bluuebunny/crossref_metadata_2025_split huggingface dataset:
Assessing the impact of a targeted educational initiative on colorectal cancer lymph node retrieval: A Fox Chase Cancer Center Partners' quality initiative
Authors: Curley B. , O'Grady M. A. , Litwin S. , Stitzenberg K. , Armitage H. , Bapat A. , Sigurdson E. R. , Meropol N. J. , Engstrom P. F. , Cohen S. J. 
Published: August 2020

6524 Background: The retrieval of ≥12 lymph nodes in a colorectal cancer surgical specimen is an established quality metric. The impact of targeted education to improve nodal yield at community hospitals has not been studied. We initiated an intensive educational program through the Fox Chase Cancer Center Partner (FCCCP) hospitals to improve nodal retrieval in colon cancer specimens. Methods: At 12 FCCCP community hospitals from 2004–05, educational initiatives were conducted by FCCC staff and included group presentations at hospital tumor boards, cancer and quality committees, and regional CME. Individual presentations to pathologists and surgeons were held. Tumor registry data were retrospectively collected from FCCCP from 2003 (pre-intervention) to 2006 (post-intervention) for patients undergoing curative colon cancer surgery. Data abstracted were age, sex, race, stage, surgical procedure, and total number of nodes examined. The primary end point was % surgical specimens with ≥12 lymph nodes. Obtaining at least 250 records per year would allow ≥90% power to detect a change from a baseline level of ∼40% to ≥50% after intervention. Results: Data from 4,208 patients from 12 FCCCP hospitals were collected. Overall characteristics: male/female (48%/52%), race (W 83%, AA 7%, other 10%), age (<50:6%, 50–70: 34%, >70:60%), node ± (39%/61%). The % of colon cancer operations with ≥12 nodes significantly increased over the four years of the study (Table, p<.00001). This difference persisted when pooling years before and after the intervention (2003–04 vs. 2005–06, p <0.0001). There was no difference in nodal yield between two pre-intervention years (2003 vs. 2004, p=0.1). No differences in other characteristics such as age, sex, race, or % lymph node positive were noted between years. Conclusions: A multi-intervention targeted educational initiative in a large community cancer network is feasible and associated with increased colon cancer nodal retrieval. [Table: see text] No significant financial relationships to disclose.
Availability of experimental therapy outside of randomized clinical trials in oncology
Authors: Hamilton E. P. , Lyman G. H. , Kim S. , Peppercorn J. 
Published: August 2020

6539 Background: Investigational cancer therapies may be available outside of trials, or “off protocol” (OPRx), with implications for patient safety, trial accrual, and access to care. Previous studies suggest OPRx is prevalent in oncology, but there is little consensus on when it should or should not be considered. We evaluated the scope and impact of OPRx through assessment of availability of the experimental arms of recent randomized trials (RCT), and evaluation of study outcomes and accrual. Methods: We conducted a Medline search to identify all English language phase III RCT of medical interventions in oncology over a 2-year period ending April 17, 2008. We determined availability of experimental interventions based on FDA approval for any indication. We limited assessment of accrual (time to trial completion, patients/month) to studies with US sites. Significance of results was assessed by Fisher's exact test and unpaired t-test. Results: We identified 172 eligible RCT. The majority of RCT (108, 63%) evaluated drugs that were available OPRx at trial initiation, while an additional 19 (11%) trial drugs became available during the trial. 64 (55%) were available due to FDA approval for the same cancer in a different setting, 40 (35%) for a different cancer, and 12 (10%) for a non-cancer indication. 25% of trials were conducted at only US sites, 15% included US and international sites, and 60% were international only. Trials in which OPRx was available had slower time to completion compared to trials in which OPRx was unavailable (48 vs. 26 months, p = 0.04) and a trend towards slower accrual (14.0 vs. 40.7 patients/month, p = 0.06). For the majority of RCT (66%), there was at least one grade 3/4 toxicity that was greater in the experimental arm, for 47% the experimental interventions proved superior for 1 major outcome, and 27% demonstrated improvement in overall survival. These outcomes did not vary based on availability OPRx. Conclusions: The majority of recent oncology trials involve experimental regimens that are available outside of a trial. The safety and efficacy of novel interventions must be determined by trials but availability of OPRX may impact accrual. Guidelines are needed for OPRx in oncology. No significant financial relationships to disclose.
Cost implications of delayed radiotherapy for early stage breast cancer
Authors: Gold H. T. , Do H. T. , Dick A. W. 
Published: August 2020

