identified, 244 (65%, range 47% to 72%) treated in concordance with the guideline, including 13% treated with capecitabine and 6% on clinical trials. The reasons for non-concordance of the 132 remaining cases were: age and co morbid conditions 48 (13%), patient choice 36 (10%), referred for treatment outside the RCC system 16 (4%), stage incorrect and other 32 (9%). Conclusions: Adjuvant chemotherapy treatment of stage III CC at the RCC across the Province of Ontario was concordant with the guideline in the majority of patients, and appropriate clinical reasons for non-compliance were identified. Data from all 11 RCC will be presented along with concordance within the eight-week time frame stated in the guideline . Refinement in province-wide data collection and interpretation will allow results from this pilot to be expanded to other PEBC practice guidelines for dissemination through the CSQI. No significant financial relationships to disclose.
Characteristics of elderly metastatic prostate cancer (M1 PC) long-term survivors in the SEER Medicare database receiving androgen-deprivation therapy (ADT)
Authors: Obeidat N. A. , Mullins C. D. , Onukwugha E. , Seal B. , Hussain A. 
Published: August 2020

e17513 Background: ADT remains standard treatment for pts with M1 PC, with radiation (RT) and chemotherapy (CT) providing additional palliation. This population-based analysis evaluated if long-term survivors (LT) receiving ADT possessed different characteristics relative to short-term survivors (ST). Methods: Pts age >/= 66y in SEER Medicare diagnosed with M1 PC between 1998 and 2002 and receiving ADT with or without subsequent CT were identified. Median overall survival (OS) for the sample was used as a cut-off to categorize ST and LT pts. Within these categories, demographic, and clinical characteristics were evaluated. Results: 2,665 ADT pts were first identified who had median OS of 26 months (95% CI 24.0 - 27.0). 1,349 pts died at </= 26 months (ST pts), while 1,245 pts survived or were lost to follow-up beyond 26 months (LT pts). Median time to first treatment with ADT was 1 mo in both ST and LT groups. Within this 66y+ population, LT pts were younger (p < 0.0001), more likely to be married (p = 0.0277), and were comprised of lower % of non-Hispanic white pts and higher % of ‘other’ races, but comparable % of African American and White-Hispanics (p = 0.0005). Distributional differences in PSA were detected, but interpreting the results was difficult due to missing or unknown information. Both ST and LT pts received RT and prostatectomy at similar rates, but LT pts had less comorbidities (p = 0.0008), and were more likely to receive CT (p = 0.0026). Conclusions: Long-term survivors were found to have demographic and clinical characteristics that differed from short-term survivors. Evidence regarding how these characteristics simultaneously impact the type and timing of treatment as well as survival deserve more exploration. [Table: see text]
Barriers to cancer clinical trial enrollment in Latinos
Authors: Lopez A. 
Published: August 2020

e17519 Background: Cancer clinical trials (CCT) improve cancer outcomes. Nonmajority participants in CCT make up no more than 1% of all participants. Latinos would be included in this 1% or less. Specific barriers and facilitators to Latino accruement to CCT have not been well elucidated. The principal objective of this study was to identify barriers and facilitators to the enrollment of Latinos in CCT. Methods: Cancer patients were randomly invited to participate in a survey while they waited for their oncology appointment. The surveys had been developed, piloted and validated with a different population of Latino cancer survivors. All instruments were translated in standard fashion and recruiters were bilingual, bicultural Latino. Survey instruments addressed knowledge, attitudes and beliefs re: participation in CCT. Assessments were made by age, gender, education, ethnicity (Latino and non-Latino), language, place of residence, having been offered a CCT, and previous participation in a CCT. Answers were evaluated with bivariate analyses and multiple logistic regressions. In the bivariate analysis the chi-squared test was used to evaluate significant differences between groups. To determine the effect of each of the variables and the most significant predictors, multiple logistic regression models were constructed. Results: Sample characteristics: 64% male and 36% females; mean age 59.66; 18% Latinos and 82% non-Latinos; 67% urban and 31% rural. 83% of the participants spoke at least some English at home whereas 4% spoke only Spanish. From the total sample 22% had previously participated in a CCT and 30% had been offered a CCT. Significant differences were noted in knowledge of CCT by age (to age 70), ethnicity (non-Latino), language (English speakers), education (some college), and having been offered or participated in a CCT (p < 0.05). There were no significant differences by sex and residence. Greatest predictors of CCT knowledge were ethnicity and education l:evel; however, no significant differences were noted by ethnicity or education level in interest in CCT participation. Conclusions: These data suggest that interventions to improve knowledge of CCT may ameliorate the disparity of CCT enrollment by Latinos. No significant financial relationships to disclose.
Treatment center (TC) variability in survival of patients (pts) with colorectal cancer (mCRC) treated with bevacizumab (BV): A subanalysis from the BRiTE Observational Study (OCS)
Authors: Barron H. V. , Purdie D. M. , Feng S. , Sing A. P. 
Published: August 2020