6549 Background: Delayed radiotherapy (RT) for early invasive breast cancer has been shown to increase recurrence rates, but whether it influences costs of treatment or downstream medical care is unknown. Methods: Using linked SEER-Medicare data from 1992–2005 for 5,905 women ages 66+ diagnosed with stage I breast cancer undergoing post-lumpectomy RT, we estimated mean total monthly costs paid by Medicare by phase of care (treatment, continuing, or terminal care). Continuing care covers costs after treatment including for recurrences, and terminal phase includes costs in the last 6 months of life. We evaluated whether costs were different by timely vs. delayed RT (delay = 12 weeks post-surgery, or 8 weeks post-chemotherapy) and patient characteristics including comorbidity, age, and race. Results: Mean monthly treatment costs were $427 lower for women with delayed RT (p < 0.00001), but monthly continuing-care costs were $129 higher (p < 0.00001). Delayed RT yielded a 26% decrease in monthly treatment costs (p < 0.0001) and 20% increase in continuing-care costs (p < 0.0001) in multivariable analyses, and inpatient comorbidity index>1 yielded cost increases of 12% (p = 0.03) and 70% (p < 0.0001) in those phases, respectively, compared to no comorbidity. Terminal phase costs were affected primarily by inpatient comorbidity index>1 (86% cost increase compared to no comorbidity, p < 0.0001) and black race (52% cost increase compared to white, p = 0.02), but not delayed RT. Treatment phase averaged 2.5 months longer for women with delayed RT (p < 0.00001). Average post-treatment follow-up was 7 years. Conclusions: Delayed RT is associated with lower mean monthly costs for treatment but higher continuing-care phase costs, possibly due to higher recurrence rates. Treatment was longer for women with delayed RT, even if total treatment cost is the same, making the average monthly cost for delayed RT lower. Preliminary analysis suggests that total average costs through follow-up are nearly $11K higher for women experiencing delayed RT. Combined with higher recurrence rates, delayed RT likely is worse in terms of both costs and effectiveness. No significant financial relationships to disclose.
Impact of brain metastases on health care costs in metastatic breast cancer: A multinational study
Authors: Walker M. D. , Lykopoulos K. , McLeod E. , Cottrell S. , Christova L. 
Published: August 2020

6555 Background: Incidence of brain metastases (BM) are thought to be particularly high among patients with ErbB2+ (HER2+) breast cancer and have been associated with a poor survival prognosis. A previous study identified such patients as a considerable financial burden for health systems in Germany and France when compared to metastatic breast cancer (MBC) without BM. The objective of this study was to extend that analysis to estimate health care costs in Italy, Spain and the UK. Methods: Patient treatment histories, including drugs, specialist visits, procedures, inpatient stays etc, were collected retrospectively from a panel of oncologists for women with MBC across Italy, Spain and the UK, last seen by the responding oncologist during Q3-Q4 2006 or Q3-Q4 2007. To identify ErbB2+ patients they all had to have received/were receiving trastuzumab (TZ) for MBC. Patients were sampled so as to ensure the collection contained a minimum of 50 cases with BM and 200 histories overall (remainder controls). All costs within the observation period (initiation of TZ to date last seen) were calculated from a payer's perspective for patients who had developed BM and those who had not. Linear stepwise regression took into account potential confounding of time related covariates. Results: The study included 268 Italian (146 cases), 215 Spanish (126 cases) and 243 UK patients (103 cases). BM diagnosis was associated with significantly more expensive treatment histories than those patients without. Service costs such as radiotherapy and hospital visits were found to be key drivers for these differences (p<.001). Conclusions: The significantly greater cost associated with treatment of BMs in ErbB2+ MBC patients from Italy, Spain and the UK is consistent with results from identical French and German analyses. Therapies that reduce the incidence of BMs may therefore decrease the overall financial burden of ErbB2+ MBC. [Table: see text] [Table: see text]
Challenges to accrual predictions to phase III cancer clinical trials: A survey of study chairs and lead statisticians of 248 NCI-sponsored trials
Authors: Schroen A. T. , Petroni G. R. , Wang H. , Djulbegovic B. , Slingluff C. L. , Wang X. F. , Gray R. , Sargent D. J. , Cronin W. , Benedetti J. 
Published: August 2020

6562 Background: Trial closure due to inadequate accrual presents a common problem in cancer research. We sought to identify factors related to trial design common to trials with successful versus unsuccessful accrual. Methods: In 2008, a 30-question web-based survey was sent to the study chair (SC) and lead statistician (LS) for all 248 phase III trials open in 1993–2002 by five national cooperative groups (NCG). SC and LS level of experience, trial design elements, accrual predictions, and perceived accrual influences were queried. Accrual success was categorized based on NCG records: successful trials (ST) closed with complete accrual or at interim analysis while unsuccessful trials (UT) closed due to inadequate accrual. Responses were analyzed by respondent role (SC/LS) and accrual success. Results: 309 eligible responses were included (response rate, 62%: LS 81%, SC 45%). Respondents represented ST (65%) and UT (35%) with no response bias by accrual success. SC academic rank was not linked to accrual success. Literature review, SC experience, and expert opinion within NCG most commonly influenced control arm selection, but did not impact accrual success. NCG experience had the greatest influence on accrual predictions in both ST and UT. Trials comparing novel with established therapies were more likely to be ST (72%) than UT (28%); head-to-head comparisons of established therapies were more equally divided between ST (59%) and UT (41%). Among the 41% of respondents citing significant accrual difficulties, no factors negatively influencing accrual were consistently identified. Among respondents not citing accrual difficulties, factors credited with positively influencing accrual were clinical relevance of study question, lack of competing trials, and protocol paralleling normal practice. Conclusions: No consistent factors were identified to explain poor trial accrual, suggesting that reasons for poor accrual are not well understood and warrant further study. An objective measure of clinical relevance would be useful to inform trial prioritization practices. Research into alternative strategies for accrual prediction is needed since NCG experience is linked to both successful and unsuccessful accrual. [Table: see text]
Importance of stratification when measuring quality of care: Results from the Project for an Ontario Women's Health Evidence-Based Report Card (POWER) study
Authors: Krzyzanowska M. K. , Barbera L. , Elit L. , Saskin R. , Yeritsyan N. , Bierman A. 
Published: August 2020

6573 Background: The goal of the POWER study is to improve health and reduce inequities among women of Ontario using population-based performance measurement. All selected indicators are stratified by sex, age, income and place of residence to determine whether there are disparities in performance associated with these factors. Results pertaining to cancer (CA) indicators are presented. Methods: A modified Delphi approach was used to identify performance measures spanning the disease spectrum from screening through follow-up care and feasible to be evaluated from administrative data. Most recently available data (2003–2005) from the Ontario Cancer Registry, Registered Persons, billing and hospital databases were then used to evaluate the selected measures stratified by above four factors. Results: Twenty-nine cancer-specific indicators were selected by the panel, majority of which related to processes of care: general indicators relevant to multiple cancers (3), screening (5), breast CA (5), lung CA (3), colorectal CA (4), gynecologic CA (4), and end-of-life care (5). Among measures relating to non-sex specific cancers, few sex-related differences in care were identified. Income-based differences in care were most pronounced among the screening indicators with individuals from low-income neighborhoods less likely to receive appropriate screening or follow-up after an abnormal screening test. Among measures relating to treatment, age was the factor most frequently associated with differences in care especially in regards to radiation- or chemotherapy-related processes of care. There were geographic differences in quality of care within the province along the entire trajectory of cancer care from screening through end-of-life care. Conclusions: Among the cancer quality indicators considered, few sex-based differences exist. However, factors such as age, income and where one lives are important predictors of care underscoring the importance of stratification by such factors when evaluating quality of care. Further work is necessary to determine whether these differences in processes of care affect outcomes and how to facilitate access to care by disadvantaged groups. No significant financial relationships to disclose.
Patient out-of-pocket payments for oral oncologic therapies: Updated results from a U.S. claims data analysis
Authors: Pelletier E. , Tierce J. , Yim Y. , Reyes C. 
Published: August 2020