e17532 Background: Treatment options and overall survival (OS) rates for pts with mCRC have increased markedly over the past decade. However, the variability in OS across TCs, and possible contributing factors (measured and unmeasured), remain unclear. We present an analysis from the BRiTE OCS assessing variability in OS as a function of TC, and sought to identify site factors that may predict better outcomes. Methods: BRiTE enrolled 1,953 pts with mCRC receiving a first-line BV-based regimen, from 248 U.S. sites, mostly community practices (Grothey et al. J Clin Oncol. 2008 26:5326). A Cox proportional hazard model was used to identify predictors of OS (age, PS, albumin, alkaline phosphatase, site of primary tumor) and calculate the expected number of deaths (E) compared to the observed number of deaths (O) within each TC. The ratio O/E was calculated and its distribution is presented. Sites with high O/E (top 25%) vs low O/E (lowest 25%) were titled “worst” (W) and “best” (B), respectively. B and W sites were compared by type (academic vs community, hospital vs clinic, urban vs rural), number of pts treated, choice of first-line chemotherapy, postprogression (PD) therapy, and duration of BV. TCs with ≥3 pts were included in the analysis (198). Results: Significant variation in the O/E ratio was observed across TCs ( Table ). The differences between W and B TCs were that pts at W TCs were less likely to receive a first-line oxali containing regimen (65% vs 67%), had shorter overall duration of BV (8 m vs 12 m) and were less likely to use BV following PD (33% vs 39%). Measured site, pt, and treatment variables explained ∼7% of the variability in O/E, suggesting most TC variability was due to unmeasured factors. Conclusions: Significant variability in OS exists across BRiTE TCs, which appears partly related to the specific therapies received by pts. Further work is needed to determine whether W TCs can be optimized and improve outcomes in pts with mCRC. [Table: see text] [Table: see text]
Medical costs of sorafenib compared with sunitinib in treatment of patients <65 years with renal cell carcinoma: A retrospective claims database analysis
Authors: Quinn D. , Barghout V. , Moyneur E. 
Published: August 2020