6582 Background: Oral oncologic therapies are increasingly becoming part of treatment options for cancer. These agents often fall within the pharmacy benefit, with the potential for increased out-of-pocket (OOP) cost burden to patients. The objective of this study is to evaluate patient OOP payments for oral oncologic therapies in U.S. managed care plans. Methods: Patients aged 18+ years with 1 of 13 oral oncologics (bexarotene, capecitabine, dasatinib, erlotinib, gefitinib, imatinib, lapatinib, lenalidomide, sorafenib, sunitinib, temozolomide, thalidomide, vorinostat) were identified in 2007 from a nationally representative database of medical and pharmacy claims from over 90 U.S. health plans. OOP payments were calculated as the allowed amount (dollar amount a health plan allows for a therapy, including any member liability) minus the paid amount (dollar amount paid by a health plan for a therapy). Results: 10,400 patients with evidence of at least 1 of 13 oral oncologic therapies were identified in 2007. The mean age was 59.2 years, 48% were male, and 83% had a commercial payer; 26% of patients were diagnosed with lung cancer, 14% with breast cancer, and 13% with colorectal cancer at the time of the first evidence of therapy use in 2007. Mean and median OOP payments for the 13 oral oncologic therapies are provided in the table below. Medicare Advantage and Medicaid had higher mean OOP payments for most therapies compared to commercial payers and self-insured patients. Conclusions: This study evaluated OOP payments for oral oncologic therapies using current claims data. Among the 13 oral oncologics studied, the average OOP costs ranged from $117 to $1,014. As costs for therapy become a greater part of treatment decisions, an understanding of patient OOP costs will be critical in informing choices. [Table: see text] [Table: see text]
Weight changes in breast cancer survivors who received adjuvant antiestrogen therapy
Authors: Harris B. M. , Broxson A. C. , Anderson L. A. , Engelbrink J. G. , Zalewski M. A. , Broglio K. R. , Hortobagyi G. N. , Green M. C. 
Published: August 2020

6588 Background: Antiestrogen therapy has dramatically improved breast cancer survival rates but weight gain may be problematic. Studies evaluating antiestrogen therapy-related weight gain have yielded mixed results. Our primary objective was to evaluate weight changes in female breast cancer survivors (BCS) who received adjuvant anti-estrogen therapy for stage 0-III breast cancer. Methods: A retrospective chart review was conducted to evaluate weight changes in female chemo naive BCS receiving anti-estrogen therapy. Weights at initiation of hormonal therapy and at 6, 12, 24, and 36 months of follow-up were recorded. Median weight changes were calculated and were compared with Wilcoxon's signed rank test or the Kurskall-Wallis test. Results: A total of 622 women were included. The majority were white (77%), had stage I disease (78%), and were postmenopausal (82%). The median age at diagnosis was 59 years (range, 26–87). Median weight at initiation of hormonal therapy among premenopausal women was 65 kg (range 45.4–122.9). Median weight gain in this group was 0.4 kg (p = 0.009), 0.7 kg (p = 0.013), 1.9 kg (p = 0.0001), and 2.4 kg (p < 0.0001) at 6, 12, 24, and 36 months respectively. Among post-menopausal women, median weight at initiation of therapy was 71.7 kg (range 41.5–152.0) and median weight gain was 0.5 kg (p < 0.0001), 1 kg (p < 0.0001), 0.85 kg (p = 0.001), and 0.85 kg (p = 0.004) at 6, 12, 24, and 36 months respectively. Premenopausal patients had significantly more weight gain at 24 (p = 0.041) and 36 months (p = 0.005), as compared to postmenopausal patients. Among premenopausal women, 110/111 were treated with tamoxifen. Among post-menopausal women (n = 510), hormonal therapy was as follows: unknown n = 28 patients, tamoxifen n = 312, and AI n = 170. Overall, BCS treated with tamoxifen vs an AI had significantly more weight gain at 24 (p = 0.003) and 36 months (p = 0.009). Conclusions: Premenopausal patients are at higher risk for weight gain than postmenopausal patients. Further prospective research is warranted examining weight gain as a long-term side effect of anti-estrogen therapy in BCS. No significant financial relationships to disclose.
Nab-paclitaxel weekly or q3w compared to docetaxel q3w as first-line therapy in patients with metastatic breast cancer: An economic analysis of a prospective randomized trial
Authors: Dranitsaris G. , Coleman R. , Gradishar W. 
Published: August 2020