e17536 Background: Sorafenib (SR) and sunitinib (SU) are FDA approved (12/05 and 1/06, respectively) tyrosine kinase inhibitors for patients (pts) with advanced renal cell carcinoma (RCC). Little is known of their cost impact. We conducted this study to quantify overall direct costs (inpatient, outpatient, pharmacy) for each treatment in privately insured pts (<65 y). Given differences between private and public insurer payment scales, pts ≥65 y were not included in this study but are the subject of a planned further analysis. Methods: A retrospective US claims-based study was conducted using data covering all US census regions for ≥18 million lives from MarketScan MedStat (1/02–12/07). Inclusion criteria were ≥2 RCC claims (ICD-9 189.0, 198.0), continuous health care coverage, >180 days of coverage before RCC diagnosis. SR and SU pts were identified based on oral therapy after initial RCC-related claim (intent-to-treat). Observation period was from first drug-dispensing date until ≤12 mo or first of therapy switch, nephrectomy, disenrollment, or study end (12/31/07). Univariate and multivariate Tobit analyses were conducted; control factors included age, sex, region, plan type, comorbidity, prior Tx/procedures, and time since RCC Dx. Results: Of 10,462 RCC pts identified, 144 and 220 received initial therapy with SR and SU, respectively. In the 180 days before RCC diagnosis, total direct medical costs, baseline demographics, and comorbidities were similar between groups. The univariate incremental total monthly medical cost for SU was $2,049 (P<.001) more than for SR, representing yearly costs for SU $24,588 more than for SR. Multivariate analyses for incremental total monthly costs for SU also remained significant at $1,399 (P<.001). Conclusions: Retrospective analysis of this US claims database for RCC pts <65 treated first with SR showed statistically significant lower total medical costs (particularly inpatient costs) than for pts treated first with SU. [Table: see text] [Table: see text]
NCCN Chemotherapy Order Templates: Enhancing patient safety through standardization
Authors: Li E. C. , Hinkel J. M. , Gallagher L. , DeVader S. R. , Vandergrift J. L. , Lepisto E. M. 
Published: August 2020

e17537 Background: NCCN Chemotherapy Order Templates (COT), which delineate antineoplastics and associated supportive care agents, monitoring and safety parameters, and instructions for self-administered agents, were launched in 2008 to complement the NCCN Clinical Practice Guidelines in Oncology and NCCN Drugs and Biologics Compendium for nine cancers. Through COT, NCCN sought to enhance patient safety by reducing medication errors, anticipating and managing adverse events, and standardizing care. NCCN developed and distributed a survey to evaluate the reception, use, and impact of COT on oncology practice. Methods: The survey included multiple-choice questions with filtering logic. Questions included 5-point Likert scale. The survey was emailed on December 18, 2008 to a convenience sample of 10,183 registered users of NCCN.org who had clicked at least once to the COT; 110 (1%) survey emails were undeliverable. 734 (7%) responded by 1/5/09 and 588 (6%) completed the survey (80% completion rate). 28 (<1%) recipients opted out of participating. Results: 476 (64%) respondents were providers, including MDs (47%), mid-level (8%) and nurses (10%); 11% were pharmacists. Of the 734 respondents, 465 (63%) had used COT. Among the 465 users, the median number COT accessed was 2 (range 0 - 9) with physicians accessing more than other providers (p = 0.002). Breast cancer COT were accessed most (68%). COT were used as a reference (52%) and for setting up chemotherapy orders (42%). 292 users (63%) agreed that COT impacted patient safety; with MDs more likely to agree (p = 0.001) compared to other providers. Of these, 89% responded that COT made chemotherapy ordering safer. 271 users (58%) agreed that using NCCN COT in practice impacted the ordering of supportive care agents. Among providers, MDs were more likely to agree (p = 0.002). Of those who agreed, 86% responded that COT made it more likely that appropriate supportive care orders were included. Conclusions: Adding NCCN Chemotherapy Order Templates to the core NCCN content was done to make the NCCN Clinical Practice Guidelines in Oncology more accessible to providers. Survey results indicate that COT users feel that template use improves the safety of chemotherapy and supportive care agents. Throughout 2009, NCCN will continue to develop COT to cover most cancers. [Table: see text]
Treatment patterns of docetaxel and paclitaxel in patients with early-stage breast cancer in a community oncology center
Authors: Tangirala M. , Lei C. , Joel H. , Christiansen N. , Sullivan S. 
Published: August 2020

e17550 Background: Docetaxel and paclitaxel have been widely used in treating breast cancer (BC). This study aimed to describe real-world treatment patterns of two taxanes in early-stage BC. Methods: Georgia Oncology Specialist Database (GOSD) was used and contained chemotherapy, medical and pharmacy claims, and lab results for nearly 170,000 patients with various types of cancer (2003–2008). Patients with stage I-III BC receiving doxirubicin-cyclophosphamide-taxane (ACT) were identified, and their pre-taxane and on-taxane periods (from first to last dose of docetaxel/paclitaxel) were examined. Number of cycles was compared using Student's t-test. Taxane dose schedule and the use of other chemotherapy in pre- and on-taxane periods were compared using Chi-Square test. A similar analysis was replicated using Pharmetrics database (2003–2008) in BC patients on ACT regimen with prior mastectomy. Results: In GOSD, 79 docetaxel (7.9%, 58.2%, 34.2% in stage I, II, III, respectively) and 139 paclitaxel (10.8%, 64.7%, 25.5% in stage I, II, III, respectively) patients were identified. Compared with paclitaxel, docetaxel patients completed more cycles (4.9 vs. 3.9, p < 0.001), were less frequently on weekly schedule, and more frequently on every-two-week (Q2w) or every-three-week (Q3W) schedules (2.5% vs. 15.2%, 27.9% vs. 62.6%, and 41.8% vs. 0%; p < 0.001). 22.8% of docetaxel patients received AC followed by docetaxel (AC>T) and 77.22% received ACT concurrently, while 100% of paclitaxel patients were on AC>T regimen. In Pharmetrics data, compared with paclitaxel (n = 211), docetaxel patients (n = 96) completed more cycles (11.3 vs. 4.6, p < 0.001), were less frequently on weekly, while more frequently on Q2W and Q3W schedules (3.1 vs. 9.5%, 9.4% vs. 62.6%, and 59.4% vs. 4.7%; p < 0.001). While 97.6% of paclitaxel patients were on AC>T regimen, AC>T and ACT regimens were evenly split among docetaxel patients (49% vs. 51%). Conclusions: Docetaxel and paclitaxel have different treatment patterns in real-world clinical practice. The patterns in a community oncology center appear to be consistent with national data. A potential limitation of this study is that the potential selection bias may not be fully adjusted. [Table: see text]
Improving the efficiency and effectiveness of clinical research regulatory review processes: Lessons from the Six Sigma Body of Knowledge
Authors: Stahl D. C. , Song C. J. , Figlin R. A. 
Published: August 2020

e17554 Background: The duration and complexity of regulatory review processes are increasingly associated with the slow pace and high cost of clinical trials. To evaluate and minimize the impact of these factors, City of Hope (COH), a NCI-designated Comprehensive Cancer Center, developed a strategic initiative to improve the efficiency and effectiveness of its clinical research review processes. The ongoing initiative is supported by Six Sigma-based techniques for problem identification and process optimization that have been successfully applied in other industries. Methods: The Six Sigma process improvement methodology known as DMAIC (Define, Measure, Analyze, Improve, and Control) was applied to five different clinical trial submission types (new study submissions, amendments, continuations, internal adverse events, external adverse events) reviewed by the COH Institutional Review Board (IRB), Cancer Protocol Review and Monitoring Committee (CPRMC), and Data and Safety Monitoring Board (DSMB). A consistent set of metrics and expectations were created for each review process to evaluate pre-review queue times, review process durations, submissions returned for corrections, and submissions returned with conditional approvals. Results: Over 7,900 submissions received during a 15 month period were evaluated quarterly to identify opportunities for improvement and the effects of previously implemented solutions. Multiple root causes for submission defects and delays were identified, including: (1) staffing and training deficiencies, (2) suboptimal workload distribution, (3) unclear policies and processes, (4) submission standardization opportunities, and (5) workflow automation and other information technology opportunities. Ongoing remediation efforts have yielded substantial improvements. Conclusions: Although Six Sigma process improvement techniques were originally developed for manufacturing applications, they can be applied in a clinical research setting to improve regulatory review processes. The methodology was most effectively introduced incrementally via application to specific problems rather than a traditional top-down implementation. Support provided by NCI P30 CA33572. No significant financial relationships to disclose.