6592 Background: In patients with MBC, the current practice is first-line chemotherapy often with a taxane such as docetaxel. However, docetaxel is associated with dose-limiting toxicities. A nanoparticle albumin-bound (nab) formulation of paclitaxel was recently developed to overcome the safety drawbacks of docetaxel and to provide additional efficacy. A randomized phase II trial comparing nab-paclitaxel 100 or 150 mg/m2 weekly 3 out of 4 and nab-paclitaxel 300 mg/m2 q3w to docetaxel 100 mg/m2 q3w reported improved progression-free survival and reduced toxicity with the former regimens (Gradishar, 2008). To measure the economic value of the nab-paclitaxel regimens, an economic analysis from the perspective of the United Kingdom (UK) was conducted. Methods: The current study extracted data captured during the randomized trial. Resource utilization data contained within the database were converted into UK cost estimates. This consisted of costs for chemotherapy, drug delivery, patient monitoring, supportive care drugs, and hospitalization due to toxicity. Multivariate regression analysis was then conducted to compare the total cost of therapy between the four regimens. Results: Growth factor use, hospital days for side effects management, and toxicity-induced protocol discontinuations were higher in the docetaxel group. When all of the cost components were combined for the entire population (n = 300), patients in the nab-paclitaxel 100 mg/m2 weekly and 300 mg/m2 q3w groups had comparable costs to the docetaxel control (£15,396 vs. £15,809 vs. £12,923; p = NS). The nab-paclitaxel 150 mg/m2 weekly arm had significantly higher overall costs of £27,222 but was associated with a significant improvement in progression-free survival relative to docetaxel. As alternatives to docetaxel, the incremental cost per progression-free year gained with nab-paclitaxel 100, 150 mg/m2 weekly and 300 mg/m2 q3w were £5,600, £31,800, and £9,900 respectively. Conclusions: Given its more favorable safety profile, superior efficacy, and reasonable economic impact, nab-paclitaxel (weekly or q3w) can be a preferred option over docetaxel as first-line chemotherapy in MBC. [Table: see text]
Is race a prognosticator for survival in metastatic non-small cell lung cancer?
Authors: Berz D. , Birnbaum A. 
Published: August 2020

6610 Background: Available cancer statistics for non-small cell lung cancer (NSCLC) in the US relate mainly to Caucasians and African Americans. NSCLC also represents a major health concern in other US American sub-populations. This study describes ethnic patterns of survival in metastatic NSCLC in eight different racial/ethnic groups. Methods: We analyzed the SEER (surveillance, epidemiology, and end results) program database for cancer specific survival rates in stage IV NSCLC patients who were diagnosed between 1991 and 2004 in the SEER catchment geographic areas. The primary exposure of interest was race. The eight different race groups were non-Hispanic whites, Hispanics, African Americans, American Indians/Alaskan natives, Filipinos, Japanese, Chinese, Hawaiians, and other. The later group consisted mainly of a mix of different Asian subpopulations. We performed uni- and multivariate non-parametrical and parametrical survival analysis and developed a final cox-proportional hazard model controlling for marital status, age at diagnosis, year of diagnosis, gender and histologic type and grade. We tested the proportional hazard assumptions with graphical and modeling methods Results: We identified 39,784 eligible patients. When compared to non-Hispanic whites the risk of death from lung cancer was highest amongst American Indians/Alaskan Natives hazard ratio 1.33(95% CI 1.09–1.62, p = 0.004). For patients with Chinese HR 0.84 (95% CI 0.77–0.91) and Filipino HR 0.80 (95% CI 0.73–0.88) ethnicity the risk of death from lung cancer was significantly lower when compared with non-Hispanic whites. Hispanics HR 1.00 (95% CI 0.94–1.07) and Blacks HR 1.00 (95% CI 0.97–1.04) had about equal hazards of death from stage IV NSCLC as whites. In patients of Japanese and Hawaiian origin a trend towards a lower hazard with HR 0.99(95% CI 0.90–1.08) and HR 0.97(95% CI 0.85–1.09) respectively was identified without reaching statistical significance. Conclusions: Significant racial disparities in the outcome in metastatic NSCLC can be observed in the US. The indigenous populations of the Western hemisphere have the worst outcome and the previously proposed worse outcome of African Americans with NSCLC when compared to non-Hispanic whites could not be confirmed in our study. No significant financial relationships to disclose.